Tubercle. 1981 Mar;62(1):13-29. doi: 10.1016/0041-3879(81)90031-3.
A controlled clinical trial of 4 regimens was undertaken in patients with bacteriologically positive, newly-diagnosed pulmonary tuberculosis. The regimens were: ethambutol 15 mg/kg plus isoniazid 400 mg, daily (E7H7); ethambutol 45 mg/kg plus isoniazid 15 mg/kg, twice a week (E2H2); ethambutol 90 mg/kg plus isoniazid 15 mg/kg, once a week plus isoniazid 15 mg/kg, mid-way between the weekly doses (E1H2); and ethambutol 90 mg/kg plus isoniazid 15 mg/kg, once a week (E1H1). All patients received streptomycin 1 g plus ethambutol 25 mg/kg body-weight plus isoniazid 400 mg daily for the first 2 weeks. The total duration of treatment was 12 months for all patients. There were 484 patients admitted to the study. After excluding 60 (41 with initial drug resistance to isoniazid), there remain 424 patients (107 E7H7, 101 E2H2, 107 E1H2, 109 E1H1) in the main analyses. The pretreatment characteristics of the 4 groups were broadly similar. A favourable response at 12 months was observed in 96%, 88%, 93% and 75% of patients respectively: the differences between the E1H1 regimen and the other 3 regimens were all significant (P less than or equal to 0.03) as was that between the E7H7 and E2H2 regimens (P = 0.05). Among the slow inactivators of isoniazid, the proportions with a favourable response at one year were similar in the 4 groups (range 95--91%). However, among the rapid inactivators, the proportion with a favourable response in the E1H1 group was only 57%. There was suggestive evidence that the E1H2 regimen was superior to the E2H2 regimen. Of the patients with bacteriologically quiescent disease at 1 year, approximately a half, at random, had no further chemotherapy and were followed up for a 4-year period. Bacteriological relapse requiring retreatment occurred in 15% of 54 E7H7 patients, 26% of 38 E2H2, 33% of 43 E1H2 and 54% of 37 E1H1 patients, a significant difference (P less than 0.001). A final evaluation of long-term (5-year) favourable response achieved by the 12-month regimens was 83% for the E7H7, 63% for the E2H2, 63% for the E1H2 and 33% for the E1H1 regimens. In general, the regimens were well tolerated and the incidence of adverse reactions to the drugs was low. Of the 424 patients, 6 (1.4%) developed a visual disturbance during the year of chemotherapy.
对细菌学检查呈阳性的新诊断肺结核患者进行了4种治疗方案的对照临床试验。这些方案分别是：乙胺丁醇15mg/kg加异烟肼400mg，每日1次（E7H7）；乙胺丁醇45mg/kg加异烟肼15mg/kg，每周2次（E2H2）；乙胺丁醇90mg/kg加异烟肼15mg/kg，每周1次，在每周剂量中间时段加服异烟肼15mg/kg（E1H2）；以及乙胺丁醇90mg/kg加异烟肼15mg/kg，每周1次（E1H1）。所有患者在最初2周均接受链霉素1g加乙胺丁醇25mg/kg体重加异烟肼400mg，每日1次。所有患者的总治疗时长均为12个月。共有484名患者纳入该研究。排除60例（其中41例初始对异烟肼耐药）后，主要分析中剩余424例患者（107例E7H7、101例E2H2、107例E1H2、109例E1H1）。4组患者的治疗前特征大致相似。12个月时观察到的良好反应率分别为96%、88%、93%和75%：E1H1方案与其他3种方案之间的差异均具有显著性（P≤0.03），E7H7与E2H2方案之间的差异也具有显著性（P = 0.05）。在异烟肼慢灭活者中，4组1年时良好反应的比例相似（范围为95% - 91%）。然而，在异烟肼快灭活者中，E1H1组良好反应的比例仅为57%。有提示性证据表明E1H2方案优于E2H2方案。1年时细菌学静止的患者中，约一半随机不再接受进一步化疗，并进行了4年随访。54例E7H7患者中有15%、38例E2H2患者中有26%、43例E1H2患者中有33%、37例E1H1患者中有54%出现需要再次治疗的细菌学复发，差异具有显著性（P＜0.001）。对12个月治疗方案实现的长期（5年）良好反应的最终评估结果为：E7H7方案为83%，E2H2方案为63%，E1H2方案为63%，E1H1方案为33%。总体而言，这些方案耐受性良好，药物不良反应发生率较低。424例患者中，6例（1.4%）在化疗期间出现视力障碍。
