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目的分析甲型H1N1疫苗AEFI监测结果,评价疫苗的安全性及AEFI监测系统敏感性,为建立规范化AEFI监测体系提供依据。方法将某区2009年甲型H1N1疫苗接种及AEFI监测资料分国庆节前后两个阶段进行描述性分析。结果 2009年某区共接种甲型H1N1疫苗100896人,接报29例AEFI,有一般反应、异常反应、偶合反应、心因性反应4种类型,总报告率28.74/10万(节前201.59/10万、节后9.89/10万);疫苗不良反应总报告率8.92/10万(节前80.64/10万明显高于节后1.10/10万),差异有统计学意义。国庆节前后反应类型、报告率、临床症状、出现反应时间及报告及时性等明显不同。结论甲型H1N1疫苗安全性良好,AEFI监测系统敏感性有待提高,新上市疫苗接种应严格掌握禁忌症。
Objective To analyze the AEFI surveillance results of H1N1 vaccine and evaluate the safety of the vaccine and the sensitivity of the AEFI monitoring system to provide a basis for establishing a standardized AEFI monitoring system. Methods A 2009 H1N1 vaccination and AEFI surveillance data were divided into two phases before and after the National Day of descriptive analysis. Results In 2009, a total of 100896 people were vaccinated with H1N1 vaccine in a certain area and 29 AEFI patients were reported. There were 4 types of general reaction, abnormal reaction, coupling reaction and cardiogenic reaction with a total reported rate of 28.74 / 100000 (201.59 / 100,000, post-holiday 9.89 / 100,000). The total rate of vaccine adverse reactions was 8.92 / 100,000 (80.64 / 100,000 in pre-holiday was significantly higher than that of post-holiday 1.10 / 100,000), the difference was statistically significant. National Day before and after the reaction type, reporting rate, clinical symptoms, reaction time and timely reporting were significantly different. Conclusion The safety of the H1N1 vaccine is good, the sensitivity of the AEFI monitoring system needs to be improved, and the contraindications should be strictly controlled in the newly introduced vaccines.