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松龄血脉康胶囊治疗高脂血症(肝阳上亢证)临床有效性和安全性双盲双模拟、阳性药平行对照Ⅱ期临床试验
王保和1, 张广明2
1.天津中医学院第二附属医院, 天津, 300150;2.河北省张家口市宣化区中医院, 张家口, 075100
摘要:
[目的]根据国家药品监督管理局2001ZL027号批文观察松龄血脉康胶囊治疗高脂血症(肝阳上亢证)临床有效性和安全性。[方法]采用双盲双模拟、阳性药平行对照方法进行临床观察。[结果]松龄血脉康有明显的降血脂作用,对甘油三酯及胆固醇均有明显的疗效,同时能明显降低TC-HDL-C/HDL-C,经统计学处理,有非常显著性差异。与阳性对照药绞股蓝总甙胶囊疗效大体相当。同时,松龄血脉康能明显改善临床症状,对头疼、眩晕、烦躁易怒、心悸、失眠均有良好的疗效。未发现不良反应。[结论]松龄血脉康胶囊有明显的降血脂作用,其疗效肯定,改善临床症状明显,且无毒副作用。
关键词:  松龄血脉康胶囊  高脂血症  肝阳上亢证  临床试验
DOI:10.11656/j.issn.1672-1519.2003.01.29
分类号:
基金项目:
Ⅱstage clinical trail of Songling Xuemai Kang Capsule on treating hyperlipemia with hyperactivity of liver yang
Wang Baohe,Zhang Guangming
The Second Affiliated Hospital to Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China
Abstract:
[Objective] To observe the clinical effect and safety of Songling Xuemai Kang Capsule (SXKC) on treating hyperlipemia with hyperactivity of liver yang.[Methods] A double blind, double model and positive drugs controlled method was used.[Results] SXKC had an obvious effect on lowing blood-lipid, especially triglyceride and cholestrol and TC-HDL-C/HDL-C. There was a marked difference between before and after treatment. It had an equal effect to that of Gynostemma Pentaphyllum Saponin Capsule, a known positive drug. It could also improve headache, vertigo, restlessness, palpitation and insomnia with no side effect.[Conclusion] SXKC can lower blood-lipid and improve clinical symptoms with no toxic and side effect.
Key words:  SXKC  hyperlipemia  hyperactivity of liver yang  clinical trial
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