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中国防痨杂志 ›› 2025, Vol. 47 ›› Issue (6): 701-707.doi: 10.19982/j.issn.1000-6621.20250005

• 论著 • 上一篇    下一篇

三种检测方法在肺结核患者病原学阳性检出中的贡献分析

赵琰枫1, 屠霞2, 王嫩寒1, 陈双双1, 田丽丽1, 樊瑞芳1, 于兰1, 李洁1, 李传友1(), 代小伟1()   

  1. 1北京市疾病预防控制中心结核病实验室,北京 100035
    2北京市疾病预防控制中心结核病门诊部,北京 100035
  • 收稿日期:2025-01-03 出版日期:2025-06-10 发布日期:2025-06-11
  • 通信作者: 李传友,Email:lichuanyou@ccmu.edu.cn;代小伟,Email:happydaixw@126.com

Contribution analysis of three diagnostic methods in the etiological detection of pulmonary tuberculosis patients

Zhao Yanfeng1, Tu Xia2, Wang Nenhan1, Chen Shuangshuang1, Tian Lili1, Fan Ruifang1, Yu Lan1, Li Jie1, Li Chuanyou1(), Dai Xiaowei1()   

  1. 1Tuberculosis Laboratory, Beijing Center for Disease Prevention and Control, Beijing 100035, China
    2Tuberculosis Outpatient Department, Beijing Center for Disease Prevention and Control, Beijing 100035, China
  • Received:2025-01-03 Online:2025-06-10 Published:2025-06-11
  • Contact: Li Chuanyou, Email: lichuanyou@ccmu.edu.cn;Dai Xiaowei, Email: happydaixw@126.com

摘要:

目的: 分析2019—2023年三种病原学检测方法对活动性肺结核患者的阳性检出率、阳性检出贡献率及变化情况,为进一步提高病原学阳性率,优化结核病检测策略提供依据。方法: 从“中国疾病预防控制信息系统”子系统“结核病信息管理系统”中,提取2019年1月1日至2023年12月31日北京市疾病预防控制中心结核病门诊部登记管理的1043例初诊活动性肺结核患者的数据,结合北京市疾病预防控制中心结核病实验室检测信息,收集痰涂片抗酸染色(简称“痰涂片”)、分枝杆菌分离培养(固体酸性罗氏培养法或BACTECTMMGIT 960液体培养法,简称“痰培养”)和GeneXpert MTB/RIF检测结果,计算肺结核患者病原学检测率、阳性率,分析三种方法的阳性检出率及阳性检出贡献率,计算痰培养、分子生物学检测在涂阴肺结核患者中的阳性检出率、阳性检出贡献率并进行统计学分析。结果: 2019—2023年北京市疾病预防控制中心结核病门诊部登记管理患者共1043例,痰涂片、痰培养和分子生物学检测的覆盖率为99.1%(1034/1043),2019—2023年患者总体病原学阳性率为56.0%(579/1034);痰涂片、痰培养和分子生物学检测的总体阳性率分别为29.3%(302/1032)、41.9%(402/959)、43.5%(428/985),差异有统计学意义(χ2=52.088,P<0.001);其中,2019—2022年痰涂片的阳性率呈下降趋势,差异有统计学意义(χ 2=12.802,P<0.001)。三种病原学检测方法同时进行检测的患者中,痰涂片、痰培养、分子生物学检测的总体阳性检出率分别为29.2%(268/919)、42.5%(391/919)、44.0%(404/919),差异有统计学意义(χ2=51.740,P<0.001);三种方法总体阳性检出贡献率分别为50.4%(268/532)、73.5%(391/532)、75.9%(404/532),差异有统计学意义(χ2=95.195,P<0.001);其中,2019—2022年痰涂片的阳性检出率和阳性检出贡献率均呈下降趋势,差异有统计学意义(χ 2=14.426,P<0.001; χ 2=15.020,P<0.001)。2019—2023年,痰培养和分子生物学检测在涂阴肺结核患者中总体阳性检出率和阳性检出贡献率差异均无统计学意义(χ2=0.098,P=0.755;χ2=0.212,P=0.645)。2019—2023年在采用全部三种检测方法的532例病原学阳性患者中,仅痰涂片阳性、仅痰培养阳性、仅分子生物学阳性检出率分别为3.2%(17/532)、16.2%(86/532)、17.1%(91/532),差异有统计学意义(χ2=60.216,P<0.001)。结论: 与传统检测方法相比,分子生物学检测具有更高的阳性检出率和阳性检出贡献率,建议进一步推广分子生物学检测,将有助于提升结核病诊断的整体效率。

关键词: 分枝杆菌,结核, 结核,肺, 分子诊断技术, 对比研究

Abstract:

Objective: To analyze the positive detection rates, positive detection contribution rates and their changes of three etiological testing methods on detecting pulmonary tuberculosis (PTB) from 2019 to 2023, in order to provide a basis for further improving etiologically positive rate of PTB patients and optimizing the configuration strategy of PTB testing methods. Methods: Data of active PTB patients registered and managed by the Tuberculosis Department of Beijing Center for Disease Prevention and Control from 2019/01/01 to 2023/12/31 was extracted from the Tuberculosis Information Management System, a subsystem of China Disease Prevention and Control Information System, and then combined with information of tuberculosis laboratory test results such as acid-fast staining of Mycobacterium tuberculosis smear (referred to as sputum smear), Mycobacterium tuberculosis isolation and culture (including solid acidic Lowenstein-Jensen culture method or BACTECTMMGIT 960 liquid culture method, referred to as sputum culture), and GeneXpert MTB/RIF test, to calculate detection rates, positive rates of these three etiological detection methods, and analyze their positive detection contribution rates. The positive rates and contribution rates of sputum culture and molecular biological methods on detecting PTB among smear-negative patients were also calculated and analyzed. Results: A total of 1043 patients were registered for management at the Tuberculosis Department of Beijing Center for Disease Prevention and Control from 2019 to 2023. Coverage rate of testing by sputum smear, culture or molecular testing was 99.1% (1034/1043). The overall etiologically positive rate was 56.0% (579/1034). The overall positive rates of sputum smear, sputum culture and molecular detection were 29.3% (302/1032), 41.9% (402/959) and 43.5% (428/985), respectively, with statistically significant difference (χ2=52.088, P<0.001). The positive rate of sputum smear showed a statistically significant downward trend from 2019 to 2022 (χ t r e n d 2=12.802, P<0.001). In patients tested by all three methods, the positive rates of sputum smear, sputum culture and molecular detection were 29.2% (268/919), 42.5% (391/919) and 44.0% (404/919), respectively, which was statistically significantly different (χ2=51.740, P<0.001). The positive detection contribution rates of the three methods were 50.4% (268/532), 73.5% (391/532), 75.9% (404/532), respectively, the difference was statistically significant (χ2=95.195, P<0.001). Among them, the positive rate and positive contribution rate of sputum smear showed a downward trend from 2019 to 2022, and the differences were statistically significant (χ t r e n d 2=14.426, P<0.001, χ t r e n d 2=15.020, P<0.001). From 2019 to 2023, there was no significant difference in the total positive detection rates and positive detection contribution rates between sputum culture and molecular biological detection among smear negative patients (χ2=0.098,P=0.755,χ2=0.212, P=0.645). From 2019 to 2023, among all 532 etiologically positive patients who had undertaken all three detection methods, the rates of only being detected positive by sputum smear, culture and molecular biological test were 3.2% (17/532), 16.2% (86/532) and 17.1% (91/532), respectively, the difference was statistically significant (χ2=60.216, P<0.001). Conclusion: Compared with traditional detection methods, molecular biological detection technology has higher positive detection rate and positive contribution rate. It is suggested to further promote molecular biological detection technology to help improving the overall efficiency of tuberculosis diagnosis.

Key words: Mycobacterium tuberculosis, Tuberculosis, pulmonary, Molecular diagnostic techniques, Comparative study

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