Takada M, Fukuoka M, Negoro S, Kusunoki Y, Matsui K, Masuda N, Sakai N, Ryu S, Takifuji N, Kudo S
Second Department of Internal Medicine, Osaka Prefectural Habikino Hospital, Japan.
Acta Oncol. 1990;29(6):821-5. doi: 10.3109/02841869009093008.
A randomized trial of combination therapy with bestatin (30 mg daily, every day) was performed in 238 patients with inoperable primary lung cancer from August, 1981 through April, 1984. Of the 238 patients, 227 were evaluable: 113 treated by bestatin combination therapy and 114 controls. There was no statistically significant difference in response rate or survival between the 2 groups. In squamous cell cancer response was observed in 34.5% of the bestatin group and 17.9% of the control group. The analysis, including Cox's proportional hazard model, revealed that the survival tended to be longer in the bestatin group (median survival 40 weeks) than in the control group (median survival 24 weeks; p = 0.051). This suggests that addition of bestatin might be beneficial in squamous cell cancer of the lung but further, more rigidly controlled, clinical trials are necessary before more definitive conclusions can be drawn.
1981年8月至1984年4月期间，对238例无法手术的原发性肺癌患者进行了一项关于联合使用抑氨肽酶B（每日30毫克，每日一次）的随机试验。在这238例患者中，227例可进行评估：113例接受抑氨肽酶B联合治疗，114例为对照组。两组之间的缓解率或生存率无统计学显著差异。在鳞状细胞癌中，抑氨肽酶B组的缓解率为34.5%，对照组为17.9%。包括Cox比例风险模型在内的分析显示，抑氨肽酶B组的生存期（中位生存期40周）倾向于比对照组（中位生存期24周；p = 0.051）更长。这表明添加抑氨肽酶B可能对肺鳞状细胞癌有益，但在得出更明确的结论之前，需要进行进一步的、更严格控制的临床试验。
