Cancer. 1987 Nov 15;60(10):2394-402. doi: 10.1002/1097-0142(19871115)60:10<2394::aid-cncr2820601008>3.0.co;2-i.
The effectiveness of immunotherapy using a streptococcal preparation, OK-432, was evaluated for cervical cancer. The 382 eligible patients were stratified by presence/absence of surgical operation and clinical stage, and then, in each stratum, were randomly divided into two groups: an OK-432 treatment group and a control treatment group. The 3-year recurrence-free rates of 221 patients in the OK-432 group and 161 patients in the control group were 71.9% and 58.6%, respectively. The intergroup difference was statistically significant (P less than 0.05). Delayed skin reactions to phytohemagglutinin (PHA) and Su-polysaccharide extracted from Streptococcus pyogenes Su-strain (Su-PS) and peripheral lymphocyte counts were reduced within two months after the initiation of therapy in both groups. The observed immunological changes were apparently reversed by 3 months after the start of the therapy in the OK-432 group, but this took at least one year in the control group, with significant intergroup differences at 6 and 12 months of the therapy (P less than 0.01). These results indicate that OK-432 can be considered as one of the most effective and useful immunotherapeutic agents for cervical cancer.
评估了使用链球菌制剂OK-432治疗宫颈癌的疗效。382例符合条件的患者按是否接受手术及临床分期进行分层，然后在各层中随机分为两组：OK-432治疗组和对照治疗组。OK-432组的221例患者和对照组的161例患者的3年无复发生存率分别为71.9%和58.6%。组间差异具有统计学意义（P<0.05）。两组在治疗开始后两个月内，对植物血凝素（PHA）和从化脓性链球菌Su菌株中提取的Su多糖（Su-PS）的迟发性皮肤反应以及外周淋巴细胞计数均降低。OK-432组在治疗开始后3个月时，观察到的免疫变化明显逆转，但对照组至少需要1年，在治疗6个月和12个月时组间差异显著（P<0.01）。这些结果表明，OK-432可被视为治疗宫颈癌最有效和有用的免疫治疗药物之一。
