摘要
目的观察奥沙利铂联合替吉奥或卡培他滨治疗晚期结直肠癌的临床疗效及安全性。方法将74例晚期结直肠癌患者随机分为对照组37例和试验组37例。对照组予以135 mg·m^(-2)奥沙利铂,静脉滴注,第1天+2500 mg·m^(-2)卡培他滨,静脉滴注,第1天;试验组予以135 mg·m^(-2)奥沙利铂,静脉注射,第1天,同时口服替吉奥40~60 mg(体表面积<1.25 m^(2)给予每次40 mg,体表面积1.25~1.50 m^(2)给予每次50 mg,体表面积>1.5 m^(2)给予每次60 mg),bid(用药2周,停药1周)。2组患者一个疗程为3周,共治疗2个疗程。比较2组患者的近期临床疗效、1年生存率和中位疾病进展时间(TTP),以及不良反应发生率。结果治疗后,试验组的疾病控制率及客观缓解率分别为91.89%和56.75%均显著高于对照组的75.68%和35.14%(P<0.05)。试验组的1年生存率为70.27%显著高于对照组的51.35%(P<0.05)。试验组和对照组的中位TTP分别为(8.53±0.82)、(8.01±0.72)个月(P>0.05)。试验组的血小板减少、恶心呕吐、腹泻、贫血、中性粒细胞减少的发生率均显著低于对照组(P<0.05)。结论与奥沙利铂联合卡培他滨方案相比,奥沙利铂联合替吉奥方案在晚期结直肠癌治疗中的临床疗效更为显著,不良反应更少。
Objective To evaluate the clinical efficacy and safety oxaliplatin combined with tegafur or capecitabine in the treatment of advanced colorectal cancer. Methods Seventy- four patients with advanced colorectal cancer were randomly divided into treatment group( n = 37)and control group( n = 37). Control group was treated with 135 mg·m-2 oxaliplatin,day 1 + 2500 mg · m-2 capecitabine,day 1. Treatment group was treated with 135 mg·m-2 oxaliplatin,day 1 + tegafur 40- 60 mg bid with medication two weeks and stopping one week( 40 mg each time for body surface area 〈1. 25 m-2,50 mg each time for body surface area 1. 25- 1. 5 m-2,60 mg each time for body surface area〉 1. 5 m-2).One course of two groups was 2 weeks,totaling 2 courses. Comparison of the short- term clinical efficacy,1- year survival rate,median time to progression( TTP) and adverse drug reactions between the two groups was conducted. Results After treatment,the disease control rate and objective response rate in treatment group were significantly higher than those of control group( 91. 89% vs 75. 68%,56. 75% vs 35. 14%,P〈 0. 05).The 1- year survival rate of treatment group was significantly higher than that of control group( 70. 27% vs 51. 35%,P〈 0. 05). The TTPs were not different between treatment and control groups [( 8. 53 ± 0. 82) vs( 8. 01 ± 0. 72)months,P〉 0. 05]. The incidences of thrombocytopenia, nausea, vomiting, diarrhea, anemia, neutropenia in treatment group were significantly lower than those of control group( P〈 0. 05). Conclusion Combination therapy of Oxaliplatin and tegafur has a definitive clinical efficacy for the treatment of advanced colorectal cancer,which has fewer adverse drug reactions.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2016年第11期978-980,共3页
The Chinese Journal of Clinical Pharmacology
基金
山东省优秀中青年科学家科研奖励基金资助项目(2014BSA01002)