摘要
目的评价福建省2011-2015年流通使用的国家免疫规划(NIP)疫苗和非NIP疫苗的安全性。方法检索全国预防接种异常反应(AEFI)信息管理系统收集福建省2011-2015年上报的AEFI病例信息,检索中国免疫规划信息管理系统收集福建省同期NIP疫苗(11种)和非NIP疫苗(19种)接种数据。对收集到的监测数据进行描述性统计分析,计算疑似AEFI和严重AEFI报告发生率及其95%置信区间(CI)。结果福建省2011-2015年共接种疫苗7097.36万剂,上报AEFI病例8987例,其中严重AEFI病例192例(2.14%),总体AEFI报告发生率(95%CI)为12.66(12.40~12.93)/10万剂,严重AEFI报告发生率(95%CI)为2.71(2.34~3.12)/100万剂。NIP疫苗共接种5570.21万剂,上报AEFI病例7347例,其中严重AEFI病例138例(1.88%),总体AEFI报告发生率(95%CI)为13.19(12.89~13.49)/10万剂,严重AEFI报告发生率(95%CI)为2.48(2.08~2.93)/100万剂;11种NIP疫苗的AEFI报告发生率(95%CI)介于0.95(0.88~1.13)/10万剂次~43.71(40.72~46.75)/10万剂次,严重AEFI报告发生率(95%CI)介于1.04(0.32~1.76)/100万剂次~6.41(2.78~10.04)/100万剂次。非NIP疫苗共接种1527.16万剂,上报AEFI病例1640例,其中严重AEFI病例54例(3.54%),总体AEFI报告发生率(95%CI)为10.74(10.23~11.27)/10万剂,严重AEFI报告发生率(95%CI)为3.54(2.66~4.61)/100万剂;19种非NIP疫苗的AEFI报告发生率(95%CI)介于2.06(0.38~3.71)/10万剂次~45.22(35.29~55.10)/10万剂次,严重AEFI报告发生率(95%CI)介于0.52(0~1.53)/100万剂次~20.89(0~44.51)/100万剂次。结论福建省2011-2015年流通使用的NIP和非NIP疫苗AEFI和严重AEFI报告发生率均较低,均具有良好的安全性。
Objective To evaluate the safety of national immunization program (NIP) vaccines and non-NIP vaccines in Fujian Province from 2011 to 2015. Methods The adverse events following immunization (AEFI) case information reported in Fujian Province from 2011 to 2015 was collected from the National AEFI Information Management System and vaccination data of NIP vaccines (11 species) and non-NIP vaccines (19 species) in the same period in Fujian Province were collected from the National Immunization Program Information Management System. The collected monitoring data were descriptively analyzed. The total and severe AEFI reporting rates and their 95% confidence intervals (CI) were calculated. Results From 2011 to 2015, a total of 70 976 300 doses of vaccines were inoculated in Fujian Province and a total of 8 987 cases of AEFI were reported, including 192 cases (2.14%) of severe AEFI. The incidence (95%CI) of reported AEFI was 12.66 (12.40-12.93) per 100 000 doses and the incidence (95%CI) of reported severe AEFI was 2.71 (2.34-3.12) per one million doses. A total of 55 702 100 doses of NIP vaccines were inoculated and 7 347 cases of AEFI were reported, of which 138 (1.88%) were severe AEFI cases. The incidence (95%CI) of reported AEFI was 13.19 (12.89-1.49) per 100 000 doses of NIP vaccines and the incidence (95%CI) of reported severe AEFI was 2.48 (2.08-2.93) per one million doses. Among the 11 NIP vaccines, the incidence (95%CI) of reported AEFI ranged from 0.95 (0.88-1.13) per 100 000 doses to 43.71 (40.72-46.75) per 100 000 doses and the incidence (95%CI) of reported severe AEFI ranged from 1.04 (0.32-1.76) per one million doses to 6.41 (2.78-10.04) per one million doses. A total of 15 271 600 doses of non-NIP vaccines were inoculated and 1 640 cases of AEFI were reported, of which 54 (3.54%) were severe AEFI cases. The total incidence (95%CI) of reported AEFI was 10.74 (10.23-11.27) per 100 000 doses and the incidence (95%CI) of reported severe AEFI was 3.54 (2.66-4.61) per one million doses. Among the 19 non-NIP vac
作者
林志强
吴瑞红
萧剑雄
周勇
张山鹰
郑奎城
Lin Zhiqiang;Wu Ruihong;Xiao Jianxiong;Zhou Yong;Zhang Shanying;Zheng Kuicheng(Fujian Provincial Key Laboratory of Zoonosis Research,Fujian Provincial Center for Disease Control and Prevention,Fuzhou 350001,China;Teaching Base,Public Health School of Fujian Medical University,Fuzhou 350122,China)
出处
《药物不良反应杂志》
CSCD
2019年第5期353-359,共7页
Adverse Drug Reactions Journal
关键词
疫苗
疫苗接种
免疫接种规划
药物相关副作用和不良反应
药物不良反应报告系统
Vaccines
Vaccination
Immunization programs
Drug-related side effects and adverse reactions
Adverse drug reaction reporting systems
