Ogura T
Gan To Kagaku Ryoho. 1983 Feb;10(2 Pt 2):366-72.
A randomized controlled study of adjuvant immunotherapy was performed using Nocardia rubra cell wall skeleton (N-CWS) for inoperable lung cancer patients in 5 institutions from October, 1978 to June, 1981. All patients without pleural effusions were treated according to common protocol including chemotherapy and/or radiotherapy, and the patients on performance status 0 to 3 were randomized to control and N-CWS group. In N-CWS group, 400 micrograms N-CWS was injected once or twice into the bronchial tumor using fiberoptic bronchoscope, and sequentially 200 micrograms N-CWS was injected once a month into the skin from shoulder to upper arms. One year survival rate of 118 N-CWS-treated patients was excellent when compared to that of 108 control patients, but statistically not significant. According to histological type, survival period of the patients with small cell carcinoma was prolonged significantly in N-CWS group. The eligible patients with pleural effusions were initially randomized to control group and N-CWS group and treated under tube thoracostomy. In control group adriamycin was injected into the affected pleural cavity. In N-CWS group adriamycin and N-CWS were injected with the same method, and intracutaneous injections of 200 micrograms N-CWS were added once every month. Not only response rate for pleural effusions but also survival rate were statistically excellent in N-CWS group. Main adverse reactions of N-CWS were skin lesions in the injected sites and fever, but these were transient and not serious.
1978年10月至1981年6月期间,在5家机构对无法手术的肺癌患者进行了一项使用红色诺卡氏菌细胞壁骨架(N-CWS)的辅助免疫治疗随机对照研究。所有无胸腔积液的患者均按照包括化疗和/或放疗的常规方案进行治疗,且体能状态为0至3级的患者被随机分为对照组和N-CWS组。在N-CWS组中,使用纤维支气管镜将400微克N-CWS注入支气管肿瘤一次或两次,随后每月一次将200微克N-CWS注入从肩部到上臂的皮肤。与108例对照患者相比,118例接受N-CWS治疗患者的一年生存率良好,但无统计学意义。根据组织学类型,N-CWS组小细胞癌患者的生存期显著延长。符合条件的胸腔积液患者最初被随机分为对照组和N-CWS组,并在胸腔闭式引流术下进行治疗。在对照组中,将阿霉素注入患侧胸腔。在N-CWS组中,以相同方法注入阿霉素和N-CWS,并每月额外进行一次200微克N-CWS的皮内注射。N-CWS组不仅胸腔积液的缓解率,而且生存率在统计学上均良好。N-CWS的主要不良反应是注射部位的皮肤病变和发热,但这些都是短暂的,并不严重。