长春瑞滨合并顺铂(NP)加参一胶囊或安慰剂治疗晚期非小细胞肺癌的多中心双盲随机临床研究报告

A randomized, prospective, multi-centre clinical trial of NP regimen (vinorelbine+cisplatin) plus Gensing Rg3 in the treatment of advanced non-small cell lung cancer patients

背景与目的 参一胶囊Rg3是由人参中提取的有效成分之一。本研究的目的是观察参一胶囊辅助长春瑞滨＋顺铂（NP方案）治疗晚期非小细胞肺癌的疗效和患者的耐受性。方法 按GCP原则由5中心应用同一方案治疗并观察患者。所有患者纳入后均接受NP化疗，并随机分入治疗组口服参一胶囊或对照组口服安慰剂。开盲前统一评定疗效和不良反应，之后统一分析生存数据。结果 共收入经病理或细胞学检查确诊的Ⅲ～Ⅳ期非小细胞肺癌115例，其中男性79例，女性36例；鳞癌29例，腺癌71例，腺鳞癌8例，其他7例；11期45例，Ⅳ期70例；既往曾经化疗者17例，初次化疗者98例；未经放疗者100例，曾经放疗者15例；曾经手术者23例，未经手术者92例。由于患者放弃治疗（4例）和治疗1周期后发生严重不良事件（5例），共9例未能完成观察，完成疗效观察者共106例。治疗组近期有效率为33．3％（17／51），对照组为14．5％（8／55）（P=0．011）；治疗组平均生存期为15．3月，对照组为9．7月；治疗组中位生存期为10．0月，对照组为8．0月，差异均有统计学意义（P=0．0088）。结论 参一胶囊辅助化疗可能提高患者的近期疗效和生存期，值得进一步临床观察。

Background and objective Gensing Rg3 is an active component from ginseng. The aim of this study is to observe the clinical anticancer effect of Rg3 in combination with chemotherapy regimen NP （vinorelbine＋cisplatin） in advanced non-small cell lung cancer （NSCLC）. Methods Stage Ⅲ-IV NSCLC patients confirmed by pathology or cytology all received vinorelbine plus cisplatin for at least two cycles, and were randomized into two groups： patients in arm A also received placebo twice a day, while patients in arm B received two tablets of Rg3 twice a day for at least two months. The endpoints of the study were the efficacy, survival and tolerance of patients. Results From July 2000 to May 2002, 115 patients were enrolled into the trial. The patients＇ characteristics were well balanced in the two groups. Sex of patients： male, 79; female 36. Types of pathology： adenocarcinoma, 71; squamous cell carcinoma, 29; adenosquamous carcinoma, 8; others, 7. TNM stage： stage Ⅲ 45; stage IV, 70. Prior chemotherapy： with, 17; without, 98. Prior radiotherapy： with, 15 ; without, 100. Prior surgical treatment： with, 23; without, 92. Nine patients discontinued from the trial due to severe adverse effects （5） and other reasons （4）, so there were 106 patients evaluable for clinical efficacy. The response rate was 14.5% （8/55） in arm A, and 33.3% （17/51） in arm B （P=0.011）. The survival time in arm A was 9.7 months （mean） and 8.0 months （median）, and 15.3 months （mean） and 10.0 months （median） in arm B （P=0. 0088）. Conclusion Preliminary results show improvements in response rate and survival time （median and mean） in Rg3 arm compared with placebo arm. It is worthy to confirm the resuits in further clinical trials.