中药复方联合GP方案治疗晚期或转移性NSCLC的临床研究

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%(P0.05),联合方案组生存率明显高于GP方案组(log-rank检验P0.05);(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P0.05);(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(P0.05);(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(P0.05),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。

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

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 cy-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 safety.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 months95%CI,5.385-6.615] for trial group and control group respectively(P<0.05).The relief rate of clinical symptoms in trial group was higher than that of those in control group(P<0.05).There were no significant differences in incidence of hepatotoxicity and nephrotoxicity between trial group and control group.In addition,the trial group reduced the incidence of hematologic toxicity,fatigue,decreased appetite.Conclusion:The addition of traditional Chinese medicine to GP regimen results in significantly and clinically meaningful improvement in survival rate,progression-free survival,incidence of hematologic toxicity and relief rate of 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.