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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。
Objective To understand the characteristics of Bacillus Calmette Guerin (BCG) suspected antivirus abnormality (AEFI) and provide a reference for AEFI surveillance, investigation, diagnosis and treatment. Methods The literature of BCG AEFI reported by China Hospital Knowledge Database (1994-2008) and Wanfang Database (1993-2008) was retrieved by computer. Relevant information was extracted from qualified documents for analysis. Results Through the search and evaluation, a total of 90 articles and 100 cases were obtained. From 2000 to 2007, the average annual coverage was> 10 cases; 65% of the cases occurred on day 1 and day 15 after inoculation; 54% of cases occurred after the first dose. Local abscess in clinical injury in 21 cases, 16 cases of local induration, lymphadenitis in 15 cases, other injuries 1 to 7 cases; 66% of cases cured. Classification of causes, vaccination implementation error in 40 cases, BCG adverse reactions in 40 cases, 18 cases of coupling, two cases of unknown reasons. Among the 40 cases of implementation errors, BCG was mistakenly used for other vaccinations in 28 cases and inoculation errors were performed in 12 cases. Of the 100 cases, 71 were diagnosed by the authors of the literature, 17 were diagnosed by the hospital, 9 were diagnosed by the Centers for Disease Control and Prevention, and 3 were diagnosed by the diagnostic team for the prevention of vaccination abnormalities. Conclusions BCG AEFI is the most frequently reported incidents of implementation errors. Serious adverse reactions such as death are mainly related to the low immunity of the recipient. Should further strengthen the vaccination personnel and clinicians and other related knowledge training, regulate vaccination and AEFI diagnosis, reduce the occurrence of AEFI and related disputes.