肿瘤康胶囊辅助治疗非小细胞肺癌的Ⅲ期临床研究

A phase Ⅲ clinical trial of Zhongliukang capsule on adjuvant treatment for non-small cell lung cancer

目的观察肿瘤康胶囊联合GP方案治疗非小细胞肺癌（NSCLC）的近期疗效和毒副反应。方法采用多中心随机对照研究,将8家医院408例经病理组织学或细胞学检查确诊为NSCLC患者随机分为试验组（306例）和对照组（102例）,均采用GP方案化疗2个周期。GP方案：吉西他滨（GEM）1000mg/m^2第1、8天,DDP30mg/m2第1-3天,21天为1周期。在化疗的基础上试验组服用肿瘤康胶囊6粒/次,每日3次;对照组口服安慰剂6粒/次,每日3次;所有患者均持续服药42天。根据WHO疗效评价及毒副反应分级标准,观察其近期疗效、毒副反应以及生活质量、体重变化等。结果试验组和对照组在瘤体大小改变方面组间差异无统计学意义（P〉0.05）;治疗后试验组患者的生活质量和体重较对照组均有明显提高（P〈0.05）;试验组咳嗽、乏力等肿瘤相关症状的改善优于对照组（P〈0.05）;试验组较对照组较少出现化疗毒副反应,尤其在消化道反应、白细胞和中性粒细胞减少、肝功能异常等发生率的差异均有统计学意义（P〈0.05）。结论肿瘤康胶囊辅助化疗治疗NSCLC可减轻化疗毒副反应,有助于提高患者生活质量。

Objective To observe the short-term efficacy and safety of Zhongliukang capsule combined with GP（gemcitabine plus cisplatin）regimen in patients with non-small cell lung cancer（NSCLC）.Methods Four hundred and eight histologically confirmed NSCLC patients in 8 hospitals were randomly divided into two groups,306 cases in the trial group and 102 cases in the control group.All patients were administrated with GP regimen（gemcitabine 1000mg/m^2 day 1 and 8,cisplatin 30mg/m^2 day 1 to 3,repeated every 21 days）.Based on chemotherapy,the trail group was given Zhongliukang capsule 6 tablets,tid and the control group was treated by placebo 6 tablets,tid.The clinical effects were compared after 42 days.The size of tumor,Karnofsky score,weight and side-effect were observed.Results The different change of the tumor size between the trail and control group had none statistical significance（P〈0.05）.The trail group had obvious improvement compared with the control in quality of life and weight after the treatment（P〉0.05）.The trail was better than the control in releasing symptoms of cough,fatigue（P〈0.05）.The trail had less side-effect for the chemotherapy,especially in the gastroenteric reaction,leucocyte,neutrophil,liver function had significant difference（P〈0.05）.Conclusion The short-term effect of Zhongliukang as an adjuvant therapy for NSCLC in trail group is better than that of control group,which shows advance of traditional Chinese medicine combined with Western medicine.Zhongliukang capsule can be used as an effective medicine in adjuvant treatment for NSCLC.