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Long-term efficacy of 6-month therapy with isoniazid and rifampin compared with isoniazid, rifampin, and pyrazinamide treatment for pleural tuberculosis

  • José Francisco García-RodríguezEmail author
  • N. Valcarce-Pardeiro
  • H. Álvarez-Díaz
  • A. Mariño-Callejo
Original Article

Abstract

Research into anti-tuberculosis treatment has mainly focused on pulmonary tuberculosis (TB), with few studies on pleural-TB. The aim of the study is to compare the long-term efficacy of a 6-month treatment regimen with isoniazid and rifampicin (6HR) with treatment regimen of isoniazid, rifampicin, and pyrazinamide (6HR2Z) for pleural-TB. A case-control study of 200 HIV-negative patients with pleural-TB prospectively followed in our TB-unit from 1995 to 2018. The primary resistance to isoniazid is < 4% in our geographic area. Pleural-TB diagnosis was based on a positive culture for M. tuberculosis (84 patients), presence of caseating granulomas in pleural biopsy (28), or characteristics of pleural fluid (88). A comparative study of demographic and clinical characteristics between the treatment groups was carried out. Out of the 200 patients followed, (112 males, 88 females; mean age 32.9 ± 18.4 years), 99 patients were treated with 6HR regimen and 101 with 6HR2Z. The groups were comparable, except the 6HR2Z had larger size of pleural effusion. All patients completed the treatment. The group treated with 6HR presented fewer adverse effects (15.3%) than 6HR2Z group (33%), p = 0.005, and lower frequency of severe hepatic toxicity (5% vs 10.9%). Four patients died from causes other than TB during treatment with 6HR2Z, and all other patients were cured during a monitoring period for 8.4 years (IQRs, 3.3–14.3). Six patients in 6HR and 10 in 6HR2Z developed residual pachypleuritis. 6HR is as effective as 6HR2Z treatment for pleural-TB, with fewer adverse effects.

Keywords

Tuberculosis Epidemiology Tuberculosis Pleural tuberculosis Therapy 

Notes

Compliance with ethical standards

The study has been approved by the institutional research ethics committee and has been carried out in accordance with the ethical standards established in the Declaration of Helsinki of 1964. The informed consent of all the individual participants included in the study was obtained.

Conflict of interest

The authors declare that they have no competing interests.

References

  1. 1.
    Mitchison DA (1985) The action of antituberculosis drugs in short-course chemotherapy. Tubercle 66(3):219–225CrossRefGoogle Scholar
  2. 2.
    Blumberg HM, Burman WJ, Chaisson RE, Daley CL, Etkind SC, Friedman LN, Fujiwara P, Grzemska M, Hopewell PC, Iseman MD, Jasmer RM, Koppaka V, Menzies RI, O’Brien RJ, Reves RR, Reichman LB, Simone PM, Starke JR, Vernon AA (2003) American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med 167:603–662CrossRefGoogle Scholar
  3. 3.
    BTS (1998) Chemotherapy and management of tuberculosis in the United Kingdom: recommendations 1998. Joint Tuberculosis Committee of the British Thoracic Society. Thorax 53:536–548CrossRefGoogle Scholar
  4. 4.
    Singapore Tuberculosis Service/British Medical Research Council (1988) Five-year follow-up of a clinical trial of three 6-month regimens of chemotherapy given intermittently in the continuation phase in the treatment of pulmonary tuberculosis. Am Rev Respir Dis 137(5):1147–1150CrossRefGoogle Scholar
  5. 5.
    Lew W, Pai M, Oxlade O, Martin D, Menzies D (2008) Initial drug resistance and tuberculosis treatment outcomes: systematic review and meta-analysis. Ann Intern Med 149:123–134CrossRefGoogle Scholar
  6. 6.
    Gegia M, Winters N, Benedetti A, van Soolingen D, Menzies D (2017) Treatment of isoniazid-resistant tuberculosis with first-line drugs: a systematic review and meta-analysis. Lancet Infect Dis 17(2):223–234CrossRefGoogle Scholar
  7. 7.
    David HL (1970) Probability distribution of drug-resistant mutants in unselected populations of Mycobacterium tuberculosis. Appl Microbiol 20(5):810–814PubMedPubMedCentralGoogle Scholar
  8. 8.
    Shaw JA, Irusen EM, Diacon AH, Koegelenberg CF (2018) Pleural tuberculosis: a concise clinical review. Clin Respir J 12(5):1779–1786CrossRefGoogle Scholar
  9. 9.
    Dutt AK, Moers D, Stead WW (1990) Smear-negative, culture-positive pulmonary tuberculosis. Six-month chemotherapy with isoniazid and rifampin. Am Rev Respir Dis 141:1232–1235CrossRefGoogle Scholar
  10. 10.
    Dutt AK, Moers D, Stead WW (1989) Smear-and culture-negative pulmonary tuberculosis: four-month short-course chemotherapy. Am Rev Respir Dis 139:867–870CrossRefGoogle Scholar
  11. 11.
    Cañete C, Galarza I, Granados A, Farrero E, Estopà R, Manresa F (1994) Tuberculous pleural effusión: experience with six months of treatment with isoniazid and rifampin. Thorax 49:1160–1161CrossRefGoogle Scholar
  12. 12.
    Dutt AK, Moers D, Stead WW (1992) Tuberculous pleural efusión: 6-month therapy with isoniazid and rifampin. Am Rev Respir Dis 145:1429–1432CrossRefGoogle Scholar
  13. 13.
    García Rodríguez JF, Mariño Callejo A, Lorenzo García MV, Rodríguez Mayo M, Domínguez Gómez D, Sesma Sánchez P (1999) Resistance of Mycobacterium tuberculosis in Ferrol, Spain. Associated factors. Med Clin (Barc) 113(15):572–574Google Scholar
  14. 14.
    American Thoracic Soviet (1994) Medical Section of the American Lung Association. Treatment of tuberculosis and tuberculosis infection in adults and children. Am J Respir Crit Care Med 149:1359–1374Google Scholar
  15. 15.
    Long MW, Snider DE Jr, Farer LS (1979) U.S. Public Health Service Cooperative trial of three rifampin-isoniazid regimens in treatment of pulmonary tuberculosis. Am Rev Respir Dis 119:879–894PubMedGoogle Scholar
  16. 16.
    Dutt AK, Moers D, Stead WW (1984) Short-course chemotherapy for tuberculosis with mainly twice-weekly isoniazid and rifampin. Community physicians’ seven-year experience with mainly outpatients. Am J Med 77:233–242CrossRefGoogle Scholar
  17. 17.
    Metersky ML, Schluger NW (2016) New guidelines for the treatment of drug-susceptible tuberculosis from the American Thoracic Society, Centers for Disease Control and Prevention, and the Infectious Diseases Society of America. Now Comes the Hard Part. Am J Respir Crit Care Med 194(7):791–793CrossRefGoogle Scholar
  18. 18.
    Light RW (2010) Update on tuberculous pleural effusion. Respirology 15(3):451–458CrossRefGoogle Scholar
  19. 19.
    García-Rodríguez JF, Álvarez-Díaz H, Lorenzo-García MV, Mariño-Callejo A, Fernández-Rial Á, Sesma-Sánchez P (2011) Extrapulmonary tuberculosis: epidemiology and risk factors. Enferm Infecc Microbiol Clin 29(7):502–509CrossRefGoogle Scholar
  20. 20.
    Ong A, Creasman J, Hopewell PC, Gonzalez LC, Wong M, Jasmer RM, Daley CL (2004) A molecular epidemiological assessment of extrapulmonary tuberculosis in San Francisco. Clin Infect Dis 38:25–31CrossRefGoogle Scholar
  21. 21.
    Smith CM, Trienekens SC, Anderson C, Lalor MK, Brown T, Story A, Fry H, Hayward AC, Maguire H (2017) Twenty years and counting: epidemiology of an outbreak of isoniazid-resistant tuberculosis in England and Wales, 1995 to 2014. Euro Surveill 22:8.  https://doi.org/10.2807/1560-7917.ES.2017.22.8.30467 CrossRefGoogle Scholar
  22. 22.
    Wright A, Zignol M, Van Deun A, Falzon D, Gerdes SR, Feldman K, Hoffner S, Drobniewski F, Barrera L, van Soolingen D, Boulabhal F, Paramasivan CN, Kam KM, Mitarai S, Nunn P, Raviglione M (2009) Global Project on Anti-Tuberculosis Drug Resistance Surveillance. Epidemiology of antituberculosis drug resistance 2002–07: an updated analysis of the Global Project on Anti-Tuberculosis Drug Resistance Surveillance. Lancet. 373(9678):1861–1873CrossRefGoogle Scholar
  23. 23.
    Zignol M, van Gemert W, Falzon D, Sismanidis C, Glaziou P, Floyd K, Raviglione M (2012) Surveillance of anti-tuberculosis drug resistance in the world: an updated analysis, 2007–2010. Bull World Health Organ 90(2):111–119.  https://doi.org/10.2471/BLT.11.092585. CrossRefPubMedGoogle Scholar
  24. 24.
    Zignol M, Dara M, Dean AS, Falzon D, Dadu A, Kremer K, Hoffmann H, Hoffner S, Floyd K (2013) Drug-resistant tuberculosis in the WHO European Region: an analysis of surveillance data. Drug Resist Updat 16(6):108–115.  https://doi.org/10.1016/j.drup.2014.02.003 CrossRefPubMedGoogle Scholar
  25. 25.
    WHO. Treatment of tuberculosis. Guidelines for treatment of drug-susceptible tuberculosis and patient care 2017 UPDATE. https://apps.who.int/iris/bitstream/handle/10665/255052/9789241550000-eng.pdf?sequence=1. Accessed on May 28 2019.
  26. 26.
    Migliori GB, Sotgiu G, Rosales-Klintz S, Centis R, D’Ambrosio L, Abubakar I et al (2018) ERS/ECDC Statement: European Union standards for tuberculosis care, 2017 update. Eur Respir J 51(5).  https://doi.org/10.1183/13993003.02678-2017
  27. 27.
    Nahid P, Dorman SE, Alipanah N, Barry PM, Brozek JL, Cattamanchi A et al (2016) Executive summary: Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: treatment of drug-susceptible tuberculosis. Clin Infect Dis 63(7):853–867CrossRefGoogle Scholar
  28. 28.
    Sharma SK, Ryan H, Khaparde S, Sachdeva KS, Singh AD, Mohan A et al (2017) Index-TB guidelines: guidelines on extrapulmonary tuberculosis for India. Indian J Med Res 145(4):448–463PubMedPubMedCentralGoogle Scholar
  29. 29.
    Liang QL, Shi HZ, Wang K, Qin SM, Qin XJ (2008) Diagnostic accuracy of adenosine deaminase in tuberculous pleurisy: a meta-analysis. Respir Med 102:744–754CrossRefGoogle Scholar
  30. 30.
    Xu HY, Li CY, Su SS, Yang L, Ye M, Ye JR, Al e (2017) Diagnosis of tuberculous pleurisy with combination of adenosine deaminase and interferon-γ immunospot assay in a tuberculosis-endemic population: a prospective cohort study. Medicine(Baltimore) 96(47):e8412.  https://doi.org/10.1097/MD.0000000000008412 CrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Infectious Diseases Unit, Department of Internal MedicineUniversity Hospital of Ferrol, SergasFerrolSpain
  2. 2.Department of PharmacyUniversity Hospital of Ferrol, SergasFerrolSpain

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