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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。
OBJECTIVE: To observe the effects of traditional Chinese medicine compound on the progression-free survival, 1-year survival, the main symptoms and the incidence of adverse reactions in patients with advanced or metastatic NSCLC after GP regimen chemotherapy and to evaluate the curative effect of combining traditional Chinese and western medicine in advanced or metastatic NSCLC and safety. Methods: A total of 204 patients with advanced or metastatic NSCLC were collected. Randomly divided into two groups: GP program treatment group and GP combined with traditional Chinese medicine compound treatment group, every 2 cycles after tumor response assessment, tumor remission or stability, continue the original program, a total of 4 cycles; tumor progression, follow-up The treatment is up to the doctor. The main outcome measures were progression-free survival and 1-year survival rates. The secondary outcome measures were the rate of primary symptom relief and adverse reaction. Results: (1) The 1-year survival rate was 54.5% in the combination group and 34.1% in the GP group (P <0.05), and the survival rate in the combination group was significantly higher than that in the GP group (P <0.05 for the log-rank test) 2) The median progression-free survival of the combination group and the GP group was 7 months [95% CI, 6.306-7.694] and 6 months [95% CI, 5.385-6.615], respectively. The progression rate of the combination group was significantly lower than that of the GP group Group (log-rank test P <0.05); (3) The combination group significantly improved the remission rate of main symptoms (cough, dyspnea, pain) affecting the quality of life of lung cancer patients (P < The incidence of adverse reactions (fatigue, loss of appetite, neutropenia) was significantly lower in the GP group than in the GP group (P <0.05). There was no significant difference in the hepatorenal toxicity between the two groups. Conclusion: Compared with GP regimen, the combination of prescription and GP regimen can further delay the tumor progression in patients with advanced or metastatic NSCLC and prolong the survival time of patients with advanced or metastatic NSCLC, and have good safety and tolerability, suggesting that the combination of traditional Chinese medicine and prescriptions is A safe, effective and economical treatment for advanced or metastatic NSCLC.