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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 observe the clinical efficacy and safety of apatinib tablets in combination with tigiao capsule and oxaliplatin injection in the treatment of advanced gastric cancer. Methods Ninety patients with advanced gastric cancer were randomly divided into control group (45 cases) and experimental group (45 cases). Patients in the control group were treated with oxaliplatin 130 mg · m -2 on day 1, intravenous drip 2 h + oral tiagogrel, and body surface area 1.25 ~ 2 m ~ 2 patients, each 50 mg, body surface area> 1.5 m ~ 2 of patients, each 60 mg, after breakfast and dinner, once every 14 d. The experimental group in the control group based on the treatment, oral apatinib 850 mg, qd, 0.5 h after meal taken. Two groups of patients with a course of 3 weeks, a total of 4 courses of treatment. The clinical efficacy and adverse drug reactions in two groups were compared. Results After treatment, the objective response rates were 40.00% (18/45 cases) and 24.44% (11/45 cases) in the experimental and control groups, respectively. The disease control rates were 77.78% (35/45) and 64.44% 29/45 cases) were statistically significant (P <0.05). The incidences of nausea and vomiting in the experimental and control groups were 11.11% and 13.33%, respectively. The incidences of neutropenia were 11.11% and 8.89% respectively. The incidence of diarrhea was 2.22%, and the incidence of hand-foot syndrome was 4.44%. The incidence of thrombocytopenia The incidence rates were 8.89% and 6.67%, respectively, with no significant difference (P> 0.05). The incidence of fatigue in the experimental group and the control group were 2.22% and 11.11% respectively. The incidences of hypertension were 2.22% and 11.11% respectively. The incidence of proteinuria was 0 and 6.67% respectively (P <0.05). Conclusion The clinical efficacy of apatinib in combination with tigei capsule and oxaliplatin injection in the treatment of advanced gastric cancer is significant and safe.