Miller A B, Taylor H E, Baker M A, Dodds D J, Falk R, Frappier A, Hill D P, Jindani A, Landi S, Macdonald A S, Thomas J W, Wall C
Can Med Assoc J. 1979 Jul 7;121(1):45-54.
A controlled clinical trial of the value of bacille Calmette--Guérin (BCG) vaccine given orally to patients with resectable carcinoma of the lung was conducted in 18 centres across Canada. A total of 308 patients were included in the analysis, 155 in the BCG group and 153 in the control group. The two groups were similar at the time of admission to the trial. BCG (120 mg) was given orally at weekly intervals for 1 month, every 2 weeks up to 3 months and then every 3 months until the total duration of therapy was 18 months. Over a 3- to 5-year follow-up period after the operation there was no difference in survival between the two groups, the proportion alive at 2 years being 61% in the BCG group and 58% in the control group. There was also no evidence of differences in the time to the detection of recurrent or metastatic disease or in the distribution of such disease. An analysis of prognostic factors confirmed the poor survival associated with histologically confirmed lymph node involvement. It may be concluded that no favourable effect from the oral administration of BCG was demonstrated.
在加拿大全国18个中心开展了一项关于口服卡介苗（BCG）对可切除肺癌患者价值的对照临床试验。共有308例患者纳入分析，BCG组155例，对照组153例。两组在进入试验时情况相似。口服BCG（120毫克），每周1次，共1个月；每2周1次，直至3个月；然后每3个月1次，直至治疗总时长为18个月。术后3至5年的随访期内，两组生存率无差异，BCG组2年生存率为61%，对照组为58%。在复发性或转移性疾病的检测时间或此类疾病的分布方面也没有差异的证据。预后因素分析证实，组织学确诊有淋巴结受累者生存率较差。可以得出结论，口服BCG未显示出有益效果。
