2000～2007年卡介苗疑似预防接种异常反应文献分析

目的了解卡介苗（Bacillus Calmette Guerin,BCG）疑似预防接种异常反应（Adverse Events FollowingImmunization,AEFI）的特点,为AEFI监测、调查诊断和处理提供参考。方法计算机检索中国医院知识数据库（1994～2008年）和万方数据库（1993～2008年）报道的BCG AEFI文献,从合格文献中提取相关信息进行分析。结果通过检索和评价,共获得90篇文献,100例案例。2000～2007年平均年报道量〉10例;65%的案例发生在接种后≤1d和≥15d;54%的案例发生在接种第1剂后。临床损伤中局部脓肿21例,局部硬结16例,淋巴结炎15例,其它损伤1～7例;病例66%治愈。发生原因分类中,预防接种实施差错事故40例,BCG不良反应40例,偶合症18例,不明原因2例。40例实施差错事故中,将BCG误作其他疫苗接种28例,接种操作错误l2例。100例中,71例由文献作者诊断,17例医院诊断,9例疾病预防控制中心诊断,3例预防接种异常反应诊断小组诊断。结论BCG AEFI主要以实施差错事故报道最多。死亡等严重不良反应主要与受种者免疫力低下有关。应进一步加强预防接种人员和临床医生等的相关知识培训,规范预防接种操作和AEFI的诊断,减少AEFI的发生和相关纠纷的产生。

Literature Review of Adverse Events Following Immunization of Bacillus Calemtte-Guerin Vaccine, 2000-2007

Objective This article is to analyze the features of adverse events following immunization （AEFI） in BCG Literatures, and to provide information for AEFI surveillance and diagnosis. Methods The literatures were collected from CHKD and WANFANG databases, then the information from qualified publications were analysed. Results 100 cases from 90 publications were involved. 〉10 literatures were published every year in 2000-2007.65% cases occurred≤ 1 day and≥ 15 days after vaccination. 54% cases occurred in the first dose. 21 cases were local redness and swelling, 16 cases were local indurations. 15 cases were suppurative lymphadenitis.66% cases were cured. Of 100 cases, 40 were program error events, 40 cases were rare, serious vaccine reactions and 18 were coincidental illnesses. In all practice error events, 28 were using BCG as other vaccines and 12 were vaccination error. 71 of 100 cases were diagnosed by author, 17 by hospital, 9 by CDC and 3 by the expert group for AEFI diagnosis. Conclusions Overall, the mainly reason of BCG AEFI was operational error event. The serious cases, such as death, were related to immunological deficiency. The training of vaccination conductors and the clinical physicians should be strengthened in order to standardize the vaccination. The standardized immunization services and diagnosis of AEFI will reduce AEFI occurrence and the disputations about AEFI.