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基于临床试验和证素辨证的银杏叶片中医功效研究
Department of Traditional Chinese Medicine, Huadong Hospital Affiliated to Fudan University, Shanghai 200040, China
  
DOI:
中文关键词:  银杏叶片  认知障碍,轻度  证候要素  辨证  临床试验
英文关键词:Ginkgo leaves table  Mild cognitive impairment  Syndrome element  Syndrome differentiation  Chinical trial
基金项目:上海市科委中药现代化专项基金项目(编号: 08DZ1972600);上海市卫生局中医药科研基金课题项目(编号:2010J001A)
作者单位
余忠海 复旦大学附属华东医院中医科(上海 200040) 
肖世源 复旦大学附属华东医院中医科(上海 200040) 
万文斌 复旦大学附属华东医院中医科(上海 200040) 
李亚明 复旦大学附属华东医院中医科(上海 200040) 
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中文摘要:
      摘 要 目的:在临床试验和证素辨证理论基础上,探讨银杏叶片治疗轻度认知障碍(MCI)的功效。方法:113例MCI患者随机分为治疗组(58例)和对照组(55例),对照组给予基础保健支持和对症治疗;治疗组在此基础上给予银杏叶片19.2 mg,po tid,共治疗12个月。治疗前后分别对两组进行MCI中医常见证素调查,观察治疗前后不同时段各组患者MCI常见证素的改变。结果:治疗12个月后,与对照组比较,治疗组血瘀证、痰证的频数减少明显,差异有统计学意义(P<0.01),病性要素中,气虚证、血虚证、阴虚证、阳虚证频数变化差异无统计学意义(P>0.05);病位要素中,心证、肺证、脾证、肝证、肾证的频数变化差异无统计学意义(P>0.05)。结论:初步推测银杏叶片具有化痰和活血化瘀的作用。
英文摘要:
      ABSTRACT Objective:To investigate the function of Ginkgo leaves tablet based on clinical trials and syndrome elements differentiation theory. Methods:All the 113 mild cognitive impairment(MCI) patients were enrolled and randomly divided into the treatment group(58 cases) and the controlled group (55 cases).The controlled group received only standard care, while the treatment group was given 19.2 mg Ginkgo leaves tablet three times a day for 12 months. The two groups were investigated for their syndrome elements of Traditional Chinese Medicine (TCM) before and after the treatment. At the same time, the changes of MCI’s common syndrome elements in the two groups were observed . Results:The 12 months follow up showed that the frequency of blood stasis syndrome and phlegm syndrome of the treatment group decreased more remarkably than that of the controlled group; therefore, there were statistically significant differences (P<0.01). There was no difference in the frequency of disease character of Qi deficiency, blood deficiency, Yin deficiency, Yang deficiency and disease locations of the heart, lung, spleen, liver and kidney between the two groups (P>0.05). Conclusion:According to the results of these clinical trials, it was preliminarily speculated that Ginkgo leaves tablet had the functions of dissipating phlegm and promoting blood circulation to remove blood stasis.
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