Efficacy and mechanism of Xiaoshuan enteric-coated capsule as an adjunctive treatment for ischemic stroke:A randomized clinical trial  

作　　者：Chunli Wen Zhixia Su Zhibin Ding Cungen Ma Fengyun Hu Lijuan Song Lingqun Zhu 

机构地区：[1]Key Laboratory of Chinese Internal Medicine of Educational Ministry and Beijing,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing,100700,China [2]Department of Traditional Chinese Medicine/Department of Neurology,Shanxi Provincial People's Hospital,Taiyuan,030012,China [3]Department of Neurology,Shanxi Bethune Hospital,Taiyuan,030032,China [4]Research Center of Neurobiology,Shanxi University of Chinese Medicine,Jinzhong,030032,China

出　　处：《Journal of Traditional Chinese Medical Sciences》2024年第4期405-414,共10页中医科学杂志（英文）

基　　金：funded by the project of the National Natural Science Foundation of China(82004028);the Shanxi Provincial Basic Research Program for Young Scientists(202203021212079);Grant of Innovative Young Talent Team of Shanxi Science and Technology Department(202204051001028);Young Scientists Cultivation Project of Shanxi University of Chinese Medicine(2021PY-QN-09);Key Specialty Cultivation Program of National Administration of Traditional Chinese Medicine during the“Twelfth Five-Year Plan”of China:Department of Geriatrics,Shanxi Provincial People's Hospital([2012]2-2-209).

摘　　要：Objective:To explore the clinical efficacy of Xiaoshuan enteric-coated capsule(XSECC)in treating ce-rebral infarction and its potential mechanism of action.Methods:Patients with acute ischemic stroke(AIS)of the qi deficiency and blood stasis type were randomly assigned to the control and observation groups.They were evaluated using the National In-stitutes of Health Stroke Scale(NIHSS),Activities of Daily Living(ADL),Hachinskilnchemic Scale(HIS),Barthel Index(BI),clinical efficacy scores,and TCM syndrome scores on days 0,14,30,and 90.Furthermore,VEGF and BDNF levels were measured on days 30 and 90.Finally,we analyzed the changes in each scale score and vascular neurological factor in both groups.Results:After 14 days of treatment,the difference values in NIHSS,ADL,and BI were higher,and TCM syndrome and clinical efficacy scores were increased in the observation group compared with those of the control group(all P<0.05).After 30 days,the NIHSS,ADL,HIS,and TCM syndrome scores were decreased compared with those of the control group,while BI and clinical efficacy scores were increased(all P<0.05).After 90 days,the difference value in ADL was higher,and TCM syndrome score was increased in the observation group compared with that of the control group(P=0.047,P=0.005,respectively).The levels of VEGF and BDNF were higher in the observation group than in the control group on days 14,30,and 90(all P<0.05).VEGF and BDNF levels on day 0 were associated with prognosis of patients with AIS;therefore,they have a predictive value for the prognosis of acute cerebral infarction.Conclusions:XSECC therapy can improve clinical outcomes in patients with acute and recurrent cerebral infarctions.Its mechanism of action may be associated with the secretion of VEGF and BDNF.

关 键 词：Cerebral infarction Xiaoshuan enteric-coated capsule Qi deficiency and blood stasis Vascular endothelial growth factor Brain-derived neurotrophic factor 

分 类 号：R285.5[医药卫生—中药学]