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胸水中の細胞非依存性結核菌DNA検査の結核性胸膜炎診断における精度：多施設横断研究

  • role： Contribute equally, First author同等贡献者, 第一作者
  • Affiliation：

    Department of Pathology, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China

Wei-Li Du1,  
  • role： Contribute equally同等贡献者
  • Affiliation：

    Senior Department of Tuberculosis, the Eighth Medical Center of Chinese PLA General Hospital, Beijing 100091, China

Jian-Qin Liang2,  
  • role： Contribute equally同等贡献者
  • Affiliation：

    Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China

Xin-Ting Yang3,  
  • role： Contribute equally同等贡献者
  • Affiliation：

    Department of Tuberculosis, Shenyang Tenth People’s Hospital, Shenyang Chest Hospital, Shenyang 110044, China

Cheng-Jun Li4,  
  • role： Contribute equally同等贡献者
  • Affiliation：

    Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China

Qing-Feng Wang3,  
  • role： Contribute equally同等贡献者
  • Affiliation：

    Department of Tuberculosis, Second People’s Hospital of Weifang, Weifang 261041, Shandong, China

Wen-Ge Han5,  
  • role： Contribute equally同等贡献者
  • Affiliation：

    Tuberculosis Department I, Anhui Chest Hospital, Anhui 230022, China

Ye Li6,  
  • role： Contribute equally同等贡献者
  • Affiliation：

    Department of Tuberculosis, Hebei Chest Hospital, Shijiazhuang 050041, China

Zhi-Hui Li7,  
  • role： Contribute equally同等贡献者
  • Affiliation：

    Department of Tuberculosis, the Infectious Disease Hospital of Heilongjiang Province, Harbin 150500, China

Dong-Mei Zhao8,  
  • role： Contribute equally同等贡献者
  • Affiliation：

    Department of Pathology, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China

Fu-Dong Xu1,  
  • Affiliation：

    Department of Tuberculosis, the Fifth Hospital of Shijiazhuang, Shijiazhuang 050021, China

Yan-Xiao Rong9,  
  • Affiliation：

    Department of Pulmonary and Critical Care Medicine, China Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100029, China

Xiao-Jing Cui10,  
  • Affiliation：

    Department of Respiratory Medicine, National Clinical Research Center of Respiratory Disease, National Center for Children’s Health, Beijing Children’s Hospital, Capital Medical University, Beijing 100045, China

Hui-Min Li11,  
  • Affiliation：

    Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China

Feng Wang12,  
  • Affiliation：

    Department of Tuberculosis, Hebei Chest Hospital, Shijiazhuang 050041, China

Peng-Chong Liu7,  
  • Affiliation：

    Senior Department of Tuberculosis, the Eighth Medical Center of Chinese PLA General Hospital, Beijing 100091, China

Dong-Lin Guo2,  
  • Affiliation：

    Department of Tuberculosis, the Fifth Hospital of Shijiazhuang, Shijiazhuang 050021, China

Hai-Bin Wang9,  
  • Affiliation：

    Department of Pathology, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China

Xu-Ya Xing1,  
  • Affiliation：

    Department of Pathology, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China

Jia-Lu Che1,  
  • Affiliation：

    Department of Pathology, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China

Zi-Chen Liu1,  
  • Affiliation：

    Department of Pathology, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China

Na-Na Zhang1,  
  • Affiliation：

    Department of Pathology, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China

Kun Li1,  
  • Affiliation：

    Biobank of Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China

Yi Liu13,  
  • Affiliation：

    Beijing Western Medical Branch of PLA General Hospital, Beijing 100091, China

Li Wang14,  
  • role： Corresponding author通信作者
  • Affiliation：

    Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University; Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing 100191, China

  • Email：wanghb_pucri@bjmu.edu.cn
  • Introduction：* wanghb_pucri@bjmu.edu.cn
Hai-Bo Wang15*,  
  • role： Corresponding author通信作者
  • Affiliation：

    Department of Pathology, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China

  • Email：chenanying@bjxkyy.cn
  • Introduction：chenanying@bjxkyy.cn
Nan-Ying Che1*

サマリー

Background:The diagnosis of tuberculous pleurisy (TP) presents a significant challenge due to the low bacterial load in pleural effusion (PE) samples. Cell-free Mycobacterium tuberculosis DNA (cf-TB) in PE samples is considered an optimal biomarker for diagnosing TP. This study aimed to evaluate the applicability of cf-TB testing across diverse research sites with a relatively large sample size.Methods:Patients suspected of TP and presenting with clinical symptoms and radiological evidence of PE were consecutively enrolled by treating physicians from 11 research sites across 6 provinces in China between April 2020 and August 2022. Following centrifugation, sediments obtained from PE were used for Xpert MTB/RIF (Xpert) and mycobacterial culture, while the supernatants were subjected to cf-TB testing. This study employed a composite reference standard to definite TP, which was characterized by any positive result for Mycobacterium tuberculosis (MTB) through either PE culture, PE Xpert, or pleural biopsy.Results:A total of 1412 participants underwent screening, and 1344 (95.2%) were subsequently enrolled in this study. Data from 1241 (92.3%) participants were included, comprising 284 with definite TP, 677 with clinically diagnosed TP, and 280 without TP. The sensitivity of cf-TB testing in definite TP was 73.6% (95% CI 68.2%–78.4%), significantly higher than both Xpert (40.8%, 95% CI 35.3%–46.7%, P<0.001) and mycobacterial culture (54.2%, 95% CI 48.4%–59.9%, P<0.001). When clinically diagnosed TP was incorporated into the composite reference standard for sensitivity analysis, cf-TB testing showed a sensitivity of 46.8% (450/961, 95% CI 43.7%–50.0%), significantly higher than both Xpert (12.1%, 116/961, 95% CI 10.2%–14.3%, P<0.001) and mycobacterial culture (16.0%, 154/961, 95% CI 13.8%–18.5%, P<0.001). The specificities of cf-TB testing, Xpert, and mycobacterial culture were all 100.0%.Conclusions:The performance of cf-TB testing is significantly superior to that of Xpert and mycobacterial culture methods, indicating that it can be considered as the primary diagnostic approach for improving TP detection.

キーワード

Cell-free Mycobacterium tuberculosis DNA (cf-TB);Pleural effusion (PE);Tuberculous pleurisy (TP);diagnosis

References

  1. 1..
    Lo Cascio CM, Kaul V, Dhooria S, Agrawal A, Chaddha U. Diagnosis of tuberculous pleural effusions: a review. Respir Med. 2021;188:106607.
  2. 2..
    Shaw JA, Diacon AH, Koegelenberg CFN. Tuberculous pleural effusion. Respirology. 2019;24(10):962-71.
  3. 3..
    Deng M, Ye X, Ma J, Xia Y, Zhang Q, Jiang B, et al. Ultrasonic elastography-guided pleural biopsy for the diagnosis of pleural effusion: a multicenter prospective study of diagnostic test performance. Ann Am Thorac Soc. 2023;20(9):1242-9.
  4. 4..
    Lewinsohn DM, Leonard MK, LoBue PA, Cohn DL, Daley CL, Desmond E, 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):111-5.
  5. 5..
    Lee CS, Chiu LC, Chang CH, Chung FT, Li SH, Chou CL, et al. The clinical experience of mycobacterial culture yield of pleural tissue by pleuroscopic pleural biopsy among tuberculous pleurisy patients. Medicina (Kaunas). 2022;58(9):1280.
  6. 6..
    Udwadia ZF, Sen T. Pleural tuberculosis: an update. Curr Opin Pulm Med. 2010;16(4):399-406.
  7. 7..
    Gopi A, Madhavan SM, Sharma SK, Sahn SA. Diagnosis and treatment of tuberculous pleural effusion in 2006. Chest. 2007;131(3):880-9.
  8. 8..
    Saha K, Maji A, Bandyopadhyay A, Jash D. Diagnostic yield of closed pleural biopsy in undiagnosed exudative pleural effusions. Maedica (Bucur). 2021;16(1):34-40.
  9. 9..
    WHO. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary tuberculosis in adults and children. Policy update. Geneva: World Health Organization, 2013.
  10. 10..
    Nasrin R, Uddin MKM, Kabir SN, Rahman T, Biswas S, Hossain A, et al. Xpert MTB/RIF Ultra for the rapid diagnosis of extrapulmonary tuberculosis in a clinical setting of high tuberculosis prevalence country and interpretation of “trace” results. Tuberculosis. 2024; 145:102478.
  11. 11..
    Kim SK, Chang J, Choi SH, Sung H, Kim MN. Performance of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis. Clin Lab. 2021. .
  12. 12..
    Huo ZY, Peng L. Is Xpert MTB/RIF appropriate for diagnosing tuberculous pleurisy with pleural fluid samples? A systematic review. BMC Infect Dis. 2018;18(1):284.
  13. 13..
    Qiu YR, Chen YY, Wu XR, Li YP, Cao XJ, Yu ZY, et al. Accuracy of Xpert MTB/RIF assay for the diagnosis of tuberculous pleural effusion. J Clin Lab Anal. 2022;36(1):e24185.
  14. 14..
    Touré NO, Wayzani M, Thiam K, Cissé MF, Mbaye FB. Contribution of the Xpert MTB/RIF to the etiological diagnosis of tuberculous pleurisy. Rev Mal Respir. 2017;34(7):758-64.
  15. 15..
    Choe J, Shin SH, Jeon K, Huh HJ, Park HD, Jeong BH. Features which discriminate between tuberculosis and haematologic malignancy as the cause of pleural effusions with high adenosine deaminase. Respir Res. 2024;25(1):17.
  16. 16..
    Zhang X, Meng Q, Miao R, Huang P. The diagnostic value of T cell spot test and adenosine deaminase in pleural effusion for tuberculous pleurisy: a systematic review and meta-analysis. Tuberculosis. 2022;135:102223.
  17. 17..
    Kim KH, Lee E, Shin AY, Ha JH, Kim JS, Ahn JH, et al. Is the current cutoff value of ADA for diagnosing tuberculosis pleurisy appropriate?. Am J Resp Crit Care Med. 2019;199:A4720.
  18. 18..
    Jiménez Castro D, Díaz Nuevo G, Pérez-Rodríguez E, Light RW. Diagnostic value of adenosine deaminase in nontuberculous lymphocytic pleural effusions. Eur Respir J. 2003;21(2):220-4.
  19. 19..
    Sivakumar P, Marples L, Breen R, Ahmed L. The diagnostic utility of pleural fluid adenosine deaminase for tuberculosis in a low prevalence area. Int J Tuberc Lung Dis. 2017;21(6):697-701.
  20. 20..
    Aggarwal AN, Agarwal R, Dhooria S, Prasad KT, Sehgal IS, Muthu V. Comparative accuracy of pleural fluid unstimulated interferon-gamma and adenosine deaminase for diagnosing pleural tuberculosis: a systematic review and meta-analysis. PLoS One. 2021;16(6):e0253525.
  21. 21..
    Lo YMD, Han DSC, Jiang P, Chiu RWK. Epigenetics, fragmentomics, and topology of cell-free DNA in liquid biopsies. Science. 2021;372(6538):eaaw3616.
  22. 22..
    Chang A, Loy CJ, Eweis-LaBolle D, Lenz JS, Steadman A, Andgrama A, et al. Circulating cell-free DNA in blood as a host response biomarker for detection of tuberculosis. Nat Commun. 2024;15(1):4949.
  23. 23..
    Che N, Yang X, Liu Z, Li K, Chen X. Rapid detection of cell-free Mycobacterium tuberculosis DNA in tuberculous pleural effusion. J Clin Microbiol. 2017;55(5):1526-32.
  24. 24..
    Li X, Du W, Wang Y, Liu Z, Li K, Chen H, et al. Rapid diagnosis of tuberculosis meningitis by detecting Mycobacterium tuberculosis cell-free DNA in cerebrospinal fluid. Am J Clin Pathol. 2020;153(1):126-30.
  25. 25..
    Yang X, Che N, Duan H, Liu Z, Li K, Li 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.e1-6.
  26. 26..
    Bossuyt PM, Reitsma JB, Bruns D, Gatsonis CA, Glasziou PP, Irwig L, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015;351:h5527.
  27. 27..
    Porcel JM. Tuberculous pleural effusion. Lung. 2009;187(5):263-70.
  28. 28..
    Kang W, Liu S, Du J, Tang P, Chen H, Liu J, et al. Epidemiology of concurrent extrapulmonary tuberculosis in inpatients with extrapulmonary tuberculosis lesions in China: a large-scale observational multi-centre investigation. Int J Infect Dis. 2022;115:79-85.
  29. 29..
    Chen S, Wang Y, Zhan Y, Liu C, Wang Q, Feng J, et al. The incidence of tuberculous pleurisy in mainland China from 2005 to 2018. Front Public Health. 2023;11:1180818.
  30. 30..
    Shimoda M, Tanaka Y, Morimoto K, Yoshiyama T, Yoshimori K, Ohta K. Diagnostic flowchart for tuberculous pleurisy, pleural infection, and malignant pleural effusion. Respir Investig. 2024;62(1):157-63.
  31. 31..
    Chu P, Chang Y, Zhang X, Han S, Jin Y, Yu Y, et al. Epidemiology of extrapulmonary tuberculosis among pediatric inpatients in mainland China: a descriptive, multicenter study. Emerg Microbes Infect. 2022;11(1):1090-102.
  32. 32..
    Peng X, Liao Q, Fang M, Zhu Y, Shi Y, Quan S, et al. Detection of pulmonary tuberculosis in children using the Xpert MTB/RIF ultra assay on sputum: a multicenter study. Eur J Clin Microbiol Infect Dis. 2022;41(2):235-43.
  33. 33..
    Bayhan GI, Sayir F, Tanir G, Tuncer O. Pediatric pleural tuberculosis. Int J Mycobacteriol. 2018;7(3):261-4.
  34. 34..
    Keys C, McLeod E, Pesti C, Armstrong D. Thoracoscopic pleural biopsy as an aid to diagnosis in pediatric tuberculosis with pleural involvement. Eur J Pediatr Surg. 2012;22(4):315-7.
  35. 35..
    Nie HM, Dai JH. Clinical value of pleural biopsy in the diagnosis of children with tuberculosis pleurisy. Chin J Pediatr. 2014;52(5):392-6.
  36. 36..
    Friedrich SO, von Groote-Bidlingmaier F, Diacon AH. Xpert MTB/RIF assay for diagnosis of pleural tuberculosis. J Clin Microbiol. 2011;49(12):4341-2.
  37. 37..
    Vierron E, Giraudeau B. Sample size calculation for multicenter randomized trial: taking the center effect into account. Contemp Clin Trials. 2007;28(4):451-8.

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