中西医结合治疗Ⅲ、Ⅳ期非小细胞肺癌的随机对照试验及其预后因子的筛选

Random-Control Trial of Chinese and Western Medicine for Non-small-cell Lung Cancer of Stages Ⅲ and Ⅳ and Screening of Its Prognostic Factors

【目的】观察中医辨证综合治疗及其与化疗结合对Ⅲ、Ⅳ期非小细胞肺癌患者的疗效和预后因子的筛选。【方法】将120例Ⅱ、Ⅳ期非小细胞肺癌患者随机分为中医药综合治疗组、西医综合治疗组和中西医综合治疗组3组。所有患者在给予一般治疗基础上,中医组予以中医辨证中药汤剂治疗;西医组予以化疗、安慰中药汤剂治疗;中西医结合组予以中医辨证、化疗综合治疗。用卡卜兰—迈尔(Kaplan-Meier)法统计分析各组的远期疗效,用COX回归模型多因素分析影响生存率的16个预后因子,筛选危险因素及保护因素。【结果】中医组的中位生存期为9.3个月,西医组为8.7个月,两组间无显著差异(P>0.05),中西医组为11.8个月,较中医组及西医组长(均P<0.01)。中医组0.5、1年的生存率分别为84.4％、18.1%;西医组为82.5％、20.6％;中西医结合组为92.5％、42.7％。中西医结合组与中医组、西医组的生存曲线差异有显著性(P<0.01),而中医组与西医组间的生存率曲线无显著性差异(P>0.05)。16个预后因子经COX回归模型多因素分析显示,患者生存期与临床分期、淋巴结是否侵犯、有否并发症、中医证候分类、疗前Karnofsky评分情况、乳酸脱氢酶、癌胚抗原、治疗方法等因素有关(P<0.05)。【结论】中医药综合治疗与化疗配合应用可延长患者生存期,提高远期?

[Objective] To observe the effects of syndrome-differential treatment with Chinese herbs and chemotherapy on non-small-cell lung cancer of stages Ⅲ and Ⅳ and to screen its prognostic factors. [Methods] One hundred and twenty cases of non-small-cell lung cancer of stages Ⅲ and Ⅳ were randomized into three groups. On the basis of routine treatment, Group A was treated with herbal decoction, Group B with chemotherapy and herbal decoction as placebo and Group C with herbal decoction and chemotherapy. Long-term therapeutic effect was analyzed by Kaplan-Meier statistical method. Sixteen related prognostic factors were analyzed by COX regression method and then the risk factors and protective factors were screened. [Results] The median survival duration lasted 9.3 months in Group A and 8.7 months in Group B, the differences being not significant ( P > 0.05) . That in Group C lasted 11.8 months, which was longer than that in Group A and Group B (P < 0.01). The 0.5-year and 1-year survival rates were 84.4% and 18.1% in Group A, 82.5% and 20.6% in Group B, and 92.5% and 42.7% in Group C respectively. The survival rate curve in Group C differed from those in Group A and Group B ( P < 0.01) , but there was no difference between Group A and Group B ( P > 0.05) . The regression analysis showed that the survival time was related to clinical stages, invasion of lymph nodes, occurrence of complications, TCM syndrome patterns, pre-treatment Kamofsky scoring, lactic dehydrogenase level, carcinoembryonic antigen and treatment methods ( P < 0.05 ). [ Conclusion ] Chinese herbs combined with chemotherapy can prolong the survival period and increase long-term survival rate and is a better combined treatment, for non-small-cell lung cancer of stages Ⅲ and Ⅳ which can not be excised.