山东省东营市采供血机构及医疗机构不同梅毒螺旋体检测方案对比分析

Contrastive analysis of different treponema pallidum detection schemes between medical institutions and blood services in Dongying City, Shandong Province

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.

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＆#39;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＆#39; 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＆#39;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＆#39;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＆#39;s Hospital of Dongying and Dongying Central Blood Station.All donors were confirmed by the ＆quot; Requirements of Donor Health Examination＆quot; （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＆#39;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.