脂可平软胶囊治疗高脂血症临床研究.pdfVIP

2004年9月第11卷第9期 中国中医药信息杂志 ·757· ·论著· 脂可平软胶囊治疗高脂血症临床研究 杜宝俊,涂秀华,李立志 (中国中医研究院西苑医院,北京 100091) 摘要：目的 评价脂可平软胶囊治疗高脂血症(气滞血瘀证)的临床疗效和安全性。方法 采用随机、双盲、 双模拟、与阳性对照药脂必妥片平行对照的观察方法,疗程为 6周。试验组 101例用脂可平软胶囊；对照组 100 例用脂必妥片。两组均同时服用模拟药安慰剂。主要观察指标为：实验室客观血脂指标TC、TG、HDL等及中医证 候表现。结果 两组患者血脂水平比较表明,治疗后患者的总胆固醇、三酰甘油、低密度脂蛋白、极低密度脂蛋白 有明显降低(P0.01),高密度脂蛋白升高,试验组降低三酰甘油和升高高密度脂蛋白的疗效优于对照组(P0.05)。 试验组治疗后载脂蛋白 Apo-A1/Apo-B100、Apo-A1均有增高,且 Apo-B100降低(P0.01),试验组升高 Apo-A1、 Apo-A1/Apo-B100和对照组组间比较,P0.05。脂可平软胶囊对高脂血症患者中医证候总有效率为 91.1%,与对照 组比较差异有统计学意义(P0.05),对患者单一中医症状胸闷气短、胸痛、胸胁胀满、舌象等有明显改善。结论 脂 可平软胶囊对改善总胆固醇和三酰甘油等血症有确切的疗效,未见明显不良反应,使用较为安全。 关键词：脂可平软胶囊；高脂血症；中医药疗法 中图分类号：R589.21 文献标识码：A 文章编号：1005-5304(2004)09-0757-03 TheClinicalStudy of ZhikepingCapsule onHyperlipidemiaDU Bao-jun, TU Xiu -hua, LI Li-zhi (Xiyuan Hospital of Chinese Academay of TCM, Beijing 100091, China) Abstract：Objective To evaluate the clinical efficiency and safety of Zhikeping (ZKP) soft capsule in treating hyperlipidemia (Qi stagnation and blood stasis syndrome of TCM). Methods Randomized, double blind and simulation methods were used in this clinical trial and Zhibituo (ZBT) tablet was used as positive controlled drug. At the same time, placeboal tablets were used for all patients. A total of 201 cases were enrolled, among them 101 cases for experimental group and 100 cases for control group. The TCM syndrome and the changes of total cholestrolemia (TC), total triglyceridemia (TG), highdensity lipoprotein (HDL) were observed. Results ZKP capsule was showed significant effect in reducing the level of TC and TG, especially for the reduction of TG in the two groups. TC was reduced significantly by the drug therapy. Compared with control