替吉奥胶囊治疗晚期胃癌的临床研究

Clinical study of advanced gastric cancer patients treated with Tegafur capsule

目的观察替吉奥胶囊(S-1)单药治疗晚期胃癌的近期疗效和不良反应。方法将39例晚期胃癌患者采用完全随机方法分为两组。试验组(n=20):采用替吉奥胶囊(80~120 mg/d),分早、晚2次餐后口服,d l^28,休息14 d为1周期,连用2周期后评价疗效。对照组(n=19):采用DCF方案治疗,即多西紫杉醇75 mg/m2,d l静脉滴注;顺铂75 mg/m2,d l静脉滴注;氟尿嘧啶300 mg/m2,d 1~5静脉滴注;亚叶酸钙200 mg/m2,d 1~5静脉滴注。每3周重复。2周期后评价疗效。结果试验组与对照组的有效率(35.0%与31.6%)和临床获益率(65%与57.9%)比较,差异无统计学意义(P>0.05);试验组不良反应发生率明显低于对照组(P<0.05)。结论 S-1治疗晚期胃癌疗效确切,安全。

Objective To evaluate the efficacy and toxicity of Tegafur （ S-1 ） in patients with advanced gastric cancer. Methods Thirty-nine cases of advanced gastric cancer were randomly divided into two groups, i.e. trial group （ n = 20） treated with Tegafur capsule （80-120 mg/d, PO, bid） for 28 days, then had a 14d rest as one cycle and control group （n = 19） treated with DCF regimen （ Docetaxel 75 mg/m^2 , dl IV drop; C-DDP 75 mg/m^2 ,d1 IV drop; Efudex 300 mg/m^2 , D1 - 5 IV drop; calcium foli-nate 200 mg/m^2, D1 -5 IV drop） , repeated every 3 weeks. The effects were evaluated after two cycles. Results The trial group showed a similar effective rate （35.0% VS 31.6% ） and a similar clinical benefit rate （65.0% VS 57.9% ） （ P 〉 0.05 ） and a reduced adverse effect rate （ P 〈 0.05 ） when compared to the control group. Conclusion Tegafur capsule is safe and therapeuti-cally effective on the patients with advanced gastric cancer.