2015-2019年中国卡介苗疑似预防接种异常反应监测

Surveillance for adverse events following immunization with bacillus Calmette-Guérin vaccine in China,2015-2019

目的分析2015-2019年中国卡介苗(Bacillus Calmette-Guérin vaccine,BCG)疑似预防接种异常反应(Adverse event following immunization,AEFI)监测数据。方法通过中国免疫规划信息管理系统和AEFI信息管理系统,收集2015-2019年BCG接种和AEFI个案信息,描述性分析BCG AEFI报告发生率。结果2015-2019年全国共报告BCG AEFI个案7262例,报告发生率为91.14/100万剂;其中一般反应、异常反应报告发生率分别为35.08/100万剂(2795例)、48.86/100万剂(3893例)。BCG淋巴结炎、局部脓肿报告发生率较高,分别为29.28/100万剂(2333例)、10.56/100万剂(841例);全身播散性BCG感染、BCG骨髓炎报告发生率分别为0.78/100万剂(62例)、0.04/100万剂(3例)。结论BCG不良反应报告发生率在预期范围内,严重不良反应极为罕见。

Objective To analyze adverse events following immunization(AEFIs)with bacillus Calmette-Guérin(BCG)vaccine during 2015-2019 in China.Methods We collected data on BCG AEFIs reported to the National AEFI Information System during 2015-2019 in China and conducted a descriptive analysis of the reported incidence of BCG AEFIs.Results A total of 7262 BCG AEFI cases were reported during 2015-2019 in China;the reported incidence was 91.14 cases per million doses administered.Reported incidences per million doses were 35.08(2795 cases)and 48.86(3893 cases)for common and rare adverse reactions,respectively.BCG lymphadenitis and local abscess had the highest reported incidence per million doses at 29.28(2333 cases)and 10.56(841 cases),respectively.The incidence of disseminated BCG infection per million doses was 0.78(62 cases)and the incidence of BCG-associated osteomyelitis was 0.04(3 cases).Conclusions The reported incidence of BCG adverse reactions was not higher than the expected;serious reactions were rare.