中医药治疗Ⅲ～Ⅳ期非小细胞肺癌的预后因素分析

Prognostic Analysis of Stage Ⅲ-Ⅳ Non-small Cell Lung Cancer Patients Treated by Traditional Chinese Medicine

背景与目的:化疗是Ⅲ～Ⅳ期非小细胞肺癌(non-smallcelllungcancer,NSCLC)的治疗手段之一,但临床疗效不理想,而中医药治疗具有一定的疗效。本研究主要比较中医药、化疗以及中西医结合对Ⅲ、Ⅳ期NSCLC生存期的影响,分析影响晚期NSCLC的预后因素。方法:采用前瞻性、多中心、随机、对照的临床研究方法,将符合纳入标准的病例按1∶1∶1比例分成中医组、化疗组及中医加化疗组。用Kaplan-Meier法(K-M法)计算中位生存期,COX回归模型分析影响中晚期NSCLC预后的因素。结果:符合入组标准的病例共294例,其中中医组99例,中医加化疗组103例,化疗组92例。经K-M分析中医组、中医加化疗组、化疗组中位生存期分别为292天、355天、236天,1年累积生存率分别为45.38%、48.86%、42.17%。COX回归模型分析,治疗因素、性别、病程、血沉、卡氏(KPS)评分、瘤体大小、体重是独立的预后因素。结论:中医药治疗与化疗配合可延长晚期NSCLC的生存期,相对于单纯化学治疗具有一定的优势。

BACKGROUND ＆ OBJECTIVE： Chemotherapy is a treatment for stage Ⅲ -Ⅳ non-small cell lung cancer （NSCLC）, but the efficacy is not ideal. Traditional Chinese medicine （TCM） has certain effect on NSCLC. This study was to investigate various factors that affect the prognosis of advanced NSCLC, and evaluate the role of TCM in enlonging survival time of patients with stage Ⅲ -Ⅳ NSCLC. METHODS： The NSCLC patients who meet the inclusive criteria were randomized into TCM group, combination （TCM plus NP regimen） group, and chemotherapy group, and received relevant treatments. The median survival time （MST） was calculated by Kaplan-Meier method. The prognosis of the patients was analyzed by COX regression method. RESULTS： A total of 294 stage Ⅲ -Ⅳ NSCLC patients were enrolled, of which 99 were in TCM group, 103 in combination group, 92 in chemotherapy group. The MST were 292 days in TCM group, 355 days in combination group, and 236 days in chemotherapy group; the cumulative survival rates were 45.38%, 48.86%, and 42.17%, respectively （P〉0.05）. Cox regression analysis indicated that therapy, gender, disease course, erythrocyte sedimentation, KPS score, tumor size, and patient＇s weight were independent prognostic factors of stage Ⅲ -Ⅳ NSCLC. CONCLUSION： Compare with chemotherapy alone, TCM combined with chemotherapy may prolong the survival time of stage Ⅲ -Ⅳ NSCLC patients.