Kikkawa F, Kawai M, Oguchi H, Kojima M, Ishikawa H, Iwata M, Maeda O, Tomoda Y, Arii Y, Kuzuya K
Department of Obstetrics and Gynecology, Nagoya University School of Medicine, Japan.
Eur J Cancer. 1993;29A(11):1542-6. doi: 10.1016/0959-8049(93)90291-m.
OK-432, a streptococcal preparation, was administered to patients with stage Ib and II cervical carcinoma except for adeno- and adenosquamous carcinomas. To evaluate the efficacy of OK-432 precisely, 177 patients were stratified by clinical stage, radiotherapy, and lymph node metastasis after complete radical hysterectomy and pelvic lymphadenectomy. Within each stratum, patients were divided randomly into OK-432 and control groups. 85 patients received OK-432 and 92 patients did not. No significant difference was observed in overall 5-year disease free rates between the OK-432 and the control groups, although the mean diameter of erythema on SU-polysaccharide (SU-PS) skin test was larger in the OK-432 group than in the control group. In stage IIb, a significant difference was observed between the OK-432 and control groups. This difference, however, could be attributed in part to the different incidence of the lymph node metastasis. In stage II without lymph node metastasis, 5-year disease free rate was significantly higher in the OK-432 group.
OK-432（一种链球菌制剂）被用于治疗Ib期和II期宫颈癌患者，但不包括腺癌和腺鳞癌患者。为了精确评估OK-432的疗效，177例患者在完全根治性子宫切除术和盆腔淋巴结清扫术后，根据临床分期、放疗和淋巴结转移情况进行分层。在每个分层内，患者被随机分为OK-432组和对照组。85例患者接受了OK-432治疗，92例患者未接受。OK-432组和对照组的总体5年无病生存率未观察到显著差异，尽管OK-432组中SU-多糖（SU-PS）皮肤试验的红斑平均直径大于对照组。在IIb期，OK-432组和对照组之间观察到显著差异。然而，这种差异部分可归因于淋巴结转移的不同发生率。在II期无淋巴结转移的患者中，OK-432组的5年无病生存率显著更高。
