法国血液透析单位中乙型肝炎表面抗原疫苗的随机安慰剂对照试验：II，血液透析患者

Randomised placebo-controlled trial of hepatitis B surface antigen vaccine in french haemodialysis units: II, Haemodialysis patients.

作者信息

Crosnier J, Jungers P, Couroucé A M, Laplanche A, Benhamou E, Degos F, Lacour B, Prunet P, Cerisier Y, Guesry P

出版信息

Lancet. 1981 Apr 11;1(8224):797-800. doi: 10.1016/s0140-6736(81)92679-9.

Abstract

A vaccine against hepatitis B surface antigen (Institut Pasteur Production) was assessed in 138 haemodialysis patients in a placebo-controlled randomised double-blind trial. In an interim analysis, hepatitis B infections were observed in 21% of the vaccine group and 45% of the placebo group (p less than 0.02). 2 of the infections in the vaccine group and 12 of the infections in the placebo group occurred after the third injection. 60% of the vaccine recipients had an immune response. 4 months after the first injection the mean titre of anti-HBs was 120 mlU/ml.

摘要

一种针对乙肝表面抗原的疫苗（巴斯德研究所生产）在138名血液透析患者中进行了安慰剂对照随机双盲试验评估。在中期分析中，疫苗组21%的患者和安慰剂组45%的患者出现了乙肝感染（p<0.02）。疫苗组的2例感染和安慰剂组的12例感染发生在第三次注射之后。60%的疫苗接种者产生了免疫反应。首次注射4个月后，抗-HBs的平均滴度为120 mIU/ml。