替吉奥单药对比奥沙利铂、5-Fu/亚叶酸钙在大肠癌患者姑息手术后化疗的临床研究

Clinical Comparison of S-1 versus Oxaliplatin Plus 5-Fu and Leucovorin in the Treatment of Colorectal Cancer after Palliative Operation

目的观察替吉奥(S-1)胶囊单药在大肠癌患者姑息手术后化疗的临床疗效及不良反应.方法将昆明医科大学第二附属医院行姑息手术后化疗的大肠癌患者42例随机分为观察组和对照组,观察组21例应用替吉奥(S-1)80 mg/m2,每日2次早晚餐后口服d1～14,21 d为1个周期;对照组21例用亚叶酸钙200 mg/m2,dl～2,静脉输注2 h,5-Fu 500 mg/m2,dl～5,静脉输注,奥沙利铂85 mg/m2,d 1,静脉输注,每14 d重复,28d为1个周期.结果观察组和对照组的药物有效治疗率(Response rate,RR)分别为28.6%和33.3%,2组差异无统计学意义(P>0.05).观察组腹泻发生率9.5%,对照组42.8%;观察组口腔黏膜炎发生率4.8%,对照组38.1%.观察组的不良反应发生率明显低于对照组(P<0.05).结论替吉奥(S-1)单药对大肠癌患者姑息手术后的治疗效果确切,毒副反应能耐受,胃肠道反应较轻,明显提高患者生活质量,值得临床推广应用.

Objective To evaluate the efficacy and toxicity of S-1 capsule in the treatment of colorectal cancer after palliative operation. Methods Forty-two patients with colorectal cancer after palliative operation were divided equally into the test group and the control group according to the method of chemotherapy. The test group was treated only with S-1 capsule 80 mg/m2,orally administered twice daily for 2 weeks, 21 days as a chemotherapy cycle. The control group was treated with combination chemotherapy of leucovorin 200 mg/m2, vein drops 2 h,d1-2;5-Fu 500 mg/m2,vein drops,d1-5; and oxaliplatin 85 mg/m2,vein drops,d1, repeated every 14 days,28 d as a cycle. Results The response rate（RR） was 28.6% and 33.3% in the test group and the control group,respectively. However, there was no significant difference between the two groups. In the test group and control group,the diarrhea rate was 9.5% and 42.8%,and the oral mucositis rate was 4.8% and 38.1%,respectively.Conclusion S-1 single-agent is effective and tolerable in the treatment of patients with colorectal cancer after palliative operation.