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NEJM:超免疫球蛋白不能阻止巨细胞病毒宫内传播

2014-11-30 MedSci MedSci原创

05年的一项非对照试验表明对原发性巨细胞病毒(cytomegalovirus,CMV)感染的孕妇使用CMV特异性超免疫球蛋白治疗,结果显著降低了胎儿宫内感染率:从40%降至16%。 目前一项研究超免疫球蛋白治疗先天性CMV感染疗效的文章发表于近期的新英格兰医学杂志上。 意大利共有11个医学中心加入到此项研究中。研究者对超免疫球蛋白的疗效进行二期临床研究,应用随机、安慰剂对照、双盲试验。共124

05年的一项非对照试验表明对原发性巨细胞病毒(cytomegalovirus,CMV)感染的孕妇使用CMV特异性超免疫球蛋白治疗,结果显著降低了胎儿宫内感染率:从40%降至16%。

目前一项研究超免疫球蛋白治疗先天性CMV感染疗效的文章发表于近期的新英格兰医学杂志上。

意大利共有11个医学中心加入到此项研究中。研究者对超免疫球蛋白的疗效进行二期临床研究,应用随机、安慰剂对照、双盲试验。共124名原发性CMV感染的孕妇在孕5-26周时被纳入研究,推测其感染CMV6周后,每4个星期进行一次超免疫球蛋白和安慰剂治疗,直到孕36周,或直到在羊水中检测出CMV之后。主要观察终点为新生儿检测出感染先天性CMV或者羊水穿刺检测到CMV。

Figure 1. Enrollment and Outcomes.

研究者对123名孕妇进行疗效分析(1个安慰剂组的孕妇中途退出)后发现,超免疫球蛋白组的先天性CMV感染率为30%,安慰剂组为44%。对比两组孕妇的病毒特异性抗体、T细胞介导的免疫反应以及血液中的病毒DNA水平,发现两组孕妇传染CMV的能力没有显著差异。两组婴儿先天性感染CMV的感染率相似。但超免疫球蛋白组的产科不良事件比安慰剂组要高。

结果表明,使用超免疫球蛋白并不能显著缓解孕期原发性感染CMV的进程。


原始出处

Revello MG1, Lazzarotto T, Guerra B, Spinillo A, Ferrazzi E, Kustermann A, Guaschino S, Vergani P, Todros T, Frusca T, Arossa A, Furione M, Rognoni V, Rizzo N, Gabrielli L, Klersy C, Gerna G; CHIP Study Group.A randomized trial of hyperimmune globulin to prevent congenital cytomegalovirus.N Engl J Med. 2014 Apr 3

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    2015-10-06 xzw113
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    2014-12-01 wwzzly
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