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目的分析海口市卡介苗(Bacille Calmette-Guerin Vaccine,BCG)疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)的发生特征,评价BCG的安全性和监测情况。方法通过以往疑似异常反应报告登记信息和全国AEFI信息管理系统,收集2003-2012年报告的接种BCG剂次数及接种后AEFI个案数据,采用描述性方法对相关指标进行流行病学分析。结果 2003-2012年共报告接种BCG后AEFI 83例,报告发生率为313.15/100万剂,其中不良反应78例,报告发生率为294.29/100万剂。不良反应中,一般反应4例,报告发生率为15.09/100万剂;异常反应74例,报告发生率为279.19/100万剂。报告最多的异常反应为BCG淋巴结炎,共72例,报告发生率为271.6/100万剂。1例BCG接种事故主要是接种剂量过大。结论 BCG安全性尚可,海口市BCG淋巴结炎高于我国监测报告水平。应继续加强培训和督导,提高接种人员接种技术,规范预防接种操作;增强BCG AEFI监测敏感性和AEFI的调查诊断,减少AEFI的发生和相关纠纷的产生。
Objective To analyze the occurrence of suspected Aivelles Following Immunization (AEFI) in Bacille Calmette-Guerin Vaccine (BCG) and evaluate the safety and monitoring of BCG. Methods Based on past registration information of suspected abnormal reaction and national AEFI information management system, the number of BCG doses inoculated during 2003-2012 and AEFI data after inoculation were collected, and the descriptive method was used to carry out epidemiological analysis of related indicators. Results A total of 83 AEFI patients were vaccinated with BCG from 2003 to 2012, with a reported incidence of 313.15 / 1 million doses. Among them, 78 were adverse reactions, with a reported incidence of 294.29 / 1 million doses. Adverse reactions, the general reaction in 4 cases, the report was 15.09 / 1 million doses; abnormal reaction in 74 cases, the report rate was 279.19 / 1 million doses. The most reported abnormal reaction was BCG lymphadenitis, a total of 72 cases, the report rate was 271.6 / 1 million doses. One case of BCG inoculation accident was mainly inoculation dose is too large. Conclusion The safety of BCG is acceptable. The incidence of BCG lymphadenitis in Haikou City is higher than the monitoring report in China. Should continue to strengthen training and supervision, vaccination technology to improve vaccination, regulate vaccination operations; enhance the sensitivity of the BCG AEFI monitoring and AEFI investigation and diagnosis, reduce the occurrence of AEFI and related disputes.