目的：：分析国内对甲型H1N1流感疫苗接种后不良反应报道的文献。方法：检索2009-2011年国内甲型H1N1流感疫苗接种不良反应文献，筛选后对疫苗接种后不良反应发生率、出现时间、持续时间、转归进行分析。结果：初步筛选后共得到15篇文献，均为人群大批量接种H1N1流感疫苗后的不良反应文献。人群接种甲型H1N1流感疫苗后不良反应发生率为0.12~36.0%，全身不良反应率在0.00~22.10%之间，局部不良反应发生率在0.00~19.10%。不良反应多出现于接种后7天之内，3~5d内多可消退；少数不良反应持续超过10d。绝大多数不良反应属轻度不良反应，少数归为中度，仅2篇文献报告有4例重度不良反应，出现不良反应的患者转归良好。结论：文献分析结果本疫苗不良反应发生率较高，但多数持续时间短、症状较轻，提示甲型H1N1疫苗具有较好的安全性。临床上应重视该流感疫苗不良反应，密切观察患者临床表现，对不同的人群关注其反应特点，并及时处理不良反应。%Objective: To Review the adverse reaction after influenza H1N1 vaccine vaccination. Methods:Literature about the adverse drug reaction of influenza A (H1N1)vaccine from 2009 to 2011 were retrieved. The incidence, occurrence time, duration and outcome of the adverse reactions were analyzed. Results:The incidence of adverse reactions of the (H1N1)influenza vaccine is 0.12-36.0%, with systemic adverse reaction rate between 0.00-22.10%, and local adverse reaction incidence between 0.00 to 19.10%. Most adverse reactions occurred within 7 days after vaccination and symptoms usually subsided within 3-5 days. In few cases, the symptoms persisted for more than 10 days. The vast majority of adverse reactions were mild, and a few were moderate. Only 2 papers reported 4 cases of severe adverse reactions. Patients with adverse reaction had favorable outcome. Conclusion:The results showed that the incidence of adverse reaction of H1N1 influenza vaccine was relatively high, but most of the ADRs were short in duration, and the symptoms were mild, which demonstrated the safety profile of the vaccine. Clinicians should pay attention to the adverse reactions of the influenza vaccine and observe the patients closely for clinical manifestations of ADR to ensure drug safety and treat the adverse reactions in time.
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