糖尿病周围神经病变中药临床试验中的几个问题

中国临床药理学与治疗学 ›› 2007, Vol. 12 ›› Issue (12): 1401-1404.

糖尿病周围神经病变中药临床试验中的几个问题

李涛, 郭兰

中国中医科学院西苑医院,北京 100091

收稿日期:2007-08-15 修回日期:2007-09-11 发布日期:2020-11-10
作者简介:李涛,男,主任医师,博士生导师,长期从事神经系统疾病的中西医结合临床医疗和中药新药临床研究。Tel:010-62875599-6213 E-mail:110016@263.nct

Issues of clinical trails on traditional Chinese new drugs for diabetic poly-neuropathy

LI Tao, GUO Lan

Xiyuan Hospital, China Academy of Chinese Medical Scienes, Beijing 100091, China

Received:2007-08-15 Revised:2007-09-11 Published:2020-11-10

摘要/Abstract

摘要： 本文对糖尿病周围神经病变的中药新药临床试验方案的诊断、对照药选择、疗程及疗效评价方法等问题进行了讨论,介绍了国际常用的糖尿病周围神经病变临床试验的方法并针对中药新药临床试验中的问题提出了建议。

关键词: 糖尿病周围神经病, 临床试验, 中药

Abstract: The paper introduced the international regulation method and discussed the diagnosis, control drugs, duration and efficacy evaluate of clinical trails on traditional Chinese new drug of diabetic polyneuropathy and made some suggestion.

Key words: diabetic neuropathy, clinical trails, traditional Chinese drug

中图分类号:

R969

李涛, 郭兰. 糖尿病周围神经病变中药临床试验中的几个问题[J]. 中国临床药理学与治疗学, 2007, 12(12): 1401-1404.

LI Tao, GUO Lan. Issues of clinical trails on traditional Chinese new drugs for diabetic poly-neuropathy[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2007, 12(12): 1401-1404.

参考文献

[1] Arerican Diabetes Association and American Academy of Neu-rology. Consensus statement: Report and recommendations ofthe San Antonio conference on diabetic neuropathy[J]. DiabetesCare, 1988;11:592-597.
[2] 蒋雨平,陆费汉倩,郑白蒂,等,糖尿病性多发性周围神经病的WHOFNIF诊断标准和10年随访[J].上海医科大学学报,1993;20(S):9-14.
[3] American Diabetes Association, Standards of medical care in di-abetes[J]. Diabetes Care, 2007;30;S4-S41.
[4] Meltzer S, Leiter L, Daneman D, et al. 1998 Clinical practiceguidelines for the management of diabetes in Canada[J].CMAJ, 1998;159;S1-S29.
[5] Dyck PI, Karmnes JL, Daube J. Clirnical and neuropathologicalcriteria for the diagnosis and staging of diabetic polyneuropathy[J]. Brain, 1985; 108:861-880.
[6] Dyck PJ, Davies JL, Litchy WJ, et al.Longitudinal assessment of diabetic polyneuropathy using a composite score in the Roch-ester Diabetie Neuropathy Study cohort[J]. Neurology, 1997;49:229-239.
[7] 汤晓芙, 主编.神经系统临床电生理学(下)[M].第一版.北京:人民军医出版社,2002:227-228.
[8] 侯瑞芳,汤正义,宁光.痛性糖尿病周围神经病变的止痛药物治疗[J].世界临床药物,2006;27:154-157.
[9] 王维治, 主编.神经病学[M].第一版.北京:人民卫生出版社,2006:394-395.
[10] Sun Y, Lai MS, Lu CI. Efctiveness of vitanin B₁₂ on diabetic neuropathy; systematic review of clinical controlled trials[J].Acls Naural Taincun 2005. 14.48-54.
[11] Laudadio C, Sima AA. Progression rates of diabetic neuropathy in placebo patients in an 18-month clinical trial[J]. J Diab Comp, 1998;12:121-127.
[12] Hotta N, Sakamoto N, Shigeta Y, et al. Clinical investigationof epalrestat, an aldose reductase inhibitor, on diabeticneurop-athy in japan: multicenter study[J]. J Diab Comp, 1996; l0:168-172.
[13] Airey M, Bennett C, Nicolucci A, et al. Aldose reductasein-hibitors for the prevention and treatment of diabetic peripheral neuropathy [J]. Cochrane Database Syst Rev, 2000; 1:CD002182.
[14] Chalk c, Benstead TJ, Moore F. Aldose reductase inhibitorsfor the treatment of diabetic polyneuropathy[J]. Cochrane Database Syst Rev, 2007;1:CD004572.
[15] 侯瑞芳,汤正义,宁光,糖尿病周围神经病变的检查方法及其诊断效率[J].国际内分泌代谢杂志,2006; 26: 270-272.
[16] Meijer JW, Bosma E, Lefrandt JD,et al. Clinical diagnosis ofdiabetic polyneuropathly with the diabetic neuropathy symptom and diabetic neuropathy examination scores[J]. Diabetes Care,2003;26:697-701.
[17] Boulton AJ, Vinik AI, Arezzo JC,et al. Diabetic neuropa-thies: a statement by the American Diabetes Association [J].Diabetes Care, 2005; 28:956-962.