本文選題：預(yù)防接種后不良事件　切入點(diǎn)：接種門診　出處：《復(fù)旦大學(xué)》2010年碩士論文　論文類型：學(xué)位論文

【摘要】： 研究背景 接種疫苗是預(yù)防控制傳染病的最有效經(jīng)濟(jì)的方法,預(yù)防接種工作已經(jīng)在全世界普遍開(kāi)展。隨著預(yù)防性生物制品的品種不斷增加和接種劑次數(shù)的升高,預(yù)防接種后不良事件的發(fā)生報(bào)告數(shù)量也越來(lái)越多,相應(yīng)地,公眾對(duì)預(yù)防接種安全日益關(guān)注,一些預(yù)防接種后不良事件已經(jīng)在社會(huì)上造成負(fù)面影響,預(yù)防接種后不良事件如果未能有效處理,將對(duì)預(yù)防接種工作造成威脅。所以迫切需要建立有效、靈敏的預(yù)防接種后不良事件監(jiān)測(cè)系統(tǒng)。2004年我國(guó)將預(yù)防接種后不良反應(yīng)納入藥品不良反應(yīng)監(jiān)測(cè)系統(tǒng),但經(jīng)該監(jiān)測(cè)系統(tǒng)不為預(yù)防接種專業(yè)人員及大眾熟知。2005年上海市建立了經(jīng)疾病預(yù)防控制機(jī)構(gòu)系統(tǒng)的預(yù)防接種后不良事件的三級(jí)報(bào)告系統(tǒng),由個(gè)人或相關(guān)單位一接種單位一疾控機(jī)構(gòu)組成,其中接種單位(主要為社區(qū)接種門診)是重要的中間環(huán)節(jié)。目前國(guó)內(nèi)文獻(xiàn)對(duì)各類疫苗的不良事件發(fā)生和報(bào)告、監(jiān)測(cè)情況顯示,不同地區(qū)、不同時(shí)期的觀察數(shù)據(jù)相差懸殊,缺乏有效的分析和評(píng)價(jià)依據(jù),同時(shí)不良事件的報(bào)告發(fā)生率可能受監(jiān)測(cè)標(biāo)準(zhǔn)、醫(yī)務(wù)人員責(zé)任心、家長(zhǎng)認(rèn)知度等多種因素影響,其可信度和真實(shí)性有待探討。為了更好地做好安全預(yù)防接種工作,有必要提高預(yù)防接種后不良事件監(jiān)測(cè)系統(tǒng)的效率和敏感性,尤其要做好接種門診這個(gè)監(jiān)測(cè)中間環(huán)節(jié)的工作。 研究目的 本課題將通過(guò)回顧性分析歷史資料和現(xiàn)況研究,旨在了解浦東新區(qū)接種門診預(yù)防接種后不良事件的監(jiān)測(cè)現(xiàn)狀,分析監(jiān)測(cè)工作開(kāi)展的接種方和受種方人員的監(jiān)測(cè)KAP現(xiàn)況及其可能的影響因素,發(fā)現(xiàn)當(dāng)前接種門診預(yù)防接種后不良事件監(jiān)測(cè)工作中存在的問(wèn)題,研究影響監(jiān)測(cè)效率的主要因素,從而為改進(jìn)和完善浦東新區(qū)接種門診預(yù)防接種后不良事件監(jiān)測(cè)工作提供指導(dǎo)依據(jù),提高其預(yù)防接種后不良事件監(jiān)測(cè)工作的效率,進(jìn)而為保障浦東新區(qū)的安全預(yù)防接種工作服務(wù)。 資料來(lái)源與方法 1、浦東新區(qū)疾病預(yù)防控中心預(yù)防接種工作業(yè)務(wù)資料中的相關(guān)資料； 2、浦東新區(qū)接種門診預(yù)防接種后不良事件監(jiān)測(cè)現(xiàn)況調(diào)查,調(diào)查對(duì)象為全區(qū)32家接種門診的條線業(yè)務(wù)負(fù)責(zé)人,調(diào)查方法為問(wèn)卷調(diào)查； 3、對(duì)浦東新區(qū)全區(qū)接種門診的工作人員共158人開(kāi)展預(yù)防接種后不良事件監(jiān)測(cè)工作KAP調(diào)查； 4、采用容量比例抽樣方法,按2007年各接種門診的接種劑次數(shù)比例抽取1163名兒童家長(zhǎng),進(jìn)行KAP調(diào)查。 主要研究結(jié)果 一、浦東新區(qū)預(yù)防接種門診預(yù)防接種后不良事件監(jiān)測(cè)現(xiàn)況 1、一般情況：全區(qū)共有32家接種門診,各接種門診的轄區(qū)面積、人口相差懸殊,鄉(xiāng)鎮(zhèn)的接種門診比街道的接種門診要服務(wù)更多的外來(lái)兒童,接種門診人力配備不足,按《上海市接種門診工作規(guī)范》來(lái)評(píng)價(jià),接種門診人力達(dá)標(biāo)率僅34.38%。 2、接種門診的預(yù)防接種后不良事件的報(bào)告敏感性逐年提高,報(bào)告發(fā)生率由2006年的26.7例/10萬(wàn)劑次升高到2008年的57.7例/10萬(wàn)劑次。參與報(bào)告的接種門診數(shù)由2006年的25家上升到2007、2008年的30家,參與報(bào)告的比例達(dá)到93.8%。 3、在全區(qū)32家接種門診中100%安排了專人負(fù)責(zé)每月的AEFI監(jiān)測(cè)報(bào)表上報(bào)工作。 4、硬件支持方面：有專用計(jì)算機(jī)、能在門診進(jìn)行計(jì)算機(jī)網(wǎng)絡(luò)報(bào)告、有專用電話線、配備專用打印機(jī)的比例分別為：68.7%、37.5%、78.1%、37.5%。 5、信息來(lái)源：主要由受種兒童家長(zhǎng)報(bào)告,構(gòu)成比為96.9%。兒童家長(zhǎng)報(bào)告的主要方式為采用電話至接種門診的方式,占84.4%。 6、漏報(bào)現(xiàn)象：在2008年,有37.5%的接種門診承認(rèn)存在漏報(bào)的現(xiàn)象。漏報(bào)的原因,有58.3%的認(rèn)為是接種門診太忙了；有58.3%認(rèn)為是報(bào)告的內(nèi)容太多或報(bào)告程序太繁瑣。 二、預(yù)防接種門診專業(yè)人員對(duì)預(yù)防接種后不良事件監(jiān)測(cè)的KAP調(diào)查 1、一般情況：全區(qū)接種門診平均在接種門診工作每周一次以上的工作人員有158名,平均年齡為39.0歲,女性構(gòu)成比85.4%,中專和大專學(xué)歷的占77.8%。 2、專業(yè)情況：55.1%d的人員專業(yè)職稱為初級(jí),無(wú)職稱的占36.0%。平均從事預(yù)防接種工作時(shí)間為8.79年；有89.9%的人有預(yù)防接種上崗證；有68.45%參加過(guò)預(yù)防接種后不良事件的處理工作。84.2%的專業(yè)人員均參加過(guò)AEFI監(jiān)測(cè)培訓(xùn)。 3、相關(guān)知曉情況：調(diào)查對(duì)象對(duì)AEFI監(jiān)測(cè)相關(guān)知識(shí)的知曉率為70.7%。對(duì)AEFI的概念分類、不良反應(yīng)的一般發(fā)生時(shí)間、對(duì)異常反應(yīng)的監(jiān)測(cè)要求報(bào)告時(shí)間,專業(yè)人員知曉率分別為58.9%、84.8%、73.4%。調(diào)查對(duì)象的年齡和從事預(yù)防接種工作時(shí)間這2個(gè)因素對(duì)專業(yè)人員的AEFI概念分類知曉率有顯著性影響。 4、相關(guān)態(tài)度：69.9%的人認(rèn)為在接種門診預(yù)防接種安全性和預(yù)防接種效果一樣重要,認(rèn)為有必要的人和非常有必要開(kāi)展AEFI監(jiān)測(cè)工作的人構(gòu)成比為94.3%；認(rèn)為有必要將哪怕是輕微的一般反應(yīng)也要納入監(jiān)測(cè)范圍的人數(shù)構(gòu)成比為66.5%。認(rèn)為有必要開(kāi)展AEFI主動(dòng)監(jiān)測(cè)工作的人構(gòu)成比為66.5%；認(rèn)為有必要將AEFI監(jiān)測(cè)報(bào)告率的納入工作考核指標(biāo)的人構(gòu)成比為49.4%。 5、相關(guān)行為：有76.6%的專業(yè)人員會(huì)按規(guī)定常規(guī)登記報(bào)告,另有22.8%的人認(rèn)為癥狀輕,就不登記報(bào)告了。對(duì)于接種門診專業(yè)人員在2008年工作查閱文獻(xiàn)的情況,有53.3%的人沒(méi)有查閱過(guò)。 調(diào)查專業(yè)人員在2008年實(shí)際監(jiān)測(cè)預(yù)防接種后不良事件的情況,顯示有79.2%的人在接到報(bào)告后將信息無(wú)遺漏地報(bào)告進(jìn)AEFI監(jiān)測(cè)系統(tǒng),另有19.8%的人只是將嚴(yán)重的事件才進(jìn)行了報(bào)告。分析報(bào)告資料的來(lái)源,其中99.0%來(lái)自于家長(zhǎng)報(bào)告。 三、預(yù)防接種受種兒童家長(zhǎng)對(duì)預(yù)防接種后不良事件監(jiān)測(cè)的KAP調(diào)查 1、一般情況：共調(diào)查兒童1163名,平均年齡為1.8歲；59.3%為本地兒童,38%為在滬居住3個(gè)月及以上的外來(lái)兒童。家長(zhǎng)主要為父母,構(gòu)成比88.7%,平均年齡32.3歲,20-40歲的人占87%,女性占61.3%。 2、相關(guān)情況：97.2%的兒童在醫(yī)院出生。兒童母親的文化程度和父親文化程度分布類似,大專及以上比例最高,占近一半。約50%的家庭年收入在3-5萬(wàn)和5-10萬(wàn)。 3、相關(guān)知曉情況：相關(guān)知識(shí)的知曉率為69.1%。聽(tīng)說(shuō)過(guò)預(yù)防接種后不良反應(yīng)的構(gòu)成比為81.7%；認(rèn)為預(yù)防接種后可能會(huì)發(fā)生不良反應(yīng)的人數(shù)構(gòu)成比為78.2%；知曉3種及以上預(yù)防接種不良反應(yīng)的構(gòu)成比為49.2%；知曉不良反應(yīng)一般發(fā)生時(shí)間的構(gòu)成比為67.5%。 4、相關(guān)態(tài)度：認(rèn)為有必要和非常有必要開(kāi)展監(jiān)測(cè)工作的構(gòu)成比為88.2%；家長(zhǎng)認(rèn)為接種安全和疫苗效果一樣重要的比例高達(dá)59.8%；對(duì)于如果兒童接種疫苗后有不良反應(yīng)發(fā)生,持一般的輕的反應(yīng)不報(bào)告的態(tài)度的人最多,占61.0%,發(fā)生嚴(yán)重的反應(yīng)的話,持向接種門診報(bào)告態(tài)度的人占46.6%,會(huì)向有關(guān)部門報(bào)告的占32.8%；從沒(méi)想到要報(bào)告的人比例為10.7%。 5、相關(guān)行為：家長(zhǎng)會(huì)選擇采用的報(bào)告AEFI方式(可多選)：到接種門診告知、電話報(bào)告的比例分別為70.2%、52.3%,但有42.8%的家長(zhǎng)不知接種門診的電話號(hào)碼；另有27.9%的人選擇在下次接種時(shí)告知門診醫(yī)師。 調(diào)查曾發(fā)生過(guò)預(yù)防接種后不良反應(yīng)的兒童的家長(zhǎng),其實(shí)際采取的AEFI監(jiān)測(cè)行為,采取向接種門診報(bào)告的人數(shù)構(gòu)成比為36.8%,未報(bào)告的比例高達(dá)62.7%。分析未報(bào)告的原因(可多選),主要是家長(zhǎng)認(rèn)為不良反應(yīng)的癥狀很輕,沒(méi)必要報(bào)告,所占比例為91.7%,其次有22.3%的家長(zhǎng)無(wú)報(bào)告意識(shí)；調(diào)查分析進(jìn)行過(guò)報(bào)告的家長(zhǎng)的報(bào)告方式,及時(shí)到接種門診去報(bào)告的最多,所占比例為45.8%,其次為用電話報(bào)告。結(jié)論和建議 1、預(yù)防接種后不良事件發(fā)生例數(shù)隨接種疫苗的品種和接種量正逐年升高,做好預(yù)防接種后不良事件的監(jiān)測(cè)工作是保障安全接種工作的重要部分。 2、接種門診是開(kāi)展預(yù)防接種后不良事件監(jiān)測(cè)工作中重要的中間環(huán)節(jié),浦東新區(qū)當(dāng)前絕大多數(shù)接種門診已配備了開(kāi)展監(jiān)測(cè)工作的硬件,有專人負(fù)責(zé)監(jiān)測(cè)報(bào)告工作,專業(yè)人員對(duì)監(jiān)測(cè)工作知曉程度尚可,但大多數(shù)接種門診專業(yè)人員配備不足,日常接種工作量超負(fù)荷及監(jiān)測(cè)報(bào)告工作程序繁瑣復(fù)雜,造成了接種門診存在接到報(bào)告時(shí)不登記上報(bào)的漏報(bào)情況,建議有關(guān)部門能增加接種門診的人力配備,簡(jiǎn)化報(bào)告程序,提高監(jiān)測(cè)的敏感性。 3、在目前開(kāi)展的預(yù)防接種后不良事件被動(dòng)監(jiān)測(cè)工作中,受種兒童家長(zhǎng)是預(yù)防接種后不良事件監(jiān)測(cè)的首要報(bào)告人。研究提示受種兒童家長(zhǎng)重視預(yù)防接種后不良事件的監(jiān)測(cè)工作,但家長(zhǎng)對(duì)輕微的一般反應(yīng)基本無(wú)報(bào)告意識(shí),雖然電話報(bào)告按是其主要報(bào)告方式,但有近半數(shù)家長(zhǎng)不知接種門診的電話號(hào)碼；因此有必要進(jìn)一步做好對(duì)兒童家長(zhǎng)的預(yù)防接種后不良事件監(jiān)測(cè)的宣傳教育工作。共建敏感、有序的預(yù)防接種后不良事件監(jiān)測(cè)系統(tǒng),提高安全預(yù)防接種水平。
[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.

【學(xué)位授予單位】：復(fù)旦大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2010
【分類號(hào)】：R186

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