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免疫球蛋白预防甲型肝炎的系统评价

李青, 秦献奎, 费宇彤, 刘建平

李青, 秦献奎, 费宇彤, 刘建平. 免疫球蛋白预防甲型肝炎的系统评价[J]. 循证医学, 2012, 12(4): 224-229. DOI: 10.3969/j.issn.1671-5144.2012.04.013
引用本文: 李青, 秦献奎, 费宇彤, 刘建平. 免疫球蛋白预防甲型肝炎的系统评价[J]. 循证医学, 2012, 12(4): 224-229. DOI: 10.3969/j.issn.1671-5144.2012.04.013
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LI Qing, QIN Xian-kui, FEI Yu-tong, LIU Jian-ping. Systematic Review on Immunoglobulins for Preventing Hepatitis A[J]. Journal of Evidence-Based Medicine, 2012, 12(4): 224-229. DOI: 10.3969/j.issn.1671-5144.2012.04.013
Citation: LI Qing, QIN Xian-kui, FEI Yu-tong, LIU Jian-ping. Systematic Review on Immunoglobulins for Preventing Hepatitis A[J]. Journal of Evidence-Based Medicine, 2012, 12(4): 224-229. DOI: 10.3969/j.issn.1671-5144.2012.04.013
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免疫球蛋白预防甲型肝炎的系统评价

  • 1.

    北京中医药大学循证医学中心,北京 100029

  • 2.

    解放军96819部队门诊部,北京 100853

详细信息
    作者简介:

    李青（1983-）, 女, 山东泰安人, 在读博士研究生, 主要研究方向为循证医学与中医临床疗效评价。

    通讯作者:

    刘建平,Tel: 010-64286760, E-mail: jianping_l@hotmail.com

  • 中图分类号: R512.6+1

Systematic Review on Immunoglobulins for Preventing Hepatitis A

  • 1.

    Center for Evidence-Based Medicine, Beijing University of Chinese Medicine, Beijing 100029, China

  • 2.

    Outpatient Department of No.96819 Army Health Center, PLA, Beijing 100853,China

摘要

    摘要
  • 摘要: 目的 评价使用免疫球蛋白对甲型肝炎暴露前和暴露后的预防效果及其安全性。 方法 电子检索Cochrane肝胆病组对照试验注册中心、Cochrane临床对照试验注册中心、Medical Literature Analysis and Retrieval System Online、Excerpta Medica Database、Science Citation Index Expanded、中国生物医学文献数据库等,手工检索3种中文杂志,收集免疫球蛋白预防甲型肝炎的随机对照试验,以甲型肝炎的发病率为主要结局,效应指标用相对危险度及其95%可信区间表示。 结果 共纳入13篇文献（567 476名患者）,2/3的文献偏倚风险较高。对于甲肝暴露前的预防: 免疫球蛋白与空白或安慰剂相比能够显著降低成年人及儿童6~12个月内的甲肝发病率（P均<0.05）;随访第4周时免疫球蛋白与灭活甲肝疫苗相比在促抗-HAV抗体阳转方面差异没有统计学意义（P>0.05）,但在随访第8、12、24周时,灭活甲肝疫苗在促抗-HAV抗体阳转方面的效果优于免疫球蛋白（P均<0.05）;高剂量与低剂量相比能够显著降低甲肝的发病率（P均<0.01）。对于甲肝暴露后的预防: 免疫球蛋白的预防效果优于安慰剂（P<0.01）。13篇文献未报告明显的全身不良事件。 结论 使用免疫球蛋白对甲型肝炎暴露前和暴露后的预防有一定效果,但是由于纳入的文献数量有限、发表年代久远及存在高偏倚风险,应慎重对待这一结论,应该设计更为严格的随机对照试验进行验证。
    Abstract: Objective To assess the efficacy and safety of the pre-exposure and post-exposure prophylaxis with immunoglobulins for preventing hepatitis A. Methods We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials in The Cochrane Library, Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Chinese Biomedical Database, and Science Citation Index Expanded for randomized trials, and hand searched three Chinese journals. Randomized clinical trials on immunoglobulin prophylaxis for preventing hepatitis A were collected, the primary outcome was incidence of hepatitis A, and the results were presented as relative risks （RR） with 95% confidence intervals. Results Thirteen trials with 567 476 participants were included, and two thirds of the 13 trials had high risk of bias. For pre-exposure prophylaxis, immunoglobulin significantly reduced the number of adults or children patients with hepatitis A at 6 to 12 months compared with no intervention or inactive control （P<0.05）. There was no significant difference between immunoglobulin and inactivated hepatitis A vaccine in seroconversion to hepatitis A vaccine antibodies at four weeks （P>0.05）, but immunoglobulin was significantly less effective than vaccine regarding antibody levels at 8, 12, or 24 weeks （P<0.05）. Higher dosage was generally more effective than lower dosage in preventing hepatitis A （P<0.01）. For post-exposure prophylaxis, immunoglobulin was more effective than placebo （P<0.01）. No significant systemic adverse events were reported. Conclusions Immunoglobulins seem to be effective for pre-exposure and post-exposure prophylaxis of hepatitis A. However, caution is warranted for the positive findings due to the limited number of trials, old publication, and risk of bias. Further well-designed randomized controlled trials are expected for rigorous evidence.
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  • 收稿日期:  2011-07-10
  • 发布日期:  2012-08-27

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