Characteristics of representative corticosteroids [5].
\\n\\n
More than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\\n\\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\\n\\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\\n\\nAdditionally, each book published by IntechOpen contains original content and research findings.
\\n\\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\\n\\n\\n\\n
\\n"}]',published:!0,mainMedia:null},components:[{type:"htmlEditorComponent",content:'
Simba Information has released its Open Access Book Publishing 2020 - 2024 report and has again identified IntechOpen as the world’s largest Open Access book publisher by title count.
\n\nSimba Information is a leading provider for market intelligence and forecasts in the media and publishing industry. The report, published every year, provides an overview and financial outlook for the global professional e-book publishing market.
\n\nIntechOpen, De Gruyter, and Frontiers are the largest OA book publishers by title count, with IntechOpen coming in at first place with 5,101 OA books published, a good 1,782 titles ahead of the nearest competitor.
\n\nSince the first Open Access Book Publishing report published in 2016, IntechOpen has held the top stop each year.
\n\n\n\nMore than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\n\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\n\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\n\nAdditionally, each book published by IntechOpen contains original content and research findings.
\n\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\n\n\n\n
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Payan-Carreira",dateSubmitted:"April 21st 2020",dateReviewed:"September 10th 2020",datePrePublished:"October 8th 2020",datePublished:"January 20th 2021",book:{id:"8545",title:"Animal Reproduction in Veterinary Medicine",subtitle:null,fullTitle:"Animal Reproduction in Veterinary Medicine",slug:"animal-reproduction-in-veterinary-medicine",publishedDate:"January 20th 2021",bookSignature:"Faruk Aral, Rita Payan-Carreira and Miguel Quaresma",coverURL:"https://cdn.intechopen.com/books/images_new/8545.jpg",licenceType:"CC BY 3.0",editedByType:"Edited by",editors:[{id:"25600",title:"Prof.",name:"Faruk",middleName:null,surname:"Aral",slug:"faruk-aral",fullName:"Faruk Aral"}],productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"}},authors:[{id:"38652",title:"Dr.",name:"Rita",middleName:null,surname:"Payan-Carreira",fullName:"Rita Payan-Carreira",slug:"rita-payan-carreira",email:"rtpayan@gmail.com",position:null,institution:{name:"University of Évora",institutionURL:null,country:{name:"Portugal"}}},{id:"309250",title:"Dr.",name:"Miguel",middleName:null,surname:"Quaresma",fullName:"Miguel Quaresma",slug:"miguel-quaresma",email:"miguelq@utad.pt",position:null,institution:{name:"University of Trás-os-Montes and Alto Douro",institutionURL:null,country:{name:"Portugal"}}}]}},chapter:{id:"73504",slug:"calf-sex-influence-in-bovine-milk-production",signatures:"Miguel Quaresma and R. Payan-Carreira",dateSubmitted:"April 21st 2020",dateReviewed:"September 10th 2020",datePrePublished:"October 8th 2020",datePublished:"January 20th 2021",book:{id:"8545",title:"Animal Reproduction in Veterinary Medicine",subtitle:null,fullTitle:"Animal Reproduction in Veterinary Medicine",slug:"animal-reproduction-in-veterinary-medicine",publishedDate:"January 20th 2021",bookSignature:"Faruk Aral, Rita Payan-Carreira and Miguel Quaresma",coverURL:"https://cdn.intechopen.com/books/images_new/8545.jpg",licenceType:"CC BY 3.0",editedByType:"Edited by",editors:[{id:"25600",title:"Prof.",name:"Faruk",middleName:null,surname:"Aral",slug:"faruk-aral",fullName:"Faruk Aral"}],productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"}},authors:[{id:"38652",title:"Dr.",name:"Rita",middleName:null,surname:"Payan-Carreira",fullName:"Rita Payan-Carreira",slug:"rita-payan-carreira",email:"rtpayan@gmail.com",position:null,institution:{name:"University of Évora",institutionURL:null,country:{name:"Portugal"}}},{id:"309250",title:"Dr.",name:"Miguel",middleName:null,surname:"Quaresma",fullName:"Miguel Quaresma",slug:"miguel-quaresma",email:"miguelq@utad.pt",position:null,institution:{name:"University of Trás-os-Montes and Alto Douro",institutionURL:null,country:{name:"Portugal"}}}]},book:{id:"8545",title:"Animal Reproduction in Veterinary Medicine",subtitle:null,fullTitle:"Animal Reproduction in Veterinary Medicine",slug:"animal-reproduction-in-veterinary-medicine",publishedDate:"January 20th 2021",bookSignature:"Faruk Aral, Rita Payan-Carreira and Miguel Quaresma",coverURL:"https://cdn.intechopen.com/books/images_new/8545.jpg",licenceType:"CC BY 3.0",editedByType:"Edited by",editors:[{id:"25600",title:"Prof.",name:"Faruk",middleName:null,surname:"Aral",slug:"faruk-aral",fullName:"Faruk Aral"}],productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"}}},ofsBook:{item:{type:"book",id:"1532",leadTitle:null,title:"Semiconductor Laser Diode",subtitle:"Technology and Applications",reviewType:"peer-reviewed",abstract:"This book represents a unique collection of the latest developments in the rapidly developing world of semiconductor laser diode technology and applications. An international group of distinguished contributors have covered particular aspects and the book includes optimization of semiconductor laser diode parameters for fascinating applications. \nThis collection of chapters will be of considerable interest to engineers, scientists, technologists and physicists working in research and development in the field of semiconductor laser diode, as well as to young researchers who are at the beginning of their career.",isbn:null,printIsbn:"978-953-51-0549-7",pdfIsbn:"978-953-51-4996-5",doi:"10.5772/1999",price:139,priceEur:155,priceUsd:179,slug:"semiconductor-laser-diode-technology-and-applications",numberOfPages:390,isOpenForSubmission:!1,hash:"67c029e3a582411c5f9ab3a7dc28884f",bookSignature:"Dnyaneshwar Shaligram Patil",publishedDate:"April 25th 2012",coverURL:"https://cdn.intechopen.com/books/images_new/1532.jpg",keywords:null,numberOfDownloads:58399,numberOfWosCitations:29,numberOfCrossrefCitations:5,numberOfDimensionsCitations:17,numberOfTotalCitations:51,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"May 2nd 2011",dateEndSecondStepPublish:"May 30th 2011",dateEndThirdStepPublish:"October 4th 2011",dateEndFourthStepPublish:"November 3rd 2011",dateEndFifthStepPublish:"March 2nd 2012",remainingDaysToSecondStep:"10 years",secondStepPassed:!0,currentStepOfPublishingProcess:5,editedByType:"Edited by",kuFlag:!1,biosketch:null,coeditorOneBiosketch:null,coeditorTwoBiosketch:null,coeditorThreeBiosketch:null,coeditorFourBiosketch:null,coeditorFiveBiosketch:null,editors:[{id:"106345",title:"Prof.",name:"Dnyaneshwar",middleName:"Shaligram",surname:"Patil",slug:"dnyaneshwar-patil",fullName:"Dnyaneshwar Patil",profilePictureURL:"https://mts.intechopen.com/storage/users/106345/images/2754_n.jpg",biography:"Dr. D. S. Patil has been graduated from Poona University with a rank. He received the M.Sc. degree in Electronics Science with a first class in 1986 from the Poona university department of Electronics-Science. He secured M.C.M. degree with A+ grade from Poona University and the Ph.D. degree in Electronics from the North Maharashtra University, Jalgaon [Maharashtra], India. He qualified state eligibility test in Electronics in 1995. Since 1991, he has been working in the North Maharashtra University, Jalgaon and presently working as a Professor. He secured high school scholarship, national merit scholarship and received Rashtriya gaurav award sponsored by India International Friendship Society. He successfully completed a major Young scientist project from Department of Science and Technology, India. His name has been considered in the Steering committee as a member for the International Conference on Nanoscience and Technology 2008, Colarado, United States of America, International vacuum Congress, China 2010. He worked on the various committees of the universities. He has published about 157 papers in reputed journals and proceedings of the conferences. His research interests include the computer simulation of semiconductor, nano and optoelectronics devices, nano-electronics, Materials development and characterization for the nano-technological and optoelectronics applications, process automation using advanced microcontrollers and embedded systems, organic electronics and computer simulation of nanostructures including quantum dots and superlattice. He has developed with his research student a novel model of probability density spreading in GaN quantum wells. He has developed with research students, computer controlled dip coating system and microcontroller based spin coating system for the deposition of nano-materials. He has guided many students for their innovative research. He visited France and Germany to attend international conferences and present his papers. Moreover, he visited Technical University, Zurich, Switzerland to know the various activities and research carried out in Electronics Technology department. He worked as a reviewer for many reputed international journals. He has delivered many invited talks and popular lectures. He developed the Electronics Practical laboratory and curriculum as a first member of Electronics Department and framed syllabus of M.Phil. (Electronics) and M.Sc.(Electronics). Despite of this, he taught various courses to M.Tech. (VLSI Technology), M.C.A and B.Tech.(Chemical Technology). Recently, his name has been considered in Marscue Who’s who in the world.",institutionString:null,position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"0",totalChapterViews:"0",totalEditedBooks:"1",institution:{name:"North Maharashtra University",institutionURL:null,country:{name:"India"}}}],coeditorOne:null,coeditorTwo:null,coeditorThree:null,coeditorFour:null,coeditorFive:null,topics:[{id:"1226",title:"Optoelectronics",slug:"optics-and-lasers-optoelectronics"}],chapters:[{id:"35899",title:"Effect of Cavity Length and Operating Parameters on the Optical Performance of Al0.08In0.08Ga0.84N/ Al0.1In0.01Ga0.89N MQW Laser Diodes",slug:"effect-of-cavity-length-and-operating-parameters-on-the-optical-performance-of-al0-08in0-08ga0-84n-a",totalDownloads:3587,totalCrossrefCites:0,authors:[{id:"104427",title:"Dr.",name:"Alaa J.",surname:"Ghazai",slug:"alaa-j.-ghazai",fullName:"Alaa J. 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In the past cochlear implantation was a “gold standard” treatment method for patients who suffer from hearing impairment and dedicated only for patients totally deaf. During the last 15 years, cochlear implantation became available also as a treatment for different types of hearing impairment. Regardless of surgical technique for cochlear implantation (cochleostomy or an approach through the round window), specialized centers have now introduced the comprehensive analysis of the nonsurgical factors that could contribute to improve rates of hearing preservation in preoperative, during surgery, or in postoperative period in patients who suffer from partial deafness. One of the approaches of many leading research centers is using pharmacotherapy (glucocorticoids) as a factor which may improve hearing functions following cochlear implantation [1, 2]. Glucocorticoids play an important role in pharmacotherapy of many different otorhinolaryngological diseases, such as Meniere’s disease, sudden sensorineural hearing loss (SSNHL), and tinnitus, and as a part of otorhinolaryngological procedures in surgeries (e.g., cochlear implantation) [3, 4]. The effects of treatment listed diseases are different and mainly depend on treatment results, adverse effects of used medications, and additional pharmacological treatment that was used during treatment. Unfortunately, the side effects of glucocorticoids are serious, and as the result, sometimes pharmacotherapy has to be stopped, and discontinuation of therapy is the only solution.
\nOn the one hand, insertion of specific electrode of cochlear implant requires perfection in surgical techniques, but on the other it is difficult to do perfectly. Clinically approved algorithm of corticosteroid therapy (local or systematic) is discussed as one factor in reducing oxidative stress, an inflammatory reaction, and as a result apoptosis of hearing cells. A major challenge in effective administration and delivery medicines is the blood-labyrinth barrier (BLB) and physical inaccessibility of the inner ear, especially the apical part of the cochlea. It seems to be crucial especially for patients who suffer from partial deafness (PD) (apical hair cells are responsible for receiving low frequencies).
\nThe adrenal cortex synthesizes two classes of steroids: corticosteroids (mineralocorticoids and glucocorticoids) and androgens. One of the differences is the number of carbon atoms. Corticosteroids have 21 carbon atoms, and androgens have 19 carbon atoms. In the human body, the main glucocorticoid is cortisol, and the main mineralocorticoid is aldosterone [5].
\nGlucocorticoid receptor (GR) is located in the cytoplasm in inactive form until it binds with the molecule of glucocorticoid. This action results in activation of receptor and translocation complex: glucocorticoid receptor for glucocorticoid to the nucleus. Activation of receptor is based on dissociation from the associated proteins. After translocation to the nucleus, a complex of glucocorticoid receptor interacts with specific, short DNA sequences with the regulatory regions. The regions are termed glucocorticoid responsive elements (GREs) and allow induction of the gene transcription by glucocorticoids. This process is very complicated because of interaction with specific cofactors and proteins and still not well and completely understood by scientists and researchers [5]. Not only positive response to glucocorticoid is possible. According to Webster and Cidlowski, genes negatively regulated by glucocorticoids were also identified [6]. An example of downregulation (negative regulation) is to repress the expression of gene responsible for encoding cytokines or enzymes (e.g., collagenase). Both play an important role in inflammatory and immune reactions. According to the information provided, this negative expression appears to play a key function in anti-inflammatory and immunosuppressive effects of the glucocorticoids. Anti-inflammatory activity of representative glucocorticoids is presented below (Table 1). Dexamethasone and betamethasone are two glucocorticoids with the highest anti-inflammatory activity. If cortisol has anti-inflammatory activity defined as 1, then prednisone, prednisolone, triamcinolone, and 6α-methylprednisolone have 4–5 times stronger anti-inflammatory properties, with longer half-life than cortisol. Examples of representative glucocorticoids and their properties are shown in Table 1.
\n\n | Anti-inflammatory activity | \nBiological half-life t1/2 (h) | \n
---|---|---|
Cortisol | \n1 | \nShort: t1/2 = 8–12 | \n
Cortisone | \n0.8 | \nShort: t1/2 = 8–12 | \n
Fludrocortisone | \n10 | \nIntermediate: t1/2 = 12–36 | \n
Prednisone | \n4 | \nIntermediate: t1/2 = 12–36 | \n
Prednisolone | \n4 | \nIntermediate: t1/2 = 12–36 | \n
6α-methylprednisone | \n5 | \nIntermediate: t1/2 = 12–36 | \n
Triamcinolone | \n5 | \nIntermediate: t1/2 = 12–36 | \n
Betamethasone | \n25 | \nLong: t1/2 = 36–72 | \n
Dexamethasone | \n25 | \nLong: t1/2 = 36–72 | \n
Characteristics of representative corticosteroids [5].
The two key roles glucocorticoids play as biological and pharmaceutical compounds are anti-inflammatory and immunosuppressive roles. Glucocorticoids also affect:
Carbohydrate and protein metabolism. Glucocorticoids stimulate the liver to form glucose in biochemical reaction (gluconeogenesis) from amino acids and glycerol or/and stimulate the liver to release glucose from glycogen. At the same time, the diminishing of glucose is reduced, reaction of lipolysis and protein breakdown increases, and as a result the blood glucose level rises. Patients suffering from diabetes or other forms of hyperglycemia during glucocorticoid therapy should be under special control. Glucocorticoids induce increased protein metabolism and deliver compounds such as amino acids for further reactions.
Lipid metabolism. One effect of therapy with corticosteroids is redistribution of fat tissue known as Cushing’s syndrome.
Water and electrolyte balance. Glucocorticoids exert negatively on metabolism of Ca2+ due to reduction of absorption from the digestive system and increased excretion via kidneys. Prophylaxis of osteoporosis requires supplementation of Ca2+ ions and physical activity adequate to possibilities of patient. Additionally, glucocorticoids reduce activity of osteoclasts and stimulate the activity of osteoblasts. Glucocorticoid therapy sometimes may cause increased retention of Na+ ions and decrease in concentration of K+ ions because of interaction with receptor for mineralocorticoids. The deterioration in ion level may affect the cardiovascular system.
Impaired wound healing. Due to reduction of synthesis of collagen, glycosaminoglycans and disturbance in fibroblast function problem with healing wound may occur.
Anti-inflammatory and immunosuppressive activity. Glucocorticoids can suppress or prevent inflammatory reactions in different ways: reduction in diapedesis of granulocytes and proliferation of lymphocytes Th, inhibition/reduction of activation of macrophages, neutrophils, mast cells and cytokines (interleukins 1, 2, 3, 4, 5, 6, 8), and tumor necrosis factor alpha (TNF-α); reduction in the expression of cyclooxygenase 2 (COX-2) resulting in dropping of production of a few prostanoids; intensification of activity of catechol amines; and reduction in production of histamine by basophils [7, 8].
Sometimes glucocorticoid treatment in the otorhinolaryngological diseases requires high doses or long time of therapy. It may cause adverse effects. Some of them are listed below:
Repression in responding on infections and injuries
Propensity to opportunistic infections
Propensity to hyperglycemia
Muscular dystrophy
Cushing’s syndrome
Glaucoma (mostly in patients genetically predisposed)
Osteoporosis
Acute discontinuation of treatment may cause adrenocortical insufficiency, especially when therapy was long-term. It is important to reduce the dose of glucocorticoids slowly, not suddenly [5].
\nMany factors have an impact on pharmacokinetics of drugs. Pharmacokinetics is described by acronym LADME (liberation, absorption, distribution, metabolism, and elimination). Firstly, the therapeutic (or its carrier) must be water-soluble, because of distribution in the blood. The protein binding of drugs is one of the key factors in initial parts in pharmacokinetic process. The greater the protein binding of drug is, the longer the activity of therapeutic due to its function as a stock of drug in the organism. Absorption depends on lipophilicity and solubility of drugs. According to the data and publications, only a few medical substances can effectively be used in otorhinolaryngological practice due to achieving sufficient concentration in the inner ear [9]. Two main groups of drugs are used in clinical practice: aminoglycoside (mainly gentamicin) in pharmacotherapy of Meniere’s disease [10] and corticosteroids (dexamethasone, triamcinolone and dexamethasone) in pharmacotherapy of idiopathic sudden sensorineural hearing loss (ISSHL) and other cases of acute hearing loss [11]. The inner ear from a pharmacokinetic point of view is a multicompartment model [12, 13] with stable fluids and balance between them (due to the presence of blood-labyrinth barrier (BLB)). Distribution process depends on many different factors such as route of administration, model of administration (single or repeated administration), dose of medicine, ionic composition, and pH or osmolarity of solution. The same factors of drug chemical and physical properties influence the elimination of drug from the organism (clearance, rate of removal).
\nIn a study published in 2017, authors in animal model (guinea pig) compared dexamethasone with saline. Both substances were administrated intravenously 60 min before implantation. As a final conclusion, authors stressed that dexamethasone could reduce scarring process as the electrode negotiated the hook region or near the electrode tip, but they did not observe the relation between dexamethasone and reduction of fibrosis relating to cochleostomy [13]. In vitro studies showed the correlation between reduction (loss) of auditory cells after exposure to tumor necrosis factor alpha (TNF-alpha) and dexamethasone-releasing polymer used to coat electrode of cochlear implant carries.
\nResearch carried out on animal model proved that prolonged steroid therapy could significantly improve hearing preservation rate (including pharmacokinetic and morphological analysis) when the electrode of cochlear implants was covered with dexamethasone (special formulation with controlled drug release) [14]. However, Honeder et al. did not confirm that steroids could have a positive impact on residual hearing in a guinea pig model. One reason why both authors gain different results may lie in different types of steroid therapy. In the first study, dexamethasone was used on the contrary to the second study where triamcinolone was administrated [15]. Douchement et al. investigated the effects of steroids using a gerbil animal model. Animals were implanted with an electrode with controlled dexamethasone delivery (1 and 10% concentration of dexamethasone) on one side and a conventional electrode on the contralateral side. Hearing levels were established based on the tone bursts on auditory brain stem responses at 4–6-week postimplantation and at 1-year postimplantation period for older gerbils. A 1-year observation period showed significantly improved results obtained for the high auditory frequencies, but the results for the low frequencies were ambiguous [16].
\nCho et al. analyzed the efficacy of preoperative and intraoperative schemes of administration of steroids for hearing preservation. Dexamethasone was administrated systematically at the dose of 5 mg/ml in the preoperative period and then topically (off-label) during cochlear implantation surgery. Pure tone audiometry (PTA) was measured in four frequencies: 250, 500, 1000, and 2000 Hz. Statistically significant differences were observed between the steroid group and the control group, supporting the observation and beneficial impact of administration steroid treatment [17].
\nDuring treatment of otologic diseases, two routes of administration of glucocorticoids are possible: local and systemic. Local administration (e.g., transtympanic injection) allows to achieve high concentration of glucocorticoid in the middle ear, but due to presence of Eustachian tube, the medication may be partly evacuated. Local drug administration to the middle and inner ear avoids “the first pass effect.” The main advantages of local drug delivery are as follows:
Reduction dose of medicine
Achieving high concentration
Better effects of treatment
Reducing possibility of adverse effects
Bypassing of the blood-labyrinth barrier (BLB)
Local drug administration may involve intracochlear administration (e.g., stem cell, gene therapy) or extracochlear administration (e.g., intratympanic injection). A combination of both routes of drug delivery to the ear is also possible [13]. According to publications, systemic administration in treatment of otorhinolaryngological diseases is known as noninvasive route of drug delivery, due to lack of damaging of tympanic membrane. Adverse effects of systemic delivery may be one of the purposes of discontinuation of the therapy. The presence of blood-labyrinth barrier (BLB) in the inner ear is one of the causes of problems with reaching high concentration of drug.
\nThis study was the first study which was carried out in the Institute of Physiology and Pathology of Hearing World Hearing Center and will be continued with different groups of patients and different implants and algorithms of glucocorticoid administration. The aim of the study was to evaluate different regimes of administration of glucocorticoids: dexamethasone and dexamethasone/prednisone to partial deafness treatment (PDT) patients who underwent cochlear implantation on the hearing preservation. Implant used in the study was the MED-EL implant with an electrode length of 28 mm (Flex 28). The impact of administrated glucocorticoids on hearing was measured in six different periods:
Preoperatively
During activation of audio processor
One month after activation of audio processor
Six months after activation of audio processor
Nine months after activation of audio processor
One year (12 months) after activation of audio processor
Forty-six patients were enrolled to the trial and then divided randomly into three subgroups. Patients from the first subgroup underwent intravenous steroid therapy (Figure 1). According to the scheme, 30 min before implantation, dexamethasone at the dose of 0.1 mg/kg body mass was administrated intravenously to patients from the first subgroup. For the next 3 consecutive days in every 12 h, dexamethasone was administrated intravenously at the same dose to each patient.
\nScheme of steroid administration in the first subgroup of patients.
Patients from the second subgroup underwent prolonged (combined) steroid therapy: oral and intravenous. Three days prior to the surgery, prednisone was administrated orally at a dose of 1 mg/kg body mass/day. Then, 30 min before the cochlear implantation surgery, dexamethasone was administrated intravenously at a dose of 0.1 mg/kg body mass. For the next 3 consecutive days in every 12 h, dexamethasone was administrated intravenously (the same as in the first subgroup). For the next 3 days, prednisone was administrated orally at the dose of 1 mg/kg body mass/day. After this period, the dose of prednisone was reduced (10 mg per every day) till complete reduction of dose, due to reducing the risk of adverse effects. The algorithm of administration of glucocorticoids to patients form the second subgroup is presented below (Figure 2).
\nScheme of steroid administration in the second subgroup of patients.
The third subgroup was a control group and underwent standard cochlear implantation procedure [18].
\nAccording to the protocol of this study, two different algorithms of administration with two different glucocorticoids were proposed in the study. Although both substances belong to the same pharmacological group, both of them have different pharmacokinetics and pharmacodynamic properties. Dexamethasone is a synthetic glucocorticoid (molecular weight 392.46 g/mol) with anti-inflammatory, anti-allergic, and immunomodulating activity. In common practice dexamethasone is administrated intravenously or off-label, e.g., transtympanic injections. After intravenous administration the mean time to peak concentration (Cmax) is between 10 and 30 min, and the half-life (t1/2) is from 2.2 to 3.8 h. Transport proteins are responsible for transport and distribution of dexamethasone in blood. Dexamethasone is mainly metabolized by the liver and eliminated with the bile. Only 2.6% of the chemically unchanged dose is eliminated via kidneys.
\nPrednisone is a synthetic glucocorticoid (derivative of cortisone) and classified according to the Anatomical Therapeutic Chemical (ATC) Classification System as H02 AB 07. Prednisone is prodrug which converts into active metabolite—prednisolone (higher anti-inflammatory activity). According to characteristic of medical product and literature data, bioavailability of prednisone administrated orally is between 70 and 90%. The mean time to peak concentration (Cmax) is between 1 and 2 h. Half-life (t1/2) is between 3.4 and 3.8 h in plasma and 18–36 h in tissue. Binding prednisone with plasma proteins is between 70 and 73% (binding prednisolone (active metabolite) to the plasma proteins is higher (90–95%)). Similar to dexamethasone, prednisone is metabolized mainly by the liver and eliminated with the bile. Pharmacodynamic and pharmacokinetic data were based on characteristics of medical products: dexamethasone and prednisone.
\nThe primary outcome variables were mean values of hearing thresholds averaged across all 11 frequencies (125–8000 Hz). The secondary outcome variable was hearing preservation (HP). Hearing preservation (HP) was calculated by comparing hearing thresholds in the 1-year postoperative period with the preoperative hearing thresholds, according to the hearing preservation (HP) formula (below) and converted to three levels: minimal, partial, and complete hearing preservation.
\nIn this equation, PTApre is the pure tone average measured preoperatively, PTApost is the pure tone average measured postoperatively, and PTAmax is the maximal sound intensity generated by a standard audiometer, usually 120 dB hearing level (HL), and HP is the rate of hearing preservation in percentage [19].
\nThe protocol of this prospective clinical trial was approved by the Bioethics Commission. Patients enrolled to the study suffered from severe-to-profound hearing loss and were classified according to Prof. H. Skarżyński partial deafness treatment (PDT) classification into two groups: partial deafness treatment-electrical stimulation (PDT-EC) and partial deafness treatment-electroacoustic stimulation (PDT-EAS) (Figure 3) [20, 21].
\nPartial deafness treatment groups for cochlear implantation. ENS, electro-natural stimulation; EC, electrical complement; EAS, electrical-acoustic stimulation; ES, electrical stimulation.
Inclusion and exclusion criteria were in accordance with the consensus of the international HEARRING group on hearing preservation in cochlear implant. Study eligibility criteria included participants ≥18 years of age with a cochlear duct length of ≥27.1 (measured by computer tomography), with:
Hearing sound levels in the range of 10–120 decibels (dB) and sound frequencies of 125–250 hertz (Hz)
Hearing sound levels of 35–120 dB and frequencies of 500–1000 Hz
Hearing sound levels of 75–120 dB and frequencies of 2000–8000 Hz [18]
Exclusion criteria included suffering from severe diseases when the steroid treatment could worsen the patient’s condition or when there would be a possibility of interaction between medication intake by patients and steroids. Nonparametric tests were used in the study due to discrepancies in the number of participants between all subgroups, small number of participants in the study, and violation of normal distribution of pure tone audiometry results [18].
\nPreoperative hearing threshold levels of patients from the first, the second, and the control subgroup were similar. The difference between patients from the three subgroups was not statistically significant, which means that hearing thresholds in preoperative period of all participants, who were enrolled to the study, were similar.
\nThe deterioration of average hearing thresholds (measured by pure tone audiometry) was observed from the first point of observation—the activation period. A significant difference was observed between two groups: patients from the second subgroup (combined steroid therapy, prednisone + dexamethasone) and the control subgroup. Patients from the second subgroup had better pure tone audiometry (PTA) results considering low frequencies in comparison with the results of patients from the control group. Similar observation was done in 1, 6, 9, and 12 months after activation follow-up periods. The results of the study may be even more a promise and beneficial for patients. The hearing of participants of the study, to whom combined (prolonged) glucocorticoid therapy was administrated, remained stable during all observed follow-up periods (activation, 1-month, 6-month, 9-month, and 12-month post-activation follow-ups), and they did not vary significantly (Figure 4).
\nMean hearing thresholds of patients with standard steroid therapy (subgroup No 1), patients with prolonged steroid therapy (subgroup No 2), and control patients (subgroup No 3) in the preoperative period, upon activation, and at 1-month, 6-month, 9-month, and 12-month follow-up after CI implantation.
The hearing preservation (HP) rate is calculated using hearing preservation formula by comparing hearing threshold in the 12-month postoperative period with the preoperative hearing thresholds. Then the results were divided, according to the hearing preservation (HP) formula, into minimal HP, partial HP, and complete HP according to Table 2. The smallest variability of results was observed in the second subgroup (patients to whom prednisone and dexamethasone were administrated) as well as the highest overall HP rate. Patients from the second subgroup (prolonged steroid therapy) and nearly 69% of the patients from the first subgroup had partial or complete hearing preservation. The majority of patients from the control group had minimal hearing preservation (Table 2 and Figure 5).
\n\n | Minimal (0–25%) | \nPartial (26–75%) | \nComplete (≤75%) | \n
---|---|---|---|
Subgroup No 1 | \n5 (31.2) | \n7 (43.8) | \n4 (25.0) | \n
Subgroup No 2 | \n0 (0.0) | \n8 (61.5) | \n5 (38.5) | \n
Control group | \n12 (70.6) | \n3 (17.6) | \n2 (11.8) | \n
Hearing preservation 12 months after CI implantation, according to the type of treatment (data are given as the number of patients (percentage in brackets).
Hearing preservation (HP) rate in three subgroups.
This study is the first study to report the results of two different regimes of steroid administration in human subjects who underwent cochlear implantation in comparison with the control group. As it was said in the previous paragraph, the findings of this study have shown that glucocorticoid therapy not only stabilizes hearing thresholds but also preserves hearing ability in adult patients. The combination of intravenously administrated dexamethasone and orally administrated prednisone in one scheme of administration seems to be the optimal treatment regimen. Previously published studies have shown that there have been new directions in the development and use of electrodes and cochlear implant surgery in recent years. Currently, researchers, clinicians, and commercial companies are working on developing modern steroid-eluting electrodes or electrodes with controlled drug delivery. The results of the preliminary study described in this chapter suggested that combined glucocorticoid administration (according to scheme of administration in the second subgroup) is beneficial in preserving and stabilizing hearing thresholds in patients undergoing cochlear implantation surgery. The findings of this study are supported by the results of similar studies [1, 17]. However, the present study adds to the findings of previous studies by having a relatively long follow-up period, of 12 months after activation, with study analysis conducted during six different follow-up periods. According to the results, administration of glucocorticoids (dexamethasone and prednisone or dexamethasone only) to the patients, who suffered from partial deafness and underwent cochlear implantation surgery, may be important in stabilization of hearing thresholds and in protection of hearing. The dispersion of measured values in the second group (the second subgroup) was lesser than in the first and the control group.
\nBacteria are often associated with diseases or with something that is frightening and disgusting. But along with advances in technology, bacteria today are not considered only as an enemy but can also be friends. Basically bacteria are micro-organisms that is part of nature that are found almost everywhere on the earth’s surface, atmosphere, also the upper atmosphere [1, 2, 3]. The shape is very small, cannot be seen by the eye but its existence is very important to maintain environmental balance. Microorganisms are usually considered to include all prokaryotes, protists and microalgae. Fungi, especially those that are small and do not form hyphae, can also be considered as a part of it, although many do not agree. Most people assume that what can be considered microorganisms are all very small organisms that can be bred in petri dishes or incubators in the laboratory and capable of reproducing themselves by mitosis [4].
Collection of beneficial microbes known as probiotics, a word derived from the Greek word that means for life. Among the researchers there were slight differences of opinion regarding what could be called probiotics, including:
Probiotics are compounds produced by a microorganism that can stimulate the growth of other microorganisms, so it is the opposite of antibiotics [5].
Probiotics are extracts from tissues that can stimulate the growth of microorganisms [6].
Probiotics are organisms and substrates that have an influence on the balance of microbiota in the digestive system [7].
Probiotics are living microorganisms that when consumed by the host will have a beneficial effect on them by improving the microbiota environment that exists in the digestive system [8].
The current definition of probiotics was formulated by FAO/WHO in 2001 as living microorganisms which, if given in sufficient quantities, provide health benefits to the host [9].
Probiotics can be found in several products depending on the intended use. They can be marketed as food, medical food, food supplements or medicine. In general, probiotics are marketed as food supplements e.g. pill/tablet products or as food items, e.g., Yogurt, Kefir. Some probiotic organisms including Lactobacillus sp., Streptococcus sp., and Bifidobacterium sp. have been “generally recognized as safe” status, which means that they are additives that are permitted in food substances. The term probiotic was originally intended as a supplement used to improve or prolong human life or health by providing a sufficient amount of good microorganisms into the body through food. Having recognized the positive benefits of probiotics on human health, many practitioners and researchers have begun to try and apply probiotics to livestock, agriculture, and fisheries.
Probiotics are actually used not only for human, but also fisheries, agriculture, and animal husbandry with the aim of increasing yield productivity and decomposing waste. In livestock farming, increased production can be achieved by optimizing environmental conditions, getting the right stocking density, improving seed quality and providing good quality feed. In addition, it can also be done through efforts to reduce mortality rates and increase individual growth rates. In intensive livestock farming, feed is the highest component of production costs, about 60–70% of operational costs [10]. The digestive system plays a vital role in the extraction of nutrients from feed and their absorption to be used by body cells. The main key that occurs in the digestive system is its ability to digest food which allows nutrients to be absorbed by the body. The digestibility value of a food ingredient illustrates the ability of livestock to digest a food and the digestibility itself is determined by the quality of the food provided. The digestive system plays a vital role in the extraction of nutrients from feed and their absorption to be used by body cells. The main key that occurs in the digestive system is its ability to digest food which allows nutrients to be absorbed by the body. Digestion is a chemical process and fermentation by microbiota in the intestine. The interaction between microbiota and nutrition is very complex. Microbiota and its metabolic products can affect the digestion and absorption of nutrients by the host. In other words, microbial balance in the digestive system plays an important role for health, feed digestibility, and production efficiency.
There are three suggested probiotic working mechanisms, namely:
Suppress harmful microbial populations through competition by producing antimicrobial compounds or through nutrition competition and attachment sites on the intestine wall,
Stimulating immunity through increased levels of antibodies or macrophage activity, and
Changing microbial metabolism by increasing or decreasing the activity of certain enzymes.
The growing livestock farming industry has a relationship with the presence of bacteria in the environment. An intensive cultivation system without good management will have a negative effect. For example, in intensive aquaculture farming with excessive feeding, maintenance of fish with high stocking densities without good management will cause disease for the fish. The resulting waste in the form of high organic matter will cause bacteria to flourish and ultimately reduce fish production and also damage the environment. Other problems with increasing intensive aquaculture activities are eutrophication, increased sedimentation and excessive plankton growth. This can result in high levels of ammonia in water and lack of oxygen.
Biological processes that occur in nature including the cultivation environment must be maintained in balance so that the quality of the environment is maintained well. One appropriate way is to use probiotics. Probiotics itself is a collection of beneficial microorganisms that help the process of absorption of food, can increase endurance and help improve environmental quality. Microorganisms that exist in probiotics are usually bacteria such as Lactobacillus sp., Bacillus sp., Micrococcus sp., Nitrobacter and Nitrosomonas. Probiotics can be given in various ways, through aquaculture feed or directly stocked into the aquatic environment. In probiotics itself there are several types of bacteria that can help the digestive process better such as Lactobacillus sp. These bacteria are able to maximize the absorption of food in the intestines of fish so that not much food is wasted and fish growth becomes faster. Under these conditions the amount of feed given is more efficient but provides maximum results. This can occur because the bacteria with its mechanism produces digestive enzymes such as amylase, protease, lipase to break down carbohydrates, proteins, fats in the feed so that it is more quickly absorbed by the body. Other probiotics with the type Nitrobacter and Nitrosomonas are able to decipher the rest of the remaining feed or feces that settles at the bottom so that the quality of water in ponds or ponds for the better. Stools and food waste that accumulate and not decompose will result in high levels of ammonia and sulfides which can be toxic to aquatic organisms.
The presence of beneficial microorganisms in aquaculture activities has been proven through several studies [11, 12, 13, 14, 15]. Fish feed with additional probiotics turned out to be able to increase the growth of catfish better than ordinary feed. Application of microorganisms to the environment is also shown by giving probiotics in the water from shrimp ponds that show a decrease in ammonia levels and maintain pH in neutral conditions compared to without giving probiotics. The antimicrobial role released by probiotic bacteria also has a role to prevent the emergence of disease, thereby increasing the resistance of fish or livestock to disease [16, 17, 18, 19, 20]. The presence of beneficial microbes that are naturally present in the intestine provides an opportunity and possibility to isolate and reproduce them, which are then reintroduced into the digestive system and used as probiotics (Table 1).
Subject | Probiotics organism | Results | Application | Reference |
---|---|---|---|---|
Aquaculture | ||||
Shrimp (Litopenaeus vannamei) | Bacteria: Bacillus thuringiensis, Bacillus megaterium, Bacillus polymyxa, Bacillus licheniformis and Bacillus subtilis Yeast: Debaryomyces hansenii, Rhodotorula sp. Algae: Chaetoceros sp. | Post-larval stage of L. vannamei treated with either bacteria and yeasts or bacteria, yeasts and Chaetoceros exhibited increases (P < 0.05) in growth and survival as compared to controls. | Food pellets in the form of microencapsulated beads using sodium alginate | [11] |
Striped catfish (Pangasianodon hypophthalmus) | Bacillus amyloliquefaciens 54A and B. pumilus 47B | The average weight gain of fish fed probiotics at 5 × 108 CFU/g significant higher than control after 90 days of feeding, but there was not significant effect on feed conversion ratio and specific growth rate. | Mixed with food pellets | [12] |
Salmon (Salmo salar L.) and Trout (Oncorhynchus mykiss) | Carnobacterium inhibens K1 | Increase appetite and feeding efficiency and increase resistance to A. salmonicida, V. ordalli and Y. ruckeri | Mixed with food pellets | [13] |
Fresh water prawn (Macrobrachium rosenbergii) | Commercial probiotic: Zymetin (Streptococcus faecalis, Clostridium butyricum, Bacillus mesentericus, Beer yeast). Super PS (Rhodobacter sp. and Rhodococcus sp.) | The production of probiotics treated pond was always higher than without probiotics treated ponds, highest growth and production were found when Zymetin and Super PS were used together. | Mixed with food pellets | [14] |
Sea bream larvae (Sparus aurata) | Lactobacillus fructivorans and Lactobacillus plantarum | The combination of probiotics (80:20 w/w) through dry or live feed promoted the sea bream larvae (Sparus aurata) intestinal microflora changes that contribute to reducing mortality in both sea bream larvae and fries. | Live feed and mixed with food pellets | [15] |
Animal husbandry | ||||
Pig | Enterococcus faecium SF 68 | Positive effect of probiotics consumption on the digestive tract thus decreasing the diarrheic diseases that are frequent in the pig husbandry. | Mixed with diet formulation | [16] |
Weaned piglets | Lactobacillus reuteri, Bacillus subtilis and Bacillus licheniformis | Digestibility of dry matter, crude protein, and crude fat increased upon treatment with probiotic and significant reduction of fecal Salmonella and E. coli counts with an increase of probiotics counts. | Mixed with diet formulation | [17] |
Broiler chicks | Lactobacillus acidophilus (LASW), L. fermentum (LF33), L. plantarum (LPL05), and Enterococcus faecium (TM39) | LAB administration showed effectiveness in antagonistic effect against Salmonella colonization, invasion, and the induced inflammation. | Mixed with diet formulation | [18] |
Dairy cows | Propionibacterium, S. cerevisiae, L. acidophilus, L. ecidophilus, L. casei and Enterococcus faecium | Significantly improves milk yield as well as the milk composition. | Direct-feds microbials | [19] |
Crossbred cows | L. acidophilus, S. cerevisiae, S. boulardii and Propionibacterium frendenreichii | Probiotics proved to be effective in increasing milk production of lactating cows. Milk fat, milk protein and solid-not-fat content tended to be higher in cows supplemented with probiotics. | Direct-feds microbials | [20] |
Agriculture | ||||
Wheat | Enterobacter, Serratia, Microbacterium, Pseudomonas and Achromobacter | Halotolerant bacterial consortia significantly (P ≥ 0.05) increased the emergence, growth, biomass and Super Oxide Dismutase activity of wheat seedlings exposed to salt stress. | Biofertilizers | [21] |
Cotton | Rhizobacteria | The bacterial inoculum (50 g/kg of seed) significantly increased seed cotton yield (21%), plant height (5%) and microbial population in soil (41%) over their respective controls | Biofertilizers | [22] |
Arabidopsis and cucumber (Cucumis sativus L.) | Trichoderma asperelloides T203 | Trichoderma spp. stimulate plant growth prior to salt stress imposition and significantly improved seed germination. | Biofertilizers | [23] |
Iceberg lettuce (Lactuca sativa L.) and rocket (Eruca sativa Mill.) | Trichoderma strains: T. virens (GV41) and T. harzianum (T22) | Trichoderma able to manage the nutrient content of leafy horticulture crops cultivated in low fertility soils, and assist vegetable growers in reducing the use of synthetic fertilizers, and optimize N use efficiency. | Biofertilizers | [24] |
Saffron (Crocus sativus L.) | R. intraradices and Funneliformis mosseae | Soilless cultivation systems enhanced by the symbiosis with arbuscular mycorrhizal fungi able to produce high quality saffron. | Biofertilizers | [25] |
Reports of the use of probiotics in aquaculture, animal husbandry, and agriculture.
The application of probiotics in agriculture has been widely used, especially as a starter in making organic fertilizer. With this probiotic can accelerate the manufacture of organic fertilizer, compost for example naturally will take 3-6 months, but with probiotic technology only takes 3-4 weeks. Inoculation of probiotic microorganisms can be used as an alternative in overcoming the scarcity of inorganic fertilizers due to the high price and availability of fertilizers in certain areas. Inoculation of probiotic microorganisms that are able to dissolve the P element in acid soils can increase the production of agricultural commodities as reported by many researchers [21, 22, 23, 24, 25].
Application of microorganisms, in this case, bacteria to improve the environment is actually not only probiotics but also the bioremediation process. In the bioremediation, microorganisms are also used to neutralize, detoxify, remove, clean up, break down, and/or decompose waste and other hazardous pollutants into less toxic or non-toxic substances. Microorganisms in the aquaculture environment are in direct contact with animals, with gills and food supplied, having easy access to the digestive tract of animals. Among the microorganisms that exist in the aquatic environment are microorganisms that are potentially pathogenic, opportunistic, those who take advantage of situations of animal stress in high stocking density, poor nutrition to cause infections, low growth and feed efficiency rates, and even death (Figure 1).
Aerial image of Cirata dam located in West Java, Indonesia (upper) showing uncontrolled density of floating cage aquaculture causing rapid degradation in its water quality (lower-left); deaths of thousands of tons of fish in floating cages aquaculture due to lack of oxygen and rising toxic gas (lower-right) causing economic loss of approx. USD 28.5 million [29]. Image courtesy of Google maps [31, 32, 33].
Mass fish deaths often occur in Indonesian waters with the greatest frequency and quantity occurring in lake/reservoir waters, followed by rivers and finally in sea/coast waters. The most common cause of mass death of fish is hypoxia, mainly due to the up-welling phenomenon, namely the increase in the mass of the bottom water to the surface, so that the waste generated from aquaculture activities in the form of organic material rises to the surface [26]. Up-welling events usually take place in the rainy season which results in differences in water density between surface water and bottom waters. Rising water will mix and carry organic materials and toxic gases (such as H2S and ammonia) that can cause poisoning to fish or cause a decrease in dissolved oxygen levels due to plankton blooming that is triggered by excess of nitrate and phosphate nutrients. In marine waters, mass fish deaths have also occurred, such as in November 2015 in Jakarta Bay or earlier in 2004 and 2005, and in Lampung Bay in 2013. The mass deaths of sea fish are usually caused by the phenomenon of algal blooming (red tide), namely the plankton population explosion that was followed by mass death and caused a decrease in oxygen content due to algal respiration processes [27, 28]. As a result, fish become oxygen deficient or there is a blockage in the fish’s respiratory organs (gills) by plankton. Besides causing economic losses because most of the fish that die suddenly cannot be utilized anymore, the remaining fish carcasses also pollute the environment due to their suboptimal handling. Potential economic loss of aquaculture sudden death in Cirata dam incident in 2013 is IDR 427,6 Billion or USD 28.5 Million [29]. For this reason, the use of probiotics for aquaculture aims not only at direct benefits for animals but also their effects on the fishing environment. There are two types of probiotic applications, first with direct feed (mixed into diet formulation) and secondly through the environment (mixed with water and/or sediment). Application of the first method can improve feed quality by adding additives in the form of probiotics containing beneficial microbes and decomposers into the feed that can function to improve feed quality by converting them into compounds that are more easily absorbed by the intestine thereby increasing feed digestibility. While the second application will improve the quality of the surrounding environment, e.g., decompose toxic substance such as ammonia, sulphide, fish excreta, also excess feed that potentially attract pathogens and other unwanted micro- and macroflora. Benefits observed in probiotic supplementation in aquaculture include:
Increasing the nutritional value of food and its absorption by increasing the extent of the absorption area;
Increased activity of digestive enzymes;
Factors driving growth;
Pathogens inhibition;
Increased immune response; and
Improving the quality of fisheries water.
Meanwhile, one way to improve soil environmental quality is by introducing microbes to the soil through compost. Making compost from organic materials, in the form of by-products of agricultural activities as well as household, market and municipal waste needs to be encouraged. More effective compost making technology can be done by using a starter or microbes that accelerates the decomposition of organic material which is beneficial for plants. Giving compost on agricultural land provides a double benefit, namely improving soil microbial composition and increasing soil organic matter content. In order to make effective use of microbes in improving agriculture, animal husbandry and fisheries, it is necessary to develop microbial cocktails for each species of plant, livestock or fish [30]. The cocktail must have key features such as:
Able to be prepared on a large enough scale,
Remain stable and viable for a long time,
Good viability and growth, and
Give a positive impact on the host.
The working mechanism of bioremediation involves several technical aspects such as biotransformation, biodegradation, mineralization, phytohydraulics, bioaccumulation, and biovolatilization where the degrading microbes or plants remove, transform, modify, and/or convert a complex compound of pollutants into simpler and less toxic compounds. This bioremediation system has been successfully applied in cleaning contaminated sites, agricultural land, sediments, ground water, surface water, and sea water. Bioremediation through microorganisms generally involves the application of aerobic and anaerobic bacteria and fungi to restore the environment. Rhizoremediation is a remediation technique of soil contaminated pollutants by the action of plants (phytoremediation) and their symbiotic rhizosphere microbes. Plant growth-promoting microbes have been used for the restoration of infertile marginal land by increasing crop productivity. The application of probiotics on a broader scale is bioremediation. Figure 2 shows the relationship between probiotics and bioremediation, where probiotics are defined as living microorganisms which, if given in sufficient quantities, provide health benefits to the host (humans, and/or animals), while bioremediation is augmentation or stimulation of microorganisms in sufficient quantities and manners, providing health benefits to the host (remediate or restoring polluted environment).
The relationship between probiotics and bioremediation on a broader scale.
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