Outcomes of Daily Dose versus Part-daily Dose Treatment for Lung Tuberculosis: A Real-World Database Study in an Indonesian Hospital

Authors

  • William William 1. Department of Pharmacology and Therapeutics, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia. 2. Department of Pharmacology, Faculty of Medicine, University of Christian Krida Wacana, Jakarta, Indonesia.
  • Purwantyastuti Ascobat Department of Pharmacology and Therapeutics, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia
  • Instiaty Instiaty Department of Pharmacology and Therapeutics, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia
  • Heidy Agustin Department of Pulmonology and Respiratory Medicine, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia

Keywords:

Adverse effects, dose regimen, treatment outcomes, pulmonary tuberculosis

Abstract

Background: a meta-analysis of randomized control trials (RCTs) on category I pulmonary tuberculosis (PTB) treatments showed that either part-daily (2RHZE/4R3H3) or daily dose (2RHZE/4RH) had the same failure and recurrence rates. However, the World Health Organization (WHO) concluded that the part-daily dose had higher failure and recurrence rates. Therefore, this study was conducted to compare the treatment outcomes between both regimens, whether daily dose regimen has a better treatment outcome than part-daily dose regimen, and the adverse effects between both regimens. Methods: this was an analytic cross-sectional study of patients at the Persahabatan General Hospital, over the period of January 2015-June 2018. Data were taken from medical records and supported by telephone interviews, each regimen group had 175 patients. Results: there were no significant differences for success rates (p=0.470), lost to follow up rates (p=0.659), failure rates (p=1.000), death rates (p=1.000), and adverse effects in the continuation phase (p=0.324) between the groups. There were, however, significant differences in cure rates (p < 0.001) and complete treatment rates (p<0.001) between the groups. Conclusion: the cure rate and complete treatment rate were found to be better for the part-daily than the daily doses. The success rate of both regimens were the same as Indonesia’s target (90%). In the continuation phase, there were no significant difference of adverse effects between both regimens.

References

Anderson L, Baddeley A, Dean A, et al. Global tuberculosis report 2018. Geneva: WHO. 2018. p. 1-265.

Sutarjo US, Budijanto D, Kurniawan R, Yudianto, Hardhana B, Siswanti T. Profil kesehatan Indonesia 2017. Jakarta: KemKes RI. 2018:159-65.

Van Den Boogard J, Kibiki GS, Kisanga ER, Boeree MJ, Aarnoutse RE. New drugs against tuberculosis: Problems, progress, and evaluation of agents in clinical development. Antimicrob Agents Chemother. 2009;53(3):849-62.

Kazosi S, Clark J, Suhail AR. Intermittent versus daily pulmonary tuberculosis treatment regimens: A meta-analysis. Clin Med Res. 2015;13(3-4):117-38.

Subuh HM, Waworuntu W, Surya A, Armanda AJ, Lukitosari E, Isbaniah F dkk. Pengobatan pasien tuberkulosis. Jakarta: KemKes RI Dirjen P3L. 2017. p. 1-116.

Johnston JC, Campbell JR, Menzies D. Effect of intermittency on treatment outcome in pulmonary tuberculosis: An update systematic review and meta-analysis. Clin Infect Dis. 2017;xx(xx):1-20.

Schunemann H, Aung ST, Bonsu F, et al. Treatment of tuberculosis: Guidelines for treatment of drug-susceptible tuberculosis and patient care 2017 update. Geneva: WHO. 2017:1-56.

Suryanto AA, van den Broek J, Matta M, de Soldenhoff R, van der Werf. Is there an increased risk of TB relapse in patients treated with fixed-dose combination drugs in Indonesia. Int J Tuberc lung Dis. 2008;12(2):174-9.

Bartacek A, Schutt D, Panosch B, Borek M. Comparison of a four-drugs fixed dose combination regimen with a single tablet regimen in smear-positive pulmonary tuberculosis. Int J Tuberc Lung Dis. 2009;13(6):760-6.

Aseffa A, Chukwu JN, Vahedi M, Aguwa EN, Bedru A, Mebrahtu T. Efficacy and safety of ‘fixed dose’ versus ‘loose’ drug regimens for treatment of pulmonary tuberculosis in two high TB-burden African country: A randomized controlled trial. PLos One. 2016;11(6):1-13.

Lienhardt C, Cook SV, Burgos M, Edwards VY, Rigouts L, Anyo G. Efficacy and safety of a 4-drugs fixed dosed combination regimen compared with separate drugs for threatment of pulmonary tuberculosis: The study C randomized controlled trial. JAMA. 2011;305(14):1415-23.

Proano A, Bravard MA, Lopez JW, et al. Dynamics of cough frequency in adults undergoing treatment for pulmonary tuberculosis. Clin Infect Dis. 2017;64(9):1174-81.

Chan CY, Au-Yeang C, Yew WW, Hui M, Cheng AFB. Postantibiotic effects of antituberculosis agents alone and in combination. Antimicrob Agents Chemother. 2001;45(12):3631-34.

Gumbo T, Louie A, Deziel MR, et al. Concentration-dependant Mycobacterium tuberculosis killing and prevention of resistance by rifampin. Antimicrob Agents Chemother. 2007;51(11):3781-8.

Gumbo T. Chemotheraphy of tuberculosis, Mycobacterum avium complex disease, and leprosy. In: Brunton LL, Chabner BA, Knollmann BJ, editors. Goodman & Gilman’s the Pharmacological Basis of Therapeutics 12nd ed. New York: McGraw-Hill Company. 2014:1363-81.

Murray JF, Schraufnagel DE, Hopewell PC. Treatment of tuberculosis: A historical perspective. Ann Am Thorac Soc. 2015;12(12):1749-59.

Gravendeel JMT, Asapa AS, Becx-Bleumink M, Vrakking HA. Preliminary results of an operational field study to compare side effect, complaints and treatment results of a single-drug short course regimen with a four-drug fixed dose-combination (4FDC) regimen in South Sulawesi, Republic of Indonesia. Tuberculosis. 2003;83:186-6.

Downloads

Published

2021-03-31

How to Cite

William, W., Ascobat, P., Instiaty, I., & Agustin, H. (2021). Outcomes of Daily Dose versus Part-daily Dose Treatment for Lung Tuberculosis: A Real-World Database Study in an Indonesian Hospital. Acta Medica Indonesiana, 53(1), 18. Retrieved from https://www.actamedindones.org/index.php/ijim/article/view/1384

Issue

Vol. 53 No. 1 (2021): Acta Medica Indonesiana

Section

ORIGINAL ARTICLE

License

Copyright

The authors who publish in this journal agree to the following requirements:

  1. Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a  Creative Commons Attribution 4.0 International License (CC BY 4.0) that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
  2. Authors can enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
  3. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) before and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work. (See The Effect of Open Access)

Privacy Statement

The names and email addresses entered in this journal site will be used exclusively for the stated purposes of this journal and will not be made available for any other purpose or to any other party.