中药三七可降低糖耐量受损向糖尿病的进展：一项双盲、随机、安慰剂对照、多中心试验。
Chinese herbal medicine Tianqi reduces progression from impaired glucose tolerance to diabetes: a double-blind, randomized, placebo-controlled, multicenter trial.
作者信息
Lian Fengmei, Li Guangwei, Chen Xinyan, Wang Xiuzhi, Piao Chunli, Wang Jingfei, Hong Yuzhi, Ba Zhuoma, Wu Shentao, Zhou Xiaoyan, Lang Jiangming, Liu Yajun, Zhang Rongfang, Hao Jianjun, Zhu Zhangzhi, Li Huilin, Fang Liu Hong, Cao Aimei, Yan Zhu, An Yali, Bai Yujing, Wang Qiang, Zhen Zhong, Yu Chunhao, Wang Chong-Zhi, Yuan Chun-Su, Tong Xiaolin
机构信息
Guang'anmen Hospital, China Academy of Chinese Medical Sciences (F.L., X.C., Y.B., Z.Zhe., X.T.), and China Academy of Chinese Medical Sciences (Z.Y.), Beijing 100053, China; Fuwai Hospital of Cardiovascular Disease (G.L., Y.A.), Beijing, China; Beijing Pinggu Hospital of Traditional Chinese Medicine (X.W.), Beijing 101200, China; The Affiliated Hospital to Changchun University of Chinese Medicine (C.P.), Changchun 130021, China; Beijing Mentougou Hospital of Traditional Chinese Medicine (J.W.), Beijing 102300, China; Hangzhou Hospital of Traditional Chinese Medicine (Y.H.), Hangzhou 310007, China; Qinghai Hospital of Traditional Chinese Medicine (Z.B.), Qinghai 810000, China; First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (S.W.), Tianjin 300192, China; Guangzhou Tianhe Hospital of Traditional Chinese Medicine (X.Z.), Guangzhou 510275, China; Foshan Hospital of Traditional Chinese Medicine (J.L.), Foshan, 528000 China; Beijing Huimin Hospital (Y.L.), Beijing, China; Yangquan First Municipal People's Hospital (R.Z.), Yangquan 045000, China; Guangzhou Huangpu Hospital of Traditional Chinese Medicine (J.H., Q.W.), Guangzhou 510700, China; First Affiliated Hospital of Guangzhou University of Chinese Medicine (Z.Zhu.), Guangzhou 510405, China; Shenzhen Hospital of Traditional Chinese Medicine (H.L.), Shenzhen 518033, China; Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine (H.F.L.), Beijing 100700, China; Beijing Changping Hospital of Traditional Chinese Medicine (A.C.), Beijing 100200, China; and Tang Center for Herbal Medicine Research (C.Y., C.-Z.W., C.-S.Y.), University of Chicago, Chicago, Illinois 60637.
出版信息
J Clin Endocrinol Metab. 2014 Feb;99(2):648-55. doi: 10.1210/jc.2013-3276. Epub 2014 Jan 16.
CONTEXT
Living in a prediabetes state significantly increases a patient's risk for both diabetes and cardiovascular disease. Tianqi capsule, containing 10 Chinese herbal medicines, is used in China for the treatment of type 2 diabetes mellitus (T2DM).
OBJECTIVE
The purpose of this study was to assess whether Tianqi prevented T2DM in subjects with impaired glucose tolerance (IGT) over the course of a 12-month treatment.
METHODS
Individuals with IGT were randomly allocated in a double-blind manner to receive Tianqi (n = 210) or a placebo (n = 210) for 12 months. Oral glucose tolerance tests were conducted every 3 months to assess the development of diabetes or restoration to normal glucose tolerance. All subjects received the same lifestyle education. The primary endpoint was the conversion of IGT to T2DM. Body weight and body mass index were observed. Adverse effects were monitored.
RESULTS
Of the 420 enrolled subjects with IGT, 389 completed the trial (198 in the Tianqi group and 191 in the placebo group). At the end of the 12-month trial, 36 subjects in the Tianqi group (18.18%) and 56 in the placebo group (29.32%) had developed diabetes (P = .01). There was a significant difference in the number of subjects who had normal glucose tolerance at the end of the study between the Tianqi and placebo groups (n = 125, 63.13%, and n = 89, 46.60%, respectively; P = .001). Cox's proportional hazards model analysis showed that Tianqi reduced the risk of diabetes by 32.1% compared with the placebo. No severe adverse events occurred in the trial. There were no statistical differences in body weight and body mass index changes between the Tianqi group and the placebo group during the 12-month trial.
CONCLUSIONS
Treatment with a Tianqi capsule for 12 months significantly decreased the incidence of T2DM in subjects with IGT, and this herbal drug was safe to use.
背景
处于糖尿病前期状态会显著增加患者患糖尿病和心血管疾病的风险。天芪胶囊含有10种中药，在中国用于治疗2型糖尿病（T2DM）。
目的
本研究旨在评估天芪在12个月的治疗过程中是否能预防糖耐量受损（IGT）受试者患T2DM。
方法
IGT个体以双盲方式随机分配，接受天芪治疗（n = 210）或安慰剂治疗（n = 210），为期12个月。每3个月进行一次口服葡萄糖耐量试验，以评估糖尿病的发生或恢复正常糖耐量情况。所有受试者接受相同的生活方式教育。主要终点是IGT转化为T2DM。观察体重和体重指数。监测不良反应。
结果
420名入选的IGT受试者中，389名完成了试验（天芪组198名，安慰剂组191名）。在12个月试验结束时，天芪组有36名受试者（18.18%）患糖尿病，安慰剂组有56名受试者（29.32%）患糖尿病（P = 0.01）。在研究结束时，天芪组和安慰剂组糖耐量正常的受试者数量存在显著差异（分别为n = 125，63.13%和n = 89，46.60%；P = 0.001）。Cox比例风险模型分析显示，与安慰剂相比，天芪使糖尿病风险降低了32.1%。试验中未发生严重不良事件。在12个月的试验期间，天芪组和安慰剂组的体重和体重指数变化无统计学差异。
结论
天芪胶囊治疗12个月可显著降低IGT受试者患T2DM的发生率，且这种草药使用安全。
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