Yajin K, Harada Y, Tagashira N, Suzuki M, Hirakawa K, Sera K, Nakata M, Takebayashi S, Okazaki H, Yashiki T
Dept. of Otolaryngology, School of Medicine, Hiroshima University.
Gan To Kagaku Ryoho. 1988 Jun;15(6):1921-7.
A randomized controlled trial was carried out on 38 pharyngeal and 59 laryngeal previously untreated cancers to evaluate the effects of adjuvant immunochemotherapy using 5-FU with and without OK-432. After each fundamental therapy, 5-FU was given orally at a dose of 200-300 mg/day for more than a year. OK-432 was intracutaneously administered at a dose of 5KE once a week for more than a year. Three-year survival rates and disease-free intervals were estimated for the two groups. In cases of pharyngeal cancer, the 3-year survival rate was 58% in both groups and the disease-free interval rates for up to 3 years after the fundamental therapy was 49% in the OK-432 + 5-FU group and 52% in the 5-FU group. These results showed no statistically significant difference. In laryngeal cancers, the 3-year survival rate was 96% in the OK-432 + 5-FU group and 82% in the 5-FU group. These results also showed no statistically significant difference. The disease-free interval rates were 87% in the OK-432 + 5-FU group and 64% in the 5-FU group, revealing a statistically significant difference (p less than 0.1). This suggests that OK-432 is more effective in producing a higher survival rate in cases of laryngeal cancer.
对38例未经治疗的下咽癌和59例喉癌进行了一项随机对照试验，以评估使用5-氟尿嘧啶（5-FU）联合或不联合OK-432进行辅助免疫化疗的效果。每次进行基础治疗后，口服5-氟尿嘧啶，剂量为每日200 - 300毫克，持续一年以上。OK-432每周皮内注射一次，剂量为5KE，持续一年以上。对两组患者的三年生存率和无病生存期进行了评估。在下咽癌病例中，两组的三年生存率均为58%，基础治疗后长达三年的无病生存期率在OK-432 + 5-FU组为49%，在5-FU组为52%。这些结果显示无统计学显著差异。在喉癌病例中，OK-432 + 5-FU组的三年生存率为96%，5-FU组为82%。这些结果也显示无统计学显著差异。无病生存期率在OK-432 + 5-FU组为87%，在5-FU组为64%，显示出统计学显著差异（p小于0.1）。这表明OK-432在提高喉癌患者生存率方面更有效。
