中国疑似预防接种异常反应、疫苗接种及疫苗可预防疾病监测系统运行现状和策略分析

Analysis on current situation and strategy of China suspected adverse events following immunization,vaccination and vaccine-preventable diseases surveillance system

目的评价全国预防接种异常反应(adverse events following immunization,AEFI)监测系统、疫苗接种监测系统、疫苗可预防疾病(vaccine preventable disease,VPD)监测系统(包括全国传染病监测系统及急性迟缓性麻痹、麻疹等专报系统)的运行现状,提出监测系统的改进建议,加强疫苗安全性和有效性的监测和评价。方法通过系统性描述全国AEFI监测系统、疫苗接种监测系统、VDP监测系统的建立、运行现状,重点评价上述系统的运行结果、质量、作用及存在问题,从而提出相关性建议。查阅《中华人民共和国传染病防治法》、《疫苗流通和预防接种管理条例》、《预防接种工作规范》、《预防接种异常反应鉴定办法》、《全国疑似预防接种异常反应监测方案》、《儿童预防接种信息报告管理工作规范(试行)》、《全国急性迟缓性麻痹(AFP)病例监测方案》、《全国流行性乙型脑炎监测方案》、《全国流行性脑脊髓膜炎监测方案》等免疫规划相关法律、法规及相关文件、文献,描述性分析监测结果,从而提出相关性建议。结果 2005年,我国启动并建立了全国AEFI监测系统,2011年11月监测结果显示全国县级覆盖率达到82%;2011年WHO对我国疫苗国家监管机构(NRA)AEFI监测职能板块评估中8项指标通过率100%,25项压指标通过率96%。1994年,我国开始建立传统四苗接种率全国报告系统;2010年,建立并升级改造"中国免疫监测信息管理系统",2011年12月31日监测结果显示全国以县为单位覆盖率达到87.30%。根据传染病发病和控制需要,2003年起我国相继建立了全国传染病监测系统、AFP、麻疹、流行性乙型脑炎和流行性脑脊髓膜炎等疾病监测系统,逐步运行了全国专病监测系统。结论上述监测系统虽然取得了很好的监测结果,但也面临经费短缺、整体规划有待明确,各系统重复和数据不能互相利用等问题。因此建议从保障机制建设、信息技术应用、专业能力建设、监督考核评级和加强预测预警能力等方面逐步完善上述监测系统,从而为我国疾病控制、AEFI预防和处置等方面提供坚实的理论和数据依据。

Objective To evaluate the operation situation of adverse events following immunization（AEFI） surveillance system,vaccination surveillance system,vaccine preventable disease surveillance system（VPD）,including infectious disease surveillance system,AFP,measles special reporting system and so on,and then to provide advices about improving surveillance systems as well as to strengthen the surveillance and evaluation of vaccine safety and effectiveness.Methods Through the systematic description of the establishment and operation status of AEFI surveillance system,vaccination surveillance system,and vaccine preventable disease surveillance system,the study evaluated the above systems operation results,quality,function and current problems,and then proposed the suggestions.The relevant documents and literatures of National Immunization Programmed were reviewed,including ＂ Law of the People＇s Republic of the Prevention and Control of Infectious Diseases＂,＂ Ordinance of Vaccine Circulation and Vaccination Management＂,＂ Vaccination Work Specification＂,＂ Identification Methods for Abnormal Reaction Following Immunization＂,＂ National Plan for the Surveillance of AEFI＂,＂ Children＇s Vaccination Information Report Management Work specification （Trial Implementation） ＂,＂ National Plan for the Surveillance of Acute Flaccid Paralysis（AFP） Cases＂,＂ National Plan for the Surveillance of Japanese Encephalitis Vaccine＂,＂ National Plan for the Surveillance of Epidemic Cerebrospinal Meningitis＂.Results China established the national AEFI surveillance system in 2005.Surveillance results showed that the coverage of reporting counties reached 82% in November,2011.All 8 indicators with 96% of 25 sub-indicators in AEFI surveillance function were met in the WHO assess of China＇s national regulatory agency（NRA） in 2011.In 1994,China established national immunization reporting system for EPI vaccines,which was upgraded in 2010.The surveillance results on December 31,2011 showed that the overage of counties using the system reached 87.3%.In order to control infectious disease,China has established the national infectious disease reporting system in 2003.Special disease surveillance systems contained AFP,measles,Japanese encephalitis and epidemic cerebrospinal meningitis.Conclusions Although the surveillance systems made a good achievement,they were facing problems including fund shortage,unclear overall design,data repetition,and issues on data exchange.We suggested that China should improve the surveillance system in the areas of maintenance mechanism,information technology application,professional ability,supervision and evaluation,and disease prediction and alerting,so as to provide solid theoretical and data basis for disease control and prevention and response to AEFI.