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

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.

一项基于乙胺丁醇和异烟肼的、WHO推荐的为期8个月的治疗方案，在随机临床试验中与为期6个月的标准治疗方案进行了比较。共1355名新确诊的涂片阳性肺结核患者被随机分配至三种治疗方案之一：每日一次的乙胺丁醇、异烟肼、利福平和吡嗪酰胺，持续2个月，随后改为乙胺丁醇和异烟肼，持续6个月（2EHRZ/6HE）；相同药物，但在初始强化阶段每周三次给药（2[EHRZ]3/6HE）；或者与第一种方案相同的初始强化阶段，随后改为每日一次的利福平和异烟肼，持续4个月（2EHRZ/4HR）。随访直至化疗开始后30个月。痰液定期通过显微镜和培养进行检测。不良结局被定义为治疗期间失败或治疗后的复发。分析基于治疗意向。