替吉奥胶囊治疗进展期胃癌临床研究

Clinical investigation of TS-1 in treatment of advanced gastric cancer

关键词:  替吉奥胶囊  进展期胃癌  化学疗法

Key words:  TS-1  exhibition period stomach cancer  chemotherapy

摘要:

［目的］以替加氟片为对照药，评价齐鲁制药有限公司生产的替吉奥胶囊联合奥沙利铂治疗进展期胃癌的安全性和有效性。［方法］实验组：替吉奥胶囊(80 mg/m2)/d，分2次口服，d1~14。奥沙利铂130 mg/m2，静脉滴注，d1。对照组：替加氟片(800 mg/m2)/d，分3次口服，d1~14。奥沙利铂130 mg/m2，静脉滴注，d1。3周为1个疗程。每例受试者至少进行2个周期的治疗方能进行疗效评价。［结果］替吉奥联合奥沙利铂治疗胃癌总有效率实验组33.3%、对照组25.0%，两组间比较差异无统计学意义(P>0.05)。临床获益率实验组75%，对照组75%，两组间比较差异无统计学意义(P>0.05) 。 试验组与对照组KPS评分改善差异无统计学意义(P>0.05)。两组主要毒性反应为血液学毒性和消化道反应，两组间比较差异无统计学意义(P>0.05) 。［结论］替吉奥胶囊联合奥沙利铂是治疗进展期胃癌安全、有效的药物。

Abstract:

［Objective］ To take Tegafur piece as the comparison medicine to appraise the safety and effectiveness of TS-1 capsule, produced by Qilu Pharmaceutical Co. Ltd. combined with Oxaliplatin in the treatment of advanced gastric cancer. ［Methods］ The trial groups included TS-1 group administered with TS-1 capsule, (80 mg/m2)/d, twice a day per oral from day 1 to day 14, and Oxaliplatin group dosed with Oxaliplatin 130 mg/m2, intravenous drip on day 1. The control groups were Tegafur piece group, (800 mg/m2)/d, three times a day, per oral from day 1 to day 14 and Oxaliplatin group, 130 mg/m2, intravenous drip on day 1. One treatment cycle covered 3 weeks. Each subject took 2 cycles of the treatment in minimum. ［Results］ The effective rates were 33.3% in the trial group, and 25% in the control group. There was no significant difference between the two groups (P>0.05). Clinical beneficial rate was 75% in both groups with no significant difference between them (P>0.05). The change of general conditions (KPS) had some, but not significant difference between the two groups (P>0.05). The main toxicity was hematological and digestive toxic reactions. ［Conclusion］ TS-1 capsule combined with Oxaliplatin is safe and effective in the treatment of advanced gastric cancer.