Clinical practice guidelines for early detection of pulmonary tuberculosis in general medical facilities

doi:10.19982/j.issn.1000-6621.20230428

Abstract

Abstract:

The diagnosis delay of pulmonary tuberculosis not only results in aggravation and treatment challenges for patients but also leads to the continuously group spreading of tuberculosis. Early detection in general medical facilities, the main primary diagnosis healthcare contact for pulmonary tuberculosis patients, plays a crucial role in achieving the goal of “End tuberculosis strategy”. The National Center of Medical Quality Control for Respiratory Diseases, Tuberculosis Branch of Chinese Medical Association, Tuberculosis Control Branch of Chinese Antituberculosis Association, and China-Japan Friendship Hospital jointly organized experts to formulate the Clinical practice guidelines for early detection of pulmonary tuberculosis in general medical facilities based on the results of China’s tuberculosis prevention practice and the relevant guidelines of the World Health Organization and supplement relevant research evidence at home and abroad. The guideline systematically summarizes the characteristics of different diagnostic techniques for pulmonary tuberculosis and proposes tuberculosis screening strategies for different target populations seeking treatment in comprehensive medical institutions, providing evidence for improving and optimizing early detection of pulmonary tuberculosis in national and regional comprehensive medical institutions.

Key words: Tuberculosis, pulmonary, Hospitals, general, Early diagnosis, Consensus development conferences as topic

CLC Number:

R521

National Center of Medical Quality Control for Respiratory Diseases , Tuberculosis Branch of Chinese Medical Association , Tuberculosis Control Branch of Chinese Antituberculosis Association , China⁃Japan Friendship Hospital . Clinical practice guidelines for early detection of pulmonary tuberculosis in general medical facilities[J]. Journal of Tuberculosis and Lung Disease , 2024, 5(1): 1-14. doi: 10.19982/j.issn.1000-6621.20230428

References 86

[1]	World Health Organization. Global tuberculosis report 2023. Geneva: World Health Organization, 2023.
[2]	高磊, 张慧, 胡茂桂, 等. 基于多中心调查数据和空间统计模型的全国结核分枝杆菌潜伏感染率估算. 中国防痨杂志, 2022, 44(1): 54-59. doi:10.19982/j.issn.1000-6621.20210661.
[3]	Zhang L, Weng TP, Wang HY, et al. Patient pathway analysis of tuberculosis diagnostic delay: a multicentre retrospective cohort study in China. Clin Microbiol Infect, 2021, 27(7): 1000-1006. doi:10.1016/j.cmi.2020.12.031.
[4]	国家卫生健康委员会. 2021年中国卫生健康统计年鉴. 北京: 中国协和医科大学出版社, 2021.
[5]	Du X, Li T, Liu X, et al. Health Facilities and Treatment Service Models of the National Tuberculosis Program-China, 2010—2020. China CDC Wkly, 2021, 3(13): 274-278. doi:10.46234/ccdcw2021.071.
[6]	中华人民共和国国家卫生和计划生育委员会. WS 196—2017 结核病分类. 2017-11-09.
[7]	医学名词审定委员会结核病学名词审定分委员会. 结核病学名词. 北京: 科学出版社, 2019.
[8]	中华人民共和国国家卫生和计划生育委员会. WS 288—2017肺结核诊断. 2017-11-09.
[9]	Pai M, Behr MA, Dowdy D, et al. Tuberculosis. Nat Rev Dis Primers, 2016, 2: 16076. doi:10.1038/nrdp.2016.76. pmid: 27784885
[10]	World Health Organization. WHO operational handbook on tuberculosis. Module 3: Diagnosis-Rapid diagnostics for tuberculosis detection, 2021 update. Geneva: World Health Organization 2021.
[11]	Deng S, Sun Y, Xia H, et al. Accuracy of Commercial Molecular Diagnostics for the Detection of Pulmonary Tuberculosis in China: A Systematic Review. Sci Rep, 2019, 9(1): 4553. doi:10.1038/s41598-019-41074-8. pmid: 30872692
[12]	Deng Y, Ma Z, Su B, et al. Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study. Emerg Microbes Infect, 2023, 12(1): 2151382. doi:10.1080/22221751.2022.2151382.
[13]	王艳萍, 谭云洪, 李欣, 等. InnowaveDX MTB/RIF对结核分枝杆菌复合群及利福平耐药检测性能评估. 中华结核和呼吸杂志, 2023, 46(7): 658-663. doi:10.3760/cma.j.cn112147-20221104-00877.
[14]	中华医学会结核病学分会临床检验专业委员会. 结核病病原学分子诊断专家共识. 中华结核和呼吸杂志, 2018, 41(9): 688-695. doi:10.3760/cma.j.issn.1001-0939.2018.09.008.
[15]	郭同磊, 曹雪芳, 高磊. 《结核分枝杆菌重组蛋白皮肤试验操作规范》解读. 中国防痨杂志, 2023, 45(2): 130-133. doi:10.19982/j.issn.1000-6621.20220407.
[16]	World Health Organization. WHO operational handbook on tuberculosis. Module 3: Diagnosis-Tests for tuberculosis infection. Geneva: World Health Organization, 2021.
[17]	Krutikov M, Faust L, Nikolayevskyy V, et al. The diagnostic performance of novel skin-based in-vivo tests for tuberculosis infection compared with purified protein derivative tuberculin skin tests and blood-based in vitro interferon-γ release assays: a systematic review and meta-analysis. Lancet Infect Dis, 2022, 22(2): 250-264. doi:10.1016/s1473-3099(21)00261-9.
[18]	张登才, 刘斌, 张丽华, 等. 抗酸染色在结核病病理诊断中的价值. 中国防痨杂志, 2014, 36(4): 274-278.
[19]	孙亚欣, 张志超, 董美玲, 等. 108例结核病变组织抗酸染色结果分析. 中国实验诊断学, 2011, 15(9): 1586-1587. doi:10.3969/j.issn.1007-4287.2011.09.064.
[20]	郝颖华, 罗森源, 汤显斌. 即时荧光定量PCR法对石蜡包埋组织中结核杆菌的检测价值探究. 中华病理学杂志, 2020, 49(10): 1068-1070. doi:10.3760/cma.j.cn112151-20200327-00263.
[21]	方木通, 杨倩婷, 王仲元, 等. 病理组织中的病原学检查对结核病的诊断价值. 中华传染病杂志, 2021, 39(2): 92-96. doi:10.3760/cma.j.cn311365-20191124-00391.
[22]	杨华林, 王黎霞, 端木宏谨, 等. 利用症状者检查作为肺结核患病率调查方法的研究. 中国防痨杂志, 2004, 26(2): 81-83. doi:10.3969/j.issn.1000-6621.2004.02.006.
[23]	Cheng J, Wang L, Zhang H, et al. Diagnostic value of symptom screening for pulmonary tuberculosis in China. PLoS One, 2015, 10(5): e0127725. doi:10.1371/journal.pone.0127725.
[24]	张慧, 成君, 于艳玲, 等. 基于社区的重点人群肺结核主动发现干预效果评价:多中心前瞻性队列研究. 中国防痨杂志, 2021, 43(12): 1248-1259. doi:10.3969/j.issn.1000-6621.2021.12.005.
[25]	Van’t Hoog A, Viney K, Biermann O, et al. Symptom- and chest-radiography screening for active pulmonary tuberculosis in HIV-negative adults and adults with unknown HIV status. Cochrane Database Syst Rev, 2022, 3(3): CD010890. doi:10.1002/14651858.CD010890.pub2.
[26]	World Health Organization. WHO consolidated guidelines on tuberculosis: Module 3: diagnosis-rapid diagnostics for tuberculosis detection. Geneva: World Health Organization, 2020.
[27]	Van’t Hoog AH, Onozaki I, Lonnroth K. Choosing algorithms for TB screening: a modelling study to compare yield, predictive value and diagnostic burden. BMC Infect Dis, 2014, 14: 532. doi:10.1186/1471-2334-14-532. pmid: 25326816
[28]	World Health Organization. WHO consolidated guidelines on tuberculosis: Module 5: Management of tuberculosis in children and adolescents. Geneva: World Health Organization, 2022.
[29]	Vonasek B, Ness T, Takwoingi Y, et al. Screening tests for active pulmonary tuberculosis in children. Cochrane Database Syst Rev, 2021, 6(6): CD013693. doi:10.1002/14651858.CD013693.pub2.
[30]	World Health Organization. Chest radiography in tuberculosis detection: summary of current WHO recommendations and guidance on programmatic approaches. Geneva: World Health Organization, 2016.
[31]	陶荔莹, 徐征, 赵鑫, 等. 2021年北京市高中及以下学段入学新生肺结核筛查结果分析. 中国防痨杂志, 2023, 45(1): 111-115. doi:10.19982/j.issn.1000-6621.20220308.
[32]	汪犇, 陈玮, 李进岚, 等. 贵州省毕节市学生肺结核密切接触者筛查结果分析. 中国预防医学杂志, 2023, 24(9): 906-911. doi:10.16506/j.1009-6639.2023.09.005.
[33]	World Health Organization. WHO consolidated guidelines on tuberculosis: Module 2: screening-systematic screening for tuberculosis disease. Geneva: World Health Organization, 2021.
[34]	World Health Organization. WHO operational handbook on tuberculosis: module 5: management of tuberculosis in children and adolescents. Geneva: World Health Organization, 2022.
[35]	吕纯阳, 罗晶晶, 石华, 等. 儿童结核病的实验室诊断现状与进展. 中国防痨杂志, 2020, 42(2): 178-184. doi:10.3969/j.issn.1000-6621.2020.02.018.
[36]	World Health Organization. WHO consolidated guidelines on tuberculosis: tuberculosis preventive treatment: module 1: prevention. Geneva: World Health Organization, 2020.
[37]	Zhou G, Luo Q, Luo S, et al. Interferon-γ release assays or tuberculin skin test for detection and management of latent tuberculosis infection: a systematic review and meta-analysis. Lancet Infect Dis, 2020, 20(12): 1457-1469. doi:10.1016/s1473-3099(20)30276-0. pmid: 32673595
[38]	Goletti D, Delogu G, Matteelli A, et al. The role of IGRA in the diagnosis of tuberculosis infection, differentiating from active tuberculosis, and decision making for initiating treatment or preventive therapy of tuberculosis infection. Int J Infect Dis, 2022, 124 Suppl 1: S12-S19. doi:10.1016/j.ijid.2022.02.047.
[39]	Sousa S, Rocha D, Silva JC, et al. Comparing the cost-effectiveness of two screening strategies for latent tuberculosis infection in Portugal. Pulmonology, 2021, 27(6): 493-499. doi:10.1016/j.pulmoe.2021.04.002.
[40]	《中华传染病杂志》编辑委员会. 发热待查诊治专家共识. 中华传染病杂志, 2017, 35(11): 641-655. doi:10.3760/cma.j.issn.1000-6680.2017.11.001.
[41]	马锦玲, 刘宏伟, 程友琴, 等. 不明原因发热689例病因分析. 疑难病杂志, 2010, 9(8): 587-589. doi:10.3969/j.issn.1671-6450.2010.08.014.
[42]	段文利. 不明原因发热病因变迁图绘出:结核病始终位列病因首位未获明确诊断比例明显上升. 协和医学杂志, 2013, 4(2):122.
[43]	侍效春, 刘晓清, 李侠, 等. 综合医院以不明原因发热为表现的结核病100例临床分析. 中华内科杂志, 2010, 49(12): 1002-1005. doi:10.3760/cma.j.issn.0578-1426.2010.12.004.
[44]	Kaya A, Ergul N, Kaya SY, et al. The management and the diagnosis of fever of unknown origin. Expert Rev Anti Infect Ther, 2013, 11(8): 805-815. doi:10.1586/14787210.2013.814436. pmid: 23977936
[45]	Tian P, Qiu R, Wang M, et al. Prevalence, Causes, and Health Care Burden of Pleural Effusions Among Hospitalized Adults in China. JAMA Netw Open, 2021, 4(8): e2120306. doi:10.1001/jamanetworkopen.2021.20306.
[46]	孙永昌, 王广发, 胡红, 等. 北京市部分医院胸腔积液诊断状况调查. 中华结核和呼吸杂志, 2001, 24(2): 124-125. doi:10.3760/j:issn:1001-0939.2001.02.029.
[47]	Christopher DJ, Dinakaran S, Gupta R, et al. Thoracoscopic pleural biopsy improves yield of Xpert MTB/RIF for diagnosis of pleural tuberculosis. Respirology, 2018, 23(7): 714-717. doi:10.1111/resp.13275. pmid: 29486527
[48]	Valdés L, Alvarez D, San José E, et al. Tuberculous pleurisy: a study of 254 patients. Arch Intern Med, 1998, 158(18): 2017-2021. doi:10.1001/archinte.158.18.2017. pmid: 9778201
[49]	杨新婷, 关国英, 王亚红, 等. 结核性胸膜炎的临床特征及诊断技术分析. 中国防痨杂志, 2017, 39(11): 1162-1168. doi:10.3969/j.issn.1000-6621.2017.11.003.
[50]	Ko Y, Kim C, Chang B, et al. Loculated Tuberculous Pleural Effusion: Easily Identifiable and Clinically Useful Predictor of Positive Mycobacterial Culture from Pleural Fluid. Tuberc Respir Dis (Seoul), 2017, 80(1): 35-44. doi:10.4046/trd.2017.80.1.35.
[51]	Bielsa S, Acosta C, Pardina M, et al. Tuberculous Pleural Effusion: Clinical Characteristics of 320 Patients. Arch Bronconeumol (Engl Ed), 2019, 55(1): 17-22. doi:10.1016/j.arbres.2018.04.014.
[52]	Wang G, Wang S, Yang X, et al. Accuracy of Xpert MTB/RIF Ultra for the Diagnosis of Pleural TB in a Multicenter Cohort Study. Chest, 2020, 157(2): 268-275. doi:10.1016/j.chest.2019.07.027. pmid: 31437432
[53]	Ruan SY, Chuang YC, Wang JY, et al. Revisiting tuberculous pleurisy: pleural fluid characteristics and diagnostic yield of mycobacterial culture in an endemic area. Thorax, 2012, 67(9): 822-827. doi:10.1136/thoraxjnl-2011-201363.
[54]	Yang X, Chen N, Duan H, et al. Cell-free Mycobacterium tuberculosis DNA test in pleural effusion for tuberculous pleurisy: a diagnostic accuracy study. Clin Microbiol Infect, 2020, 26(8): 1089. e1-1089.e6. doi:10.1016/j.cmi.2019.11.026.
[55]	Seibert AF, Haynes J Jr, Middleton R, et al. Tuberculous pleural effusion. Twenty-year experience. Chest, 1991, 99(4): 883-886. doi:10.1378/chest.99.4.883. pmid: 1901261
[56]	Maartens G, Bateman ED. Tuberculous pleural effusions: increased culture yield with bedside inoculation of pleural fluid and poor diagnostic value of adenosine deaminase. Thorax, 1991, 46(2): 96-99. doi:10.1136/thx.46.2.96. pmid: 1901672
[57]	张芸, 姜广路, 王冲, 等. 经内科胸腔镜胸膜病变活检对结核性胸膜炎的诊断价值. 中国防痨杂志, 2020, 42(11): 1158-1164. doi:10.3969/j.issn.1000-6621.2020.11.004.
[58]	Kohli M, Schiller I, Dendukuri N, et al. Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev, 2021, 1(1): CD012768. doi:10.1002/14651858.CD012768.pub3.
[59]	Villena V, López-Encuentra A, García-Luján R, et al. Clinical implications of appearance of pleural fluid at thoracentesis. Chest, 2004, 125(1): 156-159. doi:10.1378/chest.125.1.156. pmid: 14718435
[60]	Aggarwal AN, Agarwal R, Sehgal IS, et al. Adenosine deami-nase for diagnosis of tuberculous pleural effusion: A systematic review and meta-analysis. PLoS One, 2019, 14(3): e0213728. doi:10.1371/journal.pone.0213728.
[61]	Lewinsohn DM, Leonard MK, LoBue PA, et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Infect Dis, 2017, 64(2): 111-115. doi:10.1093/cid/ciw778. pmid: 28052967
[62]	Koegelenberg CF, Irusen EM, von Groote-Bidlingmaier F, et al. The utility of ultrasound-guided thoracentesis and pleural biopsy in undiagnosed pleural exudates. Thorax, 2015, 70(10): 995-997. doi:10.1136/thoraxjnl-2014-206567. pmid: 25997433
[63]	Diacon AH, Van de Wal BW, Wyser C, et al. Diagnostic tools in tuberculous pleurisy: a direct comparative study. Eur Respir J, 2003, 22(4): 589-591. doi:10.1183/09031936.03.00017103a. pmid: 14582908
[64]	Ramirez JA, Musher DM, Evans SE, et al. Treatment of Community-Acquired Pneumonia in Immunocompromised Adults: A Consensus Statement Regarding Initial Strategies. Chest, 2020, 158(5): 1896-1911. doi:10.1016/j.chest.2020.05.598. pmid: 32561442
[65]	Santín Cerezales M, Navas Elorza E. Tuberculosis in special populations. Enferm Infecc Microbiol Clin, 2011, 29 Suppl 1: 20-25. doi:10.1016/s0213-005x(11)70014-3.
[66]	World Health Organization. Global tuberculosis report 2001. Geneva: World Health Organization, 2001.
[67]	Martinez L, Cords O, Horsburgh CR, et al. The risk of tuberculosis in children after close exposure: a systematic review and individual-participant meta-analysis. Lancet, 2020, 395(10228): 973-984. doi:10.1016/s0140-6736(20)30166-5. pmid: 32199484
[68]	Gupta RK, Lucas SB, Fielding KL, et al. Prevalence of tuberculosis in post-mortem studies of HIV-infected adults and children in resource-limited settings: a systematic review and meta-analysis. AIDS, 2015, 29(15): 1987-2002. doi:10.1097/qad.0000000000000802. pmid: 26266773
[69]	Tubach F, Salmon D, Ravaud P, et al. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry. Arthritis Rheum, 2009, 60(7): 1884-1894. doi:10.1002/art.24632.
[70]	Torre-Cisneros J, Doblas A, Aguado JM, et al. Tuberculosis after solid-organ transplant: incidence, risk factors, and clinical characteristics in the RESITRA (Spanish Network of Infection in Transplantation) cohort. Clin Infect Dis, 2009, 48(12): 1657-1665. doi:10.1086/599035. pmid: 19445585
[71]	Al-Efraij K, Mota L, Lunny C, et al. Risk of active tuberculosis in chronic kidney disease: a systematic review and meta-analysis. Int J Tuberc Lung Dis, 2015, 19(12): 1493-1499. doi:10.5588/ijtld.15.0081. pmid: 26614191
[72]	Redelman-Sidi G, Sepkowitz KA. IFN-γ release assays in the diagnosis of latent tuberculosis infection among immunocompromised adults. Am J Respir Crit Care Med, 2013, 188(4): 422-431. doi:10.1164/rccm.201209-1621CI.
[73]	Hussein MM, Mooij JM, Roujouleh H. Tuberculosis and chronic renal disease. Semin Dial, 2003, 16(1): 38-44. doi:10.1046/j.1525-139x.2003.03010.x.
[74]	Shah NS, Yuen CM, Heo M, et al. Yield of contact investigations in households of patients with drug-resistant tuberculosis: systematic review and meta-analysis. Clin Infect Dis, 2014, 58(3): 381-391. doi:10.1093/cid/cit643. pmid: 24065336
[75]	Fox GJ, Barry SE, Britton WJ, et al. Contact investigation for tuberculosis: a systematic review and meta-analysis. Eur Respir J, 2013, 41(1): 140-156. doi:10.1183/09031936.00070812. pmid: 22936710
[76]	Ehrlich R, Akugizibwe P, Siegfried N, et al. The association between silica exposure, silicosis and tuberculosis: a systematic review and meta-analysis. BMC Public Health, 2021, 21(1): 953. doi:10.1186/s12889-021-10711-1. pmid: 34016067
[77]	Nandi SS, Dhatrak SV, Sarkar K. Silicosis, progressive massive fibrosis and silico-tuberculosis among workers with occupational exposure to silica dusts in sandstone mines of Rajasthan state: An urgent need for initiating national silicosis control programme in India. J Family Med Prim Care, 2021, 10(2): 686-691. doi:10.4103/jfmpc.jfmpc_1972_20. pmid: 34041062
[78]	Li Y, Teng D, Shi X, et al. Prevalence of diabetes recorded in China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. BMJ, 2020, 369: m997. doi:10.1136/bmj.m997.
[79]	Jeon CY, Murray MB. Diabetes mellitus increases the risk of active tuberculosis: a systematic review of 13 observational studies. PLoS Med, 2008, 5(7): e152. doi:10.1371/journal.pmed.0050152.
[80]	Viswanathan V, Kumpatla S, Aravindalochanan V, et al. Prevalence of diabetes and pre-diabetes and associated risk factors among tuberculosis patients in India. PLoS One, 2012, 7(7): e41367. doi:10.1371/journal.pone.0041367.
[81]	Baker MA, Harries AD, Jeon CY, et al. The impact of diabetes on tuberculosis treatment outcomes: a systematic review. BMC Med, 2011, 9: 81. doi:10.1186/1741-7015-9-81. pmid: 21722362
[82]	Sanghani RN, Udwadia ZF. The association of diabetes and tuberculosis: impact on treatment and post-treatment outcomes. Thorax, 2013, 68(3): 202-203. doi:10.1136/thoraxjnl-2012-202976. pmid: 23400366
[83]	Viswanathan V, Vigneswari A, Selvan K, et al. Effect of diabetes on treatment outcome of smear-positive pulmonary tuberculosis-a report from South India. J Diabetes Complications, 2014, 28(2): 162-165. doi:10.1016/j.jdiacomp.2013.12.003.
[84]	Hamada Y, Lujan J, Schenkel K, et al. Sensitivity and specificity of WHO’s recommended four-symptom screening rule for tuberculosis in people living with HIV: a systematic review and meta-analysis. Lancet HIV, 2018, 5(9): e515-e523. doi:10.1016/s2352-3018(18)30137-1.
[85]	Elzi L, Steffen I, Furrer H, et al. Improved sensitivity of an interferon-gamma release assay (T-SPOT.TB^TM) in combination with tuberculin skin test for the diagnosis of latent tuberculosis in the presence of HIV co-infection. BMC Infect Dis, 2011, 11: 319. doi:10.1186/1471-2334-11-319.
[86]	Heo EY, Choi NK, Yang BR, et al. Tuberculosis is frequently diagnosed within 12 months of diabetes mellitus. Int J Tuberc Lung Dis, 2015, 19(9): 1098-1101. doi:10.5588/ijtld.14.0772. pmid: 26260832