Brazilian vaccination schedule.
\\n\\n
Released this past November, the list is based on data collected from the Web of Science and highlights some of the world’s most influential scientific minds by naming the researchers whose publications over the previous decade have included a high number of Highly Cited Papers placing them among the top 1% most-cited.
\\n\\nWe wish to congratulate all of the researchers named and especially our authors on this amazing accomplishment! We are happy and proud to share in their success!
Note: Edited in March 2021
\\n"}]',published:!0,mainMedia:null},components:[{type:"htmlEditorComponent",content:'IntechOpen is proud to announce that 191 of our authors have made the Clarivate™ Highly Cited Researchers List for 2020, ranking them among the top 1% most-cited.
\n\nThroughout the years, the list has named a total of 261 IntechOpen authors as Highly Cited. Of those researchers, 69 have been featured on the list multiple times.
\n\n\n\nReleased this past November, the list is based on data collected from the Web of Science and highlights some of the world’s most influential scientific minds by naming the researchers whose publications over the previous decade have included a high number of Highly Cited Papers placing them among the top 1% most-cited.
\n\nWe wish to congratulate all of the researchers named and especially our authors on this amazing accomplishment! We are happy and proud to share in their success!
Note: Edited in March 2021
\n'}],latestNews:[{slug:"intechopen-signs-new-contract-with-cepiec-china-for-distribution-of-open-access-books-20210319",title:"IntechOpen Signs New Contract with CEPIEC, China for Distribution of Open Access Books"},{slug:"150-million-downloads-and-counting-20210316",title:"150 Million Downloads and Counting"},{slug:"intechopen-secures-indefinite-content-preservation-with-clockss-20210309",title:"IntechOpen Secures Indefinite Content Preservation with CLOCKSS"},{slug:"intechopen-expands-to-all-global-amazon-channels-with-full-catalog-of-books-20210308",title:"IntechOpen Expands to All Global Amazon Channels with Full Catalog of Books"},{slug:"stanford-university-identifies-top-2-scientists-over-1-000-are-intechopen-authors-and-editors-20210122",title:"Stanford University Identifies Top 2% Scientists, Over 1,000 are IntechOpen Authors and Editors"},{slug:"intechopen-authors-included-in-the-highly-cited-researchers-list-for-2020-20210121",title:"IntechOpen Authors Included in the Highly Cited Researchers List for 2020"},{slug:"intechopen-maintains-position-as-the-world-s-largest-oa-book-publisher-20201218",title:"IntechOpen Maintains Position as the World’s Largest OA Book Publisher"},{slug:"all-intechopen-books-available-on-perlego-20201215",title:"All IntechOpen Books Available on Perlego"}]},book:{item:{type:"book",id:"578",leadTitle:null,fullTitle:"Atomic Absorption Spectroscopy",title:"Atomic Absorption Spectroscopy",subtitle:null,reviewType:"peer-reviewed",abstract:"Atomic Absorption Spectroscopy is an analytical technique used for the qualitative and quantitative determination of the elements present in different samples like food, nanomaterials, biomaterials, forensics, and industrial wastes. The main aim of this book is to cover all major topics which are required to equip scholars with the recent advancement in this field. The book is divided into 12 chapters with an emphasis on specific topics. The first two chapters introduce the reader to the subject, it's history, basic principles, instrumentation and sample preparation. Chapter 3 deals with the elemental profiling, functions, biochemistry and potential toxicity of metals, along with comparative techniques. Chapter 4 discusses the importance of sample preparation techniques with the focus on microextraction techniques. Keeping in view the importance of nanomaterials and refractory materials, chapters 5 and 6 highlight the ways to characterize these materials by using AAS. The interference effects between elements are explained in chapter 7. The characterizations of metals in food and biological samples have been given in chapters 8-11. Chapter 12 examines carbon capture and mineral storage with the analysis of metal contents.",isbn:null,printIsbn:"978-953-307-817-5",pdfIsbn:"978-953-51-4933-0",doi:"10.5772/1090",price:119,priceEur:129,priceUsd:155,slug:"atomic-absorption-spectroscopy",numberOfPages:272,isOpenForSubmission:!1,isInWos:1,hash:"f2f4fde8403184b0e6779ba7c53dd096",bookSignature:"Muhammad Akhyar Farrukh",publishedDate:"January 20th 2012",coverURL:"https://cdn.intechopen.com/books/images_new/578.jpg",numberOfDownloads:133832,numberOfWosCitations:51,numberOfCrossrefCitations:18,numberOfDimensionsCitations:51,hasAltmetrics:1,numberOfTotalCitations:120,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"January 26th 2011",dateEndSecondStepPublish:"February 23rd 2011",dateEndThirdStepPublish:"June 30th 2011",dateEndFourthStepPublish:"July 30th 2011",dateEndFifthStepPublish:"November 27th 2011",currentStepOfPublishingProcess:5,indexedIn:"1,2,3,4,5,6,7",editedByType:"Edited by",kuFlag:!1,editors:[{id:"63182",title:"Dr.",name:"Muhammad Akhyar",middleName:null,surname:"Farrukh",slug:"muhammad-akhyar-farrukh",fullName:"Muhammad Akhyar Farrukh",profilePictureURL:"https://mts.intechopen.com/storage/users/63182/images/system/63182.png",biography:"Dr. Muhammad Akhyar Farrukh completed B.Sc (Hons.) in Chemistry and M.Sc in Physical Chemistry with first class with first positions in both examinations. He has been duly awarded THREE GOLD MEDALS for his outstanding academic performance in the M.Sc final Chemistry examination of the University of Karachi and was declared as best student of the whole Faculty of Science. He earned Ph.D in the field of Chemistry in 2003, first postdoctoral research (catalysis) in 2007 in Brazil on a fellowship awarded by the Academy of Sciences for the Developing World (TWAS), Italy and CNPq, Brazil and second postdoctoral research (nanomaterials) in 2010 in Malaysia awarded by Universiti Sains Malaysia (USM) and TWAS. He has received other Awards/Shields/ Scholarships along with four gold medals for excellent performance.\n\nHe started his career as Full Time Cooperative Teacher from the Department of Chemistry, University of Karachi (2000 to 2004). He served Pakistan Council of Scientific and Industrial Research as Senior Scientific Officer from 2004 to 2005 then Pakistan Council for Science and Technology, Ministry of Science and Technology, Islamabad as Senior Research Officer/Project Director/Head RES from 2005 to 2008. He performed his duties as Assistant/Associate Professor of Chemistry from 2008 to 2018 and Registrar from 2013 to 2016 at GC University Lahore. Currently he is serving as Associate Professor of Chemistry at Forman Christian College (A Chartered University), Lahore.\n\nDr. Muhammad Akhyar Farrukh has been awarded many international and national awards; selected by UNESCO and participated as a “Representative of Pakistan” in the first Assembly of the World Association of Young Scientists (WAYS) in Morocco in 2004, awarded “Young Chemist Award” by IUPAC in Italy in 2007, selected as “Young Scientist” by TWAS in Egypt and IAP in Germany in 2010, selected as “Young Scientist” by IAP/World Economic Forum to participate in the annual meeting of new champions 2010 in China, selected as “Young Researcher” in 2013 by the Council for Lindau Nobel Laureate Meetings for the 63rd Lindau Nobel Laureate meeting, awarded IUPAC-2015 Award for Chemists as an outstanding chemist from developing countries, received Gold Medal for Best Performance by Minister for Higher Education, Punjab in 2016, received SATHA Innovation Award 2018 with Gold Medal by South Asia Triple Helix Association (SATHA). He has been selected as “Productive Scientists of Pakistan” by PCST since 2005 and ranked 1st in Lahore, 4th in Punjab and 11th in Pakistan (Category Chemistry Young Scientists) in 2017, received Research Productivity Awards for the year 2012-2013, 2013-2014 (Category B with highest score from GC University Lahore), 2015-2016 (Category A and ranked at 1st in Lahore, 2nd in Punjab and 11th in Pakistan in Chemistry, over all 26th in Pakistan), 2017-2018 (Category C and ranked at 16th in Pakistan with highest score from GC University Lahore) by the Pakistan Council for Science and Technology.\n\nHe also participated in many international conferences/trainings sponsored by UNESCO, IUPAC, TWAS, WAYS, UNU, IAP, PSF, AKB Stiftung, INS, IFA, INN and HEC etc. He is a member of 14 international professional bodies. He has published 99 papers in international/national repute journals (IF=99.149, h-index=18), published/edited 21 books, issued 07 US patents/applications, presented 48 papers in international/national conferences and gave 43 plenary/invited lectures in 25 countries around the globe, he is on the editorial board/managing editors of 17 journals and referee of 51 journals. He has won 14 Research Grants from TWAS, USM, HEC, PSF, ORIC GCU in the area of nanotechnology and has supervised 40 M.Phil./Ph.D. theses. This biography is updated till September 2018.",institutionString:"Forman Christian College",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"0",totalChapterViews:"0",totalEditedBooks:"6",institution:{name:"Government College University, Lahore",institutionURL:null,country:{name:"Pakistan"}}}],equalEditorOne:null,equalEditorTwo:null,equalEditorThree:null,coeditorOne:null,coeditorTwo:null,coeditorThree:null,coeditorFour:null,coeditorFive:null,topics:[{id:"485",title:"Spectrometry",slug:"spectrometry"}],chapters:[{id:"26275",title:"Atomic Absorption Spectrometry (AAS)",doi:"10.5772/25925",slug:"atomic-absorption-spectrometry-aas-",totalDownloads:77248,totalCrossrefCites:13,totalDimensionsCites:30,signatures:"R. García and A. P. 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At the New York World Fair, Vital Brazil saved the life of an employee of the Bronx Zoo bitten by a rattlesnake, which induced President Theodore Roosevelt pay a visit to Butantan in 1915. In 1983, Butantan sera production situation was scary: venoms were collected from snakes and administered to horses. The horses were bled and their blood collected in rusted milk drums, precipitated with ammonium sulfate, concentrated using a dirty towel, diluted and kept in large bottles until they “mature,” and covered with mold! Probable other developing countries producers used the same ancient manufacturing process. Changing the production technology was the first goal of a recent Ph.D. group of researchers supported by the staff from the production laboratories under my supervision (Figures 1
Partial view of plasma fractionation production plant of antivenoms and antitoxins (Instituto Butantan Foundation).
Tetanus, diphtheria, and pertussis enclosed production systems.
Coverage of DTP vaccination and incidence per 100,000 inhabitants of pertussis, tetanus (except neonatal), and diphtheria in children below 1 year of age in Brazil from 1990 to 2008.
Partial view of influenza production plant (Instituto Butantan Foundation).
Partial view of the hepatitis B production plant (Butantan institute foundation).
One of the larger chromatography columns of plasma fractionation plant (Instituto Butantan Foundation).
The first idea was to replicate the milk industry profile, creating a “hands-off” fully enclosed system using large stainless steel tanks and an industrial plate centrifuge. After snake venom inoculation, horse blood was collected in a 7-liter sterile bag with anticlotting solution, stirred, and kept in a cold room overnight. After plasma been removed, the settled cells were isotonic saline solution suspended and transferred to a connected-enclosed-4-liter bag to be returned to the same horse, characterizing plasmapheresis process and thus allowing repeated blood collection at short intervals.
\nThe separated plasma was submitted to a complex process for immunoglobulin purification, began by precipitation by ammonium sulfate, followed by filtration, pepsin treatment (to remove the Fc portion of immunoglobulin to prevent complement activation), heath treatment, addition of caprylic acid to inactivate lipid-enveloped virus, finishing by an ion-exchange chromatography, which also removes viruses and other microorganisms. After sterile filtration, the final product was tested for neutralization potency and formulated to guarantee efficacy and safety.
\nAlong 1985 to 2009, the production of antibothropic, anticrotalic, antielapidic, antilonomia, and combined antiarachnidic with other antivenomous insects sera reached about 700 million vials. The technology and the enclosed system were the model basis for the production of antitetanus, antidiphtheria, antibotulinic, and antirabic sera for human use. The antisera are usually presented in 40–100 ml vials diluted with isotonic sodium chloride solution, to be administered intravenously. Vials are kept refrigerated, and the freeze-drying process started to be introduced to avoid losses. Butantan supplies the demand of the Ministry of Health and began to export antisera to Latin America, some Africa countries, India, and even to attend the request of some countries in Europe and Australia. It was an unusual experience in learning by doing.
\nThe gained experience in innovation, clinical testing, production development, and full production of antisera pushed our team to move next step into vaccine development, maintaining the dedicated enclosed plants, which guarantee hands off from the production staff [5, 6, 7, 8, 9, 10].
\nThe tetanus and diphtheria toxins production happened in enclosed large-scale cultivation systems as well as with the
A major concern was pertussis, a very common infant infection disease known as whooping cough. It can be fatal as a result of a variety of toxic substances from the classes of exotoxins and endotoxins. Among them, pertussis toxin, tracheal cytotoxin (that affect the respiratory epithelium), dermonecrotic toxin, and adenylyl cyclase (that inhibits phagocytosis) are the most studied and important.
\nWe were able to select a strain of
The safety of Butantan’s pertussis component of its DTP vaccine contrasted with the safety of DTP vaccine produced in Japan and in other countries. These vaccines are known as whole cell pertussis (wP). The development of an acellular pertussis (aP) vaccine based on purification of some virulence factors as pertussis toxin was a logical pathway. The acceptance of aP was achieved by most developed countries. These vaccines contained pertussis toxin, filamentous hemagglutinin (FHA), fimbria protein (FIM), and some pertactin. The aP vaccine required isolation and purification of all components, which raised its price from about US$ 0.16 to US$ 1.60, making it not accessible to the majority of the population from the developing countries. In 2013, CDC made a survey in the US and found that the aP confers a short protection, resulting in about 40.000 pertussis cases/year [11].
\nDTP vaccination scheme is usually carried out at 2, 4, 6, 18, and 48 months of age. One last booster occurred 10 years later. Thus, just for four DTP vaccine doses, replacing the DTwP by DTaP would represent an increase in cost of at least US$ 6.40 per capita, which is out of reach for poor countries. Even though a Brazilian publication [12] incited the use of aP for universal vaccination in Brazil at a “modest” cost of US$ 15,590 per life year saved, DTwP vaccination would cost 100x less.
\nThere are other concerns for the use of aP [13]. Fetus and newborns may be exposed to pertussis infection before they are protected against it. Immunization occurs by three doses of DTP at 2–4–6 months of age. It is estimated that 45% of infant mortality occurs before they reach 5 years and is mainly concentrated before 6 months. This leads the idea to vaccinate pregnant women in the third trimester, generating maternal antibodies to be transferred to the babies by breast feeding. It is still necessary to fully investigate the safety of this type of vaccination to guarantee that there are no effects on the fetus [14, 15, 16].
\nButantan has proposed an alternative for aP vaccine. It developed a process to remove the lipopolysaccharide (LPS), the most reactogenic component of the outer membrane of most gram-negative bacteria, without breaking the bacterial membrane, producing a whole cell pertussis vaccine low in LPS (wPlow). This vaccine was retested at Nederland Vaccine Institute [8] and currently is under additional clinical trials, as required by the Brazilian regulatory agency, to replace wP in our DTP, without increasing cost. Furthermore, the isolated LPS can be hydrolyzed to obtain monophosphoryl lipid A (MPLA), a power vaccine adjuvant.
\nOther alternative for the vaccination of the newborn is BPZE1, a live genetically attenuated pertussis, developed by Pasteur-Lilly by inactivating pertussis toxin, tracheal cytotoxin, and dermonecrotic toxin [17, 18]. This vaccine will be administered in newborns as a single-dose nasal vaccine. Its clinical assay is being proposed.
\nButantan developed a recombinant hepatitis B vaccine by genetic engineering, based on the hepatitis B surface antigen (HBs) and expressed in the yeast
Other new developments have been planned like the vaccine association with the adjuvant MPLA to reduce its concentration/dose (at least by fourfold as some assays have showed). These results consequently increase the vaccine’s potential installed capacity without increasing the vaccine cost. A new genetic construction to express the preS antigen (the N-terminal polypeptide in the large (L) HBs antigen associated with virus attachment to the host cell receptor and membrane fusion during entry) was implemented considering the about 10% of nonresponsive adults. The use of the regular vaccine and the preS vaccine to treat chronic infection was also considered, but it was not yet tested. The success of the regular vaccine to protect newborns postponed the materialization of the last proposal.
\nRecently, a study was conducted in Brazil revealing that hepatitis B is not the prevalent strain causing hepatitis, with variation in different regions. Hepatitis A represents 58.7% followed by hepatitis D and F (23.4%), while B, C, and G are minor23-24. In a world overview, B/C relation represents 60% [24]. It is estimated that there are 5.000 cases of hepatitis C. The Ministry of Health is trying to cure with a patented drug that inhibits replication of the virus, sofosbuvir combined with daclatasvir, at a cost of about US$ 9000 per patient. The Instituto Oswaldo Cruz is trying to market a generic drug for four times less. The right of the Brazilian Ministry of Health to be able to supply the drug for all is being questioned by the patent holders, although it was accepted during the AIDS epidemics.
\nButantan assumed a national leadership in vaccine production in 2007, with dedicated plants for diphtheria, tetanus, pertussis, and hepatitis B [26, 27, 28, 29, 30, 31, 32]. Going from the innovation all the way to production, Butantan provided the Society’s demand to control wide spread infections, delivering vaccines free of charge to all population at risk, at acceptable cost to the resources of the Ministry of Health.
\nThe public memoir goes back to 1918 when the “Spanish flue” reported 116.777 cases in city of São Paulo and killed 5.330 people. Those who could afford or have family elsewhere fled the country, leaving the streetcars to transport bodies to be buried in common graves. Government and Society respected the translation of “innovation” into vaccines and sera, safe, and efficient. Developing and manufacturing vaccines were different from buying bulks from large companies to formulate, fill, and label as made in the other countries. This situation was named at WHO meetings, the “coca-cola” model: buy bulk, dilute, and label made in the countries.
\nWith the few vaccines and antisera mentioned, between 1985 to 2009, Butantan was able to produce about 720 million doses of effective and safe vaccines, representing 80% of the vaccines really made in Brazil, receiving for this about 40 honors, medals, and public grants. This was made possible by creating Butantan Foundation, a not-for-profit body that could operate as a private organism, by passing the Government rules, which would make impossible to buy reagents, supplies and equipment, maintain or built new labs and dedicated production plants, hire, and trend in service, the staff, to operate the plants, without the constrains of public rules, which were not adapted to solve public emergencies.
\nThe next priority was flu epidemic risk. The “Spanish flu” reached Brazil in 1918 killing about 35,000 people. US-Barda realized, as pandemic spreads, that the total world production vaccine plants against flu could not supply the demand for vaccines, as the virus serotypes change each year and stocks could not survive and be used for the next epidemics.
\nButantan seasonal or pandemic flu first action experience was to set a pilot laboratory to maintain and replicate influenza strains certified by WHO and CDC for production, and to train the staff for produce. A control lab to test and certify vaccines was installed. The State and Federal Government granted 10 million dollars to build the production lab, ordered when possible custom-made equipment (like the machine to destroy the infected shells that was built in Brazil). A central formulation plant was constructed and equipped with a modern automated filling line, to wash and sterilize vials, fill cap, and label vials, with filling capacity of 28,000 vials per hour, containing 10 doses each. A second automated filling system was added to cover for all the vaccines produced. Flu vaccine was cultivated in fertilized chicken eggs and, after extensive purification steps, was transferred for formulation and filling. C. Merrieux (latter Sanofi) extended its help to Butantan, following the plant construction and installation, and inspecting to be sure of our suppliers of chicken eggs comply the rules established by WHO.
\nThe first formulated vaccines produced were taken to Merrieux’s laboratory to be inspected and tested for the demanded requirements of the European Community. Butantan transported the vaccines using cold trucks to the central stock of the Ministry of Health in charge to vaccine distribution to all the state centers, which transfer them to municipal facilities during vaccination. To attend actual Brazilian yearly demand, about 100 million flu vaccine doses are necessary and it is not an easy task to achieve. It took a few years until the regulatory agency approved Butantan’s vaccine, while Sanofi assumed an agreement to meantime supply the vaccine in bulk for formulation at Butantan. We reached, in 2017, the production of 60 million doses of flu vaccine given to children, young adults, pregnant women, and people above 60 years or with special health problems, doctors and nurses.
\nAbout 5 million Brazilians live above the equator line and, by mistake, they received the same Southern vaccine, in the same date. It was clear that they were vaccinated after the top of the flu season was over, and they were not protected [25]. The solution was to use part of the year to produce Northern flu vaccine to supply the population in the North. As the sole production plant in Latin America (other than a Sanofi plant that provides bulk to Birmex in Mexico), the excess vaccine production should be offered to PAHO rotating fund, solving the demand of vaccine influenza for Venezuela, Colombia, and Central America (some countries use North and other Southern vaccines).
\nButantan became interested in using adjuvants for vaccine production, if they would guarantee more vaccines doses using the same facilities and thus reducing their costs. The first attempt, in 2002, was to use a formulated vitamin A in oil as a potential adjuvant to DTP [5]. The production of flu vaccine allowed Butantan to look into adding adjuvants to reduce antigen/dose, increasing the plant capacity and reducing the purchase of fertilized eggs. A ready formulated adjuvant was offered by one of the large producers of vaccines, but that would give to this company the control of the Brazilian market. We considered formulating our adjuvant using squalene as a component, but the supplier advertised that squalene was restricted to competitors. Squalene plus tocopherol (adjuvant system ASO3) resulted in some cases of narcolepsies in Scandinavia and China, attributed to a deficiency of hypocretin secretion by hypothalamic neurons [27, 28]. ASO3 comes in two formulations, ASO3A with 11.86 mg/dose and ASO3B with 5.93 mg/dose [30]. In our assays, testing vitamins as adjuvants [29], we also included and studied tocopherol present in several multivitamins sold over the counter, and known to be toxic to monkeys. We developed the production of
We found that addition of adjuvants to influenza vaccine allowed a decrease in the usual dose of 15–3.75 μg. The adjuvant addition increased the vaccine production by 4-fold per egg, for the four split virus: A H1N1, H5N1, H3N2, and even H7N9, a new serotype spreading present in the vaccine. We also developed a whole virus vaccine technology in 2010 [35], recently being tested by several large-scale vaccine producers. Whole virus represents more than double production of vaccine/egg, as compared with split virus, and may decrease production cost by a factor of 2-to 5-fold, which would make preventive influenza vaccination affordable to developing and poor countries. In the whole virus, nucleoprotein is present, and they activate toll-3, toll-7, and toll-9 receptors of the host cell, explaining the higher immune response, but also produces antibodies that cross react with hypocretin receptor 2, which will require careful investigation before whole virus influenza vaccine is approved. There are results suggesting that the role of vaccine adjuvants like vitamin A and E increases the IgG1 response as high as squalene. Vitamin D was shown to modulate influenza immune response [35].
\nVaccine | \nAge | \nProduced by | \n
---|---|---|
Hepatitis B | \nbirth: 1, 6 months | \nButantan | \n
BCG intradermal [BCG-S1pertussis] | \nbirth | \nAtaulfo Paiva Butantan | \n
DTwP + HiB [DTwPlow + HiB] | \n2, 4, 6 months | \nImported Butantan | \n
Oral polio | \n2, 4, 6, 15 months | \nBiomanguinhos/GSK | \n
[Rotavirus] | \n2, 4 months | \nImported Butantan-NIH | \n
Pneumococcal conj 10 valente | \n2, 4, 6, 10 months | \nImported Butantan | \n
Meningitis C conj | \n3, 6, 15 months | \nImported | \n
Yellow fever | \n9 months | \nBiomanguinhos | \n
Brazilian vaccination schedule.
[vaccine]: under development.
Vaccines against
An agreement NIH-Butantan authorized Butantan to produce the pentavalent rotavirus vaccine. Butantan was the first to produce experimental lots for a clinical trial phase I, which was conducted with good results [39]. The phases II and III trials were not yet authorized by Anvisa, but opened for the GSK tetravalent vaccine, using Biomanguinhos as an importer. This occupied the Brazilian public market for about six years. A new vaccine trial comparing with the GSK vaccine was planned with NHI, but the previous Butantan board of directors and management did not act.
\nAn agreement with NIH allowed Butantan to start a pilot production of dengue vaccine. Trials at School of Public Health of Pennsylvania were successful, but the clinical trial of Butantan vaccine was delayed 2 years by ANVISA, while allowed Sanofi to test their tetravalent vaccine in Brazil. After two years delay, Butantan is conducting the clinical tests in different regions of Brazil, using pilot-scale vaccines produced by Butantan. Clinical tests about to finish slowed down by an unusual decrease in the incidence due to unexpected weather changes. Production plant building is about to be completed by 2019. Meantime, Sanofi vaccine tested in Brazil will not be used and was not approved by any other countries due to serious adverse reactions. Even so, the Brazilian State of Paraná purchased the Sanofi dengue vaccine, while Philippines sued Sanofi for its adverse events.
\nThe production plants developing antigens diphtheria and tetanus were supposed to be renovated to comply with WHO recommendations and requirements by ANVISA. Thus, at the moment, the production has been stopped. Meantime, we invested in the development of large-scale technology for MPLA from
To replace a mix of 13 to 20 serotypes of pneumococcus, Butantan developed a vaccine based on recombinant pneumococcal surface protein A (PspA) from three different strains, making production easier and less expensive [40, 41, 42].
\nBy genetic engineering, a BCG expressing pertussis S1 protein was obtained. It was shown to be more immunogenic than the regular BCG and more effective in a mouse model of bladder papilloma. With this, new BCG Butantan intends to perform proper human trials and return to produce BCG to take place at Ataulfo Paiva Institute that is closing its operation [43, 44, 45, 46, 47].
\nRabies vaccine was produced by Butantan for many years, using basic Pasteur process and using suckling mice to isolate brains [48, 49]. The rabies virus inactivation used an ultraviolet lamp. This type of production was abandoned as the Ministry of Health requirement was to immunize each year about 42,000 domestic dogs. A new process was developed using Vero Cell in a serum-free media, followed by inactivation, to be used in human who had been bitten by suspected dogs [48, 49, 50]. The production and control of this vaccine limit the production to a few producers, being an expensive vaccine. Butantan invested in a large plant to where production is expected to be transferred in 2019.
\nAccording to the Brazilian Constitution, blood cannot be purchased from donor, nor its fractions sold; thus, plasma fractionation must be a public not-for-profit operation. Butantan did not have access to the plasma, but developed a process for hemoderivatives obtaining from human placenta extracts, establishing technologies to separate a series of proteins at high purity. The process allowed to isolate and purify albumin, immunoglobulin G, and some enzymes of potential interest for medical use [50, 51, 52, 53, 54]. When we got access to bags of human blood, we developed the purification process of factor VIII [55].
\nButantan has worked in the development of a modern plant, replacing the Cohn method by sequential chromatographic steps, thus avoiding denaturation of fractions with potential clinical use caused by ethanol precipitation. The State of São Paulo with a few other states collected a large part of the human plasma collected in Brazil.
\nThe Government of São Paulo provided funds to build a plant and purchase special equipment. The plant was built and part of the equipment acquired. It was planned to be an automatized facility, and a company with expertise was contracted to design a computerized central of control system that would direct the simultaneous steps of the process. This has already represented a partial investment of about US$ 200 million, while we maintained a small pilot plant to test every step of the complete process for purification of albumin, immunoglobulin, and coagulation factors. The scientific project started at Butantan in collaboration with Pharmacia, which was willing to participate in developing a plant to process about 150,000 l/year, purifying about ten different proteins.
\nAmong other reasons, the project stopped after Pharmacia was sold to GE, which lack expertise and did not have the same interest in this project, which could be transferred to other countries, and Butantan would open its plant to train operators. A second impediment became the interest of a few large-scale plasma fractionation foreign companies, which would like to process Brazilian plasma in their existing plants, where Cohn method was utilized to supplement final purification by chromatography. There was an old precedent trying to establish a plasma fractionation plant in Brazil, expecting to produce albumin to rescue wound soldiers in the field, who were participating in the Second World War in Europe. This did not happen, but later opened the possibility for installation of a plant fractionation by a known company, which did not test the plasma to produce albumin, spreading hepatitis B in Brazil. Recently, there was a negotiation to open Butantan plant for a public private partnership, legally prohibited by the Constitution. Meantime, Butantan developed a chromatographic process to isolate as a first step the factor VIII, following with the isolation of IgG to be used to control infections, which are more specific for the country [53].
\nEach year, about 150,000 newborn dies by suffocation few minutes after the delivery. Most are premature, too small, do not cry after delivery, and do not open the alveoli. This can be corrected by administering to the newborn a lung surfactant. We assemble a team of investigators, including pediatricians from the Medical School of the University of São Paulo, which helped to develop a process for isolation of natural lung surfactant from pig lungs in an enclosed system and test in unborn piglets just after cesarean intervention [56, 57, 58, 59, 60]. The project was supported by grants of FAPESP and by a large meat producer, which supplied the pig lungs. A multistate clinical trial was carried out in public maternities with very good results, including cases of meconium aspiration. These good results supported the drug registration by the national regulatory agency.
\nThe process initially developed extracted the crude lung surfactant with the solvent trichloroethylene, which was removed and recovered by evaporation under vacuum. The final surfactant is then lyophilized. As a byproduct of the surfactant production, we recover aprotinin, used in the surgery to replace stands. The process of isolation of the lung surfactant was redesigned to use less trichloroethylene and guarantee full removal during freeze-drying.
\nA large company on meat market in Brazil showed interest in funding the new plant in Butantan and expects to distribute lung surfactant for free to other countries like Congo where 100,000 newborns die each year. In contrast with Brazil where most deliveries occur in maternities, the introduction of surfactant in some countries with untrained mid-wife may only administer the surfactant as aerosols using a portable inhaler. The use of surfactant aerosol containing tobramycin is in our agenda, to treat cystic fibrosis and to speed up the recovery from postinfluenza among elder people.
\nNot all Butantan’s projects were successful, even with the partnership of important laboratories in advanced countries. This has been the case of leishmaniosis, which affects Brazil and many countries in Africa and Asia. Visceral and cutaneous leishmaniosis infect dogs and are transmitted to man by mosquitos. It is increasing even in the developed state of São Paulo. New antigens are also been studied.
\nDifficulties are being faced also due to the reduction of funds to research institutes and even the closing of international research institutions where the developing world could find scientific support.
\nButantan has proven the feasibility of public production of good quality biopharmaceuticals in developing countries, contributing to world science and innovation, translating the research into affordable vaccines for the population.
\nThe Brazilian Constitution defines as role of the State to provide public health, specially controlling the infectious diseases where a few cases can spread the infection as epidemics to the whole population. The most effective program is to vaccinate, which should be affordable to the Government and then available for all.
\nIn the early developments, advanced countries’ governments invested in focused research, by creating public institutes and recruiting outstanding scientists to solve the needs for public health. They innovate and assay their developments for efficacy and safety, which requires an additional step going from the lab into developing production technology, which lead those scientists to create large-scale production facilities to make biopharmaceuticals available to the society. This was not the role of public institutes, and soon, large companies were created to supply, not just the national market, but developing countries, which represent 80% of the world population.
\nSoon, the public health motivated scientists were replaced by managers that measure their achievements not by saving lives but by volumes of sales, not responsible for public heath affordability. In recent time, producers of vaccines invested in innovation. Many public research institutes lost government support and some international health research institutes are closing. Developing countries lost support to receive technologies and to train scientists, so that they would be dependent forever and could not contribute to knowledge.
\nThis brief description of scientific and industrial developments to answer to public health priorities represents the efforts of members of Butantan to convert innovation not only in publications, but also in vaccines and other biopharmaceuticals at costs that the national public health system can afford. This is easy to state, but in most countries difficult to achieve. As Butantan was able to provide to the society through the government some vaccines and other biologicals at affordable costs, we became recognized by our population, while considered by the large industries in developed countries as a bad example to other developing countries, becoming a target to be absorbed by the international large producers, not to produce to the government but to receive bulk, fill vials, and label as local production.
\nAlso, some of the few local producers in developing countries were purchased to be closed. Offers for a public private partnership were not real, as both parts did not plan to implement, as large pharma had no intention to transfer recent technologies, while the local public producers, to avoid efforts and responsibilities, replace local production by buying bulks at costs dictated by the real for local filing. The large vaccine producer changed the goals, in part by transferring the leadership from scientists at service of the society to skilled managers, which measure success in terms of sales and profit, imposing their politics to developing countries market. Buying smaller pharma in developing world, in most cases does not represent local production at affordable prices, but simply removal of competition.
\nThere was an attempt to buy Butantan production units. In recent years, the institution has been suffering political and economic interferences that led to an undue stop of most of the production plants, pretending to be for major renovations. Instead, functional plants were destroyed, while purchasing the vaccines from large pharmas, without any concerns for our population or to provide affordable vaccines for the Ministry of Health.
\nRebuilding Butantan and recover the expertise of the staff are not easy tasks and will require major investment. For other Latin America countries to begin without help is practically impossible. An interim plausible solution is to use a large unfinished Butantan’s building to house a joint Latin American biotechnology center, while its plants are recovered to produce and train younger graduates participating in innovation international team, how to produce vaccines and they could take back with them the technologies developed at Butantan and maybe share with us clinical trials, avoiding the present prohibitive costs.
\nWe think Butantan must go on with its public mission recovering good early Brazilian health public experiences and efforts. The case of AIDS pandemic was emblematic. It was partially controlled with new drugs, which were denied to poor countries, until Brazil challenged the patent. Same thing is in process to be repeated with the drug for treatment of hepatitis C, sold for $US 9000/person. And many other health public problems must be considered as neonatal syphilis is back to Brazil, even though it could be controlled with penicillin G, the first antibiotic discovered. The reason for the lack of penicillin is that its price became so low that private pharma lost interest in producing, illustrating the need of careful public health attention and decisions.
\nGeneral remarks regarding chronic back pain have been reviewed in a previous study focussing on brace treatment for patients with spinal deformities [1]: within the adult population, certain complaints and diagnoses are increasing such as low back pain, degenerative scoliosis and spinal stenosis. The number of symptomatic patients with spinal stenosis complaints is not known but the main aims of interventions are to improve pain management, functional and lifestyle choices [2]. Spinal stenosis surgery is increasing, and in the 1980s and early 1990s, it is suggested by Ciol et al. [3] that the numbers increased eight-fold. It is controversial to assume that sedentary lifestyles contribute to back pain, but few discussions continue in this topic of research. It is hypothesised that there are negative consequences to this type of lifestyle, initially within muscles, which ultimately lead to compensation in the structure and function of connective tissue [4].
A sedentary choice in lifestyle may initially lead to a negative change in posture, such as a loss of lumbar lordosis. This postural position correlates significantly with a prevalence of lower back pain (LBP) and spinal claudication. In the adult population, lower back pain and spinal claudication can progress to degenerative, de novo scoliosis [5].
Research focusing on younger adolescent female patients [6] demonstrated that non-specific LBP is reported even in this younger age group, especially those reporting a family member with lower back pain.
In 60% of secondary school pupils and 32% of students, lower back pain was a reported symptom. A correlation between lower back pain and displaying a sedentary position (p < 0.001 for pupils, and p < 0.02 for other students), and smoking (p < 0.001 for students and p < 0.02 for pupils) has shown to be statistical significant in analysis [7].
Furthermore, a beneficial consequence of an increase in physical activity and leisure time has shown to reduce musculoskeletal morbidity in patients of working age, specifically in those who have sedentary jobs [8].
Postmenopausal women who have sedentary lifestyles may benefit from regular weight-bearing exercise not only to reduce their back complaints but also to slow down the loss of bone mass.
Some studies argue the contrary and do not support the hypothesis that sedentary lifestyle contributes to lower back pain [9, 10, 11]. In one study, the lordotic angle seemed to have no influence on the prevalence of low back pain [9]. The presence of lordosis and the angle of lordosis alone may not be the only influential cause, but more specifically, it is the location of lordosis and shape of the posture, specifically the lordosis in the upper lumbar section of the spine that has the most effect upon reported pain levels [12, 13].
‘Chronic low back pain’ is an umbrella term and relates to patients reporting pain in the lumbar or sacral region or even in the sacroiliac pelvic joints. As the pelvis may be involved, the iliolumbar ligaments and even some radicular symptoms may also add to the complexity of the source of pain. With the presence of radicular symptoms, the nerve root affected would determine the origin of the lower back pain [14].
Without the presence of radicular symptoms, chronic lower back pain cannot be caused by a specific nerve root and may have a more complex cause involving L5/S1 or L4/5, and or the pelvis joints or ligaments [14].
Chronic low back pain without radicular symptoms and without any other specific clinical finding (for example, spondylolisthesis) is not classified and attributed in international research as being ‘unspecific’ or ‘non-specific’. For bracing of this group of patients with chronic non-specific low back pain, simple physical tests have been published to predict the brace type the patient might benefit from. Based on the results of physical tests, a simple functional classification of ‘non-specific’ lower back pain has been developed [1].
In patients with scoliosis, besides the common cosmetics issues, pain is also a reported common issue [15]. Although back pain in patients with scoliosis is not related to the size of the curvature (Cobb angle) [16, 17], there is evidence that scoliosis patients experience statistically more back pain in later adulthood than age-matched controls [18, 19, 20, 21]. This back pain is not always disabling [19, 20, 21] and can be treated conservatively with reasonable success [16, 17, 22, 23]. While low back pain increases after surgery [24], pain in patients with scoliosis without surgery can be reduced with exercises, be it core stabilisation exercises [22, 23] or pattern-specific exercises (for example, Schroth) [16, 17].
In rare cases, the pain cannot be reduced using the functional exercise approach. For these cases, bracing can be successful [1, 12, 13, 25, 26, 27].
As outlined above in patients with scoliosis, we distinguish between different kinds of chronic back pain [28]. Most complaints come from the lower back region. Specific chronic low back pain stems from the lumbosacral region and can usually be referred to an injured or inflamed nerve root. This type of pain mainly is caused by a disc prolapse with compression of a nerve root. Specific low back pain needs a specific treatment in order to reduce the nerve compression and, commonly, surgical decompression in case of significant impairment of the nerve [28].
But as already outlined, non-specific chronic low back pain cannot be referred to a single nerve root. In patients with chronic non-specific low back pain, there may be functional impairments of the sacroiliac joints, lumbar facet joints, overuse of the iliolumbar ligament and spinal stenosis, relative or absolute. Psychological issues also play a role in the development of chronic non-specific low back pain [14, 28]. This also applies to patients with spinal deformities.
Functionally, we may distinguish between postural low back pain (PLBP) and instability low back pain (ILBP) [1] (Figure 1). While PLBP mainly is related to loss of lumbar lordosis in later adulthood, ILBP is related to joint laxity or a definite instability like in patients with spondylolisthesis. Combinations of both entities are also possible [1].
The sagittal realignment test (SRT) seen on the left and the de-lordosation test (DT) with patient in the standing position. The sagittal realignment test (SRT)—a positive result in this test will present with an immediate reduction in chronic postural LBP (PLBP). The de-lordosation test (DT) pictured on the right—a positive result on this test will present with an immediate reduction in chronic LBP if this is due to instability low back pain (ILBP). Taken from [
In a study from 2009 [26], 130 patients presenting with spinal deformities (ranging from middle aged to older adults of 69 years old) and chronic unspecific low back pain were tested, using brace treatment for their chronic lower back pain. 16 of these patients presented with symptoms of spinal claudication. The sagittal re-alignment test (SRT) was applied (a lumbar hyperextension test) and a ‘sagittal de-lordosation test’ (SDT) to each participant. In addition, three female patients with spondylolisthesis were tested, including one female with symptoms of spinal claudication. 117 of the 130 patients reported a significant pain reduction when the SRT was applied. 13 patients, when applying the SDT also had significant reductions in pain. Three out of 130 patients had no significant change in their pain levels in either test. Pain intensity for all participants was high prior to the physical tests (VRS scale 0–5) and low while performing the physical test. These differences in pain scores were highly significant in analysis. There was an exception in three patients (2.3%): a clear distribution to one of the two classes was possible. 117 patients were supplied successfully with a sagittal realignment brace and 13 with a sagittal de-lordosing brace. A clear distribution of the patients from this sample to either chronic postural or chronic instability back pain was possible. In 2.3%, a combined chronic low back pain was found. The authors concluded that chronic non-specific low back pain may be classified physically. The functional classification described is necessary to decide which specific conservative approach (lordosation/de-lordosation of the lumbar spine) should be used [1]. However, the topic spinal deformities in conjunction with brace treatment is not well established in the international literature and research. Therefore, a systematic PubMed review has been undertaken in order to find more studies with the aim to establish a scientific basis for treatment suggestions for this group of patients [15].
A PubMed review was undertaken on the April 28, 2019, using the key words: (1) scoliosis, pain, brace treatment and (2) scoliosis, pain, orthotics [15]. From both searches, the studies were extracted containing patients with the diagnosis of a scoliosis with additional chronic non-specific low back pain who were treated with a brace [15].
142 items have been found for search (1) and 111 for search (2) [15]. Nine items have been identified to fulfil the inclusion criteria from search (1) and six from the search (2). As most of the items were found in both searches, the total number of different items as found in both searches was 10 [1, 12, 26, 27, 29, 30, 31, 32, 33]. There were two pilot studies [12, 29] six case reports/case series [13, 27, 30, 31, 32, 33], one mid-term study [26] and one study containing a proposal for a simple classification allowing a specific approach for different types of low back pain as already outlined above [1].
The authors discussed the findings as follows [15]: according to the papers found, there is little overall evidence and no high-quality research studies were found for bracing in relation to pain in this patient group. Only one study had a follow-up of more than 1 year (18 months) [26], allowing some initial conclusions that brace treatment might be effective in the treatment of chronic pain in patients with spinal deformities. In this mid-term study [26], a lumbar brace increasing lordosis was used with a successful outcome, while in a recent pilot investigation, a brace reducing lumbar lordosis was suggested [29]. In the latter study published in 2018, most of these earlier studies were not cited, nor was a differential indication of braces for chronic low back pain attempted or discussed [29].
Considering the facts that (1) in most scoliosis patients, a reduction of lumbar lordosis is evident [12, 25, 26, 34, 35, 36] and that (2) loss of lumbar lordosis is correlated to low back pain in adulthood [37, 38], the assumption that reducing lumbar lordosis is an appropriate approach, is not based upon any detailed reasoning or evidence, and even possibly worsen symptoms. Additionally, it has been shown that increasing lumbar lordosis stabilises or may even correct the three-dimensional scoliosis [25, 35]. Therefore, improving lumbar lordosis in this group of patients with scoliosis should be considered as an important issue to address in the initial stages of examination and related treatment. According to the findings within this review [1, 32], only in patients with chronic back pain due to vertebral instabilities, a brace reducing lumbar lordosis is indicated.
The success rate of brace treatment in patients with non-specific chronic low back pain in general does not appear to be significant, and compliance is generally described as moderate or poor [39, 40, 41]. A significant pain reduction has not been reported upon in most of the recent literature [41, 42].
In the mid-term follow-up of scoliosis patients treated with a sagittal re-alignment brace [26], there was a high compliance and a reasonable decrease of pain intensity and pain frequency (Figures 2 and 3). Patients who were able to feel the brace action and pain reduction before the start of brace treatment using clinical examination tests [1] may have resulted in an increase in compliance and success with treatment. In order to avoid costly brace treatment without any effect, it is suggested by the conclusions of this review, to test the patients for the most beneficial approach (lumbar lordosation/lumbar de-lordosation). When patients recognise that they can benefit from specific brace treatment, by an instant reduction in their pain symptoms, the matter of compliance may be vastly improved.
Patient wearing a sagittal re-alignment brace. When the brace is adjusted to the patient, the main dorsal pressure should restore lordosis at the level of L2. Free space is necessary at the lower ribs while the pressure areas ventrally are located directly caudal of the pectoral region and cranial to the pubis. Taken from [
Design of the sagittal re-alignment brace as applied currently.
It seems important to note that true scoliosis is not easily correctable in adulthood, and therefore, specialists should be consulted when assessing these patients to ensure the examination and treatments are appropriate. In patients with an angle of trunk rotation (ATR) exceeding 10°, a pattern-specific brace is indicated [27, 31]. Symmetrical braces applied in patients with a significant rib hump/lumbar prominence will usually twist on the person’s trunk according to the asymmetry and torsion effect and therefore will not remain in the correct position, hence the need for individual bespoke fit. There are case reports and a recent report on a cohort treated with a pattern specific Chêneau style brace showing that with specific braces for lower back pain can successfully be reduced [27, 43].
There is a case study of a 37-year-old female patient with late-onset idiopathic scoliosis [27]. The patient had chronic low back pain since the age of 23 and reported daily pain at a level of 5–7 on average on a Visual Analogue Scale of 0–10. She received a short scoliosis-specific Schroth exercise programme and was also fitted with a Gensingen brace (GBW) for part-time wear. At a 16-month follow-up, the patient no longer suffered from daily low back pain (with heavy lifting only) and was fully active. Additionally, her lumbar Cobb angle and angle of trunk rotation improved. The authors concluded that patients with late-onset idiopathic scoliosis and may benefit from a pattern-specific conservative treatment approach (physiotherapy and bracing). In this population, surgical intervention should be regarded as the last resort, since there are many long-term unknowns with surgery in patients with scoliosis [44, 45, 46, 47, 48, 49, 50, 51] (Figure 4).
Left: clinical appearance of the trunk at the start of treatment; middle: X-ray at the start of treatment and on the right: Gensingen brace (GBW) as constructed for the patient. Reproduced with permission of the Society of Physical Therapy Science from [
Widjaja and Varani [43] investigated adolescent idiopathic scoliosis patients with a single lumbar curve pattern who wore a Gensingen Brace (GBW), which is a Chêneau style brace of standardised computer aided design (CAD). They included more mature or adult patients with a Risser sign of IV or V. The in-brace Cobb angle corrections were measured, and patients were monitored for 6 months after brace initiation in order to analyse the effects.
A total of 26 patients have been included. The average age was 17.7 years and the oldest patient from the study was 40 years. The average Cobb angle was 41.5° before treatment (20–72°). 19 patients from this study (73.1%) had chronic low back pain of various degrees before treatment and seven patients (26.9%) were asymptomatic but seeking treatment because of cosmetic reasons.
In-brace correction was 67%. At 6 months follow-up, correction without brace was 23% and the average Cobb angle was 33.2°. About 12 patients (54.5%) had a significant correction of >20%. After 6 months, all previously symptomatic patients reported that they no longer experienced low back pain.
As the GBW is a brace to increase lordosis of the lumbar spine from the results of this latter study [43], we may assume that in scoliosis patients with chronic low back pain, the re-alignment or increase of lumbar lordosis can be regarded as being highly effective with respect to pain reduction.
Although spinal claudication may arise from narrowing of the spinal canal, not all patients with narrowing develop symptoms [13]. The reason why some patients develop symptomatic stenosis and others do not is still unknown. Therefore, the term lumbar spinal stenosis refers to a clinical syndrome of lower extremity pain caused by mechanical compression on the neural elements or their blood supply [13]. A 47-year-old woman with a 55° lumbar scoliosis, 30° upper lumbar kyphosis, and highest pain levels under medication (Durogesic, 25 mg; Ibuprofen, 800 mg; and Mirtazapine, 15 mg) was treated with a sagittal re-alignment brace [13]. This patient is pictured in Figure 2. Self-reported walking distance was at around 800 m before the pain was referred to be ‘unbearable’ (since 5 years). Patient-reported walking distance was recorded in the brace 2 days and 10 days after adjustment. Walking distance increased to around 8000 m after 2 days and to around 12,000 after 10 days while pain intensity decreased only one point in the VRS, however now without any medication. The authors concluded: in contrary to current hypotheses about the aetiology of spinal claudication, augmentation of lordosis may lead to a significant improvement of symptoms associated with spinal stenosis and lumbar scoliosis. The brace used in this case was a physio-logic brace™ that increases lumbar lordosis [13].
In another case report, brace treatment for spinal claudication following severe spondylolisthesis has been described [32]: a 14-year-old girl with a 25° thoracic scoliosis (2 years post menarche), grade IV spondylolisthesis and spinal claudication underwent treatment with a spondylogic™ brace reducing lumbar lordosis (Figure 5). Walking distance without brace was at around 300 steps before intolerable pain was reported. Self-reported walking distance was recorded in the brace 14 days after adjustment. Walking distance increased to an unlimited number of steps after 14 days, while pain intensity decreased three points in the VRS. However, no correction effect of the orthosis on the degree of slippage was found. Although there is evidence that pain in patients with spondylolisthesis can be reduced using exercises and bracing in mild to moderate symptomatic cases, this case demonstrates that bracing can also improve signs and symptoms of spinal claudication in patients with spondylolisthesis of higher degrees [32].
The spondylogic® brace design. This 14-year-old patient has a scoliosis of <25° and a symptomatic (presenting with lower back pain) spondylolisthesis. Immediate in-brace pain relief was reported, and spinal stenosis symptoms also reduced. The patient wore the brace full-time when walking and standing to manage her pain. Further long-term effects from this brace design have not been researched at present. Taken from [
These cases show that there is not a single brace covering the necessary principles of correction for all patients with scoliosis and chronic low back pain. Soft braces are insufficient in their action on the stiff deformity of adult scoliosis patients and therefore, cannot be regarded as effective tools for the treatment of chronic low back pain in scoliosis patients [15]. Hard braces have shown effectiveness and fulfil all possible treatment requirements [1, 26, 27, 43].
A simple clinical test enables the specialised physician to estimate the appropriate approach of bracing, increasing or decreasing lumbar lordosis [1]. In patients with more significant deformities and chronic low back pain, specific braces are indicated that allow a stable positioning of the brace on the patient’s trunk [27, 43]. However, severely stiff and vast deformities may not be successfully treated by any type of brace (Figure 6). Therefore, mobility needs to be tested prior to bracing in order to avoid unnecessary treatment and costs.
Excessively stiff curves with huge complex deviations cannot be treated by specific bracing. Usually no correction is achievable: (a) view from the rear, (b) view from oblique left and (c) view from oblique right.
In view of these findings, only pattern-specific braces or symmetric braces influencing the sagittal profile can be recommended. In general, however, braces without any visible effect on the deformity continue to be prescribed [52] obviously just immobilising the spine (Figure 7). This approach today should be regarded as being outdated.
Brace for an adult with pain. No correction visible, just immobilisation of the spine. This unspecific design could be regarded as outdated. Taken from [
Patients with thoracic kyphosis in later adulthood may suffer from chronic pain in the thoracic region related to facet joint degeneration and functional impairment of the adjacent ribs. When functional treatment including physiotherapy and spinal manipulation do not reduce the symptoms satisfactorily, brace treatment can also be trialled (Figure 8). When passive correction of a thoracic kyphosis leads to significant pain reduction, a brace to reduce thoracic kyphosis may be prescribed. A standardised bracing approach to correct a thoracic kyphosis has been described in literature [53].
Patient in a Kyphologic brace™ that may also be used in patients with chronic back pain in the thoracic area. Taken from [
Adult patients may experience deformity-related stress and lack of general participation in activities because of their deformity. This fact may be measured and monitored with health-related quality of life questionnaires [54, 55, 56, 57].
Freidel et al. investigated women with idiopathic scoliosis with the help of age-appropriate health-related quality of life questionnaires (either the 36-Item Short-Form Health Status Survey, SF-36, or the Berner Questionnaire for Well-Being) [54]. The results from this sample were compared with general population norms. In univariate and multivariate analyses, it was determined whether age, Cobb angle, and brace use had an impact on health-related quality of life.
Compared with the age-matched general population norm, adolescent patients with idiopathic scoliosis reported to be less happy (P = 0.001). They reported more physical complaints (P < 0.001) and had lower self-esteem (P = 0.01) and higher depression scores (P = 0.021). Adult patients reported more psychological (P < 0.001) and physical impairment than in the population norm (P < 0.001). These results were largely independent of age and Cobb angle.
The authors concluded as follows: the results show that health-related quality of life can be impaired in patients with idiopathic scoliosis. Therefore, the psychosocial situation should be considered in the treatment of these patients [54].
Patients who experienced less body asymmetry were more satisfied with treatment and had a better quality of life [56]. This fact might indicate that quality of life is also related to curve patterns. While combined patterns of curvature (double major) are more compensated and present with less body asymmetry, single curve patterns are more decompensated with significant body asymmetry possibly leading to decreased quality of life.
While there is some evidence that cosmetic improvements can be achieved with pattern specific braces in childhood and adolescence [58, 59, 60, 61], there is no literature to be found in PubMed on adult patients with spinal deformities and improved trunk deformity after brace treatment. Nevertheless, there are case reports of adult patients showing a significant improvement of trunk asymmetry and balance (Figures 9 and 10). Therefore, high correction bracing should be tried in patients with reduced quality of life because of their trunk deformity. As to the experience of the first author, such improvements cannot be obtained in all adult scoliosis cases.
A 23-year-old woman with a cobb angle of 60° at the start of treatment with a Gensingen brace without significant improvement of cobb angle, however with a clear cosmetic improvement showing a more balanced posture after 12 months of conservative treatment. With kind permission from Dr. Budi S. Widjaja, Jakarta, Indonesia.
An 18-month follow-up of a 20-year-old woman with a cobb angle of 52° at the start of the treatment with a Gensingen brace and a final cobb of 36°. A clear cosmetic improvement has been obtained. Courtesy of Dr. Budi S. Widjaja, Jakarta, Indonesia.
On the other hand, the cosmetic effects as achieved with the help of spinal fusion surgery are not stable in the mid- or long term [48, 49, 50]. Therefore, besides offering psychological support also pattern-specific brace treatment may be tried before a decision for invasive surgery is made.
It is important to note that brace treatment in later adulthood must be accompanied by a specific daily physical exercise programme. It can be argued that brace wearing does not affect the postural muscles, when in the contrary postural muscle activity is increased while brace wearing [62, 63]. However, the reduction of mobility while wearing the brace may reduce bone mass, especially in postmenopausal women [64, 65, 66]. Therefore, regular trabecular loading should be preserved in order to keep bone mass. For patients wearing a brace for some hours per day a Qi Gong, Tai Chi or a Yoga programme involving exercises to mobilise and load the spine in all directions could be beneficial.
In adult patients with spinal deformities bracing may be indicated for pain and deformity. Soft braces are not useful for patients with stiff spinal deformities. The appropriate bracing approach can be tested before the brace is prescribed. There is some evidence that pain can successfully be reduced by these approaches mainly influencing the sagittal profile. In patients with bigger deformities and in patients aiming at reducing their deformity, pattern-specific scoliosis braces according to published cases have shown to be successful. There is no high-quality evidence supporting brace treatment for adult patients with spinal deformities; however, the existing evidence is promising.
Written informed consent for publication of the patient’s information (X-rays, photos, records, etc.) has been obtained from the patients or their parents. HRW provided the first draft and made the literature review. DT contributed to the improvement of the first draft and copyedited the final version. Some parts of the text have been reproduced with permission of the Society of Physical Therapy Science from [15]. More comprehensive information may also be found in [67].
HRW is receiving financial support for attending symposia and has received royalties from Koob GmbH & Co KG. The company is held by the spouse of HRW. HRW holds a patent on a sagittal realignment brace (EP 1604624 A1). DT is employed by an orthotic company who make orthotics, including spinal bracing.
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