典型文献
Ruyi Zhenbao Pills for Patients with Motor and Sensory Dysfunction after Stroke:A Double-Blinded,Randomized Placebo-Controlled Clinical Trial
文献摘要：
Objective:To evaluate the efficacy and safety of Tibetan medicine Ruyi Zhenbao Pills(RZPs)in the treatment of patients with motor and sensory dysfunction after stroke.Methods:A total of 120 convalescent stroke patients hospitalized in the Rehabilitation Department of Guangdong Provincial Hospital of Chinese Medicine from June 2017 to December 2019 were enrolled in this trial.Patients were assigned to control(60 cases)and research(60 cases)groups by computer random assignment.All patients received internal treatment and modem rehabilitation training.On this basis,the research group was given oral RZPs for 4 weeks,while the control group was given oral placebo.The primary outcome was motor function of the affected side evaluated by simplified Fugl-Meyer Motion Assessment Scale(FMA-M).The secondary outcomes included sensory function,activity of daily living(ADL),quality of life,balance function,and pain,which were assessed by Fugl-Meyer Sensory Assessment Scale(FMA-S),Modified Barthel Index(MBI),Special Scale of the Quality of Life(SS-QOL),Berg Balance Scale(BBS),and Visual Analogue Scale(VAS),respectively.All of the assessments were performed before treatment,and 4 and 8 weeks after treatment.Vital signs,liver and kidney functions,routine blood test,blood coagulation profile,and routine urinalysis of patients were monitored.Results:After 4-week treatment,the FMA-M,BBS and FMA-S scores in the research group significantly increased compared with the control group(P＜0.05).At 8-week follow-up,the BBS and MBI scores in the research group were higher than the control group(P＜0.05).There was no statistical difference between the 2 groups in the SS-QOL and VAS scores at 4 and 8 weeks(P＞0.05).Moreover,after treatment,there was no significant difference in vital signs,liver and kidney functions,blood coagulation function,blood routine and urinalysis between the 2 groups(P＞0.05).Conclusion:RZPs improved limb motor,balance,and sensory functions of stroke patients during recovery period with good safety.(Trial registration No.NCT04029701)
文献关键词：
中图分类号：
作者姓名：
LING Shan-shan;PAN Rui-huan;ZHAN Le-chang;LI Mei;YANG Zhi-jing;YANG Hao-dong;CHEN Hong-xia
作者机构：
Department of Rehabilitation,The Second Affiliated Hospital,Guangzhou University of Chinese Medicine,Guangzhou 510120,China;The Second Institute of Clinical Medicine,Guangzhou University of Chinese Medicine,Guangzhou 510120,China
文献出处：
引用格式：
[1]LING Shan-shan;PAN Rui-huan;ZHAN Le-chang;LI Mei;YANG Zhi-jing;YANG Hao-dong;CHEN Hong-xia-.Ruyi Zhenbao Pills for Patients with Motor and Sensory Dysfunction after Stroke:A Double-Blinded,Randomized Placebo-Controlled Clinical Trial)[J].中国结合医学杂志（英文版）,2022(10):872-878
A类：
Ruyi,Zhenbao,Blinded,RZPs,urinalysis,NCT04029701
B类：
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AB值：
0.514516
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