参一胶囊联合化疗改善晚期非小细胞肺癌患者预后的多中心大样本随机临床研究  

A multicenter, large-sample, randomized clinical trial on improving the median survival time of advanced non-small cell lung cancer by combination of Ginseng Rg3 and chemotherapy

作　　者：张英[1] 王学谦[1] 刘浩[1] 刘杰[1] 侯炜[1] 林洪生[1] Zhang Ying;Wang Xueqian;Liu Hao;Liu Jie;Hou Wei;Lin Hongsheng(Department of Oncology, Guang＇ anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China)

机构地区：[1]中国中医科学院广安门医院肿瘤科,北京100053

出　　处：《中华肿瘤杂志》2018年第4期295-299,共5页Chinese Journal of Oncology

基　　金：“双十工程”重大科技成果转化项目（20150301003YY）;中医药行业科研专项（201307006）

摘　　要：目的探讨参一胶囊联合化疗对晚期非小细胞肺癌的临床疗效。方法采用多中心、大样本、随机双盲研究方法，人组Ⅲ一Ⅳ期非小细胞肺癌患者414例，其中治疗组199例，对照组215例。治疗组采用标准一线化疗方案联合参一胶囊El服，对照组采用相同的化疗方案联合安慰剂治疗。研究两组患者的中位生存时间、卡氏体力状态（KPS）评分，中医证候评分和不良反应。结果治疗组和对照组患者的中位生存时间分别为12．03和8．46个月。差异有统计学意义（P=0．012）。化疗第1、2个疗程后，两组患者的血红蛋白和白细胞均有下降；化疗第2个疗程末，治疗组血红蛋白及白细胞下降水平均小于对照组，差异均有统计学意义（均P〈0．05）。化疗第2个疗程末，治疗组和对照组患者的KPS评分分别为（78．95±9．14）分和（76．77±9．15）分，差异有统计学意义（P〈0．05）；治疗组和对照组患者的中医证候评分分别为（2．45±1．73）分和（2．92±2．06）分，差异有统计学意义（P〈0．05）。结论参一胶囊联合化疗的中西医结合疗法治疗晚期非小细胞肺癌，能够延长患者的生存时间，改善患者的症状．减轻化疗引起的骨髓抑制。Objective To observe the efficacy of the combination of chemotherapy and Ginseng Rg3 on advanced non-small cell lung cancer （NSCLC）. Methods In the multi-center, large-sample, randomized, double blind trial, 414 patients with Ⅲ-Ⅳ NSCLC were enrolled. 199 were in the experimental group and 215 the control group. The patients in the experimental group were treated with the standard first- line chemotherapy combined with Ginseng Rg3. The patients in the control group were treated with the same chemotherapy combined with placebo. Median overall survival （OS）, Karnofsky performance scale （KPS）, Traditional Chinese Medicine （TCM） symptoms score and side effects of two groups were observed as main indexes. Results The median OS were 12.03 months in the experimental group, which was significantly better than that in the control group （ 8.46 months, P 〈 0.05 ）. Hemoglobin and white blood cells were decreased after the first and second cycle of treatment in both groups. Both adverse events were significantly milder in the treatment group （P〈0.05）. In addition, after two courses of treatment, the KPS of patients was 78.95±9.14 in the experimental group and 76.77±9.15 in the control group, while the TCM symptoms score was 2.45±1.73 in the experimental group and 2.92±2.06 in the control group, with significant difference （P〈 0.05）. Conclusions Combination of TCM with Western medicine such as chemotherapy could prolong the survival of patients with advanced NSCLC. The combined therapy improved patients＇ symptoms and reduced chemotherapy induced myelosuppression.

关 键 词：癌 非小细胞肺 中西医结合疗法 预后 随机双盲试验 

分 类 号：R734.2[医药卫生—肿瘤]