Adverse drug reactions and patients’ outcomes in Moroccan tuberculosis cases

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Ouassima Erefai
Sanae Barnou
Meryem Rais
Houria Hardouz

Abstract

Introduction: Tuberculosis (TB) remains a global health problem. Its treatment usually involves a combination of antibiotics over a prolonged period, exposing patients to a range of adverse drug reactions (ADRs).


Aim: To investigate the epidemiology and outcomes of tuberculosis patients in Rabat (Morocco), with particular emphasis on assessing the ADRs of treatment and factors contributing to their occurrence.


Methods: This retrospective study was conducted at Moulay Youssef Hospital in Rabat, from January 2021 to May 2022. Only patients hospitalized in the intensive phase of tuberculosis treatment, with known HIV status, and aged 15 or over were included. Sociodemographic characteristics, clinical presentations, manifestations of ADRs, and patient outcomes were analyzed. Uni- and multivariate logistic regression were conducted to identify factors associated with ADR occurrence.


Results: In this study, 144 patients were included. The mean age of patients was 45.82±19.26 years. A male predominance was observed with a sex ratio of 1.4. Almost one-third of the patients (31.5%) experienced at least one ADR during treatment, with gastrointestinal symptoms (50%) being prominent. Logistic regression identified higher ADR incidence in females (p-value=0.046, OR=2.123; 95%CI: 1.013-4.448) and patients with addictive habits (p-value=0.019, OR=3.358; 95%CI:1.478-8.419). Treatment success was observed in 64.58% of the cases, with ADRs showing no significant difference between patients with successful treatment and those with failed treatment.


Conclusion: The occurrence of ADR poses a significant challenge to tuberculosis patients, highlighting the need for personalized approaches to mitigate these complications and ensure treatment success.

Keywords:

Tuberculosis, Epidemiology, Adverse drug reactions, Morocco

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References

  1. Glaziou P, Floyd K, Raviglione MC. Global Epidemiology of Tuberculosis. Semin Respir Crit Care Med. 2018; 39 (3):271-285. doi: 10.1055/s-0038-1651492.
  2. Mac Neil A, Glaziou P, Sismanidis C, Date A, Maloney S, Floyd K. Global Epidemiology of Tuberculosis and Progress Toward Meeting Global Targets - Worldwide, 2018. MMWR Morb Mortal Wkly Rep. 2020; 69 (11):281-285. doi: 10.15585/mmwr.mm6911a2.
  3. World Health Organization. Global tuberculosis report. 2023. Available at: https://iris.who.int/bitstream/handle/10665/373828/9789240083851-eng.pdf?sequence=1.
  4. Royaume du Maroc. Plan stratégique national pour la prévention et le contrôle de la tuberculose au Maroc 2024-2030. pp 123.
  5. Kiran M, Nagabushan H. Adverse drug reactions monitoring in patients on antitubercular treatment in tertiary care hospital, Mandya. Biomed Pharmacol J. 2021; 14(2):701-08.
  6. Edwards IR, Aronson JK (2000) Adverse drug reactions: definitions, diagnosis, and management. Lancet. 356: 1255–1259
  7. Lorent N, Sebatunzi O, Mukeshimana G, Van den Ende J, Clerinx J. Incidence and risk factors of serious adverse events during antituberculous treatment in Rwanda: a prospective cohort study. PLoS One. 2011;6(5): e19566. doi: 10.1371/journal.pone.0019566.
  8. Farazi A, Sofian M, Jabbariasl M, Keshavarz S. Adverse reactions to antituberculosis drugs in Iranian tuberculosis patients. Tuberc Res Treat. 2014:412893. doi: 10.1155/2014/412893.
  9. Mishra GP, Gandhi SA. Study of various causes of treatment interruption among tuberculosis patients. Ind J Basic Appl Med Res. 2016; 6(1):382-86.
  10. El Hamdouni M, Ahid S, Bourkadi JE, Benamor J, Hassar M, Cherrah Y. Incidence of adverse reactions caused by first-line anti-tuberculosis drugs and treatment outcome of pulmonary tuberculosis patients in Morocco. Infection. 2020;48(1):43-50. doi: 10.1007/s15010-019-01324-3.
  11. World Health Organization. WHO consolidated guidelines on tuberculosis. Module 4: treatment drug susceptible tuberculosis treatment. 2022.pp 72.
  12. Stadler JAM. Updated WHO definitions for tuberculosis outcomes: Simplified, unified and future-proofed. Afr J Thorac Crit Care Med. 2022; 28 (2):10.7196/AJTCCM.2022.v28i2.224. doi: 10.7196/AJTCCM.2022.v28i2.224.
  13. World Medical Association, “World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects”, JAMA., vol. 310, n°. 20, p. 2191–2194, 2013. https://doi.org/10.1001/jama.2013.281053
  14. Lv X, Tang S, Xia Y, Wang X, Yuan Y, Hu D, et al. Adverse reactions due to directly observed treatment strategy therapy in Chinese tuberculosis patients: a prospective study. PLoS One. 2013;4;8(6):e65037. doi: 10.1371/journal.pone.0065037.
  15. Horton KC, MacPherson P, Houben RM, White RG, Corbett EL. Sex Differences in Tuberculosis Burden and Notifications in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis. PLoS Med. 2016; 6;13(9):e1002119. doi: 10.1371/journal.pmed.1002119.
  16. Noubom M, Nembot FD, Donfack H, Mfin PS, Tchasse F. [Characteristics of TB patients in west Cameroon: 2000-2009]. Pan Afr Med J. 2013; 16:39. https://doi.org/10.11604/pamj.201 3.16.39.2860.
  17. Sow KD, Yanogo P, Ndiaye M, Kane M, Sawadogo B, Otshudiandjeka J, et al. Epidemiological profile of Tuberculosis, Senegal, 2009-2018. J Interval Epidemiol Public Health. 2021; Suppl 3: 12. DOI: https://doi.org/10.37432/jieph.supp.2021.4.4.03.12.
  18. Arega B, Mersha A, Minda A, Getachew Y, Sitotaw A, Gebeyehu T et al. Epidemiology and the diagnostic challenge of extra-pulmonary tuberculosis in a teaching hospital in Ethiopia. PLoS One. 2020 ;15(12):e0243945. doi: 10.1371/journal.pone.0243945.
  19. Kettani AE, Jebbar S, Takourt B, Maaloum F, Diraa O, Farouqi B, et al. [HIV co- infection in patients followed up for tuberculosis in the Division of Infectious Diseases at the Ibn Rochd University Hospital in Casablanca]. Pan Afr Med J. 2018; 16; 30:276. French. doi: 10.11604/pamj.2018.30.276.13913.
  20. Soedarsono S, Mertaniasih NM, Kusmiati T, Permatasari A, Ilahi WK, Anggraeni AT. Characteristics of Previous Tuberculosis Treatment History in Patients with Treatment Failure and the Impact on Acquired Drug-Resistant Tuberculosis. Antibiotics. 2023; 12(3):598. https://doi.org/10.3390/antibiotics12030598
  21. Silva DR, Muñoz-Torrico M, Duarte R, Galvão T, Bonini EH, Arbex FF, et al. Risk factors for tuberculosis: diabetes, smoking, alcohol use, and the use of other drugs. J Bras Pneumol. 2018; 44(2):145-152. doi: 10.1590/s1806-37562017000000443.
  22. El Hamdouni M, Ahid S, Bourkadi JE, Benamor J, Hassar M, Cherrah Y. Incidence of adverse reactions caused by first-line anti-tuberculosis drugs and treatment outcome of pulmonary tuberculosis patients in Morocco. Infection. 2020;48(1):43-50. doi: 10.1007/s15010-019-01324-3.
  23. Buhari GK, Keren M, Dursun AB, Güler M, Dulkar G, Kalaç N, et al. Immediate-type hypersensitivity reactions due to antituberculosis drugs: a successful readministration protocol. Ann Allergy Asthma Immunol. 2015;115(1):39-44. doi: 10.1016/j.anai.2015.04.015.
  24. Damasceno GS, Guaraldo L, Engstrom EM, Theme Filha MM, Souza-Santos R, Vasconcelos AG, et al. Adverse reactions to antituberculosis drugs in Manguinhos, Rio de Janeiro, Brazil. Clinics. 2013;68(3):329-37. doi: 10.6061/clinics/2013(03)oa08.
  25. Panova LV, Ovsiankina ES. Chastota razvitiia i vidy pobochnykh reaktsiĭ na khimioterapiiu u podrostkov, bol'nykh tuberkulezom [Incidence of adverse reactions to chemotherapy and their types in adolescents with tuberculosis]. Probl Tuberk. 2003;(1):28-30. Russian.
  26. Tan WC, Ong CK, Kang SCL, Razak MA. Two years review of cutaneous adverse drug reaction from first line antituberculous drugs. Med J Malaysia. 2007; 62:143–5.
  27. Ravichandran M, Rajaram M, Munusamy M. Pharmacovigilance of Antitubercular Therapy in Tuberculosis. Cureus. 2022;14(2): e21915. doi: 10.7759/cureus.21915.
  28. Ramappa V, Aithal GP. Hepatotoxicity Related to Anti-tuberculosis Drugs: Mechanisms and Management. J Clin ExpHepatol. 2013;3(1):37-49. doi: 10.1016/j.jceh.2012.12.001.
  29. van Zyl Smit RN, Pai M, Yew WW, Leung CC, Zumla A, Bateman ED, et al. Global lung health: the colliding epidemics of tuberculosis, tobacco smoking, HIV and COPD. Eur Respir J. 2010; 35(1):27-33. doi: 10.1183/09031936.00072909.
  30. Thontham A, Polsook R. Symptom experience of adverse drug reaction among male and female patients with newly diagnosed pulmonary tuberculosis in Thailand. Belitung Nurs J. 2021; 7(3):195-202. doi: 10.33546/bnj.1337.
  31. World Health Organization. Global tuberculosis control: surveillance, planning, financing: WHO report 2008; Vol. 393.