Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes:A Randomized,Double-Blind,Placebo-Controlled Multicenter Clinical Study  

作　　者：QU Ling LIANG Xiao-chun TIAN Guo-qing ZHANG Gai-li WU Qun-li HUANG Xiu-mei CUI Ya-zhong LIU Yu-ling SHEN Zhu-fang MA Guo-qing LU Hao LI Yi JIANG Hong YANG Xi-yan ZHANG Guang-de YANG Chen-hua 

机构地区：[1]Department of Traditional Chinese Medicine,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,100730,China [2]Institute of Materia Medica,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,100050,China [3]Department of Endocrinology,the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine,Haerbin,150001,China [4]Department of Endocrinology,Shuguang Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai,201203,China [5]Department of Traditional Chinese Medicine,Beijing Hospital,Beijing,10005,China [6]Department of Endocrinology,the Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang,110034,China [7]Department of Geriatrics,the First Affiliated Hospital of Tianjin University of Chinese Medicine,Tianjin,300073,China [8]Department of Endocrinology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing,100091,China [9]Department of Endocrinology,Affiliated Hospital of Henan Academy of Traditional Chinese Medicine,Zhengzhou,450003,China

出　　处：《Chinese Journal of Integrative Medicine》2022年第4期304-311,共8页中国结合医学杂志（英文版）

基　　金：Supported by the National Major Science and Technology Projects of China(No.2013ZX09101005)。

摘　　要：Objective:To assess the efficacy and safety of mulberry twig alkaloids(Sangzhi alkaloids,SZ-A)for treatment of type 2 diabetes in a randomized,double-blind,placebo-controlled multicenter clinical trial.Methods:A total of 200 patients were randomized to receive SZ-A(n=100)or placebo(n=100)for 16 weeks.The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs.The primary outcome was the change in glycosylated hemoglobin(Hb A1c)level.The secondary outcome included the proportions of cases with Hb A1c<7.0%and Hb A1c<6.5%,fasting blood glucose(FBG),postprandial blood glucose(PBG),area under curve for the PBG(AUC_(0-2h)),body weight,and body mass index(BMI).Adverse events(AEs),severe adverse events(SAEs),treatment-related adverse events(TAEs),gastrointestinal disorders(GDs),blood pressure,routine blood tests,and liver and kidney function were monitored.Results:Compared with baseline,the change of Hb A1c at week 16 was-0.80%(95%CI:-0.98%to-0.62%)and-0.09%(95%CI:-0.27%to 0.09%)in SZ-A group and placebo group,respectively.The proportion of patients with Hb A1c<7%and<6.5%was higher in the SZ-A group than in the placebo group(46.8%vs.21.6%and 29.9%vs.10.8%).The observed values and changes in FBG,1 h-PBG,2 h-PBG,and AUC_(0-2h) differed significantly between groups(P<0.001),but differences were not significant in body weight and BMI(P>0.05).The incidence rates of AEs,TAEs,and GDs differed significantly between groups(P=0.010,P=0.005,and P=0.006,respectively),whereas the incidence rates of SAEs showed no significant differences between groups(P=1.000).Conclusion:SZ-A are effective and safe for treatment of type 2 diabetes.

关 键 词：type 2 diabetes mellitus mulberry twig alkaloids tablets(Sangzhi alkaloids) efficacy safety PLACEBO 

分 类 号：R587.1[医药卫生—内分泌]