Pub Date : 2009-12-01DOI: 10.1016/S1594-5804(09)60038-3
N. Marzo, F. Belda, P. Ristol, M. López, R. Gajardo, J.I. Jorquera
Instituto Grifols has developed two different sterile and ready to use anti-hepatitis B (anti-HB) enriched immunoglobulin concentrates: Niuliva® is a 5% intravenous immunoglobulin solution with 250 IU/ml anti-HB potency, and Gamma anti-hepatitis B Grifols® (Igantibe®in some countries) is a 16% intramuscular immunoglobulin solution with 200 IU/ml anti-HB potency. The production process includes careful plasma donor selection, analysis to discard specific markers of relevant viral infections in the individual donations and plasma pools and, in order to further increase the safety margin, steps aimed at eliminating potential pathogenic agents (e.g., pasteurization). Characterisation studies from both products showed high IgG purity (more than 99%) and an IgG subclass distribution similar to normal plasma. Other potential accompanying proteins (eg: IgA, IgM, albumin, transferrin, etc) were undetectable or very low. Results from additional parameters (identification, total protein, molecular distribution, etc.) meet European Pharmacopoeia's requirements. The stability profile indicates that the products are stable between 2°C and 8°C for two years (Gamma anti-hepatitis B Grifols®) or three years (Niuliva®), maintaining the anti-HB potency.
Instituto Grifols开发了两种不同的无菌和现成的抗乙型肝炎(抗hb)富集免疫球蛋白浓缩物:Niuliva®是一种5%静脉注射免疫球蛋白溶液,抗hb效力为250 IU/ml, Gamma抗乙型肝炎Grifols®(在一些国家为Igantibe®)是一种16%肌肉注射免疫球蛋白溶液,抗hb效力为200 IU/ml。生产过程包括仔细的血浆供体选择,分析以丢弃个人供体和血浆池中相关病毒感染的特定标记,以及为了进一步增加安全边际,旨在消除潜在病原体的步骤(例如巴氏消毒)。两种产品的特性研究显示IgG纯度高(超过99%),IgG亚类分布与正常血浆相似。其他可能伴随的蛋白(如:IgA, IgM,白蛋白,转铁蛋白等)检测不到或非常低。附加参数(鉴定、总蛋白、分子分布等)结果符合欧洲药典要求。稳定性分析表明,产品在2°C至8°C范围内稳定2年(Gamma抗乙肝Grifols®)或3年(Niuliva®),保持抗hb效力。
{"title":"Hyperimmune immunoglobulins: Manufacturing technologies and safety procedures","authors":"N. Marzo, F. Belda, P. Ristol, M. López, R. Gajardo, J.I. Jorquera","doi":"10.1016/S1594-5804(09)60038-3","DOIUrl":"10.1016/S1594-5804(09)60038-3","url":null,"abstract":"<div><p>Instituto Grifols has developed two different sterile and ready to use anti-hepatitis B (anti-HB) enriched immunoglobulin concentrates: Niuliva® is a 5% intravenous immunoglobulin solution with 250 IU/ml anti-HB potency, and Gamma anti-hepatitis B Grifols® (Igantibe®in some countries) is a 16% intramuscular immunoglobulin solution with 200 IU/ml anti-HB potency. The production process includes careful plasma donor selection, analysis to discard specific markers of relevant viral infections in the individual donations and plasma pools and, in order to further increase the safety margin, steps aimed at eliminating potential pathogenic agents (e.g., pasteurization). Characterisation studies from both products showed high IgG purity (more than 99%) and an IgG subclass distribution similar to normal plasma. Other potential accompanying proteins (eg: IgA, IgM, albumin, transferrin, etc) were undetectable or very low. Results from additional parameters (identification, total protein, molecular distribution, etc.) meet European Pharmacopoeia's requirements. The stability profile indicates that the products are stable between 2°C and 8°C for two years (Gamma anti-hepatitis B Grifols®) or three years (Niuliva®), maintaining the anti-HB potency.</p></div>","PeriodicalId":100375,"journal":{"name":"Digestive and Liver Disease Supplements","volume":"3 4","pages":"Pages 112-118"},"PeriodicalIF":0.0,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1594-5804(09)60038-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81004580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2009-12-01DOI: 10.1016/S1594-5804(09)60033-4
J.C. García-Valdecasas
The split liver transplant allows for the division of a graft in two parts, usually the right side for an adult and the left side for use in a child. To date, many centres have confirmed the efficacy and safety of the procedure. However, the highly demanding surgery and the relatively low activity, associated with the low number of ideal donors, and few adequate recipients, and most of all, the compromised long-term outcome, have resulted in a significant decrease of adult to adult split liver transplantation. The real incidence of morbidity and mortality has been a matter of controversy. While some authors suggest a 15% morbidity rate, others have pointed out a higher incidence reaching up to 70%. Recent data, however, show that at least 38% of all donors had some type of complication: The official European Liver Transplant Registry (ELTR) guarantees that the mortality rate associated to the donor operation is well established in Europe (0.2%, 1997–2007). To date post-transplant survival at one and three years are 92% and 84.8% respectively. To summarize, currently, adult living donor liver transplantation has the same probability of survival at 1 and 5 years when compared to deceased donor liver transplantation.
{"title":"Split and living donor liver transplantation","authors":"J.C. García-Valdecasas","doi":"10.1016/S1594-5804(09)60033-4","DOIUrl":"10.1016/S1594-5804(09)60033-4","url":null,"abstract":"<div><p>The split liver transplant allows for the division of a graft in two parts, usually the right side for an adult and the left side for use in a child. To date, many centres have confirmed the efficacy and safety of the procedure. However, the highly demanding surgery and the relatively low activity, associated with the low number of ideal donors, and few adequate recipients, and most of all, the compromised long-term outcome, have resulted in a significant decrease of adult to adult split liver transplantation. The real incidence of morbidity and mortality has been a matter of controversy. While some authors suggest a 15% morbidity rate, others have pointed out a higher incidence reaching up to 70%. Recent data, however, show that at least 38% of all donors had some type of complication: The official European Liver Transplant Registry (ELTR) guarantees that the mortality rate associated to the donor operation is well established in Europe (0.2%, 1997–2007). To date post-transplant survival at one and three years are 92% and 84.8% respectively. To summarize, currently, adult living donor liver transplantation has the same probability of survival at 1 and 5 years when compared to deceased donor liver transplantation.</p></div>","PeriodicalId":100375,"journal":{"name":"Digestive and Liver Disease Supplements","volume":"3 4","pages":"Pages 93-95"},"PeriodicalIF":0.0,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1594-5804(09)60033-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82124729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2009-12-01DOI: 10.1016/S1594-5804(09)60034-6
F. Filipponi
Graft survival is influenced by donor age especially in the long term. Use of grafts from elderly donors (ED) for liver transplantation is increasing in Europe and the US. ED have to be included in the category of extended criteria donor (ECD) grafts, with a risk of allograft failure, poor graft function and transmissible disease. Various attempts to quantify the risk associated with ECD in solid organ transplantation such as the donor risk index (DRI) have been made over the last years. The widespread attitude towards ECD and ED grafts is a careful selection of recipients, based on coupling of clinical, laboratory, and histology variables. Allocation of ECD grafts is a balance between two different policies: transplanting patients with the highest possibility of overcoming the post-transplant period course (healthiest recipients) or transplanting patients with the aim of reducing the waiting list mortality (sickest recipients). Donor grafts have to be used complying with the basic tenets of utility, quality, and transplant benefit.
{"title":"Pool expansion for organ procurement: Older donors for liver transplantation","authors":"F. Filipponi","doi":"10.1016/S1594-5804(09)60034-6","DOIUrl":"10.1016/S1594-5804(09)60034-6","url":null,"abstract":"<div><p>Graft survival is influenced by donor age especially in the long term. Use of grafts from elderly donors (ED) for liver transplantation is increasing in Europe and the US. ED have to be included in the category of extended criteria donor (ECD) grafts, with a risk of allograft failure, poor graft function and transmissible disease. Various attempts to quantify the risk associated with ECD in solid organ transplantation such as the donor risk index (DRI) have been made over the last years. The widespread attitude towards ECD and ED grafts is a careful selection of recipients, based on coupling of clinical, laboratory, and histology variables. Allocation of ECD grafts is a balance between two different policies: transplanting patients with the highest possibility of overcoming the post-transplant period course (healthiest recipients) or transplanting patients with the aim of reducing the waiting list mortality (sickest recipients). Donor grafts have to be used complying with the basic tenets of utility, quality, and transplant benefit.</p></div>","PeriodicalId":100375,"journal":{"name":"Digestive and Liver Disease Supplements","volume":"3 4","pages":"Pages 96-97"},"PeriodicalIF":0.0,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1594-5804(09)60034-6","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76940690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2009-11-01DOI: 10.1016/S1594-5804(09)60025-5
M.R. Brunetto
{"title":"New therapeutic approaches for long-term control of chronic hepatitis B","authors":"M.R. Brunetto","doi":"10.1016/S1594-5804(09)60025-5","DOIUrl":"10.1016/S1594-5804(09)60025-5","url":null,"abstract":"","PeriodicalId":100375,"journal":{"name":"Digestive and Liver Disease Supplements","volume":"3 3","pages":"Pages 67-70"},"PeriodicalIF":0.0,"publicationDate":"2009-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1594-5804(09)60025-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80488790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2009-11-01DOI: 10.1016/S1594-5804(09)60024-3
V. Di Marco
{"title":"Chronic hepatitis B: Do we know everything or is there still something to learn?","authors":"V. Di Marco","doi":"10.1016/S1594-5804(09)60024-3","DOIUrl":"10.1016/S1594-5804(09)60024-3","url":null,"abstract":"","PeriodicalId":100375,"journal":{"name":"Digestive and Liver Disease Supplements","volume":"3 3","pages":"Pages 61-66"},"PeriodicalIF":0.0,"publicationDate":"2009-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1594-5804(09)60024-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82971491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2009-07-01DOI: 10.1016/S1594-5804(09)60020-6
M. Gabrielli, L. Sparano, D. Roccarina, G. Vitale, E.C. Lauritano, A. Gasbarrini
The best therapeutic approach for patients with small bowel bacterial overgrowth is a combination of the removal of all predisposing conditions and the administration of broad-spectrum antibiotics. In the case of non-modifiable predisposing factors, patients with bacterial overgrowth need a strict follow-up after successful decontamination with antibiotics, in order to promptly assess and treat disease recurrence. Up to now, the choice of antibiotics has been primarily empiric because of the presence of several different bacterial species in the contaminating flora and the impossibility of applying in vitro susceptibility tests. Several systemic and non-absorbable antibiotic agents have been shown to be effective for decontamination of small bowel bacterial overgrowth. The best antibiotic scheme in terms of drug, dosage and duration of therapy remains, however, to be assessed. The non-absorbable agents seem to be associated with better safety and tolerability than systemic drugs. In the present paper, all available therapeutic approaches to small bowel bacterial overgrowth are reviewed.
{"title":"Treatment options for small intestinal bacterial overgrowth","authors":"M. Gabrielli, L. Sparano, D. Roccarina, G. Vitale, E.C. Lauritano, A. Gasbarrini","doi":"10.1016/S1594-5804(09)60020-6","DOIUrl":"10.1016/S1594-5804(09)60020-6","url":null,"abstract":"<div><p>The best therapeutic approach for patients with small bowel bacterial overgrowth is a combination of the removal of all predisposing conditions and the administration of broad-spectrum antibiotics. In the case of non-modifiable predisposing factors, patients with bacterial overgrowth need a strict follow-up after successful decontamination with antibiotics, in order to promptly assess and treat disease recurrence. Up to now, the choice of antibiotics has been primarily empiric because of the presence of several different bacterial species in the contaminating flora and the impossibility of applying <em>in vitro</em> susceptibility tests. Several systemic and non-absorbable antibiotic agents have been shown to be effective for decontamination of small bowel bacterial overgrowth. The best antibiotic scheme in terms of drug, dosage and duration of therapy remains, however, to be assessed. The non-absorbable agents seem to be associated with better safety and tolerability than systemic drugs. In the present paper, all available therapeutic approaches to small bowel bacterial overgrowth are reviewed.</p></div>","PeriodicalId":100375,"journal":{"name":"Digestive and Liver Disease Supplements","volume":"3 2","pages":"Pages 50-53"},"PeriodicalIF":0.0,"publicationDate":"2009-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1594-5804(09)60020-6","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89326725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2009-07-01DOI: 10.1016/S1594-5804(09)60021-8
A. Colecchia , D. Festi , E. Scaioli , V. Ruggiero , M. Berardino , P. Portincasa
The human gastrointestinal microflora is a complex ecosystem with about 500 different bacterial species. In healthy individuals, the human stomach and the proximal small bowel contain only a few bacterial species, with the terminal ileum considered a transitional zone between the proximal small bowel aerobic microflora and the colonic anaerobic bacteria. The colon hosts a complex and variegate microbiota, including anaerobes (bacteroides, bifidobacteria, lactobacilli and clostridium), and several other species. The enteric microflora is involved in protective, trophic and metabolic functions. The interaction between gut microflora and substrate leads to gas production, while their overproduction can be responsible of the “gas-related syndrome”, a constellation of non-specific gastrointestinal symptoms (bloating, borborygms, flatulence, abdominal distension and discomfort). Any condition leading to the perturbation of the equilibrium between enteric flora and the surrounding system is a predisposing factor for bacterial overgrowth. Proposed antimicrobic treatments, including tetracycline and norfloxacin, amoxicillin-clavulanic acid and S. Boulardii, are still highly empiric. The efficacy of rifaximin, a non-absorbable antibiotic with bactericidal action against anaerobes and aerobes and a low toxicity, has been evaluated in patients with small intestinal bacterial overgrowth and gas-related syndrome, and has a potential therapeutic role in a subgroup of patients.
{"title":"Bacterial flora, gas and antibiotics","authors":"A. Colecchia , D. Festi , E. Scaioli , V. Ruggiero , M. Berardino , P. Portincasa","doi":"10.1016/S1594-5804(09)60021-8","DOIUrl":"10.1016/S1594-5804(09)60021-8","url":null,"abstract":"<div><p>The human gastrointestinal microflora is a complex ecosystem with about 500 different bacterial species. In healthy individuals, the human stomach and the proximal small bowel contain only a few bacterial species, with the terminal ileum considered a transitional zone between the proximal small bowel aerobic microflora and the colonic anaerobic bacteria. The colon hosts a complex and variegate microbiota, including anaerobes (bacteroides, bifidobacteria, lactobacilli and clostridium), and several other species. The enteric microflora is involved in protective, trophic and metabolic functions. The interaction between gut microflora and substrate leads to gas production, while their overproduction can be responsible of the “gas-related syndrome”, a constellation of non-specific gastrointestinal symptoms (bloating, borborygms, flatulence, abdominal distension and discomfort). Any condition leading to the perturbation of the equilibrium between enteric flora and the surrounding system is a predisposing factor for bacterial overgrowth. Proposed antimicrobic treatments, including tetracycline and norfloxacin, amoxicillin-clavulanic acid and <em>S. Boulardii</em>, are still highly empiric. The efficacy of rifaximin, a non-absorbable antibiotic with bactericidal action against anaerobes and aerobes and a low toxicity, has been evaluated in patients with small intestinal bacterial overgrowth and gas-related syndrome, and has a potential therapeutic role in a subgroup of patients.</p></div>","PeriodicalId":100375,"journal":{"name":"Digestive and Liver Disease Supplements","volume":"3 2","pages":"Pages 54-57"},"PeriodicalIF":0.0,"publicationDate":"2009-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1594-5804(09)60021-8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73067202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2009-07-01DOI: 10.1016/S1594-5804(09)60015-2
M. Montalto , M. Di Stefano , A. Gasbarrini , G.R. Corazza
Intestinal gas metabolism involves a series of physiological processes, concerning gas production, consumption, excretion and disposal in different gut compartments. We report a summary of the actual knowledge on this complex and interesting part of intestinal physiology.
The volume of human intestinal gas is less than 200 ml and its composition varies along the gastrointestinal tract. More than 99% is composed of hydrogen, oxygen, methane, carbon dioxide and nitrogen, while less than 1% is composed of various other odoriferous gases. Intestinal gas derives from swallowed air, intraluminal production (chemical reactions and bacterial metabolism) and diffusion into the lumen from bloodstream. Gas removal from the intestinal tract occurs by eructation, absorption, bacterial consumption and anal evacuation.
{"title":"Intestinal gas metabolism","authors":"M. Montalto , M. Di Stefano , A. Gasbarrini , G.R. Corazza","doi":"10.1016/S1594-5804(09)60015-2","DOIUrl":"10.1016/S1594-5804(09)60015-2","url":null,"abstract":"<div><p>Intestinal gas metabolism involves a series of physiological processes, concerning gas production, consumption, excretion and disposal in different gut compartments. We report a summary of the actual knowledge on this complex and interesting part of intestinal physiology.</p><p>The volume of human intestinal gas is less than 200 ml and its composition varies along the gastrointestinal tract. More than 99% is composed of hydrogen, oxygen, methane, carbon dioxide and nitrogen, while less than 1% is composed of various other odoriferous gases. Intestinal gas derives from swallowed air, intraluminal production (chemical reactions and bacterial metabolism) and diffusion into the lumen from bloodstream. Gas removal from the intestinal tract occurs by eructation, absorption, bacterial consumption and anal evacuation.</p></div>","PeriodicalId":100375,"journal":{"name":"Digestive and Liver Disease Supplements","volume":"3 2","pages":"Pages 27-29"},"PeriodicalIF":0.0,"publicationDate":"2009-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1594-5804(09)60015-2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91408410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}