EFFICACY OF HEAT-INACTIVATED HEPATITIS B VACCINE IN HAEMODIALYSIS PATIENTS AND STAFF Double-blind Placebo-controlled Trial
EFFICACY OF HEAT-INACTIVATED HEPATITIS B VACCINE IN HAEMODIALYSIS PATIENTS AND STAFF Double-blind Placebo-controlled Trial
复制标题
热灭活乙型肝炎疫苗对血液透析患者和工作人员的疗效双盲安慰剂对照试验
DOI：
10.1016/s0140-6736(83)91089-9
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发表时间：
1983
期刊：
影响因子：
--
通讯作者：
H. Reesink
中科院分区：
文献类型：
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作者：
J. Desmyter;G. Groote;J. Colaert;M. Reynders;E. Reerink‐Brongers;P. Dees;P. Lelie;H. Reesink
一项安慰剂对照、双盲、随机试验对 18 个中心的 401 名血液透析患者在第 0、1、2 和 5 个月时接种热灭活乙型肝炎疫苗（3 μg 表面抗原 (HBsAg)）的效果进行了评估。对照组 435 天内乙型肝炎病毒 (HBV) 感染的发病率为 18%。在整个研究中，疫苗对所有 HBV 感染的保护效力为 78%（p= 0·00016），对第 0 天后 3 个月以上的 HBsAg 阳性肝炎的保护效力为 94%。那些发生 HBV 的患者没有表现出疫苗获得性抗 HBs 的证据。在 152 名接受三个月注射的类似随机化工作人员中，所有 5 例 HBsAg 阳性感染均发生在安慰剂组中 (p=0·022)。该疫苗在 88% 的患者和 100% 的工作人员中诱导了抗 HBs。第四次注射后，有反应的患者中的抗 HBs 水平与工作人员中的一样高。没有严重的副作用。在四剂量方案中，该疫苗为透析患者提供的保护与其他乙型肝炎疫苗为正常受试者提供的保护相同。
The efficacy of a heat-inactivated hepatitis B vaccine, 3 μg of surface antigen (HBsAg), given at 0, 1, 2, and 5 months, was evaluated in 401 haemodialysis patients in 18 centres by a placebo-controlled, double-blind, randomised trial. The attack-rate of hepatitis B virus (HBV) infections in the control group was 18% over 435 days. The protective efficacy rate of the vaccine was 78% against all HBV infections in the entire study (p= 0·00016), and 94% against HBsAg-positive hepatitis more than 3 months after day 0. Those patients in whom HBV developed showed no evidence of vaccine-acquired anti-HBs. Among 152 similarly randomised staff members receiving three monthly injections, all 5 HBsAg-positive infections occurred in the placebo group (p=0·022). The vaccine induced anti-HBs in 88% of the patients and 100% of the staff. Immediately after the fourth injection, anti-HBs levels were as high in responding patients as in staff. There were no serious side effects. In the four-dose schedule the vaccine provides dialysis patients with protection of the same order as that given by other hepatitis B vaccines to normal subjects.