SAT-TB检测法在初治涂阳肺结核患者疗效评估中的应用研究  

Application of SAT-TB in the evaluation of curative effect of initial treatment of smear-positive pulmonary tuberculosis patients

作　　者：赖静文 彭柯皓 徐镠粤 赖晓宇 黎敬忠 余美玲 梁鸿迪 陈珣珣 LAI Jingwen;PENG Kehao;XU Liuyue;LAI Xiaoyu;LI Jingzhong;YU Meiling;LIANG Hongdi;CHEN Xunxun(Guangzhou Panyu District Chronic Disease Control Station,Guangzhou,Guangdong 511400,China;Guangdong Provincial Center for Tuberculosis Prevention and Control,Guangzhou,Guangdong 510620,China)

机构地区：[1]广州市番禺区慢性病防治站,广东广州511400 [2]广东省结核病控制中心,广东广州510620

出　　处：《国际检验医学杂志》2024年第21期2577-2581,2587,共6页International Journal of Laboratory Medicine

基　　金：广东省科技计划项目(2021B1212030003);广东省感染性疾病(结核病)临床医学研究中心(2020B1111170014)。

摘　　要：目的评估实时荧光核酸恒温扩增检测法(SAT-TB)在初治涂阳肺结核患者的疗效评估中的应用价值。方法选取2022年6月至2023年6月于广州市番禺区慢性病防治站就诊的62例初治涂阳肺结核患者作为研究对象,使用液基夹层杯法、罗氏培养法、SAT-TB检测法对其进行疗效评估。所有患者均接受2HRZE/4HR标准的抗结核治疗方案,并在治疗第2、4、8周时分别使用液基夹层杯法、罗氏培养法、SAT-TB检测法检测患者痰液标本。结果62例患者中,罗氏培养法检测阳性54例,阴性8例,SAT-TB检测法阳性47例,阴性15例;结核分枝杆菌(MTB)-DNA检测阳性60例,阴性2例;3种检测方法阳性检出率分别为87.10%(54/62)、75.81%(47/62)、96.77%(60/62)。以罗氏培养法结果作为标准,SAT-TB和MTB-DNA灵敏度分别为97.87%(46/47)和90.00%(54/60),特异度分别为46.67%(7/15)和100.00%(2/2)。罗氏培养法与SAT-TB和MTB-DNA检测结果比较,差异有统计学意义(χ^(2)=20.070、P<0.05,χ^(2)=13.985、P<0.05),SAT-TB和MTB-DNA检测结果比较,差异有统计学意义(χ^(2)=8.365、P<0.05)。第2、4、8周采用3种方法检测痰MTB阴转率分别为69.35%(43/62)、29.03%(18/62)、41.94%(26/62),77.42%(48/62)、59.68%(37/62)、58.06%(36/62),82.26%(51/62)、79.03%(49/62)、75.81%(47/62);SAT-TB检测法与液基夹层杯法在第2、4周MTB阴转率比较,差异有统计学意义(χ^(2)=8.365、P<0.05,χ^(2)=4.465、P<0.05),与第2、4、8周罗氏培养法结果比较,差异均无统计学意义(χ^(2)=1.726、P>0.05,χ^(2)=0.000、P>0.05,χ^(2)=0.046、P>0.05)。结论使用SAT-TB检测法对涂阳肺结核患者进行疗效评估,可以准确快速地评估患者的痰菌阴转率和治疗效果,为指导临床治疗提供可靠依据,可作为一种有效的辅助诊断和疗效评估方法。Objective To evaluate the application value of simultaneous amplification and testing for Mycobacterium tuberculosis(SAT-TB)in evaluating the curative effect of initial treatment of smear-positive pulmonary tuberculosis patients.Methods A total of 62 newly treated smear positive pulmonary tuberculosis patients from June 2022 to June 2023 in Guangzhou Panyu District Chronic Disease Control Station were selected as the study objects,and the curative effect was evaluated by liquid-based sandwich cup method,Roche culture method and SAT-TB detection method.All patients received the standard anti-tuberculosis treatment regimen of 2HRZE/4HR standard regimen,and sputum samples were detected by liquid-based sandwich cup method,Roche culture method,and SAT-TB detection method at the 2nd,4th,and 8th week of treatment,respectively.Results Among 62 patients,54 cases were positive and 8 cases were negative using Roche culture method,47 cases were positive and 15 cases were negative using SAT-TB detection method.60 cases were positive and 2 cases were negative by Mycobacterium tuberculosis(MTB)-DNA test.The positive rates of the three methods were 87.10%(54/62),75.81%(47/62)and 96.77%(60/62),respectively.Taking Roche culture method results as the standard,the sensitivity of SAT-TB detection method and MTB-DNA was 97.87%(46/47)and 90.00%(54/60),and the specificity was 46.67%(7/15)and 100.00%(2/2),respectively.There were signifi-cant differences between Roche culture method and SAT-TB detection method and MTB-DNA test(χ^(2)=20.070,P<0.05,χ^(2)=13.985,P<0.05),the difference between the results of SAT-TB detection method and MTB-DNA test was also statistically significant(χ^(2)=8.365,P<0.05).The negative conversion rates of MTB in sputum samples were 69.35%(43/62),29.03%(18/62)and 41.94%(26/62)at the 2nd,4th,and 8th weeks,respectively.77.42%(48/62),59.68%(37/62),58.06%(36/62),82.26%(51/62),79.03%(49/62),75.81%(47/62).There were significant differences in the negative conversion rates of MTB in sputum sam-ples between SAT-TB and

关 键 词：实时荧光核酸恒温扩增检测法 涂阳肺结核 疗效评估 阴转率 

分 类 号：R440[医药卫生—诊断学] R521[医药卫生—临床医学]