黑龙江省哈尔滨市2005-2017年卡介苗疑似预防接种异常反应监测

Surveillance of adverse events following immunization with Bacille Calmette-Guerin vaccine in Harbin city of Heilongjiang province,2005-2017

目的分析黑龙江省哈尔滨市卡介苗（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。方法通过哈尔滨市AEFI报告登记信息和全国AEFI信息管理系统收集2005-2017年报告的接种BCG后AEFI个案数据,进行描述性流行病学分析。结果 2005-2017年哈尔滨市共报告接种BCG后AEFI 146例,报告发生率为174.60/100万剂。其中,一般反应66例（45.20%,78.93/100万剂）,异常反应80例（54.80%,95.67/100万剂）。在异常反应中,BCG淋巴结炎77例（52.74%,92.08/100万剂）,全身播散性BCG感染2例（1.37%,2.39/100万剂）,过敏性皮疹1例（0.68%,1.20/100万剂）。结论哈尔滨市BCG AEFI报告发生率在预期范围内,BCG安全性良好。

Objective To analyze the occurrence and characteristics of adverse reaction following immunization（AEFI） with Bacille Calmette-Guerin vaccine（BCG） in Harbin,Heilongjiang province,and to evaluate the safety of BCG vaccine. Methods We used the AEFI reporting registry in Harbin and the National AEFI Information Management System to collect AEFI case data from 2005 to 2017 for descriptive epidemiological analyses. Results A total of 146 BCG AEFI cases were reported in Harbin during2005-2017,for an incidence of 174. 60 per million doses. Among AEFIs,66（45. 20%,78. 93 per million doses） were common vaccine reactions,and 80（54. 80%,95. 67 per million doses） were rare vaccine reactions. Among the rare vaccine reactions,77（52. 74%,92. 08 per million doses） were BCG lymphadenitis,2（1. 37%,2. 39 per million doses） were systemic disseminated BCG infection,and1（0. 68%,1. 20 per million doses） was allergic rash. Conclusions The reported incidence of BCG AEFI was less than the expected,showing good safety of BCG.