| 纪文艳,卢莉,吕敏,苗良,高婷,黄若刚,索罗丹,刘东磊,马蕊,虞睿,张朱佳子,刘维祥,曾阳,李晓梅,吴疆.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[J].中华流行病学杂志,2010,31(5):481-484 |
| 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 |
| Safety and epidemiological of the first China-made mass A (H1N1) influenza vaccination |
| 收稿日期:2009-12-29 出版日期:2014-09-18 |
| DOI：10.3760/cma.j.issn.0254-6450.2010.05.001 |
| 中文关键词: 甲型H1N1流感疫苗 安全性 保护效果 |
| 英文关键词: A (H1N1) influenza vaccine Safety Epidemiological effect |
| 基金项目:“十一五”国家科技支撑计划(2009BAl80801) |
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| 中文摘要: |
| 目的 了解和掌握由中国自行研制的甲型HINl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H1NI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HINl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8l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周内未报告吉兰一巴雷综合征。甲型H1NI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。 |
| 英文摘要: |
| Objective To evaluate the safety and epidemiological effects on the fast 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 immmni}ation was carried out.Of 81 adverse reactions confirmed to be related to invnunization,with 78 (96.3%)showed mild reactions.No Guillain-Barre Syndrome related to vaccination was reported through the AEFI Management System.The epidemiological protection rate of A (H1N1) vaccine could reach 80.9% when the coverage was not considered.Conclusion The A (H1N1) influenza vaccine showed a similar safety profile to seasonal flu vaccine.The vaccine demonstrates a good epidemiological effects against A (H1N1) influenza virus infection. |
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