Shah Sayed Idrees, Ghafoor Abdul, Rahman Shafiq Ur, Ahmad Nafees, Al-Qaaneh Ayman M, Younis Faisal
Department of Pharmacy, Shaheed Benazir Bhutto University, Sheringal, Pakistan.
Programmatic Management of Drug Resistant TB Unit, Saidu Group of Teaching Hospitals, Swat, Pakistan.
J Eval Clin Pract. 2025 Sep;31(6):e14230. doi: 10.1111/jep.14230. Epub 2024 Nov 4.
Patients suffering from multidrug/rifampicin resistant tuberculosis (MDR/RR-TB) are treated for prolonged periods with a complex regimen comprised of relatively less effective and more toxic anti-TB drugs, consequently resulting in high incidence of adverse events (AEs).
The current study evaluates the incidence, types, management and predictors of AEs, and their impact on treatment outcomes in MDR/RR-TB patients receiving all oral treatment regimens.
A total of 242 eligible MDR/RR-TB patients treated at two different study sites from June 2019 to December 2021 were included in this study.
Patients' sociodemographic, microbiological, clinical characteristics, reported AEs and treatment outcomes were retrospectively abstracted from their medical records. Chi-square, and Fisher exact tests (wherever applicable) were used to find the association between the variable and the occurrence of AEs.
Majority of the patients were suffered from MDR-TB (71.9%) and were treated with longer treatment regimen (77.7%). Overall 206/242 patients (85%) experienced at least one AE during their treatment. Gastrointestinal disturbance was the most common AE (49.6%), followed by arthralgia (49.2%), psychiatric disturbances (39.3%), dermatological reactions (27.7%), body/headache (24.8%) and hyperuricemia (19%). Due to AEs, treatment modification was noted in 55 (22.72%) patients. Level of modification in the treatment regimen was higher in optic neuritis (100%) followed by neuropathies (80%) and myelosuppression (59%). Similarly, hepatotoxicity was the most serious AE in which the whole treatment regimen was terminated in 27% of patients. Furthermore, the results revealed that only patients' education status had statistically significant association with the incidence of AEs (p = 0.02). The treatment success rate was 80.6% whereas the ratio of died and LTFU patients were 15.3% and 4.1% respectively. Although patients who experienced AEs were more likely to develop successful treatment outcomes (82%) than their counterparts (72.2%), though this difference was not statistically significant.
Although AEs were highly present in the current cohort, but they were successfully managed mostly by nonpharmacological interventions or symptomatic treatment. Besides, the incidence of AEs did not have a negative impact on treatment outcomes. High-risk patients for AEs must receive special attention and enhanced clinical management.
耐多药/利福平耐药结核病（MDR/RR-TB）患者需使用由疗效相对较差且毒性更强的抗结核药物组成的复杂方案进行长期治疗，因此不良事件（AE）的发生率很高。
本研究评估接受全口服治疗方案的MDR/RR-TB患者AE的发生率、类型、管理及预测因素，以及它们对治疗结果的影响。
本研究纳入了2019年6月至2021年12月在两个不同研究地点接受治疗的242例符合条件的MDR/RR-TB患者。
回顾性地从患者病历中提取患者的社会人口统计学、微生物学、临床特征、报告的AE及治疗结果。采用卡方检验和Fisher精确检验（如适用）来发现变量与AE发生之间的关联。
大多数患者患有耐多药结核病（71.9%），并接受了较长疗程的治疗（77.7%）。总体而言，206/242例患者（85%）在治疗期间经历了至少一次AE。胃肠道不适是最常见的AE（49.6%），其次是关节痛（49.2%）、精神障碍（39.3%）、皮肤反应（27.7%）、身体不适/头痛（24.8%）和高尿酸血症（19%）。由于AE，55例（22.72%）患者的治疗方案进行了调整。视神经炎患者治疗方案的调整程度最高（100%），其次是神经病变（80%）和骨髓抑制（59%）。同样，肝毒性是最严重的AE，27%的患者终止了整个治疗方案。此外，结果显示只有患者的教育程度与AE的发生率有统计学显著关联（p = 0.02）。治疗成功率为80.6%，死亡和失访患者的比例分别为15.3%和4.1%。尽管经历AE的患者比未经历AE的患者更有可能获得成功的治疗结果（82%对72.2%），但这种差异无统计学意义。
尽管本队列中AE的发生率很高，但大多通过非药物干预或对症治疗成功处理。此外，AE的发生率对治疗结果没有负面影响。AE的高危患者必须得到特别关注和加强临床管理。
