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目的 分析湖北省肠道病毒71型 (Enterovirus 71, EV71) 灭活疫苗上市后疑似预防接种异常反应 (Adverse events following immunization, AEFI) 的发生特征和预防接种安全性.方法 通过中国AEFI信息管理系统收集2016-2017年EV71疫苗AEFI个案数据, 进行描述性流行病学分析.结果 2016-2017年湖北省共报告EV71疫苗AEFI 497例 (57.11/10万剂), 其中一般反应、异常反应分别为429例 (49.29/10万剂) 和64例 (7.35/10万剂);三个企业生产的疫苗分别为401例 (60.92/10万剂) 、75例 (49.60/10万剂) 、21例 (34.49/10万剂).一般反应主要为发热 (42.40/10万剂) 、局部红肿 (0.69/10万剂) 和局部硬结 (0.23/10万剂), 异常反应主要为过敏性皮疹 (6.32/10万剂).结论 EV71疫苗AEFI报告发生率较低, 三个企业生产的EV71疫苗均具有良好的安全性.“,”Objective To determine clinical features of adverse events following immunization ( AEFIs) associated with inactivated enterovirus 71 ( EV71) vaccine and evaluate its safety profile in Hubei.Methods AEFI cases associated with EV71 vaccine were collected from the China AEFI Information Management System during 2016-2017 for descriptive epidemiological analysis. Results In total, 497 AEFI cases associated with EV71 vaccine were reported in Hubei during 2016-2017, for an incidence of 57. 11 per 100 000 doses. Among the 497 AEFI cases, 429 ( 49. 29 per 100 000) were common vaccine reactions, and 64 ( 7. 35 per 100 000) were rare vaccine reactions; 401 ( 60. 92 per 100 000), 75 ( 49. 60 per 100 000), and 21 ( 34. 49 per 100 000) were from vaccines of the three different manufacturers. Common reactions were fever ( 42. 40 per 100 000), injection-site swelling ( 0. 69 per100 000), and induration ( 0. 23 per 100 000); allergic rash occurred at a rate of 6. 32 per 100 000.Conclusions AEFI associated with EV71 vaccine had a low incidence, demonstrating a good safety profile for three manufacturers' vaccines.