重组结核杆菌融合蛋白在结核感染中诊断价值的研究进展_Chinese Journal of Respiratory and Critical Care Medicine

Authors：

李思 , 冯银合 ,  JI Guiyi ,  毛辉

四川大学华西医院呼吸与危重症医学科（四川成都 610041）;

Corresponding author：

JI Guiyi, Email: guiyi01@wchscu.cn; 毛辉, Email: merrymh@126.com

Keywords：

DOI：

10.7507/1671-6205.202310050

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Citation： JI Guiyi. 重组结核杆菌融合蛋白在结核感染中诊断价值的研究进展. Chinese Journal of Respiratory and Critical Care Medicine, 2024, 23(3): 217-220. doi: 10.7507/1671-6205.202310050 Copy

1.	World Health Organization. Global tuberculosis report 2021. Geneva: World Health Organization, 2021. https://www.who.int/publications/i/item/9789240037021.
2.	Hartman-Adams H, Clark K, Juckett G. Update on latent tuberculosis infection. Am Fam Physician, 2014, 89(11): 889-896.
3.	World Health Organization. Global tuberculosis report 2015. Geneva: World Health Organization, 2015.https://iris.who.int/handle/10665/191102.
4.	Shah M, Dorman SE. Latent Tuberculosis Infection. N Engl J Med, 2021, 385(24): 2271-2280.
5.	Xin H, Cao X, Zhang H, et al. Protective efficacy of 6-week regimen for latent tuberculosis infection treatment in rural China: 5-year follow-up of a randomised controlled trial. Eur Respir J, 2022, 60(1): 2102359.
6.	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.
7.	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.
8.	Pai M, Denkinger CM, Kik SV, et al. Gamma interferon release assays for detection of Mycobacterium tuberculosis infection. Clin Microbiol Rev, 2014, 27(1): 3-20.
9.	Mack U, Migliori GB, Sester M, et al. LTBI: latent tuberculosis infection or lasting immune responses to M. tuberculosis? A TBNET consensus statement. Eur Respir J, 2009, 33(5): 956-973.
10.	Pai M, Zwerling A, Menzies D. Systematic review: T-cell-based assays for the diagnosis of latent tuberculosis infection: an update. Ann Intern Med, 2008, 149(3): 177-184.
11.	Aggerbeck H, Ruhwald M, Hoff ST, et al. C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial. PLoS One, 2018, 13(9): e0204554.
12.	Abubakar I, Jackson C, Rangaka MX. C-Tb: a latent tuberculosis skin test for the 21st century?. Lancet Respir Med, 2017, 5(4): 236-237.
13.	Aggerbeck H, Ruhwald M, Hoff ST, et al. Interaction between C-Tb and PPD given concomitantly in a split-body randomised controlled trial. Int J Tuberc Lung Dis, 2019, 23(1): 38-44.
14.	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.
15.	Nikitina IY, Karpina NL, Kasimceva OV, et al. Comparative performance of QuantiFERON-TB Gold versus skin test with tuberculosis recombinant allergen (Diaskintest) among patients with suspected pulmonary tuberculosis in Russia. Int J Infect Dis, 2019, 86: 18-24.
16.	Slogotskaya L, Bogorodskaya E, Ivanova D, et al. Comparative sensitivity of the test with tuberculosis recombinant allergen, containing ESAT6-CFP10 protein, and Mantoux test with 2 TU PPD-L in newly diagnosed tuberculosis children and adolescents in Moscow. PLoS One, 2018, 13(12): e0208705.
17.	卢水华, 陆伟. 新型结核菌素皮肤试验使用手册. 北京: 人民卫生出版社, 2021.
18.	张凯, 陶立峰, 韦芬, 等. 重组结核杆菌融合蛋白(EC)的免疫特性和临床前安全性研究. 中国防痨杂志, 2020, 42(8): 807-813.
19.	卢水华, 陆伟. 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.
20.	程晓, 陈哲, 焦雪峰, 等. 重组结核杆菌融合蛋白(EC)用于诊断结核分枝杆菌感染的有效性和安全性系统评价. 中国防痨杂志, 2022, 44(9): 917-926.
21.	Andersen P, Munk ME, Pollock JM, et al. Specific immune-based diagnosis of tuberculosis. Lancet, 2000, 356(9235): 1099-1104.
22.	Li F, Xu M, Qin C, et al. Recombinant fusion ESAT6-CFP10 immunogen as a skin test reagent for tuberculosis diagnosis: an open-label, randomized, two-centre phase 2a clinical trial. Clin Microbiol Infect, 2016, 22(10): 889. e9-889, e16.
23.	Xu M, Lu W, Li T, et al. Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials. Clin Infect Dis, 2022, 74(4): 668-677.
24.	Zhang H, Wang L, Li F, et al. Induration or erythema diameter not less than 5 mm as results of recombinant fusion protein ESAT6-CFP10 skin test for detecting M. tuberculosis infection. BMC Infect Dis, 2020, 20(1): 685.
25.	Li F, Xu M, Zhou L, et al. Safety of Recombinant Fusion Protein ESAT6-CFP10 as a Skin Test Reagent for Tuberculosis Diagnosis: an Open-Label, Randomized, Single-Center Phase I Clinical Trial. Clin Vaccine Immunol, 2016, 23(9): 767-773.
26.	Xia L, Xu M, Li F, et al. High accuracy of recombinant fusion protein early secretory antigenic target protein 6-culture filtrate protein 10 skin test for the detection of tuberculosis infection: a phase III, multi-centered, double-blind, hospital-based, randomized controlled trial. Int J Infect Dis, 2023, 126: 98-103.
27.	张慧. 重组结核分枝杆菌ESAT6-CFP10变态反应原的临床效用的评价及其相关统计方法研究. 中国人民解放军空军军医大学, 2020.
28.	Yuan Y, Xia L, Wu Q, et al. Utility of recombinant fusion protein ESAT6-CFP10 skin test for differential diagnosis of active tuberculosis: A prospective study. Front Immunol, 2023, 14: 1162177.
29.	周林, 初乃惠, 陆伟. 高危人群结核分枝杆菌潜伏感染检测及预防性治疗专家共识. 中国防痨杂志, 2021, 43(9): 874-878.
30.	马艳, 陆伟, 高磊, 等. 终止结核病流行须加强结核分枝杆菌潜伏感染高危人群筛查和预防性治疗的管理. 中国防痨杂志, 2022, 44(3): 209-214.
31.	杨震, 孙倩, 韩露, 等. 重组结核杆菌融合蛋白在大学生结核潜伏感染筛查中的应用分析. 中国医学前沿杂志(电子版), 2022, 14(7): 51-54.
32.	Chongxing Z, Yuanchun L, Yan H, et al. Evaluation of the diagnostic efficacy of EC-Test for latent tuberculosis infection in ambulatory people with HIV. AIDS, 2023, 37(12): 1791-1797.
33.	He Y, Cao X, Guo T, et al. Serial testing of latent tuberculosis infection in patients with diabetes mellitus using interferon-gamma release assay, tuberculin skin test, and creation tuberculin skin test. Front Public Health, 2022, 10: 1025550.
34.	张婷, 杨眉, 吴成果, 等. 重组结核分枝杆菌融合蛋白在学校结核病筛查中的应用. 预防医学情报杂志, 2021, 37(11): 1609-1613.
35.	苏倩, 汪清雅, 张婷, 等. 重组结核分枝杆菌融合蛋白皮肤试验与TST在学校结核潜伏感染筛查中的比较. 中国感染控制杂志, 2023, 22(5): 547-551.
36.	葛芳, 金樱, 吴凯, 等. 重组结核杆菌融合蛋白皮肤试验在肾透析患者诊断结核潜伏感染的应用价值. 江苏预防医学, 2023, 34(3): 272-274.
37.	杨正贵, 马瑛龙, 马玲玲, 等. 重组结核杆菌融合蛋白对HIV感染人群结核潜伏感染效果评价. 宁夏医学杂志, 2023, 45(2): 174-175.
38.	Diao S, Liu Z, Liu D, et al. Long-term economic evaluation of the recombinant Mycobacterium tuberculosis fusion protein (EC) test for the diagnosis of Mycobacterium tuberculosis infection. Front Pharmacol, 2023, 14: 1161526.
39.	Liu Z, Diao S, Zeng L, et al. Recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection: a short-term economic evaluation. Front Public Health, 2023, 11: 1105857.
40.	倪晓凤, 刁莎, 何思颐, 等. 重组结核杆菌融合蛋白的临床综合评价. 中国药房, 2023, 34(4): 391-396.

1. World Health Organization. Global tuberculosis report 2021. Geneva: World Health Organization, 2021. https://www.who.int/publications/i/item/9789240037021.
2. Hartman-Adams H, Clark K, Juckett G. Update on latent tuberculosis infection. Am Fam Physician, 2014, 89(11): 889-896.
3. World Health Organization. Global tuberculosis report 2015. Geneva: World Health Organization, 2015.https://iris.who.int/handle/10665/191102.
4. Shah M, Dorman SE. Latent Tuberculosis Infection. N Engl J Med, 2021, 385(24): 2271-2280.
5. Xin H, Cao X, Zhang H, et al. Protective efficacy of 6-week regimen for latent tuberculosis infection treatment in rural China: 5-year follow-up of a randomised controlled trial. Eur Respir J, 2022, 60(1): 2102359.
6. 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.
7. 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.
8. Pai M, Denkinger CM, Kik SV, et al. Gamma interferon release assays for detection of Mycobacterium tuberculosis infection. Clin Microbiol Rev, 2014, 27(1): 3-20.
9. Mack U, Migliori GB, Sester M, et al. LTBI: latent tuberculosis infection or lasting immune responses to M. tuberculosis? A TBNET consensus statement. Eur Respir J, 2009, 33(5): 956-973.
10. Pai M, Zwerling A, Menzies D. Systematic review: T-cell-based assays for the diagnosis of latent tuberculosis infection: an update. Ann Intern Med, 2008, 149(3): 177-184.
11. Aggerbeck H, Ruhwald M, Hoff ST, et al. C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial. PLoS One, 2018, 13(9): e0204554.
12. Abubakar I, Jackson C, Rangaka MX. C-Tb: a latent tuberculosis skin test for the 21st century?. Lancet Respir Med, 2017, 5(4): 236-237.
13. Aggerbeck H, Ruhwald M, Hoff ST, et al. Interaction between C-Tb and PPD given concomitantly in a split-body randomised controlled trial. Int J Tuberc Lung Dis, 2019, 23(1): 38-44.
14. 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.
15. Nikitina IY, Karpina NL, Kasimceva OV, et al. Comparative performance of QuantiFERON-TB Gold versus skin test with tuberculosis recombinant allergen (Diaskintest) among patients with suspected pulmonary tuberculosis in Russia. Int J Infect Dis, 2019, 86: 18-24.
16. Slogotskaya L, Bogorodskaya E, Ivanova D, et al. Comparative sensitivity of the test with tuberculosis recombinant allergen, containing ESAT6-CFP10 protein, and Mantoux test with 2 TU PPD-L in newly diagnosed tuberculosis children and adolescents in Moscow. PLoS One, 2018, 13(12): e0208705.
17. 卢水华, 陆伟. 新型结核菌素皮肤试验使用手册. 北京: 人民卫生出版社, 2021.
18. 张凯, 陶立峰, 韦芬, 等. 重组结核杆菌融合蛋白(EC)的免疫特性和临床前安全性研究. 中国防痨杂志, 2020, 42(8): 807-813.
19. 卢水华, 陆伟. 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.
20. 程晓, 陈哲, 焦雪峰, 等. 重组结核杆菌融合蛋白(EC)用于诊断结核分枝杆菌感染的有效性和安全性系统评价. 中国防痨杂志, 2022, 44(9): 917-926.
21. Andersen P, Munk ME, Pollock JM, et al. Specific immune-based diagnosis of tuberculosis. Lancet, 2000, 356(9235): 1099-1104.
22. Li F, Xu M, Qin C, et al. Recombinant fusion ESAT6-CFP10 immunogen as a skin test reagent for tuberculosis diagnosis: an open-label, randomized, two-centre phase 2a clinical trial. Clin Microbiol Infect, 2016, 22(10): 889. e9-889, e16.
23. Xu M, Lu W, Li T, et al. Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials. Clin Infect Dis, 2022, 74(4): 668-677.
24. Zhang H, Wang L, Li F, et al. Induration or erythema diameter not less than 5 mm as results of recombinant fusion protein ESAT6-CFP10 skin test for detecting M. tuberculosis infection. BMC Infect Dis, 2020, 20(1): 685.
25. Li F, Xu M, Zhou L, et al. Safety of Recombinant Fusion Protein ESAT6-CFP10 as a Skin Test Reagent for Tuberculosis Diagnosis: an Open-Label, Randomized, Single-Center Phase I Clinical Trial. Clin Vaccine Immunol, 2016, 23(9): 767-773.
26. Xia L, Xu M, Li F, et al. High accuracy of recombinant fusion protein early secretory antigenic target protein 6-culture filtrate protein 10 skin test for the detection of tuberculosis infection: a phase III, multi-centered, double-blind, hospital-based, randomized controlled trial. Int J Infect Dis, 2023, 126: 98-103.
27. 张慧. 重组结核分枝杆菌ESAT6-CFP10变态反应原的临床效用的评价及其相关统计方法研究. 中国人民解放军空军军医大学, 2020.
28. Yuan Y, Xia L, Wu Q, et al. Utility of recombinant fusion protein ESAT6-CFP10 skin test for differential diagnosis of active tuberculosis: A prospective study. Front Immunol, 2023, 14: 1162177.
29. 周林, 初乃惠, 陆伟. 高危人群结核分枝杆菌潜伏感染检测及预防性治疗专家共识. 中国防痨杂志, 2021, 43(9): 874-878.
30. 马艳, 陆伟, 高磊, 等. 终止结核病流行须加强结核分枝杆菌潜伏感染高危人群筛查和预防性治疗的管理. 中国防痨杂志, 2022, 44(3): 209-214.
31. 杨震, 孙倩, 韩露, 等. 重组结核杆菌融合蛋白在大学生结核潜伏感染筛查中的应用分析. 中国医学前沿杂志(电子版), 2022, 14(7): 51-54.
32. Chongxing Z, Yuanchun L, Yan H, et al. Evaluation of the diagnostic efficacy of EC-Test for latent tuberculosis infection in ambulatory people with HIV. AIDS, 2023, 37(12): 1791-1797.
33. He Y, Cao X, Guo T, et al. Serial testing of latent tuberculosis infection in patients with diabetes mellitus using interferon-gamma release assay, tuberculin skin test, and creation tuberculin skin test. Front Public Health, 2022, 10: 1025550.
34. 张婷, 杨眉, 吴成果, 等. 重组结核分枝杆菌融合蛋白在学校结核病筛查中的应用. 预防医学情报杂志, 2021, 37(11): 1609-1613.
35. 苏倩, 汪清雅, 张婷, 等. 重组结核分枝杆菌融合蛋白皮肤试验与TST在学校结核潜伏感染筛查中的比较. 中国感染控制杂志, 2023, 22(5): 547-551.
36. 葛芳, 金樱, 吴凯, 等. 重组结核杆菌融合蛋白皮肤试验在肾透析患者诊断结核潜伏感染的应用价值. 江苏预防医学, 2023, 34(3): 272-274.
37. 杨正贵, 马瑛龙, 马玲玲, 等. 重组结核杆菌融合蛋白对HIV感染人群结核潜伏感染效果评价. 宁夏医学杂志, 2023, 45(2): 174-175.
38. Diao S, Liu Z, Liu D, et al. Long-term economic evaluation of the recombinant Mycobacterium tuberculosis fusion protein (EC) test for the diagnosis of Mycobacterium tuberculosis infection. Front Pharmacol, 2023, 14: 1161526.
39. Liu Z, Diao S, Zeng L, et al. Recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection: a short-term economic evaluation. Front Public Health, 2023, 11: 1105857.
40. 倪晓凤, 刁莎, 何思颐, 等. 重组结核杆菌融合蛋白的临床综合评价. 中国药房, 2023, 34(4): 391-396.

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重组结核杆菌融合蛋白在结核感染中诊断价值的研究进展

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