卡培他滨片联合奥沙利铂注射剂治疗晚期结肠癌患者的临床研究  

Clinical trial of capecitabine tablets combined with oxaliplatin injection in the treatment of patients with advanced colon cancer

作　　者：郎新梅 李欣荣 徐占平[1] 牛越[2] LANG Xin-mei;LI Xin-rong;XU Zhan-ping;NIU Yue(Department of Pharmacy,Bayannur City Hospital,Inner Mongolia,Bayannaoer 015000,Inner Mongolia Autonomous Region,China;Department of Cancer Center,Bayannur City Hospital,Inner Mongolia,Bayannaoer 015000,Inner Mongolia Autonomous Region,China)

机构地区：[1]巴彦淖尔市医院药剂科,内蒙古自治区巴彦淖尔015000 [2]巴彦淖尔市医院肿瘤中心,内蒙古自治区巴彦淖尔015000

出　　处：《中国临床药理学杂志》2021年第7期802-804,808,共4页The Chinese Journal of Clinical Pharmacology

基　　金：内蒙古自治区自然科学基金资助项目(2014MS0839)。

摘　　要：目的观察卡培他滨片联合奥沙利铂注射剂治疗晚期结肠癌患者的临床疗效及安全性。方法将97例晚期结肠癌患者随机分为对照组49例和试验组48例。对照组给予130 mg·m^(-2)奥沙利铂,静脉滴注,于2~3 h内滴完,第1天;试验组在对照组治疗的基础上,给予1 250 mg·m^(-2)卡培他滨,bid,口服,第1~14天。2组患者均治疗6个疗程,每个疗程21 d。比较2组患者的临床疗效,血清癌基因ras产物P21蛋白(rasP21)和环氧化酶-2(COX-2)的水平,以及药物不良反应的发生情况。方法治疗后,试验组和对照组的总有效率分别为60.42%(29例/48例)和36.73%(18例/49例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的rasP21分别为(10.03±2.11)和(19.90±3.02)ng·mL^(-1),COX-2分别为(3.11±1.10)和(6.70±2.01)ng·mL^(-1),差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以恶心呕吐、白细胞减少、血小板减少、手足综合征、神经毒性和皮炎为主。试验组和对照组的总药物不良反应发生率分别为66.67%(32例/48例)和73.47%(36例/49例),差异无统计学意义(P>0.05)。结论卡培他滨片联合奥沙利铂注射剂治疗晚期结肠癌患者的临床疗效确切,其能明显降低血清rasP21和COX-2水平,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of capecitabine tablets combined with oxaliplatin injection in the treatment of advanced colon cancer patients.Methods A total of 97 patients with advanced colon cancer were randomly divided into control group(n=49 cases)and treatment group(n=48 cases).The control group was given 130 mg·m^(-2) oxaliplati by intravenous drip within 2-3 hours on the first day.On the basis of control group,the treatment group was given 1250 mg·m^(-2) capecitabine,bid,orally for day 1-14.Two groups were treated for 6 courses with 21 days per course.The clinical efficacy,serum levels of ras product p21 protein(rasP21)and cyclooxygenase-2(COX-2),and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of the treatment and control groups were 60.42%(29 cases/48 cases)and 36.73%(18 cases/49 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:rasp21 were(10.03±2.11)and(19.90±3.02)ng·mL^(-1),COX-2 were(3.11±1.10)and(6.70±2.01)ng·mL^(-1),the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were leucopenia,nausea and vomiting,while those in the control group were leucopenia,nausea and vomiting.The total incidences of adverse drug reactions in the treatment and control groups were 66.67%(32 cases/48 cases)and 73.47%(36 cases/49 cases)without significant difference(P>0.05).Conclusion Capecitabine tablets combined with oxaliplatin injection have a definitive clinical efficacy in the treatment of advanced colon cancer,which can significantly reduce the levels of serum rasP21 and COX-2,without increasing the incidence of adverse drug reactions.

关 键 词：卡培他滨片 奥沙利铂注射剂 晚期结肠癌 癌基因ras产物P21蛋白 环氧化酶-2 安全性评价 

分 类 号：R979.1[医药卫生—药品]