中国临床药理学杂志

目的观察贝伐珠单抗注射液联合奥沙利铂注射剂和卡培他滨片治疗晚期结肠癌的临床疗效及安全性。方法将84例晚期结肠癌患者随机分为对照组和试验组,每组42例。对照组给予130 mg·m^-2奥沙利铂,静脉滴注,第1天+1000 mg·m^-2卡培他滨,bid,口服,治疗2周后停药1周;试验组在对照组治疗的基础上,给予5 mg·kg^-1贝伐单抗,静脉滴注,第1和15天。2组患者一个疗程均为21 d,共治疗2个疗程。观察2组患者的临床疗效,以及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64.29%(27例/42例)和30.95%(13例/42例),差异有统计学意义(P<0.05)。试验组和对照组的恶心呕吐发生率分别为23.81%和28.57%,血小板减少症发生率分别为16.67%和21.43%,白细胞减少发生率分别为28.57%和23.81%,口腔炎发生率分别为11.90%和16.67%,肝肾功能受损发生率分别为23.81%和19.05%,手足综合征发生率分别为33.33%和26.19%,差异均无统计学意义(均P>0.05)。结论贝伐珠单抗注射液联合奥沙利铂注射剂和卡培他滨片治疗晚期结肠癌的临床疗效确切,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of bevacizumab injection combined with oxaliplatin injection and capecitabine tablets in the treatment of patients with advanced colon cancer.Methods A total of 84 patients with advanced colon cancer were randomly divided into control group and treatment group with 42 cases per group.The control group was given 130 mg·m^-2 oxaliplatin, intravenous drip, on the first day + 1000 mg·m^-2 capecitabine, bid, orally, after 2 weeks of treatment, the drug was stopped for 1 week.The treatment group was given 5 mg·kg^-1 bevacizumab, intravenous drip, on days 1 and 15, on the basis of control group.Two groups were treated for two cycles with 21 days per cycle.The clinical efficacy and adverse drug reactions were compared between two groups.Results After treatment, the total effective rates of treatment and control groups were 64.29%(27 cases/42 cases) and 30.95%(13 cases/42 cases) with significant difference(P<0.05).The incidences of nausea and vomiting in the treatment and control groups were 23.81% and 28.57%, the incidences of thrombocytopenia were 16.67% and 21.43%,the incidences of leucopenia were 28.57% and 23.81%,the incidences of stomatitis were 11.90% and 16.67%,the incidences of liver and kidney function damage were23.81% and 19.05%,the incidences of hand foot syndrome were 33.33% and 26.19%,the differences were not statistically significant(all P>0.05).Conclusion Bevacizumab injection combined with oxaliplatin injection and capecitabine tablets has a definitive clinical efficacy in the treatment of advanced colon cancer,without increasing the incidence of adverse drug reactions.