中医综合方案维持疗法对晚期非小细胞肺癌患者生存期的影响

Effect of Integrated Chinese Medical Treatment (as Maintenance Therapy) on the Survival Time of Patients with Advanced Non-small-cell Lung Cancer:a Clinical Study

目的观察中医综合方案维持疗法对晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者无进展生存期(progression-free survival,PFS)和总生存期(overall survival,OS)的影响。方法采用前瞻性、随机对照研究方法,将69例晚期NSCLC一线治疗后疾病无进展患者随机分成治疗组(34例)和对照组(35例),对照组采用单药化疗(吉西他滨或培美曲赛多西紫杉醇),治疗组采用中医综合方案维持疗法(中药汤剂、中药静脉制剂及穴位敷贴),21天为1个周期,治疗直至疾病进展或出现不能耐受的毒副反应或患者拒绝继续治疗,治疗结束后定期随访患者生存期。结果两组中位维持治疗周期均为2个周期,差异无统计学意义(P=0.274);治疗组中位PFS为12.43周,对照组为10.00周,差异有统计学意义(P=0.025);治疗组中位生存期(middle survival time,MST)为18.80个月,对照组为16.73个月,两组比较,差异无统计学意义(P=0.437)。结论中医综合方案维持疗法延长患者生存期的疗效与单药化疗维持治疗相当。

Objective To observe clinical effect of integrated Chinese medical （CM） treatment （as maintenance therapy） on the progression-free survival （PFS） and overall survival lOS） in patients with advanced non-small-cell lung cancer （NSCLC） after first-line chemotherapy. Methods The study was a prospective, randomized, controlled clinical trial. Totally 69 non-progressive advanced NSCLC patients treated with first-line chemotherapy were randomly assigned to the test group （34 cases） and the control group （35 cases ）. Patients in the control group were treated with one Western drug chemotherapy （Gemcitabine or Alimta or docetaxel）. Those in the test group were treated with integrated CM treatment （CM decoction, CM Intravenous preparation, and point application）. Each cycle consisted of 21 days. Treatment lasted till the disease progressed, or intolerable toxic/adverse reactions occurred, or patients refused to continue the treatment. Patients＇ life spans were regularly followed-up. Results （1） The median cycle of maintenance therapy was 2 cycles for two groups with no statistical difference （P =0.274）. The median PFS was 12.43 weeks in the test group and 10.00 weeks in the control group, showing statistical difference （P =0.025）. The middle survival time （MST） was 18.8 months in the test group and 16.73 months in the control group, showing no statistical difference （P =0.437）. Conclusion CM treatment （as maintenance therapy） showed quail effect to one Western drug chemotherapy in prolonging patients＇ life span.