本文参照2018年9月FDA发布的《变应性鼻炎医药产品行业研发指南》(allergic rhinitis:developing drug products for treatment guidance for industry)相关内容,以我国药物临床试验登记与信息公示平台中定位于变应性鼻炎的Ⅱ,Ⅲ期中药...本文参照2018年9月FDA发布的《变应性鼻炎医药产品行业研发指南》(allergic rhinitis:developing drug products for treatment guidance for industry)相关内容,以我国药物临床试验登记与信息公示平台中定位于变应性鼻炎的Ⅱ,Ⅲ期中药/天然药物临床试验方案为分析案例,结合中医药自身特点,尝试对变应性鼻炎中药新药临床研究方案设计中的总体思路、适应证定位、试验周期、有效性及安全性评价等关键问题进行探讨。以期提高相关中药临床研究方案设计水平和证据质量,为变应性鼻炎治疗中药的研发提供支持和参考。展开更多
Background:impaired glucose tolerance(IGT)is the early stage of diabetes and it would be deteriorated to type 2 diabetes mellitus(T2 DM)easily if no intervention provided.In western medicine,drug therapy assisted with...Background:impaired glucose tolerance(IGT)is the early stage of diabetes and it would be deteriorated to type 2 diabetes mellitus(T2 DM)easily if no intervention provided.In western medicine,drug therapy assisted with the intervention of lifestyle is predominated.However,drug therapy brings serious side effect and high prices,while lifestyle intervention is difficult to be insisted on by patients.Therefore,a green and effective intervention mode is urgently needed.Transcutaneous auricular vagus nerve stimulation(taVNS)is a noninvasive and green therapeutic method based on the theory of traditional Chinese medicine(TCM),which can regulate glucose metabolism and reduce blood glucose,but the clinical effect of it has not been clarified yet at present.Hence,this randomized controlled trial(RCT)aims at exploring the effectiveness and safety of taVNS in the treatment of IGT.Methods:a total of 158 patients with IGT will be randomized into a taVNS group and a transcutaneous non-auricular vagus nerve stimulation(tnVNS)group,79 cases in each one.In the taVNS group and the tnVNS group,electric stimulation would be applied to Yidan(胰胆pancreas and gallbladder,CO11)and Pi(脾spleen,CO13)on auricular concha and Jian(肩shoulder SF4,5)on auricular rim respectively.The electric stimulation parameters would be the same in the patients of two groups,for 30 min in each treatment,twice a day,6 weeks as one course and 2 courses of treatment required totally.In week 0,6 and 12 of intervention,the effectiveness indicators would be determined,i.e.fasting plasma glucose(FPG),2 h plasma glucose(2 hPG)and glycosylated hemoglobin(HbA1c)successively.On week 0 and 12,body mass index(BMI)would be calculated,respiration,pulse and blood pressure would be recorded separately.Discussion:through observing the regulatory effect of taVNS on FPG,2 hPG,HbAlc and BMI as well as the adverse reactions,the effectiveness and safety of taVNS in treatment of IGT would be evaluated.This study will provide a safe,effective,convenient and nontoxic side effect展开更多
Objective： The aim of this systematic review of randomized controlled trials （RCTs） is to determine the effects of earlyenteral nutrition supplemented with probiotics on clinical outcomes in patients with SHI.Metho...Objective： The aim of this systematic review of randomized controlled trials （RCTs） is to determine the effects of earlyenteral nutrition supplemented with probiotics on clinical outcomes in patients with SHI.Methods and analysis： A systematic search will be carried out in PubMed, Cochrane Central Register of ControlledTrials （CENTRAL）, China National Knowledge Infrastructure （CNKI）, WanFang database, and Chinese BiomedicalLiterature （CBM） in order to identify the randomized controlled trials （RCTs） investigated the potential of early enteralnutrition supplemented with probiotics on patients with severe head injury, as well as we will also manually check thebibliographies of eligible studies and topic-related reviews. We will assign two investigators to independently search allpotential citations, extracted data, and appraised risk of bias accordingly, and then STATA software version 12.0 will beused to statistically analyze all data.Ethics and dissemination： The ethics approval and patient written informed consent will not be required because allanalyses in the present study will be performed based on data from published studies. We will submit our systematicreview to a peer-reviewed scientific journal for publication.展开更多
With the internationalization and modernization of traditional Chinese medicine （TCM）, TCM clinical research has accumulated a lot of research information resources. However, these information resources are often sc...With the internationalization and modernization of traditional Chinese medicine （TCM）, TCM clinical research has accumulated a lot of research information resources. However, these information resources are often scattered in various retrieval systems, which brings some difficulties to the reference and use of this information. Therefore, we collected TCM clinical research protocols which were published in international journals and established Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD）, in order to promote the localization of high-quality researches and improve the ability of TCM clinical research in China. After analyzing the major existing problems of TCM clinical research protocols, this essay describes the necessities and feasibilities of building Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD） and puts forward some basic technological ideas, so as to provide a theoretical foundation for building the database.展开更多
文摘本文参照2018年9月FDA发布的《变应性鼻炎医药产品行业研发指南》(allergic rhinitis:developing drug products for treatment guidance for industry)相关内容,以我国药物临床试验登记与信息公示平台中定位于变应性鼻炎的Ⅱ,Ⅲ期中药/天然药物临床试验方案为分析案例,结合中医药自身特点,尝试对变应性鼻炎中药新药临床研究方案设计中的总体思路、适应证定位、试验周期、有效性及安全性评价等关键问题进行探讨。以期提高相关中药临床研究方案设计水平和证据质量,为变应性鼻炎治疗中药的研发提供支持和参考。
基金Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture:81,674,072。
文摘Background:impaired glucose tolerance(IGT)is the early stage of diabetes and it would be deteriorated to type 2 diabetes mellitus(T2 DM)easily if no intervention provided.In western medicine,drug therapy assisted with the intervention of lifestyle is predominated.However,drug therapy brings serious side effect and high prices,while lifestyle intervention is difficult to be insisted on by patients.Therefore,a green and effective intervention mode is urgently needed.Transcutaneous auricular vagus nerve stimulation(taVNS)is a noninvasive and green therapeutic method based on the theory of traditional Chinese medicine(TCM),which can regulate glucose metabolism and reduce blood glucose,but the clinical effect of it has not been clarified yet at present.Hence,this randomized controlled trial(RCT)aims at exploring the effectiveness and safety of taVNS in the treatment of IGT.Methods:a total of 158 patients with IGT will be randomized into a taVNS group and a transcutaneous non-auricular vagus nerve stimulation(tnVNS)group,79 cases in each one.In the taVNS group and the tnVNS group,electric stimulation would be applied to Yidan(胰胆pancreas and gallbladder,CO11)and Pi(脾spleen,CO13)on auricular concha and Jian(肩shoulder SF4,5)on auricular rim respectively.The electric stimulation parameters would be the same in the patients of two groups,for 30 min in each treatment,twice a day,6 weeks as one course and 2 courses of treatment required totally.In week 0,6 and 12 of intervention,the effectiveness indicators would be determined,i.e.fasting plasma glucose(FPG),2 h plasma glucose(2 hPG)and glycosylated hemoglobin(HbA1c)successively.On week 0 and 12,body mass index(BMI)would be calculated,respiration,pulse and blood pressure would be recorded separately.Discussion:through observing the regulatory effect of taVNS on FPG,2 hPG,HbAlc and BMI as well as the adverse reactions,the effectiveness and safety of taVNS in treatment of IGT would be evaluated.This study will provide a safe,effective,convenient and nontoxic side effect
文摘Objective： The aim of this systematic review of randomized controlled trials （RCTs） is to determine the effects of earlyenteral nutrition supplemented with probiotics on clinical outcomes in patients with SHI.Methods and analysis： A systematic search will be carried out in PubMed, Cochrane Central Register of ControlledTrials （CENTRAL）, China National Knowledge Infrastructure （CNKI）, WanFang database, and Chinese BiomedicalLiterature （CBM） in order to identify the randomized controlled trials （RCTs） investigated the potential of early enteralnutrition supplemented with probiotics on patients with severe head injury, as well as we will also manually check thebibliographies of eligible studies and topic-related reviews. We will assign two investigators to independently search allpotential citations, extracted data, and appraised risk of bias accordingly, and then STATA software version 12.0 will beused to statistically analyze all data.Ethics and dissemination： The ethics approval and patient written informed consent will not be required because allanalyses in the present study will be performed based on data from published studies. We will submit our systematicreview to a peer-reviewed scientific journal for publication.
文摘With the internationalization and modernization of traditional Chinese medicine （TCM）, TCM clinical research has accumulated a lot of research information resources. However, these information resources are often scattered in various retrieval systems, which brings some difficulties to the reference and use of this information. Therefore, we collected TCM clinical research protocols which were published in international journals and established Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD）, in order to promote the localization of high-quality researches and improve the ability of TCM clinical research in China. After analyzing the major existing problems of TCM clinical research protocols, this essay describes the necessities and feasibilities of building Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD） and puts forward some basic technological ideas, so as to provide a theoretical foundation for building the database.
