Sarin Rohit, Vohra Vikram, Singla Neeta, Singla Rupak, Puri M M, Munjal S K, Khalid U K, Myneedu V P, Verma Ajoy, Mathuria K K
National Institute of Tuberculosis & Respiratory Disease, Sri Aurobindo Marg, Delhi 110030, India.
National Institute of Tuberculosis & Respiratory Disease, Sri Aurobindo Marg, Delhi 110030, India.
Indian J Tuberc. 2019 Jan;66(1):184-188. doi: 10.1016/j.ijtb.2019.02.006. Epub 2019 Feb 27.
Drug-Resistant Tuberculosis (DR-TB) patients for whom a WHO recommended regimen along with Bedaquiline (BDQ) cannot be prescribed, Delamanid (DLM) was added along with other drugs to provide a "Salvage Regimen". The experience of the Institute in respect of early efficacy and safety of both drugs given together is presented.
To ascertain the early efficacy, safety and tolerability of Bedaquline and Delamanid given together as a part of salvage regimen.
BDQ and DLM were used together to make regimens along with other drugs where four effective anti TB drugs could not be prescribed as per WHO recommendations. Patients were followed up for sputum smear and culture conversion and adverse events during the treatment.
In this cohort study, 53 DR-TB patients (Median age-24) were initiated on regimens containing both BDQ and DLM. Sputum smear conversion was seen in 35% and 94% patients at the end of 1st week and 3rd month respectively. 84% patients had culture conversion at the end of 4th month. 29 adverse events (AE) were reported among 17 patients and there were 11 deaths. QTc prolongation more than 500 MS was seen in only 1 patient.
BDQ and DLM given together in a salvage regimen is efficacious with low rate of adverse events. The combination provides hope to DR-TB patients with limited treatment options and should be provided as a life saving option.
对于无法开具世界卫生组织推荐方案加贝达喹啉（BDQ）的耐多药结核病（DR-TB）患者，除其他药物外还添加了德拉马尼（DLM）以提供“挽救方案”。本文介绍了该机构关于两种药物联合使用的早期疗效和安全性的经验。
确定作为挽救方案一部分联合使用贝达喹啉和德拉马尼的早期疗效、安全性和耐受性。
当无法按照世界卫生组织的建议开具四种有效的抗结核药物时，将BDQ和DLM与其他药物联合使用制定方案。在治疗期间对患者进行痰涂片和培养转阴情况以及不良事件的随访。
在这项队列研究中，53例DR-TB患者（中位年龄24岁）开始使用包含BDQ和DLM的方案。分别在第1周和第3个月末，35%和94%的患者痰涂片转阴。在第4个月末，84%的患者培养转阴。17例患者报告了29起不良事件（AE），有11例死亡。仅1例患者出现QTc延长超过500毫秒。
在挽救方案中联合使用BDQ和DLM是有效的，不良事件发生率低。这种联合用药为治疗选择有限的DR-TB患者带来了希望，应作为一种挽救生命的选择提供给患者。
