2010～2013年上海市徐汇区卡介苗疑似预防接种异常反应监测分析

Study on Surveillance of Adverse Events Following Immunization of Bacille Calmette-Guerin Vaccine in Xuhui District of Shanghai,2010-2013

目的分析2010~2013年上海市徐汇区卡介苗（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预防接种安全性。方法通过全国AEFI信息管理系统（AEFI Information Management System,AEFIIMS）收集徐汇区2010~2013年报告的BCG接种后AEFI个案数据,通过徐汇区预防接种报表收集接种剂次。应用描述性流行病学方法对相关指标进行分析。结果 2010~2013年徐汇区共报告接种BCG后AEFI 27例,报告发生率为3.63/万剂次,其中BCG淋巴结炎26例（96.30%）,报告发生率为3.50/万剂次。冬春季接种BCG后发生AEFI报告发生率高于夏秋季,不同接种单位报告发生率介于1.01/万剂次~5.98/万剂次,两家BCG生产企业报告发生率分别为3.79/万剂次和2.94/万剂次。BCG AEFI医疗费用支出人均为8 942.4元。结论徐汇区BCG淋巴结炎报告发生率在世界卫生组织估算发生率范围之内,整体安全性尚可。

Objective To analyze the occurrence feature of adverse events following immunization （AEFI） related to Bacille Calmette-Guerin vaccine （BCG） from 2010 to 2013 in Xuhui District, and to evaluate the vaccine safety. Methods The data about BCG AEFI cases were collected from National AEFI Information Management System; BCG Immunization doses were collected from Xuhui District vaccination reports. Descriptive epidemiological analysis was used in this study. Results 27 BCG AEFI cases were reported in Xuhui District from 2010 to 2013, with an incidence rate of 3.63 per 10,000 doses administered. 26 （96.30%） BCG lymphadenitis cases were reported with an incidence of 3.50 per 10, 000 doses. The incidence in winter and spring was higher than that in summer and autumn. The reported incidence rates among different immunization units ranged 1.01 -5.98 per 10,000 doses. For BCG products from 2 manufacturers, their reported incidence rates were 3.79 and 2.94 per 10,000 doses, respec- tively. The average medical cost for each BCG AEFI case was 8942.4 RMB. Conclusion The reported incidence rate of BCG lymphadenitis in Xuhui District was not higher than the expected rate from Word Health Organization documents.