七叶灵颗粒对晚期非小细胞肺癌化疗疗效和安全性影响的随机盲法研究  

Clinical trial of Qiyeling granule in the treatment of advanced non-small-cell lung cancer

作　　者：郭毅峻[1] 顾嘉钦[2] 朱珺[2] 金长娟[1] 张铭[1] 李蕾[1] 崔清[1] 董昀[1] 蔡霄月[1] 

机构地区：[1]上海交通大学附属胸科医院中西医结合科,上海200030 [2]上海交通大学附属胸科医院药剂科,上海200030

出　　处：《世界临床药物》2014年第7期404-408,共5页World Clinical Drug

基　　金：上海市科委中医重点项目(项目编号:12401902500)

摘　　要：目的分析探讨七叶灵颗粒结合化疗治疗晚期非小细胞肺癌(NSCLC)的有效性及安全性。方法 100例Ⅲ、Ⅳ期NSCLC患者采用双盲随机法分为治疗组(n=50)和对照组(n=50)。对照组给予化疗+七叶灵空白颗粒;治疗组采用化疗配合口服七叶灵颗粒,观察并比较两组治疗前后化疗疗效、生存质量、不良反应及免疫功能变化情况。结果两组化疗疗效差异无统计学意义;治疗组的生存质量显著优于对照组(P<0.05);治疗组化疗后的重度骨髓抑制、腹泻、恶心呕吐和肝肾不良反应发生率均显著低于对照组(P<0.05),两组化疗后心功能、药物性发热及口腔炎发生率无明显差异;治疗组化疗后自然杀伤细胞水平较对照组显著升高(P<0.05)。结论七叶灵颗粒辅助化疗可减轻化疗不良反应、提高生活质量和机体免疫功能,对晚期NSCLC化疗患者疗效和安全性俱佳。Objective To evaluate the efficacy and the safety of Qiyeling granule combined with chemotherapy in the treatment of advanced non-small-cell lung cancer （NSCLC）. Methods One hundred stage III and IV NSCLC patients were randomly divided into observation group and control group with 50 patients each. Control group was treated with chemotherapy only, while observation group was treated by chemotherapy combined with Qiyeling granule. The effects of chemotherapy, life quality, untoward effect of chemotherapy and immunologic function change were observed before and after treatment. Results The effects of chemotherapy between two groups had no significant difference. The life quality in observation group was higher than that in control group （P〈0.05）. The incidence of severe bone marrow suppression, diarrhea, severe nausea and vomiting, liver function and kidney damage in observation group were significantly lower than those in control group （P〈0.05）. There was no significant difference on the incidence of heart function damage, drug fever and stomatitis between the two groups. After chemotherapy, the cell content of NK cells in observation group was significantly higher than that in control group （P〈0.05）. Conclusion Qiyeling granule can improve the curative effect of chemotherapy on the treatment of advanced NSCLC patients.

关 键 词：非小细胞肺癌(NSCLC) 七叶灵颗粒 安全性 生存质量 双盲 

分 类 号：R979.1[医药卫生—药品] R734.2[医药卫生—药学]