结核菌素皮肤试验的应用及其优化

doi:10.3969/j.issn.1000-6621.2021.03.003

摘要/Abstract

摘要：

中国是结核病和结核分枝杆菌感染高负担国家,针对感染和发病的高危人群开展预防干预是结核病防控工作的重要内容。结核菌素皮肤试验作为一种成熟的结核分枝杆菌感染的免疫学检测方法,尽管其结果受卡介苗接种、环境非结核分枝杆菌感染、宿主免疫状态等多种因素的影响,但在高危人群筛查、结核病辅助诊断、重点人群监测等工作中发挥着重要作用。结合中国国情及结核分枝杆菌感染的流行特征,通过优化应用策略可以在有效控制影响因素的基础上发挥结核菌素皮肤试验作为感染筛查手段的优势;同时,在科学数据支撑下,针对不同目标人群细化应用和结果解读也将为其更好地服务中国结核病防控工作提供质量保证。

关键词: 分枝杆菌,结核, 结核菌素试验, 预防干预

Abstract:

China is one of the high-burden country for both tuberculosis (TB) and Mycobacterium tuberculosis (MTB) infection, implementing preventive intervention among populations under high risk of MTB infection and active disease development is an important component of TB control in China. The tuberculin skin test (TST) has been widely used for MTB infection testing and played an important role in assistant diagnosis of TB and high-risk populations monitoring, even though it’s result might be affected by multiple factors including BCG vaccination, environmental non-tuberculosis mycobacteria (NTM) infection and host immune status. Given the national conditions and the epidemiological characteristics of MTB infection in China, such influences could be controlled by innovating application strategy to guarantee the advantages of TST on MTB screening in big populations. In addition, with respect to the characteristics of various target populations, more detailed protocols on operation and result interpretation should be developed based on systematic studies to improve quality assurance of TST.

Key words: Mycobacterium tuberculosis, Tuberculin test, Preventive intervention

何翼君, 张浩然, 辛赫男, 高磊. 结核菌素皮肤试验的应用及其优化[J]. 中国防痨杂志, 2021, 43(3): 204-210. doi: 10.3969/j.issn.1000-6621.2021.03.003

HE Yi-jun, ZHANG Hao-ran, XIN He-nan, GAO Lei. Optimizing the application of tuberculin skin test[J]. Chinese Journal of Antituberculosis, 2021, 43(3): 204-210. doi: 10.3969/j.issn.1000-6621.2021.03.003

参考文献 47

[1]	World Health Organization. Global tuberculosis report 2020. Geneva: World Health Organization, 2020.
[2]	Houben RM, Dodd PJ. The Global Burden of Latent Tuberculosis Infection: A Re-estimation Using Mathematical Modelling. PLoS Med, 2016,13(10):e1002152. doi: 10.1371/journal.pmed.1002152. doi: 10.1371/journal.pmed.1002152 URL pmid: 27780211
[3]	O’Garra A, Redford PS, McNab FW, et al. The immune response in tuberculosis. Annu Rev Immunol, 2013,31:475-527. doi: 10.1146/annurev-immunol-032712-095939. doi: 10.1146/annurev-immunol-032712-095939 URL pmid: 23516984
[4]	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.
[5]	Huebner RE, Schein MF, Bass JB Jr. The tuberculin skin test. Clin Infect Dis, 1993,17(6):968-975. doi: 10.1093/clinids/17.6.968. doi: 10.1093/clinids/17.6.968 URL pmid: 8110954
[6]	Turk JL. Von Pirquet, allergy and infectious diseases: a review. J R Soc Med, 1987,80(1):31-33. URL pmid: 3550077
[7]	Von Pirquet C. Frequency of tuberculosis in childhood. JAMA, 1909,LII(9):675-678. doi: 10.1001/jama.1909.25420350001001.
[8]	Edwards PQ, Edwads LB. Story of the tuberculin test from an epidemiologic viewpoint. Am Rev Respir Dis, 1960, 81(1)Pt 2:1-47.
[9]	Affronti LF, Caprio JJ, Edwards PQ, et al. What is PPD-S? A statement by the Committee on Diagnostic Skin Testing. Am Rev Respir Dis, 1969,99(3):460-461. doi: 10.1164/arrd.1969.99.3.460. doi: 10.1164/arrd.1969.99.3.460 URL pmid: 5765640
[10]	Yang H, Kruh-Garcia NA, Dobos KM. Purified protein deriva-tives of tuberculin--past, present, and future. FEMS Immunol Med Microbiol, 2012,66(3):273-280. doi: 10.1111/j.1574-695X.2012.01002.x. doi: 10.1111/j.1574-695X.2012.01002.x URL pmid: 22762692
[11]	都伟欣, 赵爱华, 王国治, 等. 结核菌素类产品的发展历程概述. 中国防痨杂志, 2019,41(10):1080-1083. doi: 10.3969/j.issn.1000-6621.2019.10.003.
[12]	全国结核病流行病学抽样调查技术指导组, 全国结核病流行病学抽样调查办公室. 2000年全国结核病流行病学抽样调查报告. 中国防痨杂志, 2002,24(2):3-46.
[13]	Gao L, Lu W, Bai L, et al. Latent tuberculosis infection in rural China: baseline results of a population-based, multicentre, prospective cohort study. Lancet Infect Dis, 2015,15(3):310-319. doi: 10.1016/S1473-3099(14)71085-0. doi: 10.1016/S1473-3099(14)71085-0 URL pmid: 25681063
[14]	Laurenti P, Raponi M, de Waure C, et al. Performance of interferon-γ release assays in the diagnosis of confirmed active tuberculosis in immunocompetent children: a new systematic review and meta-analysis. BMC Infect Dis, 2016,16:131. doi: 10.1186/s12879-016-1461-y. doi: 10.1186/s12879-016-1461-y URL pmid: 26993789
[15]	中华人民共和国国家卫生计生委办公厅, 中华人民共和国教育部办公厅. 学校结核病防控工作规范(2017版). 国卫办疾控发〔2017〕22号. 2017-06-26.
[16]	中华人民共和国国家卫生健康委办公厅, 中华人民共和国教育部办公厅. 中国学校结核病防控指南(2020版). 国卫办疾控函〔2020〕910号. 2020-10-16.
[17]	Hartman-Adams H, Clark K, Juckett G. Update on latent tuberculosis infection. Am Fam Physician, 2014,89(11):889-896. URL pmid: 25077395
[18]	Health Protection Surveillance Centre (HPSC), National TB Advisory Committee. Guidelines on the prevention and control of tuberculosis in Ireland 2010. Dublin: Health Protection Surveillance Centre (HPSC), 2010.
[19]	American Thoracic Society, American Thoracic Society. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR Recomm Rep, 2000,49(RR-6):1-51. URL pmid: 10881762
[20]	Adams S, Ehrlich R, Baatjies R, et al. Incidence of occupational latent tuberculosis infection in South African healthcare workers. Eur Respir J, 2015,45(5):1364-1373. doi: 10.1183/09031936.00138414. doi: 10.1183/09031936.00138414 URL pmid: 25700382
[21]	Colditz GA, Berkey CS, Mosteller F, et al. The efficacy of bacillus Calmette-Guérin vaccination of newborns and infants in the prevention of tuberculosis: meta-analyses of the published literature. Pediatrics, 1995,96(1 Pt 1):29-35. URL pmid: 7596718
[22]	Farhat M, Greenaway C, Pai M, et al. False-positive tuberculin skin tests: what is the absolute effect of BCG and non-tuberculous mycobacteria? Int J Tuberc Lung Dis, 2006,10(11):1192-1204. URL pmid: 17131776
[23]	Gao L, Jin Q. Differences in BCG vaccination and tuberculin skin-test positivity—Authors’ reply. Lancet Infect Dis, 2015,15(9):1003-1005. doi: 10.1016/S1473-3099(15)00251-0. URL pmid: 26333326
[24]	Yu X, Liu P, Liu G, et al. The prevalence of non-tuberculous mycobacterial infections in mainland China: Systematic review and meta-analysis. J Infect, 2016,73(6):558-567. doi: 10.1016/j.jinf.2016.08.020. doi: 10.1016/j.jinf.2016.08.020 URL pmid: 27717784
[25]	Jung JY, Lim JE, Lee HJ, et al. Questionable role of inter-feron-γ assays for smear-negative pulmonary TB in immunocompromised patients. J Infect, 2012,64(2):188-196. doi: 10.1016/j.jinf.2011.09.008. doi: 10.1016/j.jinf.2011.09.008 URL pmid: 22120597
[26]	Sollai S, Galli L, de Martino M, et al. Systematic review and meta-analysis on the utility of Interferon-gamma release assays for the diagnosis of Mycobacterium tuberculosis infection in children: a 2013 update. BMC Infect Dis, 2014,14 Suppl 1(Suppl 1):S6. doi: 10.1186/1471-2334-14-S1-S6.
[27]	Nasiri MJ, Pormohammad A, Goudarzi H, et al. Latent tuberculosis infection in transplant candidates: a systematic review and meta-analysis on TST and IGRA. Infection, 2019,47(3):353-361. doi: 10.1007/s15010-019-01285-7. URL pmid: 30805899
[28]	Ferguson TW, Tangri N, Macdonald K, et al. The diagnostic accuracy of tests for latent tuberculosis infection in hemodialysis patients: a systematic review and meta-analysis. Transplantation, 2015,99(5):1084-1091. doi: 10.1097/TP.0000000000000451. doi: 10.1097/TP.0000000000000451 URL pmid: 25286055
[29]	World Health Organization. WHO consolidated guidelines on tuberculosis: tuberculosis preventive treatment: Module 1: prevention. Geneva: World Health Organization, 2020.
[30]	Magnus K, Edwards LB. The effect of repeated tuberculin testing on post-vaccination allergy; a preliminary note. Lancet, 1955,269(6891):643-644. doi: 10.1016/s0140-6736(55)92482-x. doi: 10.1016/s0140-6736(55)92482-x URL pmid: 13252947
[31]	Salles CG, Ruffino-Netto A, Lapa-e-Silva JR, et al. The pre-sence of a booster phenomenon among contacts of active pulmonary tuberculosis cases: a retrospective cohort. BMC Public Health, 2007,7:38. doi: 10.1186/1471-2458-7-38. doi: 10.1186/1471-2458-7-38 URL pmid: 17371600
[32]	中华人民共和国国家卫生健康委办公厅. 中国结核病预防控制工作技术规范(2020年版). 国卫办疾控函〔2020〕279号. 2020-04-02.
[33]	高磊, 权竹声, 成君, 等. 结核分枝杆菌感染检测两步法在学校结核病控制工作中的应用探讨. 中华预防医学杂志, 2020,54(4):385-391. doi: 10.3760/cma.j.cn112150-20191204-00909.
[34]	Internal Clinical Guidelines Team (UK). Tuberculosis: Prevention, Diagnosis, Management and Service Organisation. London: National Institute for Health and Care Excellence (UK), 2016.
[35]	Schaberg T, Bauer T, Brinkmann F, et al. Tuberculosis Guideline for Adults-Guideline for Diagnosis and Treatment of Tuberculosis including LTBI Testing and Treatment of the German Central Committee (DZK) and the German Respiratory Society (DGP). Pneumologie, 2017,71(6):325-397. doi: 10.1055/s-0043-105954. doi: 10.1055/s-0043-105954 URL pmid: 28651293
[36]	Al Jahdali HH, Baharoon S, Abba AA, et al. Saudi guidelines for testing and treatment of latent tuberculosis infection. Ann Saudi Med, 2010,30(1):38-49. doi: 10.4103/0256-4947.59373. doi: 10.4103/0256-4947.59373 URL pmid: 20103957
[37]	Erkens CG, Dinmohamed AG, Kamphorst M, et al. Added value of interferon-gamma release assays in screening for tuberculous infection in the Netherlands. Int J Tuberc Lung Dis, 2014,18(4):413-420. doi: 10.5588/ijtld.13.0589. doi: 10.5588/ijtld.13.0589 URL pmid: 24670695
[38]	Diel R, Nienhaus A, Loddenkemper R. Cost-effectiveness of interferon-gamma release assay screening for latent tuberculosis infection treatment in Germany. Chest, 2007,131(5):1424-1434. doi: 10.1378/chest.06-2728. doi: 10.1378/chest.06-2728 URL pmid: 17494792
[39]	Pooran A, Booth H, Miller RF, et al. Different screening strategies (single or dual) for the diagnosis of suspected latent tuberculosis: a cost effectiveness analysis. BMC Pulm Med, 2010,10:7. doi: 10.1186/1471-2466-10-7. doi: 10.1186/1471-2466-10-7 URL pmid: 20170555
[40]	Muñoz L, Santin M, Alcaide F, et al. QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial. Clin Infect Dis, 2018,66(3):396-403. doi: 10.1093/cid/cix745. doi: 10.1093/cid/cix745 URL pmid: 29020191
[41]	Keshavarz Valian S, Mahmoudi S, Pourakbari B, et al. Screening of healthcare workers for latent tuberculosis infection in the low tuberculosis burden country: QuantiFERON-TB gold in tube test or tuberculin skin test? Arch Environ Occup Health, 2019,74(3):109-114. doi: 10.1080/19338244.2017.1394254. doi: 10.1080/19338244.2017.1394254 URL pmid: 30516445
[42]	Freund R, Granger B, Francois C, et al. Cost-effectiveness analysis of strategies using new immunological diagnostic tests of latent tuberculosis infection before TNF-blockers therapy. Presse Med, 2018,47(2):e9-e13. doi: 10.1016/j.lpm.2017.09.029. doi: 10.1016/j.lpm.2017.09.029 URL pmid: 29478790
[43]	Li H, Xin H, Qian S, et al. Testing of tuberculosis infection among Chinese adolescents born after terminating the Bacillus Calmette-Guérin booster vaccination: subgroup analysis of a population-based cross-sectional study. Front Med, 2017,11(4):528-535. doi: 10.1007/s11684-017-0573-0. URL pmid: 29101754
[44]	Gao L, Li X, Liu J, et al. Incidence of active tuberculosis in individuals with latent tuberculosis infection in rural China: follow-up results of a population-based, multicentre, prospective cohort study. Lancet Infect Dis, 2017,17(10):1053-1061. doi: 10.1016/S1473-3099(17)30402-4. doi: 10.1016/S1473-3099(17)30402-4 URL pmid: 28716677
[45]	Ruhwald M, Aggerbeck H, Gallardo RV, et al. Safety and efficacy of the C-Tb skin test to diagnose Mycobacterium tuberculosis infection, compared with an interferon γ release assay and the tuberculin skin test: a phase 3, double-blind, randomised, controlled trial. Lancet Respir Med, 2017,5(4):259-268. doi: 10.1016/S2213-2600(16)30436-2. doi: 10.1016/S2213-2600(16)30436-2 URL pmid: 28159608
[46]	中国防痨协会, 中国防痨协会学校与儿童结核病防治专业分会, 《中国防痨杂志》编辑委员会. 重组结核杆菌融合蛋白(EC)临床应用专家共识. 中国防痨杂志, 2020,42(8):761-768. doi: 10.3969/i.issn.1000-6621.2020.08.001.
[47]	Cui X, Gao L, Cao B. Management of latent tuberculosis infection in China: Exploring solutions suitable for high-burden countries. Int J Infect Dis, 2020,92S:S37-S40. doi: 10.1016/j.ijid.2020.02.034. doi: 10.1016/j.ijid.2020.02.034 URL pmid: 32114201