社区人群结核杆菌潜伏性感染诊断方法的成本效益研究

Cost-effectiveness study of diagnosis methods of latent tuberculosis infection in a community population

目的对常用的结核潜伏感染诊断方法进行成本效益研究,为我国将来开展大规模全社区人群结核感染状况调查和选择适宜的干预措施提供基础数据。方法采用横断面研究设计,整体抽取丹阳市导墅镇2个村全人群作为研究对象,选择自身对照研究方法,对研究对象同时开展结核菌素试验(TST)和γ-干扰素释放试验(选用Quanti FERON-TB Gold InTube,QFT-GIT)检测其结核分枝杆菌感染情况,并模拟TST与QFT-GIT法联用检测,计算3种方法筛查目标人群的感染阳性率、精准率、试剂费、检测费,并分析其成本效益。结果以TST法检测,分别以注射硬结平均直径≥5mm、≥10mm为结核杆菌感染标准,研究人群感染率分别为44.1%、37.3%;以QFT-GIT法检测,人群感染率为19.7%,显著低于TST法检测结果(P值均<0.01);模拟TST+QFT-GIT法检测人群感染率为18.6%,与单纯使用QFT-GIT法差异无统计学意义(P>0.05)。以GFT-GIT检测阳性感染为标准,TST检测成本最低为30元,误诊率为47.1%;QFT-GIT法检测成本最高为500元;TST+QFT-GIT法结合使用的成本为250.4元,显著低于单纯使用QFT-GIT法。每检出一个结核杆菌阳性感染者,TST、QFT-GIT、TST+QFT-GIT的成本分别为80.7元、2 539.8元、1 342.9元。结论目前,TST、QFT-GIT、TST+QFTGIT等3种结核感染检测方法均存在缺陷,TST+QFT-GIT法结合使用虽具有较好的成本效益,但成本依旧过高无法应用于大范围筛查。研发其他特异性强、价格合理、方便使用的结核菌感染高危人群筛查方法迫在眉睫。

Objective To evaluate the cost-effectiveness of common diagnosis methods for latent tuberculosis infection（LTBI）;to provide baseline data for large-scale community-scale tuberculosis infection investigation and selection of appropriate intervention measures in the future in China.Methods Cross-sectional study design was employed,all residents of 2 villages in Danyang city were selected as the research subjects.All eligible participants using self-control were tested by 2 methods of tuberculin test（TST）and interferon-γrelease test（Quanti FERON-TB Gold In-Tube QFT-GIT）at the same time for LTBI,the combined use of TST and QFT-GIT was simulated.The positive rates,precise rates,reagent fees and detection fees of the3 methods such as TST,QFT-GIT,combined use of TST and QFT-GIT were calculated and cost-effectiveness were compared.Results The LTBI of population was 44.1% and 37.3% by using the TST method（PPD Diametercutoff=5 mm and10 mm）,respectively,which were much higher than results of QFT-GIT method with a LTBI rate of 19.7%（all P〈0.01）.The simulated combined use of TST and QFT-GIT method resulted LTBI rate of 18.6%,with no statistical difference compared to that of QFT-GIT method（P〉0.05）.Taking QFT-GIT LTBI result as standard,the cost of TST was the lowest（30 RMB/case）,the misdiagnosis rate was 47.1%;the cost of QFT-GIT method was highest（500 RMB/case）,and the cost of combined use of TST and QFT-GIT was 250.4 RMB/case,which was significantly lower than the QFT-GIT method.The costs were 80.7 RMB,2 539.8 RMB and 1 342.9 RMB for every LTBI patients identified by TST,QFT-GIT,combined use of TST and QFT-GIT methods,respectively.Conclusion Now the LTBI detection methods such as TST,QFT-GIT,combined use of TST and QFT-GIT were all have defects.The cost-effectiveness of combined use of TST and QFT-GIT was the highest,however the cost is still far more expensive for large scale screen for LTBI,which highlights the importance to develop a highly specific and convenient analysis method with reasonable cost for screen of LTBI high risk population.