2017—2020年聊城市疑似预防接种异常反应监测系统分析

Analysis of the surveillance system for adverse events following immunization in Liaocheng City from 2017 to 2020

目的分析2017—2020年山东省聊城市疑似预防接种异常反应(adverse events following immunization, AEFI)流行病学特征,评价AEFI监测系统运转情况和疫苗预防接种的安全性,为今后疫苗的安全管理和预防接种提供科学依据。方法通过AEFI监测系统收集2017—2020年聊城市AEFI监测数据,采用描述性流行病学方法对AEFI报告病例进行统计学分析,并对聊城市AEFI监测系统运行情况进行评价。结果 2017—2020年聊城市共累计报告AEFI病例6 233例,共接种国家免疫规划(national immunization program, NIP)疫苗和非NIP疫苗9 067 370剂次,年均AEFI报告发生率为68.74/10万剂次。48 h内报告率、AEFI分类率和地区覆盖率均为100%。无细胞百白破联合疫苗(diphtheria, tetanus and acellular pertussis combined vaccine, DTP)AEFI报告最多,有2 063例,占39.55%,报告发生率153.83/10万剂次;非NIP疫苗AEFI报告例数1 017例,占16.32%。全年每月均有AEFI报告病例,从1月开始缓慢上升,6月最高点后又逐渐下降至10月低点,全年上下波动不是十分明显。聊城市8个县(市、区)中,报告病例最多的地区为东昌府区,有1 291例,占20.71%;莘县报告病例较少,有487例,仅占7.81%。AEFI报告病例人群分布中,男女性别比1.34∶1;0~5岁组最多,共5 779例,占92.72%;1岁以下年龄组中,>8~9月龄组报告占19.84%;主要是散居儿童,占88.29%。临床诊断以发热/红肿/硬结的一般反应为主,有6 184例,占99.20%;治愈或好转6 226例,占99.89%;治疗中4例,占0.06%;后遗症1例,占0.02%;死亡2例,占0.03%,2例死亡病例均是偶合症。结论 2017—2020年聊城市AEFI监测系统运行良好,AEFI监测重点是5岁及以下儿童和接种疫苗后24 h发生情况。目前上市的NIP疫苗和非NIP疫苗的安全性都比较好。

Objective In order to evaluate the implementation of AEFI surveillance system and the safety of vaccination, then provide scientific evidence for vaccine safety management and vaccination in the future, the epidemiological characteristics of adverse events following immunization(AEFI) in Liaocheng City from 2017 to 2020 were analyzed. Methods The data collected through the national AEFI information management system in Liaocheng City from 2017 to 2020. The descriptive epidemiological methodology was used to statistically analyze AEFI reported cases and effectively appraised AEFI surveillance system. Results A total of 6 233 cases of AEFI were reported in Liaocheng City from 2017 to 2020, and 9 067 370 doses of national immunization program(NIP) vaccines and non-national immunization program(N-NIP) vaccines were administered. The average reported incidence of AEFI was 68.74/105 doses. The indexes of surveillance content, including the report rate within 48 hours, the classification rate of AEFI, the coverage rate of reporting area, were all achieved 100%. A total of 2 063 cases(39.55%) of AEFI were immunized of diphtheria, tetanus and acellular pertussis combined vaccine(DTaP) which was the most reported, and the reported incidence of AEFI was 153.83/105 doses. A total of 1 017 cases of AEFI were immunized of N-NIP vaccine(16.32%). AEFI cases reported all year round. The cases of AEFI began to rise slowly from January, reached the highest point in June, and then gradually declined to the low point in October. The year-round fluctuation was not very obvious. Among the 8 Counties(Cities, Districts) in Liaocheng City, the highest number of reported cases was Dongchangfu District(1 291 cases, 20.71%);and the fewest was Shen County(487 cases, 7.81%). In the population distribution of AEFI reported cases, the gender ratio of male to female was 1.34:1, and 5 779 cases(92.72%) were under 5 years old group. In the age group below 1 year old, 19.84% cases were older than 8 to 9 months children;88.29% cases were Diaspora children. 6 184 cases(99.20%) were general response(fever, redness or calluses);6 226 cases(99.89%) were heal or get better;4 cases(0.06%) were in treatment;1 cases(0.02%) were in sequelae;2 cases(0.03%) died of coincidental event. Conclusion The AEFI surveillance system was well operated in Liaocheng City from 2017 to 2020, the monitoring keypoint would be AEFI investigation under 6 years old children or within 24 hours after vaccination. Also, the safety of NIP vaccines and N-NIP vaccines were better as AEFI surveillance results for vaccines on market.