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中国首批次甲型H1N1流感疫苗上市后安全性与保护效果的研究 被引量:29

Safety and epidemiological effects of the first China-made mass A (H1N1) influenza vaccination
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摘要 目的了解和掌握由中国自行研制的甲型H1N1流感疫苗的安全性与保护效果。方法采用描述流行病学、队列研究方法,对95244名首批次接种甲型H1N1流感疫苗的受种者,开展安全性与流行病学保护效果评价。结果95244名首批次接种甲型H1N1流感疫苗人员中,累计报告不良反应人数为193例,报告率为2.03‰;其中71.0%(137/193)的病例发生在接种后24h内。有81例不良反应确认与接种疫苗有关,其中78例(96.3%)属轻微反应。所有接种对象在接种后12周内未报告吉兰-巴雷综合征。甲型H1N1流感疫苗在不考虑接种率的情况下保护率可达到80.9%。结论甲型H1N1流感疫苗具有良好的安全性和流行病学保护效果。 Objective To evaluate the safety and epidemiological effects on the first mass vaccination program, using the China-made A (H1N1) influenza vaccine. Methods Descriptive epidemiology and cohort study design were used to assess the influenza A H1N1 vaccine on its safety and epidemiological effects. Results 95 244 subjects were immunized with A (H1N1) influenza vaccine. 193 adverse events were reported through AEFI Management System, with the Reported rates of AEFI as 2.03‰. Most of the adverse events (137/193,71.0%) happened during the first 24 hours after immunization was carried out. Of 81 adverse reactions confirmed to be related to immunization, with 78 (96.3%) showed mild reactions. No Guillain-Barre Syndrome related to vaccination was reported through the AEFI Management System vaccine could reach 80.9% when the coverage The epidemiological protection rate of A (H1N1) was not considered. Conclusion The A (H1N1) influenza vaccine showed a similar safety profile to seasonal flu vaccine. The vaccine demonstrated a good epidemiological effects against A (H1N1) influenza virus infection.
出处 《中华流行病学杂志》 CAS CSCD 北大核心 2010年第5期481-484,共4页 Chinese Journal of Epidemiology
关键词 甲型H1N1流感疫苗 安全性 保护效果 A (H 1 N 1 ) influenza vaccine Safety Epidemiological effect
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