目的 通过对山东省东营市采供血机构及医疗机构不同梅毒螺旋体(TP)检测方案进行对比分析,探讨TP筛查和诊断的最佳方案,旨在指导采供血机构TP筛查和计划生育服务部门婚前TP筛查方案的制定,以及TP的临床诊断.方法 选择2013年5月至2014年12月于山东省东营市东营区人民医院接受TP筛查的22 471例患者和2013年1月至2014年12月于东营市中心血站无偿献血前接受TP筛查的26 148例无偿献血者为研究对象,分别纳入医疗机构组(n=22 471)和采供血机构组(n=26 148).其中,采供血机构组无偿献血前接受TP筛查者,均采用2个不同生产厂家的TP-酶联免疫吸附试验(ELISA)试剂盒进行TP特异性抗体检测,同时开展TP-甲苯胺红不加热血清试验(TRUST),对TP检测结果TP抗体呈阳性者,再进行TP明胶颗粒凝集试验(TPPA)进行确诊.对医疗机构组受试者先采用TP-ELISA进行初筛,TP检测结果TP抗体呈阳性者,再对其进行TRUST和TPPA筛查予以诊断.对医疗机构组和采供血机构组2种TP筛查方案的TP筛查结果进行统计学分析.另外,以发生于东营区人民医院的实例说明该区某计划生育服务部门对婚前个体TP筛查只进行TP非特异性抗体筛查作为TP筛查方案的弊端.本研究遵循的程序符合东营区人民医院与东营市中心血站人体试验委员会制定的伦理学标准,得到该委员会批准,并征得受试对象的知情同意.所有献血者均符合《献血者健康检查要求》(GB18467-2011).所有献血者血液采集前均取得其知情同意,并在知情同意一栏签字后献血.两组受试对象年龄、性别构成比等基线资料比较,差异均无统计学意义(P＞0.05).结果 ①医疗机构组TP-ELISA的TP阳性检出率为1.40％(315/22 471),显著高于采供血机构组的0.41％(108/26 148),差异有统计学意义(x2=234,P＜0.05);而TRUST和TPPA的TP阳性检出率均显著低于采供血机构组(0.03％比0.23％,0.04％比0.23％),差异亦均有统计学意义(x2 =35,64;P＜0.05).②采供血机构组TP-ELISA检测结果TP抗体呈阳性者为108例,TRUST检测结果TP抗体呈阳性者为61例,TPPA确认试验结果TP抗体呈阳性者为63例,3种检测方法的检测结果TP抗体均为TP抗体阳性者为32例,TP-ELISA和TPPA检测结果TP抗体均呈阳性者为62例,TRUST和TPPA检测结果TP抗体均呈阳性者为33例,1例为TRUST和TPPA检测结果TP抗体均呈阳性,而TP-ELISA检测结果TP抗体呈阴性.③该区某计划生育服务部门因婚前TP筛查只开展TP非特异性抗体检查,而未开展TP特异性抗体检查,曾今发生1例婚前TP非特异性抗体筛查结果呈阴性妇女,而婚后TP特异性抗体检测结果呈阳性.由此可能导致其婚姻破裂或感情裂痕问题.结论 医疗机构、采供血机构及计划生育服务部门婚前检测的服务目的不同,应采用不同TP检测方案.医疗机构以诊断治疗为目的,而采供血机构为了保证用血安全,所以其采用的TP检测方案,均为目前TP检测的最佳方案,即采用TP特异性抗体与非特异性抗体结合检测的方案为最佳.计划生育服务部门婚前TP检测由于重视不够,所以仅采取TP非特异性抗体检测,计划生育服务部门对此应予以重视和改进.
目的 通過對山東省東營市採供血機構及醫療機構不同梅毒螺鏇體(TP)檢測方案進行對比分析,探討TP篩查和診斷的最佳方案,旨在指導採供血機構TP篩查和計劃生育服務部門婚前TP篩查方案的製定,以及TP的臨床診斷.方法 選擇2013年5月至2014年12月于山東省東營市東營區人民醫院接受TP篩查的22 471例患者和2013年1月至2014年12月于東營市中心血站無償獻血前接受TP篩查的26 148例無償獻血者為研究對象,分彆納入醫療機構組(n=22 471)和採供血機構組(n=26 148).其中,採供血機構組無償獻血前接受TP篩查者,均採用2箇不同生產廠傢的TP-酶聯免疫吸附試驗(ELISA)試劑盒進行TP特異性抗體檢測,同時開展TP-甲苯胺紅不加熱血清試驗(TRUST),對TP檢測結果TP抗體呈暘性者,再進行TP明膠顆粒凝集試驗(TPPA)進行確診.對醫療機構組受試者先採用TP-ELISA進行初篩,TP檢測結果TP抗體呈暘性者,再對其進行TRUST和TPPA篩查予以診斷.對醫療機構組和採供血機構組2種TP篩查方案的TP篩查結果進行統計學分析.另外,以髮生于東營區人民醫院的實例說明該區某計劃生育服務部門對婚前箇體TP篩查隻進行TP非特異性抗體篩查作為TP篩查方案的弊耑.本研究遵循的程序符閤東營區人民醫院與東營市中心血站人體試驗委員會製定的倫理學標準,得到該委員會批準,併徵得受試對象的知情同意.所有獻血者均符閤《獻血者健康檢查要求》(GB18467-2011).所有獻血者血液採集前均取得其知情同意,併在知情同意一欄籤字後獻血.兩組受試對象年齡、性彆構成比等基線資料比較,差異均無統計學意義(P＞0.05).結果 ①醫療機構組TP-ELISA的TP暘性檢齣率為1.40％(315/22 471),顯著高于採供血機構組的0.41％(108/26 148),差異有統計學意義(x2=234,P＜0.05);而TRUST和TPPA的TP暘性檢齣率均顯著低于採供血機構組(0.03％比0.23％,0.04％比0.23％),差異亦均有統計學意義(x2 =35,64;P＜0.05).②採供血機構組TP-ELISA檢測結果TP抗體呈暘性者為108例,TRUST檢測結果TP抗體呈暘性者為61例,TPPA確認試驗結果TP抗體呈暘性者為63例,3種檢測方法的檢測結果TP抗體均為TP抗體暘性者為32例,TP-ELISA和TPPA檢測結果TP抗體均呈暘性者為62例,TRUST和TPPA檢測結果TP抗體均呈暘性者為33例,1例為TRUST和TPPA檢測結果TP抗體均呈暘性,而TP-ELISA檢測結果TP抗體呈陰性.③該區某計劃生育服務部門因婚前TP篩查隻開展TP非特異性抗體檢查,而未開展TP特異性抗體檢查,曾今髮生1例婚前TP非特異性抗體篩查結果呈陰性婦女,而婚後TP特異性抗體檢測結果呈暘性.由此可能導緻其婚姻破裂或感情裂痕問題.結論 醫療機構、採供血機構及計劃生育服務部門婚前檢測的服務目的不同,應採用不同TP檢測方案.醫療機構以診斷治療為目的,而採供血機構為瞭保證用血安全,所以其採用的TP檢測方案,均為目前TP檢測的最佳方案,即採用TP特異性抗體與非特異性抗體結閤檢測的方案為最佳.計劃生育服務部門婚前TP檢測由于重視不夠,所以僅採取TP非特異性抗體檢測,計劃生育服務部門對此應予以重視和改進.
목적 통과대산동성동영시채공혈궤구급의료궤구불동매독라선체(TP)검측방안진행대비분석,탐토TP사사화진단적최가방안,지재지도채공혈궤구TP사사화계화생육복무부문혼전TP사사방안적제정,이급TP적림상진단.방법 선택2013년5월지2014년12월우산동성동영시동영구인민의원접수TP사사적22 471례환자화2013년1월지2014년12월우동영시중심혈참무상헌혈전접수TP사사적26 148례무상헌혈자위연구대상,분별납입의료궤구조(n=22 471)화채공혈궤구조(n=26 148).기중,채공혈궤구조무상헌혈전접수TP사사자,균채용2개불동생산엄가적TP-매련면역흡부시험(ELISA)시제합진행TP특이성항체검측,동시개전TP-갑분알홍불가열혈청시험(TRUST),대TP검측결과TP항체정양성자,재진행TP명효과립응집시험(TPPA)진행학진.대의료궤구조수시자선채용TP-ELISA진행초사,TP검측결과TP항체정양성자,재대기진행TRUST화TPPA사사여이진단.대의료궤구조화채공혈궤구조2충TP사사방안적TP사사결과진행통계학분석.령외,이발생우동영구인민의원적실례설명해구모계화생육복무부문대혼전개체TP사사지진행TP비특이성항체사사작위TP사사방안적폐단.본연구준순적정서부합동영구인민의원여동영시중심혈참인체시험위원회제정적윤리학표준,득도해위원회비준,병정득수시대상적지정동의.소유헌혈자균부합《헌혈자건강검사요구》(GB18467-2011).소유헌혈자혈액채집전균취득기지정동의,병재지정동의일란첨자후헌혈.량조수시대상년령、성별구성비등기선자료비교,차이균무통계학의의(P＞0.05).결과 ①의료궤구조TP-ELISA적TP양성검출솔위1.40％(315/22 471),현저고우채공혈궤구조적0.41％(108/26 148),차이유통계학의의(x2=234,P＜0.05);이TRUST화TPPA적TP양성검출솔균현저저우채공혈궤구조(0.03％비0.23％,0.04％비0.23％),차이역균유통계학의의(x2 =35,64;P＜0.05).②채공혈궤구조TP-ELISA검측결과TP항체정양성자위108례,TRUST검측결과TP항체정양성자위61례,TPPA학인시험결과TP항체정양성자위63례,3충검측방법적검측결과TP항체균위TP항체양성자위32례,TP-ELISA화TPPA검측결과TP항체균정양성자위62례,TRUST화TPPA검측결과TP항체균정양성자위33례,1례위TRUST화TPPA검측결과TP항체균정양성,이TP-ELISA검측결과TP항체정음성.③해구모계화생육복무부문인혼전TP사사지개전TP비특이성항체검사,이미개전TP특이성항체검사,증금발생1례혼전TP비특이성항체사사결과정음성부녀,이혼후TP특이성항체검측결과정양성.유차가능도치기혼인파렬혹감정렬흔문제.결론 의료궤구、채공혈궤구급계화생육복무부문혼전검측적복무목적불동,응채용불동TP검측방안.의료궤구이진단치료위목적,이채공혈궤구위료보증용혈안전,소이기채용적TP검측방안,균위목전TP검측적최가방안,즉채용TP특이성항체여비특이성항체결합검측적방안위최가.계화생육복무부문혼전TP검측유우중시불구,소이부채취TP비특이성항체검측,계화생육복무부문대차응여이중시화개진.
Objective By contrastive analysis of different treponema pallidum (TP) detection schemes between blood services and medical institutions,to explore the best TP screening and diagnosis schemes,so as to guide the clinical diagnosis and unpaid blood donation and TP screening before marriage.Methods From May 2013 to December 2014,a total of 22 471 cases of patients receiving TP screening in Dongying District People's Hospital of Dongying,Shandong Province,as medical institution group (n =22 471) and from January 2013 to December 2014,a total of 26 148 cases of blood donors in Dongying Central Blood Station,as blood service group (n=26 148) were included into this study.In Dongying Central Blood Station,two kinds of TP-enzyme-linked immunosorbent assay (ELISA) kit from different manufacturers and toluidine red unheated serum test (TRUST) kit were used to detect these donors' TP,respectively.The donors whose TP-ELISA or TRUST detection results were positive were required to be retested by TP particle agglutination (TPPA) test.In Dongying District People's Hospital of Dongying,TP-ELISA was used to detect patients who wanted to receive TP screening at first.And the patients whose TP-ELISA detection results were positive were required to be retested by TRUST and TPPA test.The two TP detection schemes were analyzed by statistical methods.In addition,an example in Dongying District People's Hospital of Dongying was introduced to explain the disadvantages of only detecting TP nonspecific antibody before marriage in family planning services.The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Dongying District People's Hospital of Dongying and Dongying Central Blood Station.All donors were confirmed by the " Requirements of Donor Health Examination" (GB18467-2011).Informed consent was obtained from all participants.There were no significant differences about age and gender composition between two groups (P ＞ 0.05).Results ①Among 22 471 cases of patients in medical institution group,a total of 315 cases were TP-ELISA positive,accounting for 1.40％ which was obviously higher than that of blood service group (108/26 148,0.41％),and the difference was statistically different (-x2 =234,P＜0.05).While the TRUST and TPPA positive rates of medical institution group were both obviously lower than those of blood service group (0.03％ vs 0.23％,0.04％ vs 0.23％),and the differences were statistically different (x2 =35,64;P＜0.05).② In blood service group,a total of 108 cases were TP-ELISA positive,61 cases were TRUST positive and 63 cases were TPPA positive,32 cases were all TP-ELISA,TRUST and TPPA positive,62 cases were both TP-ELISA and TPPA positive,33 cases were both TRUST and TPPA positive,one case were TP-ELISA negative but TRUST and TPPA positive.③ In a family planning service department,only TP nonspecific antibody screening was carried out for premarital TP screening.So one case of pregnant woman's TP nonspecific antibody screening results were negative before marriage while TP specific antibody test results were positive after marriage,and thus leading to breakdown of marriage.Conclusions Different services should adopt different TP detection schemes.The main purpose of medical institutions is diagnosis and treatment,and the blood services aim at ensuring the blood quality,the current detection scheme is the best,that is the combination of TP specific antibody and nonspecific antibody detection scheme is the best.Family planning service departments do not pay so much attention to TP detection,and just take TP nonspecific antibody screening.
