Spengler M, Cagatay M
Bayer AG, Medical Department Germany, Institute for Biometry, Wuppertal, Germany.
Clin Invest Med. 1995 Aug;18(4):325-31.
The efficacy and tolerability of acarbose were examined in a postmarketing surveillance study of 10,462 patients (829 insulin-dependent diabetes mellitus (IDDM), 9,440 non-insulin-dependent diabetes mellitus (NIDDM), 193 not classified) during a 12-week treatment period. The median duration of diabetes was 60 months for men and 72 months for women in IDDM patients, and 40 months for men and 60 months for women in NIDDM patients. Of the Type II patients, 28.9% were treated with diet only; 58.1% additionally with sulfonylureas; 8.6% with insulin; and 4.3% with both sulfonylureas and insulin. The additional acarbose therapy led to a reduction of the mean fasting blood glucose levels (51 mg/dL for IDDM; 52 mg/dL for NIDDM) and 1 h postprandially (55 mg/dL for IDDM; 63 mg/dL for NIDDM). The HbA1 levels were reduced by 1.5%. Tolerability was good: 78.6% of patients had no adverse events; 19% reported meteorism/flatulence; 3.2%, diarrhea. Hypoglycemia was found in 0.8% of Type I and 0.6% of Type II patients who received concurrent insulin (n = 8) or glibenclamide (n = 1) treatment. Laboratory investigations gave no indication of other adverse effects, e.g. elevated levels of transaminases or creatinine. This postmarketing surveillance study documents the therapeutic benefit and the good tolerability of acarbose.
在一项针对10462例患者（829例胰岛素依赖型糖尿病（IDDM）、9440例非胰岛素依赖型糖尿病（NIDDM）、193例未分类）的上市后监测研究中，对阿卡波糖的疗效和耐受性进行了为期12周的治疗期检查。IDDM患者中，男性糖尿病的中位病程为60个月，女性为72个月；NIDDM患者中，男性为40个月，女性为60个月。在II型患者中，28.9%仅接受饮食治疗；58.1%还接受磺脲类药物治疗；8.6%接受胰岛素治疗；4.3%同时接受磺脲类药物和胰岛素治疗。额外的阿卡波糖治疗使平均空腹血糖水平降低（IDDM患者降低51mg/dL；NIDDM患者降低52mg/dL），餐后1小时血糖水平也降低（IDDM患者降低55mg/dL；NIDDM患者降低63mg/dL）。糖化血红蛋白（HbA1）水平降低了1.5%。耐受性良好：78.6%的患者无不良事件；19%报告有胃肠胀气；3.2%报告有腹泻。在接受胰岛素（n = 8）或格列本脲（n = 1）联合治疗的I型患者中，0.8%出现低血糖，II型患者中0.6%出现低血糖。实验室检查未显示其他不良反应，如转氨酶或肌酐水平升高。这项上市后监测研究证明了阿卡波糖的治疗益处和良好耐受性。
