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静脉注射免疫球蛋白:在造血干细胞移植中的适当适应证及应用

Intravenous immunoglobulin: appropriate indications and uses in hematopoietic stem cell transplantation.

作者信息

Sokos Denise R, Berger Melvin, Lazarus Hillard M

机构信息

Department of Pharmacy, Comprehensive Cancer Center of University Hospitals of Cleveland, Case Western Reserve University, Ohio, USA.

出版信息

Biol Blood Marrow Transplant. 2002;8(3):117-30. doi: 10.1053/bbmt.2002.v8.pm11939601.

DOI:10.1053/bbmt.2002.v8.pm11939601
PMID:11939601
Abstract

Intravenous immune globulin (IVIG) therapy has been prescribed in many different disease states. Hyperimmune products are also available. Recently, routine use for many indications has come under scrutiny secondary to high cost, limited supply, and unclear benefit. IVIG is U.S. Food and Drug Administration-approved for application in hematopoietic stem cell transplantation (HSCT), a very common indication for its use. In an attempt to clarify the most appropriate indications and doses in HSCT recipients, we conducted a MEDLINE search in which we reviewed all relevant articles from 1966 to the present. Search terms included bone marrow transplantation, intravenous immune globulin, hyperimmune globulin, GVHD, and cytomegalovirus (CMV). Also, the references of all pertinent studies and review articles were scanned for studies missed via MEDLINE. CMV prophylaxis/treatment and GVHD prophylaxis are the 2 indications with the most significant clinical support, but there are very few prospective, randomized, controlled trials reported. Furthermore, sample size usually was small, included heterogeneous patient populations, and employed different primary end points. Several reports support IVIG therapy in combination with ganciclovir for prevention and treatment of CMV infection, whereas others have shown ganciclovir monotherapy to be effective, blurring the benefit of IVIG administration. CMV IgG data are also imprecise and difficult to interpret. The role of IVIG therapy in prevention and treatment of GVHD also is vague. Only 1 randomized investigation showed a benefit in the prevention of acute GVHD, and no studies showed efficacy in chronic GVHD prophylaxis and therapy. Reports examining the utility of IVIG or CMV IgG in HSCT are hampered by marked variation in trial design and dosing and diverse patient characteristics. Although IVIG may be useful as a component of preemptive therapy and treatment of CMV disease, its contribution to the prevention of reactivation of CMV infection is dubious. Extended IVIG therapy during GVHD prevention may impair recovery of humoral immunity, and its role in prophylaxis and therapy of GVHD has not been clearly defined. Hospital monitoring programs may be a valuable way to detect areas of high use and allow for streamlining of prescribing.

摘要

静脉注射免疫球蛋白(IVIG)疗法已被用于多种不同的疾病状态。也有高免疫球蛋白产品可供使用。最近,由于成本高、供应有限且益处不明确,许多适应症的常规使用受到了审视。IVIG已获美国食品药品监督管理局批准用于造血干细胞移植(HSCT),这是其非常常见的一种使用适应症。为了阐明HSCT受者中最合适的适应症和剂量,我们进行了一次MEDLINE检索,回顾了1966年至当前的所有相关文章。检索词包括骨髓移植、静脉注射免疫球蛋白、高免疫球蛋白、移植物抗宿主病(GVHD)和巨细胞病毒(CMV)。此外,还浏览了所有相关研究和综述文章的参考文献,以查找通过MEDLINE遗漏的研究。CMV预防/治疗和GVHD预防是最有显著临床依据的两个适应症,但报道的前瞻性、随机、对照试验非常少。此外,样本量通常较小,包括异质性患者群体,且采用了不同的主要终点。几份报告支持IVIG疗法联合更昔洛韦用于预防和治疗CMV感染,而其他报告则表明更昔洛韦单药治疗有效,这使得IVIG给药的益处变得模糊。CMV IgG数据也不准确且难以解读。IVIG疗法在预防和治疗GVHD中的作用也不明确。只有1项随机研究显示在预防急性GVHD方面有获益,没有研究表明在慢性GVHD预防和治疗中有疗效。研究IVIG或CMV IgG在HSCT中的效用的报告受到试验设计和给药的显著差异以及多样的患者特征的阻碍。尽管IVIG可能作为抢先治疗和CMV疾病治疗的一个组成部分有用,但其对预防CMV感染再激活的贡献值得怀疑。在预防GVHD期间延长IVIG治疗可能会损害体液免疫的恢复,其在GVHD预防和治疗中的作用尚未明确界定。医院监测项目可能是检测高使用区域并实现处方合理化的一种有价值的方式。

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