Efficacy and safety of acarbose chewable tablet in patients with type 2 diabetes: a multicentre, randomized, double-blinded, double-dummy positive controlled trial.
Efficacy and safety of acarbose chewable tablet in patients with type 2 diabetes: a multicentre, randomized, double-blinded, double-dummy positive controlled trial.
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DOI：
10.1111/j.1756-5391.2012.01188.x
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发表时间：
2012-08-01
影响因子：
--
通讯作者：
Tian, Hao Ming
中科院分区：
文献类型：
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作者：
Wu, Qian Lin;Liu, Yu Ping;Tian, Hao Ming
目的：目的：评价阿卡波糖咀嚼片对2型糖尿病患者糖化血红蛋白（HbA 1c）和血糖控制的有效性和安全性。234例2型糖尿病患者随机分为阿卡波糖咀嚼片组（试验组，n = 116）和阿卡波糖治疗组（对照组，n = 118）。在临床试验开始和结束时，测量HbA 1c和血糖以及安全性指标。治疗后，实验组和对照组餐后2 h手指血糖（PPBG）分别下降4.15 mmol/L（26.82%）和3.54 mmol/L（22.77%）。实验组和对照组静脉2 h PPBG分别下降4.04 mmol/L（25.38%）和2.75 mmol/L（17.26%），HbA 1c平均值分别下降11.67%和12.44%。两组的空腹血糖（FBG）也显著降低。两组患者体重均明显减轻（P < 0.0001）。结论：阿卡波糖咀嚼片治疗2型糖尿病疗效确切，治疗12周后HbA 1c和血糖水平明显下降。
OBJECTIVE: To evaluate the effect and safety of HbA1c and glycemic control of acarbose chewable tablets in patients with type 2 diabetic.METHOD: A multicentre, randomized, double-blinded, double-dummy, positive controlled clinical trial was conducted. Two hundred thirty-four Chinese patients with type 2 diabetic were enrolled in eight clinical centres, who were divided randomly into the acarbose chewable tablet group (experimental group, n = 116) and the acarbose treatment group (control group, n = 118).RESULTS: Two hundred seven patients (88.5%) took part in the 12-week trial. At the beginning and end of the clinical trial, HbA1c and blood glucose as well as safety indexes were measured. After the treatment, the level of finger two-hour postprandial blood glucose (PPBG) was decreased 4.15 mmol/L (26.82%) and 3.54 mmol/L (22.77%), respectively, in the experiment group and the control group. The levels of venous two-hour PPBG in the experiment group and the control group were decreased 4.04 mmol/L (25.38%) and 2.75 mmol/L (17.26%), respectively, with the means of HbA1c lowering 11.67% and 12.44%, respectively. Fasting blood glucose (FBG) also was reduced significantly in both groups. Patients in both groups showed obvious weight reduction (P < 0.0001). There were no significant differences in the incidence of adverse events between the two groups.CONCLUSION: In summary, acarbose chewable tablets have a definite curative effect in treating type 2 diabetic patients as HbA1c and blood glucose levels decreased significantly after the 12-week treatment.