<b>Two 8-month regimens of chemotherapy for treatment of newly diagnosed pulmonary tuberculosis: international multicentre randomised trial. (Study A)<b></b></b>

A WHO-recommended 8-month regimen based on ethambutol and isoniazid was evaluated in a randomised clinical trial against a 6-month standard regimen. 1355 patients with newly diagnosed smear-positive pulmonary tuberculosis were randomly assigned one of three regimens: daily ethambutol, isoniazid, rifampicin, and pyrazinamide for 2 months, followed by ethambutol and isoniazid for 6 months (2EHRZ/6HE); the same drugs but given three times weekly in the initial intensive phase (2[EHRZ]3/6HE); or the same initial intensive phase as the first regimen, followed by 4 months of daily rifampicin and isoniazid (2EHRZ/4HR). Follow-up was to 30 months after the start of chemotherapy. Sputum was regularly examined by microscopy and culture. Unfavourable outcome was defined as failure during treatment or relapse afterwards. Analyses were by intention to treat.

本研究针对世界卫生组织（World Health Organization, WHO）推荐的以乙胺丁醇与异烟肼为基础的8个月治疗方案，开展随机临床试验，与6个月标准治疗方案进行疗效对照。共纳入1355例初诊痰涂片阳性肺结核患者，按随机分配原则接受以下三种治疗方案之一：① 前2个月每日予乙胺丁醇、异烟肼、利福平及吡嗪酰胺，后续6个月每日予乙胺丁醇与异烟肼（方案代号：2EHRZ/6HE）；② 药物组成与方案①一致，但初始强化期采用每周3次给药（方案代号：2[EHRZ]3/6HE）；③ 初始强化期与方案①相同，后续4个月每日予利福平与异烟肼（方案代号：2EHRZ/4HR）。所有患者均接受化疗启动后长达30个月的随访，定期留取痰液标本行显微镜检查与细菌培养。本研究将治疗期间治疗失败或治疗后复发定义为不良结局，并采用意向性治疗（intention to treat）原则进行数据分析。