Yadav Arun Kumar, Mehrotra Ashok Kumar, Agnihotri S P, Swami Shivani
Associate Professor, Department of Respiratory Medicine, NIMS Medical College, Jaipur, Rajasthan, India.
Associate Professor, Department of Respiratory Medicine, NIMS Medical College, Jaipur, Rajasthan, India.
Indian J Tuberc. 2016 Oct;63(4):255-261. doi: 10.1016/j.ijtb.2016.09.013. Epub 2016 Nov 22.
CAT IV regimen or the standardized drug regimen (SDR) under the Revised National Control Program (RNTCP) uses six second-line anti-tubercular drugs in the initial intensive phase (IP). These drugs have many side effects and toxicity; they are less efficacious and have poor acceptability. The present study was conducted to evaluate the efficacy and outcome of Cat-IV regimen and the factors which influence the treatment outcome in MDR TB patients.
It was a prospective observational study, which was done in the CAT II treatment failure, LPA proven MDR TB patients, above the age of 18 years, who were referred to DOTS Plus center for treatment. The study was approved by the hospital ethics committee and patient consent was obtained before inclusion.
We observed culture conversion in 63.04% and ADR in 96.5%, default in 15.65%, and death in11.3% cases. The factors which influenced outcome included low body weight, long duration of illness cavitatory disease and indulgence in both tobacco & alcohol. The radiological favorable response strongly and significantly correlated with the bacteriological and clinical response during the IP.
We suggest that the efficacy can be further augmented by reducing default and controlling deaths which accounts for substantial numbers and occur mostly during IP.
在修订后的国家结核病控制规划(RNTCP)下,第四类方案(CAT IV)或标准化药物方案(SDR)在初始强化期(IP)使用六种二线抗结核药物。这些药物有许多副作用和毒性;它们疗效较差且可接受性不佳。本研究旨在评估第四类方案的疗效和结局以及影响耐多药结核病患者治疗结局的因素。
这是一项前瞻性观察性研究,针对年龄在18岁以上、经CAT II治疗失败且经线性探针分析(LPA)证实为耐多药结核病的患者,这些患者被转诊至DOTS Plus中心进行治疗。该研究经医院伦理委员会批准,并在纳入研究前获得患者同意。
我们观察到63.04%的患者培养转阴,96.5%的患者出现药物不良反应,15.65%的患者中断治疗,11.3%的患者死亡。影响结局的因素包括体重低、病程长、有空洞性病变以及吸烟和饮酒。在初始强化期,影像学上的良好反应与细菌学和临床反应密切且显著相关。
我们建议,通过减少中断治疗和控制死亡人数(这些情况占相当比例且大多发生在初始强化期),可以进一步提高疗效。