中医药对提高非小细胞肺癌中位生存期的作用研究

Effect of Chinese Herbal Medicine in Prolonging Median Survival Time in Patients with Non-small-cell Lung Cancer

[目的]观察中医药在提高Ⅲ、Ⅳ期非小细胞肺癌生存期中的作用,探讨晚期非小细胞肺癌(NSCLC)的治疗方案。[方法]采用前瞻性、多中心、随机、对照的临床研究方法,将符合标准的病例按1:1:1比例分成中医组、中西医级以及西医组,临床试验在6家医院进行,纳入研究的合格病例294例,其中中医组99例,中西医组103例,西医组92例。用Ka-plan-Meier法分析主要终点指标中位生存期及中位疾病进展时间。[结果]中医组、中西医组、西医组中位生存期分别为292d、355d、236d,1年累积生存率分别为45.38%、48.86%、42.17%(组间比较,P=0.4508)。中位疾病进展时间3组分别为187d、239d、180d,1年累积疾病无进展率分别为33.22%、37.44%、28.28%(组间比较,P=0.2890)。[结论]由于样本量的原因,组间比较未出现显著性差异,但就总体趋向来看,中医药治疗可使Ⅲ、Ⅳ期NSCLC的中位生存期达到近10个月,与化疗联合应用可进一步提高生存期至近12个月,是一种有效的治疗方案。

[Objective] To observe the effects of Chinese herbal medicine in prolonging survival time in patients with non-small-cell lung cancer (NSCLC) at stages Ⅲ and Ⅳ and to search a regimen for late NSCLC. [ Methods ] A prospective, multi-center, randomized and control trial was carried out in 294 cases of NSCLC from 6 hospitals. The cases were allocated to three groups at the proportion of 1:1:1. Group A (n =99) received Chinese herbal medicine, group B ( n = 103) was treated with western and Chinese medicine and group C ( n = 92) with western medicine. Kaplan-Meier method was used to analyze the main outcome indexes of median survival time (MST) and median time to progression (TTP). [Results] In groups A, B and C, MST was 292, 355 and 236 days, the one-year accumulative survival rate was 45.38% , 48.86% and 42.17% (P = 0.4508), median TTP was 187, 239 and 180 days, and one-year accumulative non-progressed rate was 33.22 % , 37.44 % and 28.28 % (P = 0.2890), respectively. [ Conclusion ] For the sample size is small, the difference between groups is insignificant; however, MST is prolonged to 10 months in patients treated with Chinese herbal medicine and to 12 months in patients treated with the combination of Chinese herbal medicine and chemotherapy, indicating that Chinese herbal medicine is effective.