益肺清化膏辅助治疗非小细胞肺癌术后患者多中心随机对照临床研究  

Multicenter Randomized Controlled Trial on Adjuvant Therapy of Yifei Qinghua Soft Extract( 益肺清化膏) in the Treatment of Postoperative Patients with Non-small Cell Lung Cancer

作　　者：李道睿[1] 花宝金[1] 张培彤[1] 熊露[1] 刘浩[1] 林洪生[1] 朴炳奎[1] 

机构地区：[1]中国中医科学院广安门医院,北京市西城区北线阁5号100053

出　　处：《中医杂志》2016年第5期396-400,共5页Journal of Traditional Chinese Medicine

基　　金：首都医学发展基金(ZD199902);中国中医研究院创新工程项目(CX-00-06)

摘　　要：目的观察益肺清化膏辅助治疗非小细胞肺癌术后患者的临床疗效及安全性。方法采用多中心、大样本、随机对照的临床试验设计方法,将360例I~ⅢA期非小细胞肺癌术后患者随机分为治疗组184例和对照组176例。两组ⅠB~ⅢA期患者术后辅助化疗方案,选择顺铂或卡铂联合长春瑞滨或紫杉醇或吉西他滨,化疗4个周期;ⅢA期及切缘阳性患者术后辅助胸部放疗。治疗组再给予口服益肺清化膏口服,每次20 g,每日3次。两组疗程均为6个月,观察时间为2年。采用美国肺癌患者生存质量测定量表（FACT-L中文版）评价生存质量,观察治疗前后中医证候积分、卡氏评分、体重及免疫功能的变化,判定中医证候疗效。结果剔除脱落及缺失病例后,治疗组117例中中医证候疗效显效22例,有效81例,无效14例,对照组91例中显效8例,有效53例,无效30例,治疗组疗效优于对照组（P〈0.01）。治疗组治疗3个月开始FACT-L中文版量表身体状况领域评分开始较治疗前逐渐降低,治疗6个月开始社会家庭状况、情感状况、功能状况、附加的关注情况领域评分开始较治疗前逐渐降低（P〈0.05或P〈0.01）。治疗组治疗后及随访时各领域评分在一定程度上优于对照组,以身体状况、社会家庭状况及功能状况最明显（P〈0.05或P〈0.01）。治疗组治疗后卡氏评分变化、体重变化及免疫功能变化亦优于对照组（P〈0.05或P〈0.01）。结论益肺清化膏辅助治疗非小细胞肺癌术后患者疗效确切,可明显改善患者生存质量状况及临床症状,调节患者免疫功能,无严重不良反应。Objective To observe the clinical effect and safety of Yifei Qinghua Soft Extract as an adjuvant therapy in the treatment of postoperative patients with non-small cell lung cancer. Methods A multicenter, large sample, randomized controlled clinical trial was designed. Three hundred and sixty cases of postoperative patients with Ⅰ - Ⅲ A stage of non-small cell lung cancer were randomly divided into treatment group with 184 cases and control group with 176 cases. Patients with ⅠB -ⅢA stage of disease in the both two groups were treated with Cisplatin or Carboplatin combined with Vinorelbine or Paclitaxel or Gemcitabine as the postoperative adjuvant chemotherapy for 4 episodes; while patients with stage Ⅲ A of disease or positive resection margin were accept postoperative adjuvant radiotherapy. The treatment group received additional oral administration of Yifei Qinghua Soft Extract, 20 g each time, 3 times a day. The course of treatment in both groups was 6 months, and the fellow-up was 2 years. The quality of life measurement scale of patients with lung cancer in the United States （ FACT-L V4. 0 Chinese version） was used to evaluate the quality of patients＇ life, the changes of the Chinese medicine syndromes, Karnofsky score, body weight, and immune function were observed before and after treatment to determine the curative effect of Chinese medicine syndrome. Results For the treatment of Chinese medicine syndrome, among 117 cases in the treatment group, 22 cases showed markedly effective, 81 cases effective, and 14 cases ineffective; in the control group with 91 cases, 8 cases showed markedly effective, 53 cases effective, and 30 cases were ineffective. The curative effect in the treatment group was better than that in the control group （P 〈0.01 ）. In the treatment group, the physical condition score of the FACT-L V 4. 0 Chinese version began to decrease gradually after 3 months of treatment compared with that before treatment, and the scores of social family status, affective status, functi

关 键 词：非小细胞肺癌 益肺清化膏 生存质量 随机对照试验 

分 类 号：R734.2[医药卫生—肿瘤]