阿帕替尼片治疗晚期胃癌的临床研究

Clinical trial of apatinib tablets in the treatment of advanced gastric cancer

目的观察阿帕替尼片联合替吉奥胶囊和奥沙利铂注射剂治疗晚期胃癌的临床疗效和安全性。方法将90例晚期胃癌患者随机分为对照组45例和试验组45例。对照组予以第1天奥沙利铂130 mg·m^(-2),静脉滴注2 h+口服替吉奥,体表面积<1.25 m^2的患者,每次40 mg,体表面积1.25~1.5 m^2的患者,每次50 mg,体表面积>1.5 m^2的患者,每次60 mg,早晚餐后各一次,连用14 d。试验组在对照组治疗的基础上,予以口服阿帕替尼850 mg,qd,餐后0.5 h服用。2组患者1个疗程均为3周,共治疗4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,试验组和对照组的客观缓解率分别为40.00%(18/45例)和24.44%(11/45例),疾病控制率分别为77.78%(35/45例)和64.44%(29/45例)差异均有统计学意义(P<0.05)。试验组和对照组恶心呕吐发生率分别为11.11%,13.33%;粒细胞减少发生率分别为11.11%,8.89%;腹泻发生率均为2.22%;手足综合征发生率均为4.44%;血小板下降发生率分别为8.89%,6.67%差异均无统计学意义(P>0.05)。试验组和对照组乏力发生率分别为2.22%,11.11%;高血压发生率分别为2.22%,11.11%;蛋白尿发生率分别为0,6.67%差异均有统计学意义(P<0.05)。结论阿帕替尼片联合替吉奥胶囊和奥沙利铂注射剂治疗晚期胃癌的临床疗效显著,且安全性较高。

Objective To study the clinical efficacy and safety of apatinib tablets combined with tegafur,gimeracil and oteracil potassium capsules（S-1） and oxaliplatin injections in the treatment of advanced gastric cancer.Methods A total of 90 patients with advanced gastric cancer were randomly divided into control group and treatment group with 45 cases per group.Control group was given 130 mg ·m^（-2） oxaliplatin,intravenous infusion for 2 h in the first day ＋oral S-1 twice a day after breakfast and dinner for 14 days,the dosages were 40,50,60 mg per time for the patients with the surface area 1.25 m,1.25-1.5 m^2, 1.5 m,respectively.Treatment group orally received apatinib 850 mg qd,0.5 h after meal,on the basis of control group.Two groups were treated for 4 cycles with 3 weeks per cycle.The clinical efficacy and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates in treatment and control groups were 40.00%（18/45 cases） and 24.44%（11/45 cases）,disease control rates in treatment and control groups were 77.78%（35/45 cases） and 64.44%（29/45 cases）,the differences were statistically significant（P 0.05）.In the treatment and control groups,the incidences of nausea and vomiting were 13.33%and 11.11%;neutropenia were 11.11% and 8.89%;diarrhea were 2.22%and 2.22%;hand-foot syndrome were 4.44% and 4.44%;thrombocytopenia were 6.67% and 8.89%,without significant difference（P 0.05）.In the treatment and control groups,the incidences of fatigue were 2.22% and 11.11%;hypertension were 2.22% and 11.11%;proteinuria were 0 and 6.67%,the differences were statistically significant P 0.05）.Conclusion Apatinib tablets combined with S-1 and oxaliplatin injections have a definitive clinical efficacy and safety in the treatment of advanced gastric cancer.