Watanabe Y, Shimizu J, Oda M, Yoshida M, Watanabe S, Iwa T
First Department of Surgery, Kanazawa University School of Medicine, Japan.
Nihon Geka Gakkai Zasshi. 1991 Sep;92(9):1217-20.
To evaluate the clinical efficacy of OK-432 immunotherapy as an surgical adjuvant for lung cancer patients, three kinds of randomized controlled trials were done. In the first trial, patients were randomized into two groups: an immunochemotherapy (IM-C) group and a chemotherapy (control) group. For IM-C group, OK-432 (2KE/w) was injected intramuscularly for three years. Significant improvement of the survival rates in the IM-C group was noted in the following items: all resected cases, stages I+II cases, stage III cases, completely resected cases, incompletely resected cases and cases with epidermoid carcinoma. However, in comparison to adenocarcinoma there was no significant difference between the two groups. In the second trial, patients were randomized into an intramuscular injection group and an intradermal injection group. In comparisons to the survival rates, there were no significant differences between the two groups. In the third trial, stage I patients were randomized into a group treated with intradermal injection (5KE/w) and no adjuvant group. To date, there was no significant difference between the two groups. It is concluded that OK-432 immunotherapy, with concomitant use of chemotherapy, have favourable effect on the patient with squamous cell carcinoma. No definitive difference of clinical effects between intramuscular injection and intradermal injection.
为评估OK-432免疫疗法作为肺癌患者手术辅助治疗的临床疗效，进行了三种随机对照试验。在第一项试验中，患者被随机分为两组：免疫化疗（IM-C）组和化疗（对照组）。对于IM-C组，肌肉注射OK-432（2KE/周），持续三年。在以下各项中，IM-C组的生存率有显著提高：所有切除病例、I+II期病例、III期病例、完全切除病例、不完全切除病例和表皮样癌病例。然而，与腺癌相比，两组之间没有显著差异。在第二项试验中，患者被随机分为肌肉注射组和皮内注射组。在生存率比较方面，两组之间没有显著差异。在第三项试验中，I期患者被随机分为接受皮内注射（5KE/周）治疗的组和无辅助治疗组。迄今为止，两组之间没有显著差异。得出结论，OK-432免疫疗法与化疗同时使用，对鳞状细胞癌患者有良好效果。肌肉注射和皮内注射之间的临床效果没有明确差异。
