浦东新区预防接种后不良事件监测及相关知信行研究

发布时间：2018-03-06 00:07

本文选题：预防接种后不良事件　切入点：接种门诊　出处：《复旦大学》2010年硕士论文　论文类型：学位论文

【摘要】： 研究背景接种疫苗是预防控制传染病的最有效经济的方法,预防接种工作已经在全世界普遍开展。随着预防性生物制品的品种不断增加和接种剂次数的升高,预防接种后不良事件的发生报告数量也越来越多,相应地,公众对预防接种安全日益关注,一些预防接种后不良事件已经在社会上造成负面影响,预防接种后不良事件如果未能有效处理,将对预防接种工作造成威胁。所以迫切需要建立有效、灵敏的预防接种后不良事件监测系统。2004年我国将预防接种后不良反应纳入药品不良反应监测系统,但经该监测系统不为预防接种专业人员及大众熟知。2005年上海市建立了经疾病预防控制机构系统的预防接种后不良事件的三级报告系统,由个人或相关单位一接种单位一疾控机构组成,其中接种单位(主要为社区接种门诊)是重要的中间环节。目前国内文献对各类疫苗的不良事件发生和报告、监测情况显示,不同地区、不同时期的观察数据相差悬殊,缺乏有效的分析和评价依据,同时不良事件的报告发生率可能受监测标准、医务人员责任心、家长认知度等多种因素影响,其可信度和真实性有待探讨。为了更好地做好安全预防接种工作,有必要提高预防接种后不良事件监测系统的效率和敏感性,尤其要做好接种门诊这个监测中间环节的工作。研究目的本课题将通过回顾性分析历史资料和现况研究,旨在了解浦东新区接种门诊预防接种后不良事件的监测现状,分析监测工作开展的接种方和受种方人员的监测KAP现况及其可能的影响因素,发现当前接种门诊预防接种后不良事件监测工作中存在的问题,研究影响监测效率的主要因素,从而为改进和完善浦东新区接种门诊预防接种后不良事件监测工作提供指导依据,提高其预防接种后不良事件监测工作的效率,进而为保障浦东新区的安全预防接种工作服务。资料来源与方法 1、浦东新区疾病预防控中心预防接种工作业务资料中的相关资料； 2、浦东新区接种门诊预防接种后不良事件监测现况调查,调查对象为全区32家接种门诊的条线业务负责人,调查方法为问卷调查； 3、对浦东新区全区接种门诊的工作人员共158人开展预防接种后不良事件监测工作KAP调查； 4、采用容量比例抽样方法,按2007年各接种门诊的接种剂次数比例抽取1163名儿童家长,进行KAP调查。主要研究结果一、浦东新区预防接种门诊预防接种后不良事件监测现况 1、一般情况：全区共有32家接种门诊,各接种门诊的辖区面积、人口相差悬殊,乡镇的接种门诊比街道的接种门诊要服务更多的外来儿童,接种门诊人力配备不足,按《上海市接种门诊工作规范》来评价,接种门诊人力达标率仅34.38%。 2、接种门诊的预防接种后不良事件的报告敏感性逐年提高,报告发生率由2006年的26.7例/10万剂次升高到2008年的57.7例/10万剂次。参与报告的接种门诊数由2006年的25家上升到2007、2008年的30家,参与报告的比例达到93.8%。 3、在全区32家接种门诊中100%安排了专人负责每月的AEFI监测报表上报工作。 4、硬件支持方面：有专用计算机、能在门诊进行计算机网络报告、有专用电话线、配备专用打印机的比例分别为：68.7%、37.5%、78.1%、37.5%。 5、信息来源：主要由受种儿童家长报告,构成比为96.9%。儿童家长报告的主要方式为采用电话至接种门诊的方式,占84.4%。 6、漏报现象：在2008年,有37.5%的接种门诊承认存在漏报的现象。漏报的原因,有58.3%的认为是接种门诊太忙了；有58.3%认为是报告的内容太多或报告程序太繁琐。二、预防接种门诊专业人员对预防接种后不良事件监测的KAP调查 1、一般情况：全区接种门诊平均在接种门诊工作每周一次以上的工作人员有158名,平均年龄为39.0岁,女性构成比85.4%,中专和大专学历的占77.8%。 2、专业情况：55.1%d的人员专业职称为初级,无职称的占36.0%。平均从事预防接种工作时间为8.79年；有89.9%的人有预防接种上岗证；有68.45%参加过预防接种后不良事件的处理工作。84.2%的专业人员均参加过AEFI监测培训。 3、相关知晓情况：调查对象对AEFI监测相关知识的知晓率为70.7%。对AEFI的概念分类、不良反应的一般发生时间、对异常反应的监测要求报告时间,专业人员知晓率分别为58.9%、84.8%、73.4%。调查对象的年龄和从事预防接种工作时间这2个因素对专业人员的AEFI概念分类知晓率有显著性影响。 4、相关态度：69.9%的人认为在接种门诊预防接种安全性和预防接种效果一样重要,认为有必要的人和非常有必要开展AEFI监测工作的人构成比为94.3%；认为有必要将哪怕是轻微的一般反应也要纳入监测范围的人数构成比为66.5%。认为有必要开展AEFI主动监测工作的人构成比为66.5%；认为有必要将AEFI监测报告率的纳入工作考核指标的人构成比为49.4%。 5、相关行为：有76.6%的专业人员会按规定常规登记报告,另有22.8%的人认为症状轻,就不登记报告了。对于接种门诊专业人员在2008年工作查阅文献的情况,有53.3%的人没有查阅过。调查专业人员在2008年实际监测预防接种后不良事件的情况,显示有79.2%的人在接到报告后将信息无遗漏地报告进AEFI监测系统,另有19.8%的人只是将严重的事件才进行了报告。分析报告资料的来源,其中99.0%来自于家长报告。三、预防接种受种儿童家长对预防接种后不良事件监测的KAP调查 1、一般情况：共调查儿童1163名,平均年龄为1.8岁；59.3%为本地儿童,38%为在沪居住3个月及以上的外来儿童。家长主要为父母,构成比88.7%,平均年龄32.3岁,20-40岁的人占87%,女性占61.3%。 2、相关情况：97.2%的儿童在医院出生。儿童母亲的文化程度和父亲文化程度分布类似,大专及以上比例最高,占近一半。约50%的家庭年收入在3-5万和5-10万。 3、相关知晓情况：相关知识的知晓率为69.1%。听说过预防接种后不良反应的构成比为81.7%；认为预防接种后可能会发生不良反应的人数构成比为78.2%；知晓3种及以上预防接种不良反应的构成比为49.2%；知晓不良反应一般发生时间的构成比为67.5%。 4、相关态度：认为有必要和非常有必要开展监测工作的构成比为88.2%；家长认为接种安全和疫苗效果一样重要的比例高达59.8%；对于如果儿童接种疫苗后有不良反应发生,持一般的轻的反应不报告的态度的人最多,占61.0%,发生严重的反应的话,持向接种门诊报告态度的人占46.6%,会向有关部门报告的占32.8%；从没想到要报告的人比例为10.7%。 5、相关行为：家长会选择采用的报告AEFI方式(可多选)：到接种门诊告知、电话报告的比例分别为70.2%、52.3%,但有42.8%的家长不知接种门诊的电话号码；另有27.9%的人选择在下次接种时告知门诊医师。调查曾发生过预防接种后不良反应的儿童的家长,其实际采取的AEFI监测行为,采取向接种门诊报告的人数构成比为36.8%,未报告的比例高达62.7%。分析未报告的原因(可多选),主要是家长认为不良反应的症状很轻,没必要报告,所占比例为91.7%,其次有22.3%的家长无报告意识；调查分析进行过报告的家长的报告方式,及时到接种门诊去报告的最多,所占比例为45.8%,其次为用电话报告。结论和建议 1、预防接种后不良事件发生例数随接种疫苗的品种和接种量正逐年升高,做好预防接种后不良事件的监测工作是保障安全接种工作的重要部分。 2、接种门诊是开展预防接种后不良事件监测工作中重要的中间环节,浦东新区当前绝大多数接种门诊已配备了开展监测工作的硬件,有专人负责监测报告工作,专业人员对监测工作知晓程度尚可,但大多数接种门诊专业人员配备不足,日常接种工作量超负荷及监测报告工作程序繁琐复杂,造成了接种门诊存在接到报告时不登记上报的漏报情况,建议有关部门能增加接种门诊的人力配备,简化报告程序,提高监测的敏感性。 3、在目前开展的预防接种后不良事件被动监测工作中,受种儿童家长是预防接种后不良事件监测的首要报告人。研究提示受种儿童家长重视预防接种后不良事件的监测工作,但家长对轻微的一般反应基本无报告意识,虽然电话报告按是其主要报告方式,但有近半数家长不知接种门诊的电话号码；因此有必要进一步做好对儿童家长的预防接种后不良事件监测的宣传教育工作。共建敏感、有序的预防接种后不良事件监测系统,提高安全预防接种水平。
[Abstract]:Research background
Vaccination is the most effective and economical method to control infectious diseases, vaccination has been generally carried out in the world. With the increase of preventive biological products and increasing variety of inoculation times, number of reports of adverse events following immunization is also more and more, accordingly, the public pays more attention to the safety of vaccination and some adverse events following immunization has caused a negative impact on society, adverse events following immunization if not treated effectively, it will pose a threat to the vaccination work. So there is an urgent need to establish an effective monitoring system for adverse events,.2004 years after the sensitive vaccination in China after vaccination adverse reactions included adverse drug reaction monitoring system but, through the monitoring system for vaccination professionals and the public known.2005 in Shanghai city was established by the institution of disease prevention and control system Three grade reporting system of adverse events following immunization, by a person or a unit of a relevant unit inoculated disease control agencies, including the vaccination units (mainly for community vaccination clinics) is an important intermediate link. At present, the literature on various types of vaccine adverse events occurred and report monitoring shows that in different regions, observation the data of different periods vary, based on the lack of effective analysis and evaluation, and reporting of adverse events incidence may be affected by the monitoring standard, medical personnel responsibility, many factors influence the awareness of parents, to explore its reliability and authenticity. In order to better the safety of immunization, it is necessary to improve the efficiency and sensitivity of prevention after vaccination adverse event monitoring system, in particular to do the monitoring of the middle part of the vaccination clinic work.
research objective
This paper through the review of research data and historical status of the analysis, in order to understand the Pudong New Area vaccination clinic after vaccination status monitoring of adverse events, analysis of factors in monitoring KAP vaccination party monitoring work carried out and the staff and the possible influence, found that in the presence of adverse event monitoring before vaccination clinics after vaccination work in the problem, the main influence factors of the monitoring efficiency, so as to improve and perfect the Pudong New Area vaccination clinics to provide guidance for the monitoring of adverse events following immunization work, improve the efficiency of the adverse events following immunization monitoring work, so as to guarantee the safety of Pudong New Area vaccination service.
Sources and methods of data
1, related information in the business information of the Pudong New Area Center for prevention and control of disease prevention and control;
2, the current situation of adverse events monitoring after vaccination in outpatient clinic in Pudong New Area was investigated. The survey was conducted by 32 people in charge of vaccination in outpatient department.
3, a total of 158 people who were inoculated in the whole area of Pudong New Area were investigated by KAP to monitor the adverse events after vaccination.
4, using the method of capacity proportional sampling, 1163 parents of children were selected according to the proportion of inoculants in each outpatient vaccination in 2007, and the KAP survey was carried out.
Main research results
The present situation of adverse events monitoring after vaccination in Pudong New Area vaccination clinic
1 general situation: there were 32 vaccination clinics, the immunization clinic of the area, the population difference between vaccination clinics than Street Township vaccination clinics to serve more migrant children, lack of vaccination outpatient service human resource, press < Shanghai > standard to evaluate the vaccination clinics, outpatient vaccination compliance rate of only human 34.38%.
2, vaccination clinics after vaccination report sensitivity of adverse events increased year by year, reported 57.7 cases of /10 from 26.7 cases of /10 million in 2006 to 2008 increased dose dose. The number of million vaccination clinics in the report from 25 in 2006 rose to 20072008 years of 30, in the report of the proportion reached 93.8%.
3, 100% of the 32 vaccination outpatients in the whole area were assigned to report a monthly report on the AEFI report.
4, hardware support: there are special computers, which can make computer network reports in outpatient service. The percentage of private telephone lines and special printers is 68.7%, 37.5%, 78.1%, 37.5%. respectively.
5, the source of information is mainly reported by parents of parents of children. The constituent ratio is 96.9%.. The main way for parents to report children is from phone to vaccination clinic, accounting for 84.4%..
6, the phenomenon of missing report: in 2008, 37.5% of the vaccination clinics admitted that there was a missing report. 58.3% of the reasons for missing reporting were vaccination too busy, and 58.3% thought it was too much report or too cumbersome reporting procedure.
Two, a KAP survey on the monitoring of adverse events after vaccination by the professionals in the vaccination clinic
1, the general situation is: the whole district vaccination clinic has an average of 158 workers in the vaccination clinic once a week, the average age is 39 years old, the female ratio is 85.4%, the secondary vocational school and the junior college degree account for 77.8%..
2, professional: 55.1%d professional titles for junior titles accounted for 36.0%., no mean engaged in vaccination work for 8.79 years; 89.9% of the people have the vaccination certificate; 68.45% participated in the treatment of adverse events following immunization of.84.2% professionals participated in the training of AEFI monitoring.
3, related knowledge: the survey of AEFI monitoring rate of the knowledge for the concept of classification of AEFI 70.7%., the general occurrence time of adverse reaction, monitoring of the abnormal reaction time required to report, 58.9% respectively, about 84.8% professional staff, 73.4%. survey of the age and in the vaccination work time AEFI concept classification the 2 factors of professional awareness have significant influence.
4, attitude: 69.9% of people think that the safety of vaccination and vaccination effect as important in vaccination clinics, thinks it is necessary and very necessary to carry out the monitoring of AEFI people accounted for 94.3%; it is necessary to even a slight general response should be included in the scope of monitoring the number ratio 66.5%. think it is necessary to carry out active surveillance of AEFI workers accounted for 66.5%; it is necessary to constitute a ratio of 49.4%. index into the work of assessment AEFI monitoring report rate of people
5, related behaviors: 76.6% of the professionals will register the reports according to the rules, and 22.8% of them think the symptoms are mild. They will not register the reports. 53.3% of the people who had been working in the clinic in 2008 were not consulted.
Survey of professional real monitoring of adverse events following immunization in 2008 showed that 79.2% of the people after receiving the report information without missing report into the AEFI monitoring system, and another 19.8% people just the worst cases were reported. The source data analysis report, 99% of them from the parents.
Three, a KAP survey on the monitoring of adverse events after vaccination by parents of vaccinated children
1, the general situation: a total of 1163 children were investigated, the average age was 1.8 years old, 59.3% were local children, and 38% were migrant children who lived in 3 months or more in Shanghai. The parents were mainly parents, with a ratio of 88.7%. The average age was 32.3 years old, 20-40 years old accounted for 87%, and women accounted for 61.3%..
2, the related situation: 97.2% of the children were born in the hospital. The education level of their mothers was similar to that of their fathers' educational level. The proportion of the college students was above the highest level, accounting for nearly half of them. About 50% of the family's annual income was 3-5 Vanward 5-10 million.
3, related knowledge: the awareness rate of 69.1%. heard constitute adverse reactions after vaccination ratio is 81.7%; that number may occur after vaccination adverse reactions accounted for 78.2%; a known 3 or more adverse reactions of vaccination ratio is 49.2%; the time of occurrence of adverse reactions of general knowledge a ratio of 67.5%.
4, attitude that constitute necessary and very necessary to carry out the monitoring of the ratio is 88.2%; the proportion of parents think the safety and effect of vaccine inoculation as important as high as 59.8%; for the vaccination of children if any adverse reactions occur, holding general light reaction report of the attitude of the people the most, accounting for 61%, the occurrence of serious reaction, to report vaccination outpatient service attitude of the people accounted for 46.6%, will report to the relevant departments accounted for 32.8%; the proportion of people never expected to report for 10.7%.
5, related behavior: parents will choose to use the AEFI report (s): to inform the telephone report of vaccination clinics, were 70.2% and 52.3%, but the parents do not know the phone number of the 42.8% vaccination clinics; another 27.9% of people choose to inform the doctor at the next door of vaccination.
Parents of children adverse reactions occurred after vaccination survey, monitoring the behavior of the actual AEFI to take, take to number of vaccination clinics reported accounted for 36.8%, why did not report the proportion as high as 62.7%. analysis did not report (s), mainly parents think adverse reaction symptom is light, no necessary to report, the proportion of 91.7%, followed by 22.3% of the parents had no report consciousness; investigation and analysis of the report of parents report, in a timely manner to most vaccination clinics to report, the proportion of 45.8%, followed by telephone report. Conclusions and recommendations
1, the number of adverse events after vaccination is increasing year by year with the variety and inoculation of vaccination. Monitoring of adverse events after vaccination is an important part of ensuring the safety of vaccination.
2 is to carry out vaccination outpatient service important link monitoring of adverse events following immunization in Pudong New Area, the vast majority of vaccination clinics have been equipped with monitoring hardware, a person responsible for monitoring and reporting, professional knowledge of the monitoring work is available, but most vaccination clinics insufficiency of professional staff, the daily workload over vaccination the load and the monitoring and reporting procedure is tedious and complicated, resulting in existence of vaccination clinics received the report does not register the underreporting reported, it is suggested that relevant departments should increase the immunization clinic with the human, simplify reporting procedures, improve the monitoring sensitivity.
3, in the current development of adverse events following immunization passive monitoring work, the parents of children is the first report of adverse event monitoring after vaccination. The children's parents pay attention to the work of adverse event monitoring after vaccination, but the parents of the general light reaction of no report consciousness, although reports by telephone is the main way of reporting, but nearly half of the parents do not know the phone number of vaccination clinics; therefore it is necessary to further improve the children's parents after vaccination adverse event monitoring of the publicity and education work. Build a sensitive, adverse event monitoring orderly after vaccination system, improve the safety level of vaccination.

【学位授予单位】：复旦大学
【学位级别】：硕士
【学位授予年份】：2010
【分类号】：R186

【引证文献】