Gurumurthy Meera, Gopalan Narendran, Patel Leena, Davis Andrew, Srinivasalu Vignes Anand, Rajaram Shakira, Goodall Ruth, Bronson Gay
Vital Strategies, Singapore, Singapore.
Indian Council of Medical Research - National Institute for Research in Tuberculosis, Chennai, India.
PLOS Glob Public Health. 2025 Apr 1;5(4):e0004259. doi: 10.1371/journal.pgph.0004259. eCollection 2025.
There is limited evidence on the effect of DM co-morbidity in those undergoing treatment for MDR-TB. We report post-hoc analyses of participants from the STREAM Clinical Trial (Stage 1 and 2 combined). Participants who self-reported diabetes, had random blood glucose ≥200mg/dl at baseline, or reported taking concomitant medication for diabetes were classified as the DM group. In total, 896 (n=84 DM, n=812 non-DM) and 976 (n=87 DM, n=889 non-DM) participants were included respectively in the efficacy and safety analyses reported here. Summary statistics for efficacy and safety outcomes were calculated. Hazard ratios (HR) for time-to-event outcomes were estimated using Cox-proportional hazard models. Compared to the non-DM group, the DM group were significantly older, more likely to be male and had a higher BMI. The DM group experienced a significantly higher proportion of serious adverse events (SAEs) (41% vs. 22%, p<0.001) but was comparable to the non-DM group on all other safety (grade 3-5 adverse events, deaths, unscheduled visits) as well as all efficacy parameters (proportion with unfavourable outcome, proportion FoR, time to FoR and culture conversion) assessed. The STREAM clinical trial experience indicated that it is possible to achieve similar treatment outcomes in people with MDR-TB who have a DM co-morbidity. However, this sub-population experienced more SAEs, underscoring the importance of close monitoring to manage their impact and improve MDR-TB treatment outcomes.
关于耐多药结核病（MDR-TB）治疗患者中糖尿病合并症的影响，证据有限。我们报告了STREAM临床试验（1期和2期合并）参与者的事后分析。自我报告患有糖尿病、基线随机血糖≥200mg/dl或报告正在服用糖尿病伴随药物的参与者被归类为糖尿病组。在此报告的疗效和安全性分析中，分别纳入了896名（n = 84名糖尿病患者，n = 812名非糖尿病患者）和976名（n = 87名糖尿病患者，n = 889名非糖尿病患者）参与者。计算了疗效和安全性结果的汇总统计数据。使用Cox比例风险模型估计事件发生时间结果的风险比（HR）。与非糖尿病组相比，糖尿病组年龄显著更大，男性比例更高，体重指数（BMI）更高。糖尿病组发生严重不良事件（SAE）的比例显著更高（41%对22%，p<0.001），但在所有其他安全性指标（3 - 5级不良事件、死亡、非计划访视）以及所有评估的疗效参数（不良结局比例、失败率比例、达到失败的时间和培养转阴）方面与非糖尿病组相当。STREAM临床试验经验表明，对于合并糖尿病的耐多药结核病患者，有可能实现相似的治疗结果。然而，这一亚组经历了更多的严重不良事件，突出了密切监测以控制其影响并改善耐多药结核病治疗结果的重要性。
