Effectiveness and safety of regimen containing bedaquiline and delamanid in patients with drug-resistant tuberculosis.

Q2 Medicine
Perspectives in Clinical Research Pub Date : 2024-04-01 Epub Date: 2023-09-11 DOI:10.4103/picr.picr_1_23
Oki Nugraha Putra, Yulistiani Yulistiani, Soedarsono Soedarsono, Susi Subay
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引用次数: 0

Abstract

Background: Bedaquiline and delamanid have been included in the individualized treatment regimen (ITR) to treat patients with drug-resistant tuberculosis (DR-TB).

Objective: The objective of this study is to compare the effectiveness of sputum culture conversion and the safety of ITR containing bedaquiline and delamanid.

Methods: Data were collected retrospectively from medical records of DR-TB patients who received ITR between January 2020 and December 2021. Patients were divided into bedaquiline and bedaquiline-delamanid groups. Sputum culture was evaluated until 6 months of treatment. Measurement of QTc interval, renal and liver function test, and serum potassium were evaluated to assess safety during the study period. We used Chi-square to analyze a difference in cumulative culture conversion; meanwhile, Wilcoxon and Mann-Whitney tests were used to analyze differences in laboratory data for each and between the two groups, respectively.

Results: Fifty-one eligible DR-TB patients met the inclusion criteria, 41 in the bedaquiline and 10 in bedaquiline-delamanid group. 43/51 patients had a positive culture at baseline. After 6 months of treatment, 42/43 DR-TB patients (97.6%) had sputum culture conversion and no difference between the two groups (P ≥ 0.05). QTc interval within normal limit and no patient had a QTc >500 ms during the study period. Creatinine levels significantly differed between the two groups 6 months after treatment (P < 0.05).

Conclusion: DR-TB patients who received all oral ITR containing bedaquiline and or delamanid demonstrated favorable sputum conversion with a tolerable safety profile.

对耐药性结核病患者采用含有贝达喹啉和地拉那米的治疗方案的有效性和安全性。
背景:贝达喹啉(Bedaquiline)和德拉马尼(delamanid)已被纳入个体化治疗方案(ITR),用于治疗耐药结核病(DR-TB)患者:贝达喹啉和德拉马尼已被纳入个体化治疗方案(ITR),用于治疗耐药结核病(DR-TB)患者:本研究旨在比较含有贝达喹啉和地拉马尼的个体化治疗方案的痰培养转换效果和安全性:从2020年1月至2021年12月期间接受ITR治疗的DR-TB患者的病历中回顾性收集数据。患者被分为贝达喹啉组和贝达喹啉-德拉马尼组。对治疗 6 个月前的痰培养进行评估。为评估研究期间的安全性,还对 QTc 间期、肝肾功能检测和血清钾进行了评估。我们使用Chi-square来分析累计培养转换率的差异;同时,使用Wilcoxon和Mann-Whitney检验分别分析每组和两组之间实验室数据的差异:51例符合纳入标准的DR-TB患者中,41例为贝达喹啉组,10例为贝达喹啉-地拉那米德组。43/51 名患者的基线培养结果呈阳性。治疗 6 个月后,42/43 例 DR-TB 患者(97.6%)痰培养转阴,两组间无差异(P≥0.05)。研究期间,QTc 间期在正常范围内,没有患者 QTc >500 ms。两组患者在治疗 6 个月后的肌酐水平有明显差异(P < 0.05):结论:接受含有贝达喹啉和或地拉马尼的所有口服 ITR 的 DR-TB 患者的痰液转阴情况良好,且安全性可耐受。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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