摘要
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 caused by influenza A H1N1 vaccine and evaluate its safety.Methods：From October to December 2009,the medical professionals of Peking University First Hospital,who were vaccinated with influenza A H1N1 vaccine,were followed-up within 3 months after vaccination.The baseline characteristics of medical professionals,the incidence,intensity,clinical manifestations,latency,and duration of adverse reactions as well as the relationship between the adverse reactions and allergic history of medical professionals were investigated and analyzed.Results：A total of 898 medical professionals were vaccinated.They comprised 226 men and 672 women with age of 18-87 [mean age（38±13）years].The incidence of adverse reactions was 17.7%（158/898）;of them,the men accounted for 14.6%（33/226）and women 18.8%（126/672）.There was no statistically significant difference in the incidence of adverse reactions between genders（χ2 =1.42,P=0.23）.The incidence of adverse reactions in medical professionals with or without allergic history were 39.5%（17/43）and 16.6%（142/855）,respectively.The difference was statistically significant（P〈0.01）.Of 159 persons who experienced adverse reactions,67 experienced local reactions（42.1%）and its main manifestation was injection-site pain,107 experienced systemic reactions including headache,sore throat,dizziness,asthenia,runny nose,fever,aching pain over the entire body,somnolence,and cough.The median latency and duration of local reactions were 0.08（0.02-8.00）hours and 48.00（1.00-720.00）hours,respectively.The median latency and duration of systemic reactions were 8.00（0.02-672.00）hours and 48（0.07-672.00）hours,respectively.The intensity of local and systemic reactions was mild to moderate,mainly mild（136/159,85.5%）.Conclusion：The adverse effects to influenza A H1N1 vaccine are mild and short-time,and the vaccine is a relatively safe agent.
出处
《药物不良反应杂志》
2010年第5期317-320,共4页
Adverse Drug Reactions Journal
关键词
甲型H1N1流感疫苗
不良反应
安全性
调查
influenza A H1 N1 vaccine
adverse drug reactions
safety
investigation
