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目的:调查甲型H1N1流感疫苗的不良反应,评估其安全性。方法:对北京大学第一医院2009年10至12月接种甲型H1N1流感疫苗的医务人员在接种疫苗后3个月内进行随访。调查分析接种人员的基本情况、不良反应的发生率、反应程度、临床表现、潜伏期、持续时间及其与过敏史的关系。结果:接种疫苗者共898人,男226人,女672人,年龄18～87(38±13)岁。不良反应发生率为17.7%(159/898),男性接种者发生率为14.6%(33/226),女性为18.8%(126/672),不同性别间不良反应发生率差异无统计学意义(χ2=1.42,P=0.23)。有、无过敏史接种者的不良反应发生率分别为39.5%(17/43)和16.6%(142/855),差异有统计学意义(P<0.01)。发生不良反应的159人中,出现局部反应者67人,主要表现为注射部位疼痛;出现全身反应者107人,主要表现为头痛、咽痛、头晕、乏力、流涕、发热、全身酸痛、嗜睡和咳嗽。局部反应的中位潜伏期为0.08(0.02～8.00)h,中位持续时间为48.00(1.00～720.00)h;全身反应的中位潜伏期为8.00(0.02～672.00)h,中位持续时间为48.00(0.07～672.00)h。局部和全身不良反应程度均为轻度和中度,以轻度为主(136/159,85.5%),所有不良反应均可自愈或经对症治疗后消失。结论:甲型H1N1流感疫苗的不良作用轻而短,是一种较为安全的疫苗。
Objective: To investigate the adverse reactions of influenza A (H1N1) vaccine and assess its safety. Methods: The medical staff of the First Hospital of Peking University who vaccinated the Influenza A (H1N1) vaccine from October to December 2009 were followed up within 3 months after vaccination. Investigation and analysis of the basic situation of vaccination personnel, the incidence of adverse reactions, the degree of response, clinical manifestations, latency, duration and its relationship with the history of allergies. Results: A total of 898 vaccinated people, 226 men and 672 women, aged 18 to 87 (38 ± 13) years. The incidence of adverse reactions was 17.7% (159/898). The incidence of male vaccination was 14.6% (33/226) and that of women was 18.8% (126/672). There was no significant difference in the incidence of adverse reactions among different sexes χ2 = 1.42, P = 0.23). The incidences of adverse reactions in those with and without allergies were 39.5% (17/43) and 16.6% (142/855), respectively, with significant differences (P <0.01). Of the 159 patients who developed adverse reactions, 67 were local responders, mainly showing pain in the injection site; 107 patients showed systemic reactions, mainly headache, sore throat, dizziness, fatigue, runny nose, fever, body aches, somnolence And cough. The median response time was 0.08 (0.02-8.00) h and the median duration was 48.00 (1.00-720.00) h. The median latency of systemic reaction was 8.00 (0.02-672.00) h with a median duration of 48.00 ( 0.07 ~ 672.00) h. Local and systemic adverse reactions were mild and moderate, with mild (136 / 159,85.5%), all the adverse reactions can be self-healing or disappear after symptomatic treatment. Conclusion: Influenza A H1N1 influenza vaccine has the advantages of light and short side effects and is a safer vaccine.