重組結核桿菌融合蛋白在結核感染中診斷價值的研究進展_Chinese Journal of Respiratory and Critical Care Medicine

Authors：

李思 , 馮銀合 ,  JI Guiyi ,  毛輝

四川大學華西醫院呼吸與危重癥醫學科（四川成都 610041）;

Corresponding?author：

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

Keywords：

DOI：

10.7507/1671-6205.202310050

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Citation： JI Guiyi. 重組結核桿菌融合蛋白在結核感染中診斷價值的研究進展. 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.	盧水華, 陸偉. 新型結核菌素皮膚試驗使用手冊. 北京: 人民衛生出版社, 2021.
18.	張凱, 陶立峰, 韋芬, 等. 重組結核桿菌融合蛋白(EC)的免疫特性和臨床前安全性研究. 中國防癆雜志, 2020, 42(8): 807-813.
19.	盧水華, 陸偉. 重組結核桿菌融合蛋白(EC)臨床應用專家共識. 中國防癆雜志, 2020, 42(8): 761-768.
20.	程曉, 陳哲, 焦雪峰, 等. 重組結核桿菌融合蛋白(EC)用于診斷結核分枝桿菌感染的有效性和安全性系統評價. 中國防癆雜志, 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.	張慧. 重組結核分枝桿菌ESAT6-CFP10變態反應原的臨床效用的評價及其相關統計方法研究. 中國人民解放軍空軍軍醫大學, 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, 陸偉. 高危人群結核分枝桿菌潛伏感染檢測及預防性治療專家共識. 中國防癆雜志, 2021, 43(9): 874-878.
30.	馬艷, 陸偉, 高磊, 等. 終止結核病流行須加強結核分枝桿菌潛伏感染高危人群篩查和預防性治療的管理. 中國防癆雜志, 2022, 44(3): 209-214.
31.	楊震, 孫倩, 韓露, 等. 重組結核桿菌融合蛋白在大學生結核潛伏感染篩查中的應用分析. 中國醫學前沿雜志(電子版), 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.	張婷, 楊眉, 吳成果, 等. 重組結核分枝桿菌融合蛋白在學校結核病篩查中的應用. 預防醫學情報雜志, 2021, 37(11): 1609-1613.
35.	蘇倩, 汪清雅, 張婷, 等. 重組結核分枝桿菌融合蛋白皮膚試驗與TST在學校結核潛伏感染篩查中的比較. 中國感染控制雜志, 2023, 22(5): 547-551.
36.	葛芳, 金櫻, 吳凱, 等. 重組結核桿菌融合蛋白皮膚試驗在腎透析患者診斷結核潛伏感染的應用價值. 江蘇預防醫學, 2023, 34(3): 272-274.
37.	楊正貴, 馬瑛龍, 馬玲玲, 等. 重組結核桿菌融合蛋白對HIV感染人群結核潛伏感染效果評價. 寧夏醫學雜志, 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.	倪曉鳳, 刁莎, 何思頤, 等. 重組結核桿菌融合蛋白的臨床綜合評價. 中國藥房, 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. 盧水華, 陸偉. 新型結核菌素皮膚試驗使用手冊. 北京: 人民衛生出版社, 2021.
18. 張凱, 陶立峰, 韋芬, 等. 重組結核桿菌融合蛋白(EC)的免疫特性和臨床前安全性研究. 中國防癆雜志, 2020, 42(8): 807-813.
19. 盧水華, 陸偉. 重組結核桿菌融合蛋白(EC)臨床應用專家共識. 中國防癆雜志, 2020, 42(8): 761-768.
20. 程曉, 陳哲, 焦雪峰, 等. 重組結核桿菌融合蛋白(EC)用于診斷結核分枝桿菌感染的有效性和安全性系統評價. 中國防癆雜志, 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. 張慧. 重組結核分枝桿菌ESAT6-CFP10變態反應原的臨床效用的評價及其相關統計方法研究. 中國人民解放軍空軍軍醫大學, 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, 陸偉. 高危人群結核分枝桿菌潛伏感染檢測及預防性治療專家共識. 中國防癆雜志, 2021, 43(9): 874-878.
30. 馬艷, 陸偉, 高磊, 等. 終止結核病流行須加強結核分枝桿菌潛伏感染高危人群篩查和預防性治療的管理. 中國防癆雜志, 2022, 44(3): 209-214.
31. 楊震, 孫倩, 韓露, 等. 重組結核桿菌融合蛋白在大學生結核潛伏感染篩查中的應用分析. 中國醫學前沿雜志(電子版), 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. 張婷, 楊眉, 吳成果, 等. 重組結核分枝桿菌融合蛋白在學校結核病篩查中的應用. 預防醫學情報雜志, 2021, 37(11): 1609-1613.
35. 蘇倩, 汪清雅, 張婷, 等. 重組結核分枝桿菌融合蛋白皮膚試驗與TST在學校結核潛伏感染篩查中的比較. 中國感染控制雜志, 2023, 22(5): 547-551.
36. 葛芳, 金櫻, 吳凱, 等. 重組結核桿菌融合蛋白皮膚試驗在腎透析患者診斷結核潛伏感染的應用價值. 江蘇預防醫學, 2023, 34(3): 272-274.
37. 楊正貴, 馬瑛龍, 馬玲玲, 等. 重組結核桿菌融合蛋白對HIV感染人群結核潛伏感染效果評價. 寧夏醫學雜志, 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. 倪曉鳳, 刁莎, 何思頤, 等. 重組結核桿菌融合蛋白的臨床綜合評價. 中國藥房, 2023, 34(4): 391-396.

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重組結核桿菌融合蛋白在結核感染中診斷價值的研究進展

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