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Hyperimmune immunoglobulins: Manufacturing technologies and safety procedures 超免疫免疫球蛋白:制造技术和安全程序
Pub Date : 2009-12-01 DOI: 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。
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引用次数: 2
Split and living donor liver transplantation 劈裂肝和活体肝移植
Pub Date : 2009-12-01 DOI: 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.

分裂式肝移植允许将移植物分成两部分,通常是成年人的右侧和儿童的左侧。迄今为止,许多中心已经证实了该程序的有效性和安全性。然而,高要求的手术和相对较低的活动,与理想供体数量少,合适的受体很少有关,最重要的是,长期预后受损,导致成人对成人分离肝移植的显著减少。发病率和死亡率的真实发生率一直是一个有争议的问题。一些作者认为发病率为15%,而另一些人则指出更高的发病率可达70%。然而,最近的数据显示,至少38%的捐赠者出现了某种类型的并发症:官方的欧洲肝移植登记处(ELTR)保证,在欧洲,与捐赠者手术相关的死亡率是确定的(1997-2007年,0.2%)。迄今为止,移植后1年和3年生存率分别为92%和84.8%。综上所述,目前,成人活体供肝移植与死亡供肝移植相比,在1年和5年的生存概率相同。
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引用次数: 3
Pool expansion for organ procurement: Older donors for liver transplantation 扩大器官获取池:老年肝移植供体
Pub Date : 2009-12-01 DOI: 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.

移植物的存活受供体年龄的影响,尤其是长期的。在欧洲和美国,使用老年供体(ED)进行肝移植的情况正在增加。ED必须被列入扩展标准供体(ECD)移植物的类别,具有同种异体移植物衰竭,移植物功能差和传染性疾病的风险。在过去的几年中,已经有各种量化实体器官移植中与ECD相关的风险的尝试,例如供体风险指数(DRI)。对ECD和ED移植的普遍态度是仔细选择受体,基于临床、实验室和组织学变量的耦合。ECD移植的分配是两种不同政策之间的平衡:最有可能克服移植后病程的移植患者(最健康的受者)或以减少等候名单死亡率为目的的移植患者(最疾病的受者)。供体移植物的使用必须符合效用、质量和移植效益的基本原则。
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引用次数: 0
Liver Transplantation Interdisciplinary Conference (1) 肝移植跨学科会议(1)
Pub Date : 2009-12-01 DOI: 10.1016/S1594-5804(09)00017-5
Vicente Arroyo (Professor of Medicine)
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引用次数: 0
New therapeutic approaches for long-term control of chronic hepatitis B 长期控制慢性乙型肝炎的新治疗方法
Pub Date : 2009-11-01 DOI: 10.1016/S1594-5804(09)60025-5
M.R. Brunetto
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引用次数: 1
Conclusions 结论
Pub Date : 2009-11-01 DOI: 10.1016/S1594-5804(09)60026-7
M. Colombo
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引用次数: 0
Chronic hepatitis B: Do we know everything or is there still something to learn? 慢性乙型肝炎:我们是否知道一切,还是还有一些需要学习?
Pub Date : 2009-11-01 DOI: 10.1016/S1594-5804(09)60024-3
V. Di Marco
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引用次数: 1
Treatment options for small intestinal bacterial overgrowth 小肠细菌过度生长的治疗方案
Pub Date : 2009-07-01 DOI: 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.

小肠细菌过度生长患者的最佳治疗方法是去除所有易感条件和使用广谱抗生素的结合。在易感因素不可改变的情况下,细菌过度生长的患者在抗生素去污成功后需要严格随访,以便及时评估和治疗疾病复发。到目前为止,抗生素的选择主要是经验性的,因为在污染菌群中存在几种不同的细菌种类,而且不可能进行体外药敏试验。一些全身性和不可吸收的抗生素已被证明是有效的去污小肠细菌过度生长。然而,就药物、剂量和治疗时间而言,最佳抗生素方案仍有待评估。不可吸收的药物似乎比全身药物具有更好的安全性和耐受性。在本文中,所有可用的治疗方法小肠细菌过度生长的综述。
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引用次数: 2
Bacterial flora, gas and antibiotics 细菌菌群,气体和抗生素
Pub Date : 2009-07-01 DOI: 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.

人类胃肠道菌群是一个复杂的生态系统,大约有500种不同的细菌。在健康个体中,人的胃和近端小肠只含有少数细菌种类,回肠末端被认为是近端小肠需氧微生物群和结肠厌氧细菌之间的过渡区。结肠是复杂多样的微生物群的宿主,包括厌氧菌(拟杆菌、双歧杆菌、乳酸杆菌和梭状芽胞杆菌)和其他几种微生物。肠道菌群具有保护、营养和代谢功能。肠道菌群和底物之间的相互作用导致气体产生,而它们的过量产生可能导致“气体相关综合征”,这是一系列非特异性胃肠道症状(腹胀、胃气胀、肠胃胀气、腹胀和不适)。任何导致肠道菌群与周围系统平衡被扰乱的情况都是细菌过度生长的诱发因素。建议的抗菌素治疗,包括四环素和诺氟沙星,阿莫西林-克拉维酸和S.博拉迪,仍然是高度经验的。利福昔明是一种不可吸收的抗生素,对厌氧菌和需氧菌具有杀菌作用,毒性低,已对小肠细菌过度生长和气体相关综合征患者的疗效进行了评估,并在一个亚组患者中具有潜在的治疗作用。
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引用次数: 2
Intestinal gas metabolism 肠道气体代谢
Pub Date : 2009-07-01 DOI: 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.

肠道气体代谢涉及一系列生理过程,包括气体在不同肠道间室的产生、消耗、排泄和处置。我们报告了对肠道生理学这一复杂而有趣的部分的实际知识的总结。人体肠道气体的体积小于200毫升,其成分沿胃肠道变化。99%以上由氢、氧、甲烷、二氧化碳和氮组成,而由各种其他有气味的气体组成的不到1%。肠道气体来自于吞咽空气、腔内产生(化学反应和细菌代谢)以及从血液扩散到腔内。肠道气体通过排泄、吸收、细菌消耗和肛门排出排出。
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引用次数: 12
期刊
Digestive and Liver Disease Supplements
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