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目的评价中国(未包括香港、澳门特别行政区和台湾地区)流行性乙型脑炎减毒活疫苗(Japanese Encepha-litis Vaccine,Live;JEV-l)和流行性乙型脑炎灭活疫苗(Japanese Encephalitis Vaccine,Inactivated;JEV-i)上市后预防接种的安全性。方法通过全国疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)监测系统,收集9个省(自治区、直辖市)2005~2006年JEV-l和JEV-i严重不良反应的监测数据,采用描述性方法对两种疫苗不良反应的发生特征进行比较分析。结果中国JEV-l和JEV-i上市后,严重不良反应总报告发生率分别为11.4/100万剂和22.0/100万剂;临床损害均以过敏性皮疹、发热和热性惊厥为主,且第1剂反应危险性高。JEV-l和JEV-i聚集性反应发生率分别为1.2/100万剂和3.8/100万剂;JEV-i发生聚集性反应的危险性高于JEV-l。结论JEV-l和JEV-i上市后均具有较好的预防接种安全性;研究显示JEV-1安全性优于JEV-i;建议儿童常规免疫优先选择JEV-l。
Objective To evaluate the efficacy and safety of Japanese Encepha-litis Vaccine (Live; JEV-1) and Japanese encephalitis inactivated vaccine (excluding Japanese, Hong Kong and Macao Special Administrative Regions and Taiwan) Encephalitis Vaccine, Inactivated; JEV-i) Vaccination Safety after Listing. Methods The surveillance data of adverse reactions of JEV-1 and JEV-i in 9 provinces (autonomous regions and municipalities) from 2005 to 2006 were collected through the national surveillance system of suspected adverse reactions (AEFI). A descriptive method The incidence of adverse reactions of the two vaccines were analyzed comparatively. Results After the listing of JEV-1 and JEV-i in China, the total incidence of serious adverse reactions was 11.4 / 1 million doses and 22.0 / 1 million doses respectively. The clinical damage was mainly allergic rash, febrile seizures and febrile seizures The first dose is dangerous to respond to. JEV-1 and JEV-i aggregative reaction rates were 1.2 / 1 million doses and 3.8 / 1 million doses; JEV-i aggregation reaction risk higher than JEV-l. Conclusion Both JEV-1 and JEV-i have good vaccination safety after they are marketed. JEV-1 is superior to JEV-i in safety, and JEV-1 is recommended as routine immunization in children.