中药复方联合GP方案治疗晚期或转移性NSCLC的临床研究  

Clinical Effects of Traditional Chinese Medicine Puls GP Regimen in Treatment of Advanced Non-small Cell Lung Cancer Patients

作　　者：谢丹[1] 林源[1] 黎杏群[1] 杨阿莉[1] 

机构地区：[1]中南大学湘雅医院中西医结合研究所,湖南长沙410008

出　　处：《中华中医药学刊》2012年第10期2363-2366,共4页Chinese Archives of Traditional Chinese Medicine

摘　　要：目的:观察中药复方对GP方案化疗后晚期或转移性NSCLC患者无进展生存期、1年生存率、主要症状缓解率及不良反应发生率的影响,评价晚期或转移性NSCLC中西结合治疗的疗效和安全性。方法:共收集晚期或转移性NSCLC病人204例。随机分入两组:GP方案治疗组以及GP联合中药复方治疗组,每2个周期后进行肿瘤反应评估,肿瘤缓解或稳定者,继续原方案,共治疗4个周期;肿瘤进展者,后续的治疗由医生决定。主要观察指标为无进展生存期和1年生存率,次要观察指标为主要症状缓解率及不良反应发生率。结果:(1)联合组与GP组的1年生存率分别为54.5%和34.1%(P<0.05),联合方案组生存率明显高于GP方案组(log-rank检验P<0.05);(2)联合组与GP组中位无进展生存期分别为7个月[95%CI,6.306-7.694]和6个月[95%CI,5.385-6.615],联合组疾病进展率明显低于GP组(log-rank检验P<0.05);(3)联合组显著提高了影响肺癌患者生活质量的主要症状(咳嗽、呼吸困难、疼痛)的缓解率(P<0.05);(4)联合组与治疗相关的不良反应(疲乏、食欲下降、粒细胞减少)发生率明显低于GP组(P<0.05),两组的肝肾毒性作用无统计学差异。结论:方剂联合GP方案较GP方案进一步延缓晚期或转移性NSCLC患者肿瘤进展,并显著延长晚期或转移性NSCLC患者生存时间,且有良好的安全性和耐受性,提示中药复方联合方剂治疗是一安全、有效、经济的晚期或转移性NSCLC的治疗方案。Abstract：Objective ：To evaluate the therapeutic effects of traditional Chinese medicine puls GP regimen for advanced non small cell lung cancer patients. Methods：From May 2009 to May 2011 ,two hundred and four histologically or ey tologically confirmed stage IIIB and IV NSCLC patients with no other diseases and ECOG performance status 0 2 were enrolled in a randomized, blind, controlled trial, either trial group ： GP regimen （ gemcitabine 1250mg/m3, on day 1 and day 8;cisplatin 80 mg/m3 on day 1 ） plus traditional Chinese medicine（ days 10 to 21 ） or control group： GP regimen （ gemcitabine 1250mg/m3, on day 1 and day 8, cisplatin 80 mg/m3 on day 1 ）. every 3 weeks for 1 cycle, for2 4cycles. The trial endpoints included 1 year survival rate, progression free survival and relief rate of clinical symptoms and safe ty. Results ： Of 200 assessable patients, 1 year survival rate was 54.5 % in trial group and 34.1% in control group （ P 〈 0.05 ）. The median FPS was 7months [ 95 % CI, 6. 306 7. 694 ] and 6 months [ 95% CI, 5. 385 6.615 ] for trial group and control group respectively （ P 〈 0.05 ）. The relief rate of clinical symptoms in trim group was higher than that of those in control group（ P 〈 0.05 ）. There were no significant differences in incidence of hepatotoxicity and nephrotoxicity be tween trial group and control group. In addition, the trial group reduced the incidence of hematologic toxicity, fatigue, de creased appetite. Conclusion：The addition of traditional Chinese medicine to GP regimen results in significantly and clini cally meaningful improvement in survival rate, progression free survival, incidence of hematologic toxicity and~ relief rateof clinical symptoms compared with GP alone in advanced NSCIC patients. Traditional Chinese medicine in combination with chemotherapy shows a synergic activity, favorable toxicity and economic profile in advanced NSCLC cancer patients.

关 键 词：中药复方 GP方案 晚期或转移性非小细胞肺癌 临床研究 

分 类 号：R222.19[医药卫生—中医基础理论]