河南省2016-2018年卡介苗疑似预防接种异常反应发生率

Incidence of adverse events following immunization with Bacillus Calmette-Guerin vaccine in Henan province,2016-2018

目的分析河南省2016-2018年卡介苗(Bacillus Calmette-Guerin vaccine,BCG)疑似预防接种异常反应(Adverse event following immunization,AEFI)发生率。方法通过中国免疫规划信息管理系统收集河南省2016-2018年报告的BCG AEFI和预防接种信息,描述性分析BCG AEFI发生率。结果河南省2016-2018年共报告BCG AEFI 243例,报告发生率为5.92/10万剂。一般反应报告发生率(/10万剂)为2.65,其中发热、红肿、硬结分别为1.29、1.02、0.51;异常反应报告发生率(/10万剂)为3.00,其中BCG淋巴结炎、局部脓肿、接种BCG后结缔组织增生、全身播散性BCG感染、过敏性皮疹、BCG骨髓炎报告发生率分别为2.03、0.66、0.10、0.10、0.10、0.02。结论河南省2016-2018年BCG不良反应发生率在预期范围内,严重反应罕见。

Objective To determine the incidence of adverse events following immunization(AEFIs) with Bacillus Calmette-Guerin(BCG) vaccine during 2016-2018 in Henan province. Methods We collected data on BCG vaccination and AEFI cases reported to the Chinese Immunization Information Management System during 2016-2018 in Henan province and conducted a descriptive analysis of BCG AEFI incidence. Results A total of 243 BCG AEFIs were reported during 2016-2018 in Henan, for an incidence of 5.92 cases per 100 000 doses administered. The incidence per 100 000 doses was 2.65 for common adverse reactions, with 1.29, 1.02, and 0.51 for fever, local redness/swelling, and induration, respectively. The incidence per 100 000 doses was 3.00 for rare adverse reactions, with 2.03, 0.66, 0.10, 0.10, 0.10, and 0.02 for BCG-associated lymphadenitis, local abscess, BCG-associated connective tissue hyperplasia, systemic disseminated BCG infection, allergic rash, and BCG-associated osteomyelitis, respectively. Conclusion The incidence of adverse reactions after BCG vaccination during 2016-2018 in Henan was not higher than the expected, and serious reactions were rare.