Br Med J. 1973 Apr 7;2(5857):7-11.
A controlled clinical trial was undertaken in 247 patients with newly diagnosed pulmonary tuberculosis to assess the relative efficacies of a fully supervised twice-weekly oral regimen of isoniazid plus PAS (para-aminosalicylic acid) and a standard self-administered daily regimen of the same drugs following an initial intensive phase of two weeks of daily streptomycin, PAS, and isoniazid. Among patients who had isoniazid-sensitive cultures initially and who attended the clinic regularly the numbers with a favourable bacteriological response at the end of the year of chemotherapy were 79 (88%) out of 90 for the twice-weekly regimen and 72 (87%) out of 83 for the daily regimen; the numbers of patients with considerable radiographic improvement were 54 (60%) and 53 (64%) respectively. Complaints of vomiting or diarrhoea that did not require a reduction of the PAS dosage were made on one or two occasions by 23(21%) out of 109 twice-weekly and 25 (23%) out of 108 daily patients, and on at least three occasions by 4 (4%) and 12 (11%) respectively. Finally, all five patients who had chemotherapy changed on account of hypersensitivity to PAS had been receiving the daily regimen, as also had one patient who died of agranulocytosis.
对247例新诊断的肺结核患者进行了一项对照临床试验,以评估在最初两周每日使用链霉素、对氨基水杨酸(PAS)和异烟肼强化治疗后,每周两次的异烟肼加PAS口服全监督方案与相同药物的标准自我给药每日方案的相对疗效。在最初培养对异烟肼敏感且定期到诊所就诊的患者中,化疗一年结束时细菌学反应良好的人数,每周两次方案组90例中有79例(88%),每日方案组83例中有72例(87%);X线片有显著改善的患者人数分别为54例(60%)和53例(64%)。109例每周两次用药的患者中有23例(21%)、108例每日用药的患者中有25例(23%)有一两次呕吐或腹泻主诉,但无需减少PAS剂量,每周两次用药组有4例(4%)、每日用药组有12例(11%)至少有三次上述主诉。最后,因对PAS过敏而更改化疗方案的所有5例患者均采用每日方案治疗,还有1例死于粒细胞缺乏症的患者也采用每日方案治疗。