替吉奥胶囊联合同步放疗治疗晚期胃癌的临床研究

Clinical trial of tegafur gimeracil and oteracil potassium capsules combined with radiotherapy in the treatment of advanced gastric cancer

目的观察替吉奥胶囊联合同步放疗治疗晚期胃癌的临床疗效和安全性。方法将92例晚期胃癌患者随机分为对照组46例和试验组46例。对照组予以同步放疗,每周5次;试验组在对照组治疗的基础上,予以40 mg·m-2替吉奥,早晚各1次,口服,连服14 d后停药7 d。2组患者一个疗程21 d,共治疗2个疗程。比较2组患者的临床疗效和药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为67.39%(31例/46例)和45.65%(21例/46例),1年存活率分别为69.57%(32例/46例)和45.65%(21例/46例),差异均有统计学意义(均P<0.05)。试验组和对照组的Ⅲ~Ⅳ级恶心呕吐发生率分别为2.17%和15.22%,Ⅰ~Ⅱ级转氨酶升高发生率分别为17.39%和36.96%,Ⅲ~Ⅳ级白细胞减少发生率分别为10.87%和39.13%,差异均有统计学意义(均P<0.05)。结论替吉奥胶囊联合同步放疗治疗晚期胃癌的临床疗效显著,且安全性较好。

Objective To observe the clinical efficacy and safety of tegafur gimeracil and oteracil potassium capsules combined with radiotherapy in the treatment of advanced gastric cancer.Methods A total of 92 patients with advanced gastric cancer were randomly divided into control group and treatment group with 46 cases per group.Control group received radiotherapy,five times a week.Treatment group was given 40 mg·m-2 tegafur gimeracil and oteracil potassium capsules,every morning and night,orally for 14 day and stop for 7 days,on the basis of control group.Two groups were treated for 2 cycles with 21 d per cycle.The clinical efficacy and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates in the treatment and control groups were 67.39%（31 cases/46 cases） and45.65%（21 cases/46 cases）,the 1-year survival rates in the treatment and control groups were 69.57%（32 cases/46 cases） and 45.65%（21 cases/46 cases）,the differences were statistically significant（all P 〈 0.05）.In the treatment and control groups,the incidences of nausea and vomiting with grade Ⅲ-Ⅳ were 2.17% and 15.22%,the incidences of increasing transaminase with grade Ⅰ-Ⅱ were 17.39% and 36.96%,the incidences of leukopenia with grade Ⅲ-Ⅳ were 10.87% and39.13%,the differences were statistically significant（all P 〈 0.05）.Conclusion Tegafur gimeracil and oteracil potassium capsules combined with radiotherapy have a definitive clinical efficacy and safety in the treatment of advanced gastric cancer.