综合医院引入GeneXpert MTB/RIF技术早期发现病原学阳性和耐药肺结核患者的效果分析  

Analysis of the effect of GeneXpert MTB/RIF technology on early detection of bacteriologically confirmed and drug-resistant pulmonary tuberculosis in general hospitals

作　　者：阮云洲[1] 张红伟 李月华 马樱子[4] 成诗明 樊海英 李仁忠[1] 赵雁林[1] Ruan Yunzhou;Zhang Hongwei;Li Yuehua;Ma Yingzi;Cheng Shiming;Fan Haiying;Li Renzhong;Zhao Yanlin(National Center for Tuberculosis Control and Prevention,Chinese Center for Diseases Control and Prevention,Beijing 102206,China;Tuberculosis Control and Prevention Center,Beijing Center for Diseases Control and Prevention,Beijing 100035,China;Office of Wuhan Institute for Tuberculosis Control,Wuhan 430030,China;Department of Tuberculosis Prevention and Control,Chengde Center for Diseases Control and Prevention,Chengde 067026,China;Chinese Antituberculosis Association,Beijing 100710,China)

机构地区：[1]中国疾病预防控制中心结核病预防控制中心,北京102206 [2]北京市疾病预防控制中心结核病预防控制所,北京100035 [3]武汉市结核病防治所办公室,武汉430030 [4]承德市疾病预防控制中心结核病防治科,承德067026 [5]中国防痨协会,北京100710

出　　处：《中国防痨杂志》2023年第11期1072-1077,共6页Chinese Journal of Antituberculosis

基　　金：综合医疗机构引入新技术早期发现传染性和耐药肺结核项目(01202204)。

摘　　要：目的:了解综合医院使用GeneXpert MTB/RIF(简称“GeneXpert”)技术诊断病原学阳性肺结核及耐药肺结核的现状,以更好地发挥综合医院在肺结核发现中的作用。方法:采用回顾性队列研究方法,以配备GeneXpert的8家三级甲等综合医院纳入的患者为研究组,以未配备GeneXpert的3家三级甲等综合医院纳入的患者为对照组,对比分析两组患者病原学阳性检出比例、利福平耐药检出比例、肺结核诊断时间和利福平耐药诊断时间。结果:研究组经GeneXpert检测的370例患者和对照组未经GeneXpert检测的342例患者纳入分析。研究组病原学阳性率(88.9%,329/370)高于对照组(67.0%,229/342),差异有统计学意义(χ^(2)=50.560,P<0.001);病原学阳性患者中,研究组首诊确诊肺结核的比例(96.4%,317/329)高于对照组(75.1%,172/229),差异有统计学意义(χ^(2)=56.228,P<0.001)。研究组肺结核诊断时间[1(1,5) d]短于对照组[4(1,11) d],差异有统计学意义(非参数秩和检验,P<0.001)。研究组发现利福平耐药患者的比例为80.0%(8/10),对照组发现的比例为0(0/6),差异有统计学意义(Fisher确切概率法,P=0.007)。研究组利福平耐药诊断时间[1(1,4) d]明显短于对照组[20(11,29) d],差异有统计学意义(非参数秩和检验,P=0.005)。研究组GeneXpert与痰涂片同时开展检测的患者中,GeneXpert检出结核分枝杆菌的比例(82.0%,242/295)高于痰涂片(33.6%,99/295),差异有统计学意义(χ^(2)=142.092,P<0.001);GeneXpert与痰培养同时开展检测的患者中,GeneXpert检出结核分枝杆菌的比例(86.3%,107/124)高于痰培养(63.7%,79/124),差异有统计学意义(χ^(2)=16.860,P<0.001)。结论:GeneXpert技术有助于综合医院早期诊断病原学阳性肺结核和耐药肺结核。建议综合医院常规开展GeneXpert检查,并将其纳入医保报销目录,以提高其使用效率。Objective:To understand the current situation of GeneXpert MTB/RIF(GeneXpert)technology in the diagnosis of bacteriologically confirmed pulmonary tuberculosis and drug-resistant pulmonary tuberculosis in general hospitals,so as to better play the role of general hospitals in the detection of pulmonary tuberculosis.Methods:A retrospective cohort study was conducted with pulmonary tuberculosis patients that from 8 tertiary general hospitals equipped with GeneXpert as the study group and those from 3 tertiary general hospitals not equipped with GeneXpert as the control group.The proportion of bacteriologically confirmed patients,the proportion of rifampicin-resistant patients,the diagnosis time of pulmonary tuberculosis patients and the diagnosis time of rifampicin-resistant patients were compared and analyzed between the two groups.Results:A total of 370 patients who were tested by GeneXpert in the study group and 342 patients who were not tested by GeneXpert in the control group were enrolled in the study.The proportion of bacteriologically confirmed patients in the study group(88.9%,329/370)was higher than that in the control group(67.0%,229/342;χ^(2)=50.560,P<0.001).Among the patients with bacteriologically confirmed,the proportion of first diagnosis in the study group(96.4%,317/329)was higher than that in the control group(75.1%,172/229;χ^(2)=56.228,P<0.001).The diagnosis time of pulmonary tuberculosis in the study group(1(1,5)d)was shorter than that in the control group(4(1,11)d;nonparametric test,P<0.001).The study group found that the proportion of patients with rifampicin resistance was 80.0%(8/10),while the proportion found in the control group was 0(0/6;Fisher’s exact test,P=0.007).The diagnosis time of rifampicin resistance in the study group(1(1,4)d)was significantly shorter than that in the control group(20(11,29)d;nonparametric test,P=0.005).Among the patients in the study group who underwent both GeneXpert and sputum smear testing,the proportion of MTB detected by GeneXpert(82.0%,242/295)was high

关 键 词：结核 肺 抗药性 分子诊断技术 对比研究 

分 类 号：R521[医药卫生—内科学]