摘要
目的观察中医综合方案维持治疗晚期非小细胞肺癌(non-small cell lungcancer,NSCLC)对疾病进展时间(time to progression,TTP)和生活质量(qualityoflife,QOL)的影响。方法采用前瞻性、随机、对照研究方法,将50例晚期NSCLC一线治疗后疾病无进展者按1∶1分为治疗组(中药制剂静脉滴注、中药汤剂口服及穴位敷贴联合应用的中医综合方案,25例)和对照组(单药维持化疗,25例),21天为1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。终点指标为TTP,次要指标为QOL。统计分析符合方案集,包括50例患者的TTP和43例患者2周期治疗前后的EORTC QLQ-LC43评分。结果 (1)治疗组较对照组延长TTP23天,差异无统计学意义(87天vs64天,P=0.063);(2)治疗组患者QOL明显改善,EORTC QLQ-LC43中的各功能领域及总健康状况得分上升,各症状领域得分下降,除社会功能、认知功能、咽下困难、其他部位痛外,与对照组比较,差异均有统计学意义(P<0.05)。结论 (1)中医综合方案维持治疗晚期NSCLC在延长TTP方面具有与单药维持化疗相当的疗效,在提高QOL方面更具优势。(2)需要扩大样本量进一步肯定中医药维持治疗晚期NSCLC的临床疗效。
Objective To observe the effect of Chinese medicine （CM） comprehensive regimen as the maintenance therapy （MT） on time to progression （TTP） and quality of life （QOL） of patients with advanced non-small-cell lung cancer （NSCLC）. Methods The study was a prospective, randomized and controlled clinical trial. Fifty non-progressive patients with advanced NSCLC who responded to first-line therapy were randomized into the test group （25 cases, treated with CM comprehensive regimen： intravenous dripping of Chinese herbal preparation, oral administration of Chinese herbal decoction, and point application） and the control group [25 cases, treated with one of three single-agent maintenance chemotherapy regimens： pemetrexed （500 mg/m2, day 1）, docetaxel （75 mg/m2, day 1）, and gemcitabine （1000 mg/m2, day 1 and day 8） in the ratio of 1∶1]. Each cycle consisted of 21 days. Cycles were repeated until the disease progressed, or untolerable toxic or adverse reaction occurred, or patients refused to continue the treatment. The primary end point was TTP and the secondary end point was QOL. QOL was evaluated using the European Organization for Research and Treatment of Cancer quality-of-life questionnaire QLQ-LC43 （EORTC QLQ-LC43）. TTP of fifty patients and QOL of 43 patients had been statistically analyzed. Results （1） The TTP in the test group was prolonged for 23 days when compared with that of the control group, with insignificant difference （87 days vs 64 days, P=0.063）. （2） The scores of domains in EORTC QLQ-LC43 were statistically significantly better in the test group than in the control group （P0.05） except cognitive and social functions, the symptoms of dysphagia and pain in other parts. Conclusions（1） The CM comprehensive regimen as MT had equivalent efficacy on TTP when compared with single-agent maintenance chemotherapy regimen. It was advantageous over improving the QOL. （2） It is necessary to enlarge the sample size to further confirm the therapeutic efficacy of CM comprehensive regimen as MT in treatment of patients with advanced NSCLC.
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2011年第10期1311-1316,共6页
Chinese Journal of Integrated Traditional and Western Medicine
基金
上海市科学技术委员会科研计划项目(No.09dZ1977000)
关键词
非小细胞肺癌
维持治疗
中医综合方案
疾病进展时间
生活质量
non-small cell lung cancer
maintenance therapy
Chinese medicine comprehensive regimen
time to progression
quality of life
