Nima Gaki, Dorji Thinley, Dorji Chencho, Zangpo Tandin
Department of Internal Medicine Jigme Dorji Wangchuck National Referral Hospital Thimphu Bhutan.
Department of Geriatrics and Rehabilitation Medicine Sir Charles Gairdner and Osborne Park Hospital Perth Western Australia Australia.
Health Sci Rep. 2025 Sep 12;8(9):e71241. doi: 10.1002/hsr2.71241. eCollection 2025 Sep.
Bhutan first introduced the Shorter Regimen, consisting of a combination of Amikacin, Clofazamine, Ethionamide, Ethambutol, high dose Isoniazid, Moxifloxacin and Pyrazinamide, for the treatment of rifampicin or multidrug resistant tuberculosis (RR/MDR-TB) in 2018. This study describes the outcome, time to sputum conversion and adverse events of treatment among MDR-TB patients treated with the Shorter Regimen in Bhutan.
This was a longitudinal study among patients with RR/MDR-TB who were treated with the Shorten Regimen between 2018 and 2020. Throughout the treatment period, sputum smear, culture, and blood investigations were monitored.
There were 52 patients who received the shorter regimen for MDR-TB. Forty-seven patients (90%) had pulmonary TB (PTB) and five (10%) had extra-pulmonary TB (EPTB). Forty-one patients (79%) had confirmed MDR-TB and 11 (21%) had RR-TB. MDR-TB was detected in new cases in 35 patients (69%), while 11 (22%) were cases of TB relapse and five (10%) were cases of treatment failure. There were 40 patients (86%) who achieved sputum smear conversion by the end of 4 months while all patients became culture negative by the end of 3 months. All patients achieved culture conversion by the end of 3 months. The treatment success rate was 94% and there were no deaths. The common side effects were nausea, vomiting, arthralgia, dizziness, sleep disturbances, depressed mood and skin rash. QTc prolongations were observed in six patients, for which five patients needed dose modification of Moxifloxacin. Five patients had hepatitis, and two needed dose modification. Two patients were switched to the longer regimen due to amikacin-induced profound hearing loss and nephrotoxicity.
The treatment success rate of MDR-TB was high, with high sputum and culture conversion rates. Adequate monitoring of side effects is important in providing timely intervention.
不丹于2018年首次引入了由阿米卡星、氯法齐明、乙硫异烟胺、乙胺丁醇、高剂量异烟肼、莫西沙星和吡嗪酰胺组成的短程方案，用于治疗利福平耐药或耐多药结核病（RR/MDR-TB）。本研究描述了不丹采用短程方案治疗的MDR-TB患者的治疗结果、痰菌转阴时间及不良事件。
这是一项针对2018年至2020年间接受短程方案治疗的RR/MDR-TB患者的纵向研究。在整个治疗期间，监测痰涂片、培养及血液检查情况。
有52例患者接受了MDR-TB短程方案治疗。47例（90%）为肺结核（PTB），5例（10%）为肺外结核（EPTB）。41例（79%）确诊为MDR-TB，11例（21%）为RR-TB。35例（69%）新发病例检测出MDR-TB，11例（22%）为结核复发病例，5例（10%）为治疗失败病例。40例（86%）患者在4个月末实现痰涂片转阴，所有患者在3个月末痰培养均转为阴性。所有患者在3个月末实现培养转阴。治疗成功率为94%，无死亡病例。常见的副作用有恶心、呕吐、关节痛、头晕、睡眠障碍、情绪低落和皮疹。6例患者观察到QTc延长，其中5例患者需要调整莫西沙星剂量。5例患者出现肝炎，2例需要调整剂量。2例患者因阿米卡星导致严重听力损失和肾毒性而改用长程方案。
MDR-TB的治疗成功率较高，痰菌转阴率和培养转阴率也较高。充分监测副作用对于及时干预很重要。
