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| 糖末宁颗粒治疗糖尿病性周围神经病变(气虚络阻证)432例临床研究 | |
| 引用本文： | 寇秋爱,张广德,魏子孝,李涛.糖末宁颗粒治疗糖尿病性周围神经病变(气虚络阻证)432例临床研究[J].中药新药与临床药理,2007,18(1):66-69. |
| 作者姓名： | 寇秋爱 张广德 魏子孝 李涛 |
| 作者单位： | 1. 中国中医科学院西苑医院国家药品临床研究基地,北京,100091 2. 中国中医科学院西苑医院内分泌科,北京,100091 3. 中国中医科学院西苑医院神经内科,北京,100091 |
| 摘 要： | 目的评价糖末宁颗粒治疗糖尿病性周围神经病变(气虚络阻证)的安全性和有效性。方法采用随机、阳性药平行对照、多中心临床试验方法,试验组口服糖末宁颗粒,对照组口服弥可保片,8周为1个疗程。结果糖末宁颗粒对糖尿病性周围神经病变的肌电图疗效的显效率为60.06%,总有效率为68.47%;中医证候疗效的显效率为23.12%,总有效率为90.99%。以15%为非劣效标准,对糖末宁组的肌电图疗效及中医证候疗效进行非劣效性检验,非劣效性检验合格。结论糖末宁颗粒能改善糖尿病性周围神经病变气虚络阻证的病情,同时安全性良好。 |
| 关 键 词： | 糖末宁颗粒 糖尿病性周围神经病变 气虚络阻证 临床试验 |
| 文章编号： | 1003-9783（2007）01-0066-04 |
| 收稿时间： | 2006-05-26 |
| 修稿时间： | 2006年5月26日 |
Effect of Tangmoning Granule in Treating Diabetic Peripheral Neuropathy with Qi- deficiency and Collateral Stagnation Syndrome: An Observation of 432 Cases |
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| KOU Qiu'ai,ZHANG Guangde,WEI Zixiao,LI Tao.Effect of Tangmoning Granule in Treating Diabetic Peripheral Neuropathy with Qi- deficiency and Collateral Stagnation Syndrome: An Observation of 432 Cases[J].Traditional Chinese Drug Research & Clinical Pharmacology,2007,18(1):66-69. | |
| Authors: | KOU Qiu'ai ZHANG Guangde WEI Zixiao LI Tao |
| Institution: | 1. National Base for Drug Clinical Research, Xiyuan Hospital, China Science Academy of Traditional Chinese Medicine, Beijing 100091; 2. Department of Incretion, Xiyuan Hospital, China Science Academy of Traditional Chinese Medicine, Beijing 100091; 3. Department of Neurology, Xiyuan Hospital, China Science Academy of traditional Chinese Medicine, Beijing 100091 |
| Abstract: | Objective To observe the efficacy and safety of Tangmoning Granule(TMG)in treating diabetic peripheral neuropathy with Qi-deficiency and collateral stagnation syndrome.Methods A randomized,positive drug parallel controled,multi-center clinical trial was adopted.The tested group was treated with TMG orally and the control group received Mikebao tablet orally.Treatment course of each group was 8 weeks.Results The marked effective rate and total effective rate on electromyogram was 60.06 %and 68.47 %respectively in the tested group,and those on TCM Syndrome were 23.12 %and 90.99 %respectively.Non-inferiority test with the criterion of 15 %was conducted on the efficacy of electromyogram and TCM Syndrome,and the result showed statistical significant.Conclusion TMG has good efficacy and safety in treating diabetic peripheral neuropathy with Qi-deficiency and collateral stagnation syndrom. |
| Keywords: | Tangmoning Granule Diabetic peripheral neuropathy Qi-deficiency and collateral stagnation syndrome Clinical trial |
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