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首页> 外文期刊>Clinical drug investigation >Evaluation of the Efficacy and Tolerability of Acarbose in Patients with Diabetes Mellitus A Postmarketing Surveillance Study
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Evaluation of the Efficacy and Tolerability of Acarbose in Patients with Diabetes Mellitus A Postmarketing Surveillance Study

机译：阿卡波糖对糖尿病患者的疗效和耐受性评估上市后监测研究

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Objective: The efficacy and tolerability of acarbose were examined in a postmarketing surveillance study of 27 803 patients with diabetes mellitus (26 044 were diagnosed as having type 2 diabetes) over a 12-week treatment period.Patients and methods: Overall efficacy data were reported for type 1 and type 2 diabetes, and a detailed data analysis was conducted for patients with type 2 diabetes. Tolerability was described for the total group. Of the type 2 diabetes patients, 37.6% were treated with diet only; 44.2% were additionally treated with sulphonylureas; 6.3% with metformin or metformin plus sulphonylurea; and 11.6% with insulin alone or in combination with oral treatment. The frequency of two or more concomitant diseases was 45.8% for all type 2 diabetes patients, and 62.4% in elderly patients (age >70 years).Results: In patients with type 2 diabetes, acarbose administration in addition to the existing treatment resulted in reductions in mean blood glucose levels (fasting 50 mg/dL, lh post-prandial [pp] 60 mg/dL, 2h pp 56 mg/dL), glycosylated haemoglobin (HbA_(1c) 1.3%; HbA_1 1.6%) and bodyweight (1.5 kg). Results for type 1 diabetes patients were similar. No clinically relevant influence of age, body mass index or number of concomitant diseases on the results could be observed. Tolerability was good: 83% of patients had no adverse events, 13.7% reported flatulence, and 2.2% had at least one occurrence of diarrhoea. Hypoglycaemia was found in 0.07% of patients, mainly in combination with metformin or insulin. Tolerability was independent of patients' age. Laboratory investigations gave no indication of other adverse events.Conclusion: This postmarketing surveillance study documents the therapeutic benefit and good tolerability and compliance of acarbose as mono- and combination therapy, even in elderly and multimorbid patients.
机译：目的：在为期12周的治疗期间，对27803名糖尿病患者（诊断为2044型糖尿病）的27803名糖尿病患者进行了上市后监测研究，检查了阿卡波糖的疗效和耐受性。患者和方法：报告了总体疗效数据针对1型和2型糖尿病，并针对2型糖尿病患者进行了详细的数据分析。描述了整个组的耐受性。在2型糖尿病患者中，仅饮食治疗占37.6％;另外有44.2％的患者接受磺脲类药物治疗; 6.3％服用二甲双胍或二甲双胍加磺脲类药物;单独使用胰岛素或与口服治疗合用时为11.6％。在所有2型糖尿病患者中，两种或更多种并发疾病的发生率为45.8％，在老年患者（年龄> 70岁）中为62.4％。结果：在2型糖尿病患者中，除了现有治疗外，还进行了阿卡波糖治疗降低平均血糖水平（空腹50 mg / dL，餐后1h餐后[pp] 60 mg / dL，2h pp 56 mg / dL），糖基化血红蛋白（HbA_（1c）1.3％; HbA_1 1.6％）和体重（ 1.5公斤）。 1型糖尿病患者的结果相似。没有观察到年龄，体重指数或并发疾病数对结果的临床相关影响。耐受性良好：83％的患者无不良反应，13.7％的人有肠胃气胀，2.2％的人至少发生一次腹泻。在0.07％的患者中发现低血糖症，主要是与二甲双胍或胰岛素联用。耐受性与患者年龄无关。实验室调查没有发现其他不良事件的迹象。结论：这项售后监测研究证明了阿卡波糖作为单药和联合疗法的治疗益处，良好的耐受性和依从性，即使在老年和多病患者中也是如此。

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