Futatsuki K, Komita T, Kamano T, Watanabe H
Gan To Kagaku Ryoho. 1987 May;14(5 Pt 1):1274-80.
We have carried out Phase II study by single oral administration of UFT fine granule preparation consisting of 1-(2-tetrahydrofuryl)-5-fluorouracil(FT-207) and uracil in the molar ratio of 1 : 4. There were 40 evaluable cases out of 54 registered cases, and PR rate was 10.0%. We have observed 2 PR cases out of 14 evaluable cases with stomach cancer, and the response rate was 14.3%. There were PR cases in hepatoma and breast cancer also. Myelosuppression appeared in 10.6% and subjective and objective side effects in 27.1%, in which major symptoms were gastrointestinal disorder similar to those observed in the study of UFT Capsule preparation. We did not observe hepatic and renal malfunctions.
我们对由1-(2-四氢呋喃基)-5-氟尿嘧啶（FT-207）和尿嘧啶按1:4摩尔比组成的优福定细粒制剂进行了单次口服的II期研究。在54例登记病例中有40例可评估病例，PR率为10.0%。在14例可评估的胃癌病例中有2例PR病例，有效率为14.3%。肝癌和乳腺癌病例中也有PR病例。骨髓抑制发生率为10.6%，主观和客观副作用发生率为27.1%，其中主要症状是与优福定胶囊制剂研究中观察到的类似的胃肠道紊乱。我们未观察到肝肾功能障碍。
