多西紫杉醇联合吉西他滨和顺铂治疗非小细胞肺癌的临床研究  

Clinical trial of docetaxel combined with gemcitabine and cisplatin in the treatment of non-small cell lung cancer

作　　者：谢忠海[1] 沈琦斌[1] 李鸿伟[1] 余才华[1] 

机构地区：[1]湖州市中心医院心胸外科,浙江湖州313000

出　　处：《中国临床药理学杂志》2016年第11期972-974,共3页The Chinese Journal of Clinical Pharmacology

基　　金：浙江省自然科学基金资助项目(LY16H160001)

摘　　要：目的观察多西紫杉醇联合吉西他滨和顺铂治疗晚期非小细胞肺癌(NSCLC)的临床疗效及安全性。方法将84例晚期NSCLC患者随机分为对照组42例和试验组42例。对照组予以静脉滴注1000～1250 mg·m^(-2)吉西他滨,第1,8天+静脉滴注25～30 mg·m^(-2)顺铂,第1~3天;试验组在对照组的基础上,联合75 mg·m^(-2)多西紫杉醇,静脉滴注1 h,第1天。2组患者一个周期均为21 d,共治疗2个周期。比较2组患者的临床疗效、血浆中分子标志物表达水平,以及不良反应的发生率。结果治疗后,对照组和试验组的客观缓解率分别为35.71%,38.10%,中位进展时间分别为6.46,7.82个月,1年生存率分别为40.48%,47.62%,2组比较差异均无统计学意义(P>0.05)。治疗后,试验组转化生长因子-β1的表达水平显著高于对照组(P<0.05),循环游离DNA的表达水平显著低于对照组(P>0.05)。治疗后,2组患者转化生长因子-α的表达水平比较差异无统计学意义(P>0.05),但均较治疗前显著降低(P<0.05)。试验组Ⅲ~Ⅳ级中性粒细胞减少及恶心呕吐的发生率显著低于对照组(P<0.05)。结论多西紫杉醇联合吉西他滨和顺铂治疗晚期NSCLC具有较好的临床疗效,可减轻不良反应的发生率。Objective To evaluate the clinical efficacy and safety of docetaxel combined with gemcitabine and cisplatin in the treatment of advanced non- small cell lung cancer（ NSCLC）. Methods Eighty- four patients with NSCLC were randomly divided into control group（ n = 42）and treatment group（ n = 42）. Control group was treated with1000-1250 mg·m-2gemcitabine,day 1,8 ＋ 25- 30 mg·m-2cisplatin,day 1- 3. Treatment group was treated with 75 mg·m-2docetaxel for 1h,day 1,on the basis of control group. Per cycle of two groups was 21 d for 2 cycles. After treatment,the clinical efficacy,incidence of adverse drug reactions and expression levels of molecular markers in plasma were compared between two groups. Results After treatment,the objective response rate,time to progression and one- year survival rate of control and treatment groups were 35. 71%, 6. 46 months, 40. 48% and38. 10%,7. 82 months,47. 63% respectively,without statistical difference（ P〉 0. 05）. After treatment,the expression level of transforming growth factor- β1of treatment group was higher than that of control groupand circulating cell- free DNA of treatment group was lower than that of control group with significant difference（ P〈 0. 05）. After treatment,there was no significant difference in the expression levels of transforming growth factor-α between two groups. The incidence of Ⅲ- Ⅳ degree of neutropenia,nausea and vomiting in treatment group were significantly lower than those in control group（ P〈 0. 05）. Conclusion Docetaxel combined with gemcitabine and cisplatin has a definitive clinical efficacy for the treatment of advanced NSCLC,without increasing the incidence of adverse drug reactions.

关 键 词：非小细胞肺癌 多西紫杉醇 吉西他滨 顺铂 临床疗效 

分 类 号：R979.1[医药卫生—药品]