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目的了解高选择性β1受体阻滞剂富马酸比索洛尔对高血压或冠状动脉性心脏病(冠心病)伴2型糖尿病患者血浆糖化血红蛋白(HbA1c)水平的影响。方法入选高血压或冠心病伴2型糖尿病患者,采用治疗前后比较的试验方法。由主管医生根据病情决定富马酸比索洛尔的用量(2.5~10.0mg/d),共治疗20周。主要终点为血浆HbA1c的变化,次要终点为空腹血糖、血脂、血压和心率的变化,并观察不良反应。结果 87.2%(342/392)的患者完成研究。与基线比较,富马酸比索洛尔治疗12和20周后,HbA1c[(6.5±1.0)%、(6.5±1.1)%比(6.5±0.7)%]、空腹血糖[(6.7±1.5)、(6.7±1.7)比(6.7±1.4)mmol/L]和血脂水平差异无统计学意义(均P>0.05)。治疗后血压和心率明显下降,未发现严重不良事件。低、中、高剂量富马酸比索洛尔的HbA1c水平差异也无统计学意义。结论富马酸比索洛尔治疗高血压或冠心病伴2型糖尿病患者20周,在明显降低血压和心率的情况下,对HbA1c水平无明显影响。
Objective To investigate the effect of high selective β1 blocker bisoprolol on plasma HbA1c levels in patients with type 2 diabetes mellitus or coronary heart disease (CHD). Methods Selected patients with hypertension or coronary heart disease with type 2 diabetes, using the test method before and after treatment. By the competent doctor according to the disease decided bisoprolol fumarate dosage (2.5 ~ 10.0mg / d) for a total of 20 weeks. The primary endpoint was changes in plasma HbA1c, with secondary end points as changes in fasting blood glucose, blood lipids, blood pressure, and heart rate, and adverse reactions observed. Results 87.2% (342/392) of patients completed the study. HbA1c [(6.5 ± 1.0)%, (6.5 ± 1.1)% vs (6.5 ± 0.7)%], fasting blood glucose [(6.7 ± 1.5), (6.7 ± 1.7) vs (6.7 ± 1.4) mmol / L] and blood lipid levels (P> 0.05). After treatment, blood pressure and heart rate decreased significantly, no serious adverse events were found. HbA1c levels in low, middle and high doses of bisoprolol fumarate were also not significantly different. Conclusion Bisoprolol fumarate treatment of hypertension or coronary heart disease with type 2 diabetes for 20 weeks, in the case of significantly lower blood pressure and heart rate, HbA1c levels had no significant effect.