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Purpose <p>Tuberculosis (TB) treatment with first-line anti-TB drugs is frequently associated with adverse drug reactions (ADRs) that may compromise treatment adherence, safety, and outcomes. Given the limited real-world evidence from Southern Morocco, this study aimed to investigate the incidence of ADRs in patients treated for drug-sensitive TB with the RHZE regimen, identify associated sociodemographic and clinical risk factors, and evaluate their impact on treatment outcomes among TB patients in the Laâyoune-Sakia El Hamra region.</p> Methods <p>A retrospective exhaustive study was conducted on 346&#xa0;TB patients treated with the RHZE regimen at the Center for Tuberculosis and Respiratory Diseases of Laâyoune (CDTMRL) between January 2023 and December 2024 to assess ADR frequency, patterns, associated risk factors, and treatment outcomes. ADRs were systematically evaluated by a specialist clinician, and outcomes were classified according to World Health Organization guidelines.</p> Results <p>Among 346&#xa0;TB patients, 26.59% experienced at least one ADR, mainly during the intensive phase. ADRs were significantly associated with sex, age, smoking, and comorbidities (diabetes and HIV). Hepatic ADRs were the most frequent (13.87%), followed by gastrointestinal (9.83%), renal (6.36%), articular (6.07%), and cutaneous (5.78%) reactions. Neurological (2.60%), immunoallergic (1.45%), cardiovascular (1.45%), and urogenital (0.58%) were less common. Most ADRs were mild to moderate, with few treatment modifications and no deaths. Treatment success was 80.6%, while 11.0% had unfavorable outcomes.</p> Conclusion <p>Adverse effects related to RHZE therapy occur frequently, highlighting the importance of rigorous clinical monitoring, especially during the intensive treatment phase. Enhanced pharmacovigilance systems and focused monitoring of high-risk populations are crucial to improve therapeutic safety and treatment outcomes.</p>

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Characterization of Adverse Drug Reactions to the RHZE Antitubercular Regimen, Risk Factors and Treatment Outcomes: A Retrospective Exhaustive Study in Southern Morocco

  • 期刊论文

  • 发表日期：

    2026年7月2日

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  • Omar Er-Rguibi,
  • Hasnae Dahdah,
  • Habiba Saou

摘要

Purpose

Tuberculosis (TB) treatment with first-line anti-TB drugs is frequently associated with adverse drug reactions (ADRs) that may compromise treatment adherence, safety, and outcomes. Given the limited real-world evidence from Southern Morocco, this study aimed to investigate the incidence of ADRs in patients treated for drug-sensitive TB with the RHZE regimen, identify associated sociodemographic and clinical risk factors, and evaluate their impact on treatment outcomes among TB patients in the Laâyoune-Sakia El Hamra region.

Methods

A retrospective exhaustive study was conducted on 346 TB patients treated with the RHZE regimen at the Center for Tuberculosis and Respiratory Diseases of Laâyoune (CDTMRL) between January 2023 and December 2024 to assess ADR frequency, patterns, associated risk factors, and treatment outcomes. ADRs were systematically evaluated by a specialist clinician, and outcomes were classified according to World Health Organization guidelines.

Results

Among 346 TB patients, 26.59% experienced at least one ADR, mainly during the intensive phase. ADRs were significantly associated with sex, age, smoking, and comorbidities (diabetes and HIV). Hepatic ADRs were the most frequent (13.87%), followed by gastrointestinal (9.83%), renal (6.36%), articular (6.07%), and cutaneous (5.78%) reactions. Neurological (2.60%), immunoallergic (1.45%), cardiovascular (1.45%), and urogenital (0.58%) were less common. Most ADRs were mild to moderate, with few treatment modifications and no deaths. Treatment success was 80.6%, while 11.0% had unfavorable outcomes.

Conclusion

Adverse effects related to RHZE therapy occur frequently, highlighting the importance of rigorous clinical monitoring, especially during the intensive treatment phase. Enhanced pharmacovigilance systems and focused monitoring of high-risk populations are crucial to improve therapeutic safety and treatment outcomes.