«上一篇/Previous Article|本期目录/Table of Contents|下一篇/Next Article»

《中华肺部疾病杂志》[ISSN:1006-6977/CN:61-1281/TN]

卷:

期数:

2022年02期

页码:

161-165

栏目:

论著

出版日期:

2022-04-20

文章信息/Info

Title:

Application of Gen-XpertMTB/RIF and fluorescence PCR melting curve method in rapid diagnosis of drug-resistant tuberculosis

作者:

刘 莉¹; 张 宁¹; 王科文²; 姚 莎¹; 杨康丽¹; 马纪龙²

710100 西安,陕西省结核病防治院¹ 721006 宝鸡,联勤保障部队第九八七医院结核科²

Author(s):

Liu Li¹;  Zhang Ning¹;  Wang Kewen²;  Yao Sha¹;  Yang Kangli¹;  Ma Jilong².

¹The Tuberculosis Prevention and Care Hospital in Shanxi Province, Xi'an 710100, China; ²Department of Lung, the 987 Hospital of People's Liberation Army Joint Support Force, Baoji 721006, China

关键词:

耐药肺结核;  荧光 PCR 溶解曲线法;  Gen-XpertMTB/RIF;  表型药敏;  成本效果比;  快速诊断

Keywords:

Drug-resistant tuberculosis;  Fluorescence PCR dissolution curve;  Gen-XpertMTB/RIF;  Phenotypic drug sensitivity;  Cost-effectiveness ratio;  Rapid diagnosis

分类号:

R562

DOI:

10.3877/cma.j.issn.1674-6902.2022.02.005

摘要:

目的 Gen-XpertMTB/RIF和荧光 PCR 熔解曲线法(MeltPro)在耐药结核病快速诊断中的意义。方法 选取2019年1月至12月陕西省结核病防治院收治的TB患者850例,均行表型药敏和Gen-XpertMTB/RIF检测,对Gen-XpertMTB/RIF检测阳性样本中利福平(RFP)耐药患者行MeltPro。以药敏法为金标准,分析Gen-XpertMTB/RIF对TB患者RFP耐药的诊断价值、成本效果比(C/E)和检测时间; 分析Gen-XpertMTB/RIF联合MeltPro对耐多药(MDR)和准广泛耐药(Pre-XDR)的诊断价值、C/E和检测时间。结果 Gen-XpertMTB/RIF对TB患者RFP耐药的诊断准确率为94.59%(804/850)。Gen-XpertMTB/RIF和药敏法对TB初治和复治患者RFP耐药的诊断一致性均较好。Gen-XpertMTB/RIF联合MeltPro诊断TB患者MDR的准确率为98.71%(839/850),且和药敏法对TB初治和复治患者MDR的诊断一致性均较好。Gen-XpertMTB/RIF诊断RFP耐药的C/E和诊断时间均低于药敏法。Gen-XpertMTB/RIF联合MeltPro诊断MDR、Pre-XDR的C/E高于药敏法,诊断时间低于药敏法。结论 Gen-XpertMTB/RIF应用于TB患者RFP耐药检测,Gen-XpertMTB/RIF联合MeltPro应用于TB患者MDR、Pre-XDR检测,与药敏法诊断一致性均较高,且能够明显缩短检测时间,为诊断和治疗耐药肺结核赢得时间,减少耐药结核菌的传播,降低耐药结核病的发生率。

Abstract:

Objective To analyze the application of Gen-XpertMTB/RIF and fluorescence PCR melting curve method in rapid diagnosis of drug-resistant tuberculosis were analyzed. Methods All of 850 TB patients admitted to Shaanxi Provincial Tuberculosis Prevention and Treatment Hospital from January to December 2019 were included, and were tested for phenotypic drug sensitivity and Gen-XpertMTB/RIF. Fluorescent PCR dissolution curve method was performed on rifampicin(RFP)-resistant patients in Gen-XpertMTB/RIF positive samples. Using the drug susceptibility method as the gold standard, the diagnostic value, cost-effectiveness ratio(C/E)and testing time of Gen-XpertMTB/RIF for TB patients'RFP resistance were analyzed; the diagnostic value, C/E and testing time of Gen-XpertMTB/RIF combined with fluorescent PCR melting curve method for multi-drug resistance(MDR)and pre-extensive drug resistance(Pre-XDR)were analyzed. Results The diagnostic accuracy of Gen-XpertMTB/RIF for RFP resistance in TB patients was 94.59%(804/850). Gen-XpertMTB/RIF and drug susceptibility method had good consistency in the diagnosis of RFP resistance in TB initial treatment and retreatment patients. The accuracy of Gen-XpertMTB/RIF combined with fluorescent PCR dissolution curve to diagnose MDR in TB patients was 98.71%(839/850), and the consistency of the diagnosis of MDR in TB patients with initial treatment and retreatment with the drug susceptibility method was good. The C/E and diagnosis time of Gen-XpertMTB/RIF for the diagnosis of RFP resistance were lower than that of the drug susceptibility method. The C/E of Gen-XpertMTB/RIF combined with MeltPro in the diagnosis of MDR and Pre-XDR was higher than that of drug sensitivity method, and the diagnosis time was lower than that of drug sensitivity method. Conclusion Gen-XpertMTB/RIF used in the detection of RFP resistance in TB patients, and the Gen-XpertMTB/RIF combined with fluorescent PCR melting curve method used in the detection of MDR and Pre-XDR in TB patients, both have high consistency with the drug sensitivity method and can significantly shorten the detection time, buy time for clinicians to diagnose and treat drug-resistant tuberculosis, thereby helping to reduce the spread of drug-resistant tuberculosis and the incidence of drug-resistant tuberculosis.

参考文献/References:

1 World Health Organization. Global tuberculosisi report 2019[R]. Geneva: World Health Organization, 2019.
2 高振秋, 王东方, 任成山. 耐多药结核病临床研究的回顾与展望[J/CD]. 中华肺部疾病杂志(电子版), 2010, 3(5): 353-363.
3 任成山, 林 辉, 杨仕明. 结核病的流行特征与耐多药的窘迫及其策略[J/CD]. 中华肺部疾病杂志(电子版), 2019, 12(3): 269-274.
4 Borisov S, Danila E, Maryandyshev A, et al. Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report[J]. Eur Res J, 2020, 54(6): 61-70.
5 雪 娟, 刘银萍, 张俊仙, 等. 应用基因芯片直接检测结核病患者各类标本中利福平和异烟肼耐药的价值[J]. 中国防痨杂志, 2019, 41(2): 138-144.
6 宋 婧, 车南颖. 结核分枝杆菌耐药机制和检测方法的研究进展[J]. 中国医药导报, 2018, 15(29): 29-34.
7 中华人民共和国卫生部. 肺结核诊断标准(WS288-2017). 北京. 中华人民共和国卫生部, 2017.
8 唐神结, 高 文. 临床结核病学(第2版)[M]. 北京: 人民卫生出版社, 2019: 124-126.
9 赵雁林, 逄 宇. 结核病实验室检验规程[M]. 北京: 人民卫生出版社, 2015: 59-75.
10 中国防痨协会. 耐药结核病化学治疗指南(2019年简版)[J]. 中国防痨杂志, 2019, 41(10): 1025-1073.
11 中华医学会结核病学分会. 中国耐多药和利福平耐药结核病治疗专家共识(2019年版)[J]. 中华结核和呼吸杂志, 2019, 42(10): 733-749.
12 张 玉, 侯双翼, 周丽平, 等. 2007-2017年湖北省利福平耐药肺结核流行病学特征分析[J]. 疾病监测, 2019, 34(7): 667-671.
13 陈振华, 张小萍, 余艳艳, 等. 结核分枝杆菌固体培养结合不同分子生物学检测的应用分析[J]. 临床检验杂志, 2020, 38(4): 273-275, 279.
14 马进宝, 杨 翰, 任 斐, 等. 三种分子生物学方法检测结核分枝杆菌耐药性的效能分析[J]. 中国防痨杂志, 2019, 14(4): 440-446.
15 王云格. Xpert MTB/RIF在肺结核及耐药结核检测中的价值[J]. 中国实用医药, 2021, 16(11): 103-104.
16 刘 艳, 古丽比克?木拉提, 玛力亚木?阿布力提甫, 等. 荧光PCR熔解曲线法检测结核分枝杆菌耐药基因的结果分析[J]. 中国防痨杂志, 2018, 40(9): 959-963.
17 陈 兴, 陈勇毅. 阳江市肺结核患者耐药状况调查及影响因素分析[J]. 实用药物与临床, 2019, 22(3): 321-324.
18 刘旭晖, 张爱梅, 卢水华. XpertMTB/RIF试验用于肺结核快速检测的临床研究[J/CD]. 中华肺部疾病杂志(电子版), 2016, 9(5): 4-6.
19 刘立宾, 王 静, 李 浩, 等. PCR-荧光探针法和Xpert MTB/RIF检测非呼吸道标本在结核病诊断中的应用价值[J]. 中华临床感染病杂志, 2019, 12(3): 180-185.
20 周 欣, 汤纯洁. GeneXpertMTB/RIF和Hain技术对痰涂片阴性肺结核诊断价值及利福平耐药性的评估[J]. 公共卫生与预防医学, 2020, 31(1): 93-96.
21 赖惠英, 齐志强, 李燕明, 等. 两种分子生物学方法在结核分枝杆菌及其耐药基因检测中的比较分析[J]. 标记免疫分析与临床, 2019, 26(9): 1565-1569.
22 Groessl EJ, Ganiats TG, Hillery N, et al. Cost analysis of rapid diagnostics for drug-resistant tuberculosis[J]. BMC Infect Dis, 2018, 18(1): 102.

备注/Memo

备注/Memo:

基金项目: 陕西省卫生健康科研基金项目(2018D046) 通信作者: 马纪龙, Email: 457134303@qq.com

常用功能

更新日期/Last Update: 2022-04-20