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

doi:10.19982/j.issn.1000-6621.20230313

中国防痨杂志 ›› 2023, Vol. 45 ›› Issue (11): 1072-1077.doi: 10.19982/j.issn.1000-6621.20230313

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

阮云洲¹, 张红伟², 李月华³, 马樱子⁴, 成诗明⁵, 樊海英⁵, 李仁忠¹(), 赵雁林¹()

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

收稿日期:2023-08-28 出版日期:2023-11-10 发布日期:2023-11-03
通信作者: 李仁忠,Email:lirz@chinacdc.cn;赵雁林,Email:zhaoyl@chinacdc.cn
基金资助:
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)

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

Ruan Yunzhou¹, Zhang Hongwei², Li Yuehua³, Ma Yingzi⁴, Cheng Shiming⁵, Fan Haiying⁵, Li Renzhong¹(), Zhao Yanlin¹()

¹National Center for Tuberculosis Control and Prevention, Chinese Center for Diseases Control and Prevention, Beijing 102206, China
²Tuberculosis Control and Prevention Center, Beijing Center for Diseases Control and Prevention, Beijing 100035, China
³Office of Wuhan Institute for Tuberculosis Control, Wuhan 430030, China
⁴Department of Tuberculosis Prevention and Control, Chengde Center for Diseases Control and Prevention, Chengde 067026, China
⁵Chinese Antituberculosis Association, Beijing 100710, China

Received:2023-08-28 Online:2023-11-10 Published:2023-11-03
Contact: Li Renzhong, Email: lirz@chinacdc.cn; Zhao Yanlin, Email: zhaoyl@chinacdc.cn
Supported by:
Introducing New Technologies in General Hospital for Early Detection of Infectious and Drug-Resistant Tuberculosis(01202204)

摘要/Abstract

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(χ²=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(χ²=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(χ²=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(χ²=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。

关键词: 结核, 肺, 抗药性, 分子诊断技术, 对比研究

Abstract:

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; χ²=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; χ²=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 higher than that detected by sputum smear (33.6%, 99/295; χ²=142.092, P<0.001); when GeneXpert and sputum culture were tested simultaneously, the proportion of MTB detected by GeneXpert (86.3%, 107/124) was higher than that of sputum culture (63.7%, 79/124; χ²=16.860, P<0.001). Conclusion: GeneXpert technology is helpful for the early diagnosis of bacteriologically confirmed pulmonary tuberculosis and drug-resistant pulmonary tuberculosis in general hospitals. It is suggested that general hospitals should routinely carry out GeneXpert test and incorporate it into the medical insurance reimbursement catalogue to improve its efficiency.

Key words: Tuberculosis, pulmonary, Drug resistance, Molecular diagnostic techniques, Comparative study

中图分类号:

R521

阮云洲, 张红伟, 李月华, 马樱子, 成诗明, 樊海英, 李仁忠, 赵雁林. 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[J]. 中国防痨杂志, 2023, 45(11): 1072-1077. doi: 10.19982/j.issn.1000-6621.20230313

Ruan Yunzhou, Zhang Hongwei, Li Yuehua, Ma Yingzi, Cheng Shiming, Fan Haiying, Li Renzhong, Zhao Yanlin. Analysis of the effect of GeneXpert MTB/RIF technology on early detection of bacteriologically confirmed and drug-resistant pulmonary tuberculosis in general hospitals[J]. Chinese Journal of Antituberculosis, 2023, 45(11): 1072-1077. doi: 10.19982/j.issn.1000-6621.20230313

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参考文献 11

[1]	王宇. 全国第五次结核病流行病学抽样调查资料汇编. 北京: 军事医学科学出版社, 2011: 33.
[2]	何燕超, 揭志军. 综合医院活动性肺结核的早期筛查策略. 结核与肺部疾病杂志, 2022, 3(4): 334-337. doi:10.19983/j.issn.2096-8493.20220078.
[3]	中华人民共和国卫生部. 结核病防治管理办法. 卫生部令第92号. 2013-03-24.
[4]	何贤礼. 综合性医院应加强结核病诊治能力建设——读《为结核病历史性地回归呼吸科而奋斗》有感. 中国呼吸与危重监护杂志, 2016, 15(4): 321-322. doi:10.7507/1671-6205.2016076.
[5]	World Health Organization. WHO consolidated guidelines on tuberculosis. Module 3: diagnosis-rapid diagnostics for tuberculosis detection. Geneva: World Health Organization, 2020.
[6]	World Health Organization. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF assay for the diagnosis of pulmonary and extra-pulmonary TB in adults and children. Policy update. Geneva: World Health Organization, 2013.
[7]	World Health Organization. Global tuberculosis report 2022. Geneva: World Health Organization, 2022.
[8]	母双, 刘建民, 何权瀛. 综合医院“肺结核”诊断状况调查与分析. 医师进修杂志, 2002, 25(10):26-28. doi:10.3760/cma.j.issn.1673-4904.2002.10.013.
[9]	郭华征, 邢振川. 北京市某综合医院呼吸科病房肺结核患者特征及转诊情况分析. 结核与肺部疾病杂志, 2022, 3(2): 110-117. doi:10.19983/j.issn.2096-8493.20210152.
[10]	Vesga JF, Hallett TB, Reid MJA, et al. Assessing tuberculosis control priorities in high-burden settings: a modelling approach. Lancet Glob Health, 2019, 7(5):e585-e595. doi:10.1016/S2214-109X(19)30037-3.
[11]	崔晓敬, 魏栋, 王春雷, 等. 分子生物学和液体培养方法提高综合医院结核病病原学诊断能力的价值. 中国防痨杂志, 2021, 43(2): 143-146. doi:10.3969/j.issn.1000-6621.2021.02.008.

特征	研究组(370例)	对照组(342例)	统计检验值	P值
性别[例(构成比,%)]			χ²=0.458	0.499
男性	218(58.9)	210(61.4)
女性	152(41.1)	132(38.6)
年龄组[例(构成比,%)]			χ²=1.973	0.373
15~34岁	84(22.7)	65(19.0)
35~54岁	85(23.0)	90(26.3)
≥55岁	201(54.3)	187(54.7)
患者来源[例(构成比,%)]			χ²=46.547	<0.001
门诊	116(31.4)	194(56.7)
住院	254(68.6)	148(43.3)
住院天数[d,M(Q₁,Q₃)]	5(3,7)	7(4,9)	-^a	<0.001^a

分类	研究组(370例)	对照组(342例)	统计检验值	P值
病原学检查结果[例(构成比,%)]			χ²=50.560	<0.001
病原学阳性	329(88.9)	229(67.0)
综合医院首诊确诊	317(96.4)	172(75.1)	χ²=56.228	<0.001
转诊到定点医院确诊	12(3.6)	57(24.9)
病原学阴性	41(11.1)	113(33.0)
病例分类[例(构成比,%)]			χ²=163.653	<0.001
疑似肺结核	1(0.3)	83(24.3)
临床诊断肺结核	44(11.9)	87(25.4)
确诊肺结核	325(87.8)	172(50.3)
肺结核诊断时间[d,M(Q₁,Q₃)]	1(1,5)	4(1,11)	-^a	<0.001^a

分类	研究组	对照组	统计检验值	P值
首诊发现的病原学阳性患者[例(构成比,%)]	317(100.0)	172(100.0)	χ²=592.802	<0.001
本院直接开展利福平耐药性检测	314(99.1)	0(0.0)
转到定点医院开展利福平耐药性检测	2(0.6)	105(61.0)
未开展利福平耐药性检测	1(0.3)	67(39.0)
利福平耐药患者[例(构成比,%)]	10(100.0)	6(6/6)	-^a	0.007^a
本院发现的利福平耐药	8(80.0)	0(0/6)
转到定点医院发现的利福平耐药	2(20.0)	6(6/6)
利福平耐药诊断时间[d,M(Q₁,Q₃)]	1(1,4)	20(11,29)	-^b	0.005^b

[1]	丁芹, 张胜康, 任斐, 陈晓红, 胡春梅, 陈薇, 范琳. 耐药肺结核患者的营养状况调查及影响因素分析:一项多中心、大样本研究[J]. 中国防痨杂志, 2023, 45(9): 826-832.
[2]	车贝贝, 王小平, 邱青, 陈诚, 郑旭彬, 赵琦, 徐飚. 2009—2020年江苏省南通市耐多药/利福平耐药肺结核诊疗服务特征的纵向研究[J]. 中国防痨杂志, 2023, 45(9): 864-871.
[3]	杜毓, 张海鹏, 王鹏. 分枝杆菌噬菌体的研究现状及应用进展[J]. 中国防痨杂志, 2023, 45(9): 897-903.
[4]	任汝颜, 薛毅, 梁倩, 黄海荣. 堪萨斯分枝杆菌临床分离株对异烟肼敏感性差异机制研究[J]. 中国防痨杂志, 2023, 45(8): 728-733.
[5]	王庆, 丁彩红, 高绪胜, 解丹, 蒋培培, 熊瑜. 含贝达喹啉方案治疗非结核分枝杆菌病三例[J]. 中国防痨杂志, 2023, 45(8): 814-817.
[6]	王嫩寒, 田丽丽, 陈双双, 赵琰枫, 樊瑞芳, 陈昊, 任怡宣, 张洁, 易俊莉, 杨新宇, 于兰, 丁北川, 李传友, 代小伟. 荧光PCR探针熔解曲线技术检测痰标本结核分枝杆菌利福平耐药性的研究[J]. 中国防痨杂志, 2023, 45(6): 583-588.
[7]	王泊宁, 李涛, 陈伟. 耐药结核病经济负担研究进展[J]. 中国防痨杂志, 2023, 45(6): 607-612.
[8]	李姗姗, 王玉峰, 舒薇, 逄宇. 结核病实验室诊断技术研发新进展[J]. 中国防痨杂志, 2023, 45(5): 446-453.
[9]	宋瑞雪, 魏荣荣, 董静, 贾红彦, 杜博平, 孙琦, 邢爱英, 李自慧, 朱传智, 张宗德, 潘丽萍. γ-干扰素诱导蛋白-10 mRNA检测技术对结核病辅助诊断的价值[J]. 中国防痨杂志, 2023, 45(5): 471-476.
[10]	闫晓婧, 王庆枫, 杨扬, 初乃惠, 聂文娟. 支气管肺泡灌洗液纳米孔测序对涂片阴性肺结核诊断价值的验证性研究[J]. 中国防痨杂志, 2023, 45(5): 487-492.
[11]	付亮, 任坦坦, 张培泽, 卢水华. 世界卫生组织《结核病整合指南模块4:耐药结核病治疗2022年更新版》解读[J]. 中国防痨杂志, 2023, 45(4): 336-348.
[12]	朱玉梅, 夏子涵, 李金莉, 何慧珊, 王峰. 多色探针熔解曲线分析技术检测准广泛耐药肺结核的应用价值[J]. 中国防痨杂志, 2023, 45(4): 406-411.
[13]	邹远妩, 李静, 王彪, 王卓, 屈少毅, 袁志敏, 仵倩红. 结核分枝杆菌RNA恒温扩增实时荧光检测技术检测肺泡灌洗液诊断肺结核的价值[J]. 中国防痨杂志, 2023, 45(4): 434-436.
[14]	刘月园, 苏伟, 郑建刚, 王萌, 曾忠, 黄钦, 谢添, 李仁忠. 江西省经济欠发达地区发挥地市级结核病定点医院作用提升肺结核发现水平的研究[J]. 中国防痨杂志, 2023, 45(3): 279-284.
[15]	姚黎明, 姚晓伟, 董昭良, 刘丰胜, 王连波, 贾晨光. 宏基因组二代测序技术对髋/膝关节结核的诊断价值[J]. 中国防痨杂志, 2023, 45(3): 292-296.

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

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