卡培他滨维持性口服治疗宫颈癌的临床研究

Clinical study of capecitabine in the maintenance treatment of patients with cervical cancer

目的探讨卡培他滨维持性口服治疗宫颈癌的近期疗效及不良反应。方法将96例宫颈癌患者随机分为高剂量维持组、低剂量维持组及对照组各32例。对照组单纯予以紫杉醇联合顺铂化疗方案治疗。在对照组治疗基础上,高剂量维持组应用卡培他滨1000mg/m2进行维持性治疗,低剂量维持组应用卡培他滨500mg/m2进行维持性治疗。比较3组的临床近期疗效及不良反应。结果高剂量维持组、低剂量维持组及对照组有效率分别为50.0%、46.9%、46.9%,3组间比较差异无统计学意义(P>0.05)。在1年生存率、中位进展时间和中位生存时间方面,均为低剂量维持组>高剂量维持组>对照组(P<0.05)。且低剂量维持组不良反应发生情况优于高剂量维持组,差异有统计学意义(P<0.05)。结论卡培他滨维持性口服治疗晚期宫颈癌疗效佳,且低剂量药物引起的不良反应明显较高剂量轻,临床应用方便,利于长期使用。

Objective To study the efficacy and adverse effect of capecitabine in the maintenance treatment of patients with metastatic cervical cancer. Methods 98 patients with metastatic cervical cancer were randomly divided into high maintenance dose group,low maintenance dose group and control group,each of 32 cases. The control group was given Taxol plus Cisplatin. The high maintenance dose group was given Capecitabine for maintenance treatment,1000mg/m2 ,bid,d1 - d14 based on the control group. The low maintenance dose group were given capecitabine for maintenance treatment,500mg/m2 , bid,d1 - d14 based on the control group. Results The effective rate of high maintenance dose group,low maintenance dose group and control group was 50. 0% 、46. 9% 、46. 9% respectively,and there were no significant differences among the 3 groups （P ＆gt;0. 05） . In aspect of 1 year survival rate,median time to progression and median survival time,the low maintenance dose group was higher than the high maintenance dose group,and the high maintenance dose group was higher than the control group （P ＆lt;0. 05） . The incidence of adverse reactions of the low maintenance dose group was better than that of the high maintenance dose group,and the difference was statistically significant （P ＆lt; 0. 05） . Conclusion For the patients with cervical cancer,the efficacy of capecitabine maintenance treatment is good. The adverse reaction of the low dose group is milder than that of the high dose one. So the low dose capecitabine maintenance treatment is convenient for long-term use.