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Efficacy and Safety of Mulberry Twig Alkaloids Tablet for the Treatment of Type 2 Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy, and Parallel Controlled Clinical Trial.

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收录情况： ◇ SCIE

作者：
Ling Qu[1] * ; Xiaochun Liang[1] ; Guoqing Tian[1] ; Gaili Zhang[1] ; Qunli Wu[1] ; Xiumei Huang[1] ; Yazhong Cui[1] ; Yuling Liu[2] ; Zhufang Shen[2] ; Changqing Xiao[3] ; Yingfen Qin[4] ; Heng Miao[5] ; Yongyan Zhang[6] ; Ziling Li[7] ; Shandong Ye[8] ; Xuezhi Zhang[9] ; Jing Yang[10] ; Guiwen Cao[11] ; Yi Li[12] ; Gangyi Yang[13] ; Ji Hu[14] ; Xiaoyue Wang[15] ; Zhengfang Li[16] ; Yukun Li[17] ; Xiuzhen Zhang[18] ; Guangde Zhang[19] ; Li Chen[20] ; Wenjin Hua[21] ; Ming Yu[22] ; Chunyan Lu[23] ; Xiaomei Zhang[24] ; Hong Jiang[25] ;
机构： [1]Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [2]Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [3]Department of Endocrinology and Metabolism, The First Affiliated Hospital, Guangxi Medical University, Guangxi, China [4]Department of Endocrinology, The First Affiliated Hospital, Guangxi Medical University, Guangxi, China [5]Department of Endocrinology, The Second Affiliated Hospital, Nan Jing Medical University, Jiangsu, China [6]Department of Endocrinology, Shengjing Hospital of China Medical University, Liaoning, China [7]Department of Endocrinology, Inner Mongolia Baogang Hospital, Baotou, Inner Mongolia Autonomous Region, China [8]Department of Endocrinology, The First Affiliated Hospital of University of Science and Technology of China (USTC), Division of Life Sciences and Medicine, USTC, Hefei, Anhui, China [9]Traditional Chinese Medicine and Integrative Medicine Department, Peking University First Hospital, Beijing, China [10]Department of Endocrinology, The First Affiliated Hospital, Shanxi Medical University, Shanxi, China [11]Department of Endocrinology, The Forth Affiliated Hospital, Jilin University, Jilin, China [12]Department of Traditional Chinese Medicine, Beijing Hospital, Beijing, China [13]Department of Endocrinology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China [14]Department of Endocrinology, The Second Affiliated Hospital, Suzhou University, Jiangsu, China [15]Department of Endocrinology, The First People’s Hospital of Yueyang, Hunan, China [16]Department of Endocrinology, The Second Affiliated Hospital, Kunming Medical University, Yunnan, China [17]Department of Endocrinology, The Third Affiliated Hospital, Hebei Medical University, Hebei, China [18]Department of Endocrinology, Tongji Hospital, Tongji University, Shanghai, China [19]Department of Endocrinology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, China [20]Department of Endocrinology, Qilu Hospital, Shandong University, Shandong, China [21]Department of Endocrinology, The Third People’s Hospital of Wuxi, Jiangsu, China [22]Department of Endocrinology, Central Hospital of Putuo District, Shanghai, China [23]Department of Endocrinology, West China Hospital, Sichuan University, Sichuan, China [24]Department of Endocrinology, The First Affiliated Hospital of Bengbu Medical College, Anhui, China [25]Department of Endocrinology, The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Liaoning, China
出处：
DOI： 10.2337/dc20-2109
ISSN：

摘要：
This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids [SZ-A]) in the treatment of type 2 diabetes (T2D). This was a multicenter, randomized, double-blind, double-dummy, and parallel controlled noninferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group (n= 360) or acarbose group (n= 240). The primary efficacy end point was the change of glycosylated hemoglobin (HbA1c) compared with baseline. In addition, adverse events (AEs), severe AEs (SAEs), treatment-related AEs (TAEs), and gastrointestinal disorders (GDs) were monitored. After treatment for 24 weeks, the change in HbA1c was -0.93% (95% CI -1.03 to -0.83) (-10.2 mmol/mol [-11.3 to -9.1]) and -0.87% (-0.99 to -0.76) (-9.5 mmol/mol [-10.8 to -8.3]) in the SZ-A and acarbose groups, respectively, and the least squares mean difference was -0.05% (95% CI -0.18 to 0.07) (-0.5 mmol/mol [-2.0 to 0.8]) between the two groups, with no significant difference on the basis of covariance analysis (P > 0.05). The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group (P < 0.01), but no differences for AEs or SAEs between the two groups were observed (P > 0.05). SZ-A exhibited equivalent hypoglycemic effects to acarbose in patients with T2D. Nevertheless, the incidence of TAEs and GDs was lower following SZ-A treatment than acarbose treatment, suggesting good safety. © 2021 by the American Diabetes Association.

基金：
This study was supported by the National Science and Technology Major Project (2013ZX09101005).
语种：
外文
被引次数：
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中科院(CAS)分区：
出版当年[2021]版：
大类 | 1 区 医学
小类 | 1 区 内分泌学与代谢
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 内分泌学与代谢
JCR分区：
出版当年[2020]版：
Q1 ENDOCRINOLOGY & METABOLISM
最新[2023]版：
Q1 ENDOCRINOLOGY & METABOLISM

影响因子： 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者：
第一作者机构： [1]Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
通讯作者：
推荐引用方式(GB/T 7714)：
Ling Qu,Xiaochun Liang,Guoqing Tian,et al.Efficacy and Safety of Mulberry Twig Alkaloids Tablet for the Treatment of Type 2 Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy, and Parallel Controlled Clinical Trial.[J].DIABETES CARE.2021,44(6):1324-1333.doi:10.2337/dc20-2109.
APA：
Ling Qu,Xiaochun Liang,Guoqing Tian,Gaili Zhang,Qunli Wu...&Hong Jiang.(2021).Efficacy and Safety of Mulberry Twig Alkaloids Tablet for the Treatment of Type 2 Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy, and Parallel Controlled Clinical Trial..DIABETES CARE,44,(6)
MLA：
Ling Qu,et al."Efficacy and Safety of Mulberry Twig Alkaloids Tablet for the Treatment of Type 2 Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy, and Parallel Controlled Clinical Trial.".DIABETES CARE 44..6(2021):1324-1333

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