甲型H1N1流感疫苗接种不良反应调查

Survey of adverse drug reaction after inoculation with influenza A virus subtype H1N1 vaccine

目的分析甲型H1N1流感病毒裂解疫苗接种后不良反应(ADR)的发生情况,为安全性评价提供依据。方法对辖区2009年11月10日～20日接种甲型H1N1流感病毒裂解疫苗的人员进行调查,包括被接种人员的一般情况、ADR发生率、临床表现、转归、ADR发生的严重程度等进行统计分析。结果 1 346例接种者中ADR发生率为31.56%(425/1 346),其中局部反应占58.35%(248/425),持续时间中位数为3d;全身反应41.65%(177/1 346),持续时间中位数为2d;男女性接种者ADR发生率分别为28.02%(195/696)和35.38%(230/650)(χ2=8.44,P<0.05)。甲型H1N1病毒裂解流感疫苗所致ADR多为轻度和中度(轻度占56.94%)。结论接种甲型H1N1流感病毒裂解疫苗后ADR发生率虽高,但多为轻度和中度反应,接种相对较安全。

Aim To survey the adverse drug reaction（ADR） caused by influenza A（H1N1） vaccine inoculation.Methods There 1346 persons with ADR after vaccination with influenza A（H1N1） vaccine in the area of jurisdiction during November 10-20,2009 were surveyed.Results The ADR incidence rate was 31.56%（425/1346）,the local reactions accounted for 58.35%（248/425）,the duration median was 3 days.The systemic reaction 41.65%（177/1346）,the duration median is 2 days;ADR incidence rate occur to males or females were 28.02%（195/696） and 35.38（230/650）（χ2=8.44,P0.05）.Most of the ADR was from mild to moderate.Conclusion ADR incidence rate after vaccination with influenza A（H1N1） vaccine is high,but most ADRs are mild and moderate,thus influenza A（H1N1） is safe.