糖尿病足潰瘍外用中藥新藥臨床研究的思考
發(fā)布時(shí)間:2018-11-03 12:31
【摘要】:糖尿病足潰瘍(DFU)是糖尿病的嚴(yán)重并發(fā)癥之一,致殘率高、截肢率高,嚴(yán)重影響患者的身心健康。中醫(yī)外用藥治療DFU具有一定的療效和優(yōu)勢(shì)。本文分析了DFU的臨床特點(diǎn)和外用藥應(yīng)用現(xiàn)狀,提出了研發(fā)治療DFU的中醫(yī)外用新藥的必要性,指出了DFU中藥新藥研發(fā)過程中的難點(diǎn)和臨床試驗(yàn)研究時(shí)的關(guān)注點(diǎn),并給出了初步的建議。
[Abstract]:Diabetic foot ulcer (DFU) is one of the serious complications of diabetes mellitus, which has high disability rate and high amputation rate, which seriously affects the physical and mental health of patients. Traditional Chinese medicine has certain curative effect and advantage in treating DFU. This paper analyzes the clinical characteristics of DFU and the current situation of its application, puts forward the necessity of developing and developing new Chinese medicine for external use of DFU, and points out the difficulties in the research and development of new Chinese medicine for DFU and the points of concern in clinical trial research. Some preliminary suggestions are given.
【作者單位】: 天津中醫(yī)藥大學(xué)第二附屬醫(yī)院中醫(yī)外科;國(guó)家食品藥品監(jiān)督管理總局藥品審評(píng)中心;
【基金】:天津市衛(wèi)計(jì)委中醫(yī)中西醫(yī)結(jié)合科研基金資助項(xiàng)目(2015112) 天津市中醫(yī)重點(diǎn)?茖2√悄虿∽阒嗅t(yī)專病基金資助項(xiàng)目
【分類號(hào)】:R259
[Abstract]:Diabetic foot ulcer (DFU) is one of the serious complications of diabetes mellitus, which has high disability rate and high amputation rate, which seriously affects the physical and mental health of patients. Traditional Chinese medicine has certain curative effect and advantage in treating DFU. This paper analyzes the clinical characteristics of DFU and the current situation of its application, puts forward the necessity of developing and developing new Chinese medicine for external use of DFU, and points out the difficulties in the research and development of new Chinese medicine for DFU and the points of concern in clinical trial research. Some preliminary suggestions are given.
【作者單位】: 天津中醫(yī)藥大學(xué)第二附屬醫(yī)院中醫(yī)外科;國(guó)家食品藥品監(jiān)督管理總局藥品審評(píng)中心;
【基金】:天津市衛(wèi)計(jì)委中醫(yī)中西醫(yī)結(jié)合科研基金資助項(xiàng)目(2015112) 天津市中醫(yī)重點(diǎn)?茖2√悄虿∽阒嗅t(yī)專病基金資助項(xiàng)目
【分類號(hào)】:R259
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