Castelo A, Jardim J R, Goihman S, Kalckman A S, Dalboni M A, da Silva E A, Haynes R B
Escola Paulista de Medicina, São Paulo, Brazil.
Lancet. 1989 Nov 18;2(8673):1173-6. doi: 10.1016/s0140-6736(89)91788-1.
A randomised controlled trial compared the effectiveness and toxicity in pulmonary tuberculosis of two drug regimens containing rifampicin and isoniazid given daily or twice-weekly for 4 months after a 2-month period of intensive treatment with daily isoniazid, rifampicin, and pyrazinamide. 667 patients with newly diagnosed pulmonary tuberculosis were randomly allocated to continue daily treatment with isoniazid (400 mg) and rifampicin (600 mg) or to twice-weekly treatment with isoniazid (900 mg) and rifampicin (600 mg). 544 of the 667 patients (81%) completed the 6-month course (287 of 337 [85%] treated daily and 257 of 330 [79%] treated twice-weekly). Drug toxicity was not a great problem; the treatment was permanently discontinued in only 2% of patients. There was no significant difference at the end of months 5 and/or 6 of chemotherapy between the groups treated daily and twice-weekly in the proportions with bacteriological failure (at least one positive sputum culture with more than 20 colonies) or who had died from tuberculosis (17 [6%] vs 10 [3%]). Nor was there a significant difference in the relapse rate (17 [7%] treated daily vs 10 [4%] treated twice-weekly) during follow-up of 12 months. Thus, the twice-weekly regimen was at least as effective as the daily regimen for treatment of pulmonary tuberculosis.
一项随机对照试验比较了两种含利福平与异烟肼的药物治疗方案对肺结核的有效性和毒性。在每日服用异烟肼、利福平和吡嗪酰胺进行2个月强化治疗后,这两种方案分别采用每日给药或每周给药两次的方式持续治疗4个月。667例新诊断的肺结核患者被随机分配,继续接受异烟肼(400mg)和利福平(600mg)每日给药治疗,或异烟肼(900mg)和利福平(600mg)每周给药两次治疗。667例患者中有544例(81%)完成了6个月疗程(每日给药治疗的337例中有287例[85%],每周给药两次治疗的330例中有257例[79%])。药物毒性不是大问题;仅2%的患者永久停药。在化疗第5个月和/或第6个月末,每日给药组和每周给药两次组在细菌学治疗失败(至少一次痰培养阳性且菌落数超过20个)比例或死于肺结核的比例方面(17例[6%]对10例[3%])无显著差异。在12个月的随访期间,复发率也无显著差异(每日给药治疗组为17例[7%],每周给药两次治疗组为10例[4%])。因此,每周给药两次方案治疗肺结核的效果至少与每日给药方案相同。