Shortage of appropriate donor grafts is the foremost current problem in organ transplantation. As a logical consequence, waiting times have extended and pretransplant mortality rates were significantly increasing. The...Shortage of appropriate donor grafts is the foremost current problem in organ transplantation. As a logical consequence, waiting times have extended and pretransplant mortality rates were significantly increasing. The implementation of a priority-based liver allocation system using the model of end-stage liverdisease(MELD) score helped to reduce waiting list mortality in liver transplantation(LT). However, due to an escalating organ scarcity, pre-LT MELD scores have significantly increased and liver recipients became more complex in recent years. This has finally led to posttransplant decreasing survival rates, attributed mainly to elevated rates of infectious and immunologic complications. To meet this challenging development, an increasing number of extended criteria donor grafts are currently accepted, which may, however, aggravate the patients' infectious and immunologic risk profiles. The administration of intravenous immunoglobulins(IVIg) is an established treatment in patients with immune deficiencies and other antibody-mediated diseases. In addition, IVIg was shown to be useful in treatment of several disorders caused by deterioration of the cellular immune system. It proved to be effective in preventing hyperacute rejection in highly sensitized kidney and heart transplants. In the liver transplant setting, the administration of specific Ig against hepatitis B virus is current standard in post-LT antiviral prophylaxis. The mechanisms of action of IVIg are complex and not fully understood. However, there is increasing experimental and clinical evidence that IVIg has an immuno-balancing impact by a combination of immuno-supporting and immuno-suppressive properties. It may be suggested that, especially in the context of a worsening organ shortage with all resulting clinical implications, liver transplant patients should benefit from immuno-regulatory capabilities of IVIg. In this review, perspectives of immune modulation by IVIg and impact on outcome in liver transplant patients are described.展开更多
目的探究静脉注射用免疫球蛋白的特点及临床应用,旨在为临床用药提供全面、有效的参考。方法通过以"静脉注射用免疫球蛋白""免疫球蛋白""IVIG""immunoglobulin"为关键词,检索CNKI、万方、PubMe...目的探究静脉注射用免疫球蛋白的特点及临床应用,旨在为临床用药提供全面、有效的参考。方法通过以"静脉注射用免疫球蛋白""免疫球蛋白""IVIG""immunoglobulin"为关键词,检索CNKI、万方、PubMed、Embase、Web of Science等国内外多个数据库近十年发表的期刊文献和国内外最新临床治疗指南,汇总静脉注射用免疫球蛋白信息,着重介绍静脉注射用免疫球蛋白临床使用的证据支持。结果国内外静脉注射用免疫球蛋白制剂临床应用广泛,从作用机制、药动学特点、循证证据综合探究,对临床合理用药具有指导意义。结论未来需要结合临床需求开展真实世界研究或临床试验研究,获得更多循证证据的支持,保障IVIG临床合理使用,让更多患者获益。展开更多
静注人免疫球蛋白(intravenous immunoglobulin,IVIG)p H 4目前已广泛用于治疗各种免疫缺陷疾病及自身免疫性疾病。严格的质量控制是确保IVIG临床疗效的重要保障,欧美及我国药典均对IVIG的质控作出了严格规定。但IVIG成分复杂,随着其作...静注人免疫球蛋白(intravenous immunoglobulin,IVIG)p H 4目前已广泛用于治疗各种免疫缺陷疾病及自身免疫性疾病。严格的质量控制是确保IVIG临床疗效的重要保障,欧美及我国药典均对IVIG的质控作出了严格规定。但IVIG成分复杂,随着其作用机制逐渐明确以及新的临床适应症不断增加,现有的规定可能需实时补充、完善和改进。本文比较了目前国际主流药典关于IVIG制品质量控制要求的差异,以及现有文献资料中对于IVIG制品质量控制新方法的探索,以期对相关人员研究及血液制品企业生产质控有所启发。展开更多
文摘Shortage of appropriate donor grafts is the foremost current problem in organ transplantation. As a logical consequence, waiting times have extended and pretransplant mortality rates were significantly increasing. The implementation of a priority-based liver allocation system using the model of end-stage liverdisease(MELD) score helped to reduce waiting list mortality in liver transplantation(LT). However, due to an escalating organ scarcity, pre-LT MELD scores have significantly increased and liver recipients became more complex in recent years. This has finally led to posttransplant decreasing survival rates, attributed mainly to elevated rates of infectious and immunologic complications. To meet this challenging development, an increasing number of extended criteria donor grafts are currently accepted, which may, however, aggravate the patients' infectious and immunologic risk profiles. The administration of intravenous immunoglobulins(IVIg) is an established treatment in patients with immune deficiencies and other antibody-mediated diseases. In addition, IVIg was shown to be useful in treatment of several disorders caused by deterioration of the cellular immune system. It proved to be effective in preventing hyperacute rejection in highly sensitized kidney and heart transplants. In the liver transplant setting, the administration of specific Ig against hepatitis B virus is current standard in post-LT antiviral prophylaxis. The mechanisms of action of IVIg are complex and not fully understood. However, there is increasing experimental and clinical evidence that IVIg has an immuno-balancing impact by a combination of immuno-supporting and immuno-suppressive properties. It may be suggested that, especially in the context of a worsening organ shortage with all resulting clinical implications, liver transplant patients should benefit from immuno-regulatory capabilities of IVIg. In this review, perspectives of immune modulation by IVIg and impact on outcome in liver transplant patients are described.
文摘目的探究静脉注射用免疫球蛋白的特点及临床应用,旨在为临床用药提供全面、有效的参考。方法通过以"静脉注射用免疫球蛋白""免疫球蛋白""IVIG""immunoglobulin"为关键词,检索CNKI、万方、PubMed、Embase、Web of Science等国内外多个数据库近十年发表的期刊文献和国内外最新临床治疗指南,汇总静脉注射用免疫球蛋白信息,着重介绍静脉注射用免疫球蛋白临床使用的证据支持。结果国内外静脉注射用免疫球蛋白制剂临床应用广泛,从作用机制、药动学特点、循证证据综合探究,对临床合理用药具有指导意义。结论未来需要结合临床需求开展真实世界研究或临床试验研究,获得更多循证证据的支持,保障IVIG临床合理使用,让更多患者获益。
文摘静注人免疫球蛋白(intravenous immunoglobulin,IVIG)p H 4目前已广泛用于治疗各种免疫缺陷疾病及自身免疫性疾病。严格的质量控制是确保IVIG临床疗效的重要保障,欧美及我国药典均对IVIG的质控作出了严格规定。但IVIG成分复杂,随着其作用机制逐渐明确以及新的临床适应症不断增加,现有的规定可能需实时补充、完善和改进。本文比较了目前国际主流药典关于IVIG制品质量控制要求的差异,以及现有文献资料中对于IVIG制品质量控制新方法的探索,以期对相关人员研究及血液制品企业生产质控有所启发。
