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此项上市后监测的目的是为了评价中国的2型糖尿病患者日常实际使用阿卡波糖的有效性、安全性和接受程度。中国共有231位临床医师招募了2 480例2型糖尿病患者参加了本次开放性、前瞻性,非对照、非随机的多中心研究。主要的疗效参数是阿卡波糖治疗后空腹和餐后血糖水平的变化以及HbA_(IC)水平的变化。大部分患者入组之前曾接受其他口服降糖药或胰岛素的治疗,并且在平均为13．5周的观察期内接受了降糖药物联合治疗。大部分患者阿卡波糖的起始剂量为50 mg,3次/日。在整个研究期间,阿卡波糖使空腹血糖浓度下降了56．1 mg/dl(18 mg/dl葡萄糖=1 mmol/L葡萄糖),餐后2 h血糖下降了111．3 mg/dl,HbA_(IC)下降了1．9%,体重下降0．9 kg。研究期间出现了76次阿卡波糖相关的不良事件,两例患者出现严重不良事件。主治医师对90．1%的患者做出“非常好”或“较好”的评价,患者对阿卡波糖的耐受性为89．1%,接受程度为87．1%。无论作为单药治疗还是和其他降糖药物合用,每天常规使用阿卡波糖对于中国的2型糖尿病患者是有效、安全和接受程度较好的。
The purpose of this postmarketing monitoring is to evaluate the effectiveness, safety and acceptability of acarbose in daily routine use in people with type 2 diabetes in China. A total of 2380 clinicians from China enrolled 2 480 patients with type 2 diabetes in an open, prospective, uncontrolled, nonrandomized multicenter study. The main efficacy parameters are fasting and postprandial blood glucose levels and HbA_ (IC) levels after acarbose treatment. Most patients had received other oral hypoglycemic agents or insulin prior to enrollment and had received combination therapy for hypoglycemic agents within an average of 13.5 weeks of observation. Acarbose in most patients initial dose of 50 mg, 3 times / day. Acarbose decreased fasting blood glucose levels by 56.1 mg / dl (18 mg / dl glucose = 1 mmol / L glucose) throughout the study, decreased blood glucose by 111.3 mg / dL at 2 h postprandial, and HbA_ (IC) fell 1.9%, weight loss 0.9 kg. During the study, 76 episodes of acarbose related adverse events occurred, and two patients experienced serious adverse events. The attending physician rated 90.1% of patients as “very good” or “better,” with 89.1% of patients receiving acarbose and 87.1% of those receiving acarbose. Whether used as monotherapy or in combination with other hypoglycemic agents, daily routine use of acarbose is effective, safe and well-accepted in people with type 2 diabetes in China.