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中国防痨杂志 ›› 2021, Vol. 43 ›› Issue (10): 1089-1095.doi: 10.3969/j.issn.1000-6621.2021.10.020

• 论著 • 上一篇    下一篇

含分子生物学检测技术诊断流程在肺结核患者发现中的应用情况

马建军*(), 张铁娟, 侯伟, 潘艳, 刘昕   

  1. 130062 长春,吉林省结核病防治科学研究院诊疗质量评价所(马建军),预防控制所(张铁娟、潘艳),实验室(刘昕); 吉林省疾病预防控制中心财务科(侯伟)
  • 收稿日期:2021-08-28 出版日期:2021-10-10 发布日期:2021-10-11
  • 通信作者: 马建军 E-mail:kevin_ma2016@163.com
  • 基金资助:
    中国国家卫生和计划生育委员会-比尔及梅琳达·盖茨基金会结核病防治合作项目三期(OPP1137180)

Application of diagnostic procedures containing molecular biology detection technology in pulmonary tuberculosis case finding

MA Jian-jun*(), ZHANG Tie-juan, HOU Wei, PAN Yan, LIU Xin   

  1. *Tuberculosis Diagnosis and Treatment Quality Evaluation Department,Jilin Provincial Institute of Tuberculosis Prevention and Treatment,Changchun 130062,China
  • Received:2021-08-28 Online:2021-10-10 Published:2021-10-11
  • Contact: MA Jian-jun E-mail:kevin_ma2016@163.com

摘要:

目的 了解吉林省实施“中国国家卫生和计划生育委员会-比尔及梅琳达·盖茨基金会结核病防治合作项目”第三期(简称“中盖项目三期”)后,含分子生物学检测技术的诊断流程对肺结核患者发现的实施效果。方法 回顾性收集并分析中盖项目三期实施后,含分子生物学检测技术诊断流程对2019年吉林省所有结核病定点医疗机构登记的肺结核可疑症状者结核分枝杆菌及其耐药情况的检测结果。结果 55983例肺结核可疑症状者经分子生物学检测流程,共检出疑似活动性肺结核患者10278例(18.36%),其中,涂阳3895例、涂阴6383例;接受分子生物学技术检测结核分枝杆菌的比例为98.35%(8885/9034),检出率为54.25%(4820/8885);其中,涂阴患者检测结核分枝杆菌比例和检出率分别为97.67%(6234/6383)和35.15%(2191/6234);培养阳性13例;共计检出病原学阳性患者6099例,阳性率为59.34%(6099/10278),且全部接受分子生物学快速耐药检测。病原学阳性患者中,利福平耐药和耐多药检出率分别为17.02%(1038/6099)和6.48%(395/6099);其中,初、复治患者的利福平耐药检出率分别为11.37%(594/5222)和50.63%(444/877),耐多药检出率分别为4.00%(209/5222)和21.21%(186/877)。结论 吉林省中盖项目三期全面推广含分子生物学技术的新诊断流程,显著提高了疑似活动性肺结核患者的病原学阳性检出率和利福平耐药患者的发现水平。

关键词: 结核, 分子诊断技术, 卫生服务研究, 总结性报告

Abstract: Objective To analyze the effect of the diagnosis process with molecular biology detection technology on the pulmonary tuberculosis case finding after the third phase of the “China National Health and Family Planning Commission-Bill and Melinda Gates Foundation Tuberculosis Prevention and Control Cooperation Project” (referred to as the “China-Gates Project Phase Ⅲ”) ending in Jilin Province. Methods Data of Mycobacterium tuberculosis detection and its drug resistance by using diagnostic process containing molecular biology detection technology in persons with suspected tuberculosis symptoms registered in all designated tuberculosis medical institutions in Jilin Province in 2019 were retrospectively collected and analyzed after finishing the third phase of the China-Gates Project. Results A total of 10278 (18.36%) suspected active pulmonary tuberculosis patients were identified by the molecular biology testing process among 55983 persons with suspected pulmonary tuberculosis symptoms, of which 3895 were smear positive and 6383 were smear negative. The proportion of Mycobacterium tuberculosis tested by using molecular biology technology was 98.35% (8885/9034), with detection rate being 54.25% (4820/8885). Among them, the proportion of Mycobacterium tuberculosis detected in smear-negative patients and the detection rate were 97.67% (6234/6383) and 35.15% (2191/6234), respectively, and another 13 tuberculosis patients were culture-positive. A total of 6099 pathogenic positive tuberculosis patients were identified, with a pathogenic positive rate of 59.34% (6099/10278), and all received molecular biology rapid drug-resistance testing. Detection rates of rifampicin resistance and multidrug resistance were 17.02% (1038/6099) and 6.48% (395/6099) among all pathogenic positive tuberculosis patients. In initial and retreated tuberculosis patients, rifampicin resistant rates were 11.37% (594/5222) and 50.63% (444/877), and multidrug resistant rates were 4.00% (209/5222) and 21.21% (186/877), respectively. Conclusion The third phase of the China-Gates Project in Jilin Province comprehensively promoted the new diagnostic process containing molecular biology technology, which significantly increased the pathogenic positive rate of suspected pulmonary tuberculosis patients and the detection level of rifampicin-resistant patients.

Key words: Tuberculosis, Molecular diagnostic techniques, Health services research, Consensus development conference