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首页> 外文期刊>Transfusion: The Journal of the American Association of Blood Banks >Isoagglutinin reduction in intravenous immunoglobulin ( IgPro10 IgPro10 , Privigen) by specific immunoaffinity chromatography reduces its reporting rates of hemolytic reactions: an analysis of spontaneous adverse event reports
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Isoagglutinin reduction in intravenous immunoglobulin ( IgPro10 IgPro10 , Privigen) by specific immunoaffinity chromatography reduces its reporting rates of hemolytic reactions: an analysis of spontaneous adverse event reports

机译：通过特定免疫亲凭色谱法减少静脉内免疫球蛋白（IgPro10 IgPro10，Livigen）的异血糖素减少了其溶血反应的报告率：自发不良事件报告分析

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摘要

BACKGROUND Hemolysis is an infrequent but recognized and potentially serious adverse effect of intravenous immunoglobulin (IVIG). Relatively elevated hemolysis reporting rates were seen with some IVIG products with high anti‐A/B isoagglutinin content, among which IgPro10 (Privigen, CSL Behring). For IgPro10, two isoagglutinin reduction measures were successively implemented: 1) anti‐A donor screening and 2) immunoaffinity chromatography (IAC; Ig IsoLo)–based isoagglutinin reduction step included in the production process. The aim of this analysis was to investigate the effects of these isoagglutinin reduction measures on the reporting rates of IgPro10 hemolysis worldwide. STUDY DESIGN AND METHODS Between February 2008 and December 2018, hemolysis reports from the CSL Behring Global Safety Database were analyzed in relationship to changes in IVIG IgPro10 production methods. Further analysis classified hemolysis reports by indication and blood group. RESULTS Median (minimum‐maximum) anti‐A/anti‐B titers were 32 (8‐64)/16 (8‐32) at baseline, 32 (8‐64)/16 (8‐32) after donor screening, and 8 (8‐32)/4 (2‐8) after implementation of IAC. The reporting rate of hemolytic reactions per 1000?kg IgPro10 sold was 4.05 cases at baseline, 2.00 after donor screening, and 0.50 after implementation of IAC. In 2018, there were seven reports of hemolytic reactions; representing 0.18 cases per 1000?kg IgPro10 sold, with a reduction of 95.6% versus baseline. CONCLUSION Following implementation of the IAC isoagglutinin reduction step, spontaneous reports of hemolytic events with IgPro10 were significantly and consistently reduced versus IgPro10 without isoagglutinin reduction, offering patients a more favorable benefit‐risk profile.
机译：背景技术溶血是静脉内免疫球蛋白（IVIG）的不常见但公认和潜在的严重不良影响。用具有高抗A / B异血糖素含量的一些IVIG产物观察到相对升高的溶血报告速率，其中IGPRO10（Privigen，CSL Behring）。对于IGPRO10，连续实施两种异葡萄蛋白还原措施：1）抗助力筛选和2）免疫亲和层析（IAC; IAIAS; IALO）基于制备方法的异葡萄蛋白还原步骤。该分析的目的是探讨这些异血糖素还原措施对全球IGPRO10溶血的报告率的影响。 2018年2月至2018年12月之间的研究设计和方法，分析了CSL Behring全球安全数据库的血液溶解报告与IVIG IGPRO10生产方法的变化关系。进一步分析通过迹象和血液组分析血液溶解报告。结果中位数（最小）抗A /抗B滴度为32（8-64）/ 16（8-32），在供体筛选后32（8-64）/ 16（8-32）， 8（8-32）/ 4（2-8）实施后IAC。每1000次溶血性反应的报告率为4.05例为基线，供体筛选后2.00，实施后0.50。 2018年，有七份溶血反应报告;代表0.18例每1000个？KG IGPRO10出售，减少95.6％与基线。结论在实施IAC Isoagglutinin还原步骤后，具有IgPro10的溶血事件的自发报告显着且始终如一地减少了IgPro10，而没有异葡萄酒素减少，提供患者更有利的益处风险概况。

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