Sieradzki J, Soszyński P
Katedry i Kliniki Chorób Metabolicznych Collegium Medicum Uniwersytetu Jagiellońskiego w Krakowie.
Przegl Lek. 1999;56(5):335-41.
Acarbose (Glucobay, Bayer) is a competitive inhibitor of intestinal alpha-glucosidases, which use causes inhibition of carbohydrate digestion. The aim of the study was to prospectively observe scheme of acarbose use as well as efficacy and safety of the drug in diabetic patients in general health care. The study was performed in general health care centres all around Poland. 200 physicians were involved, each one was asked to supervise use of acarbose in 3 patients. The whole patients population consisted of 600 persons. The physicians were asked to make records in provided formularies, prior to acarbose use and then after 4 and 8 weeks of the treatment: data from the interview (among others on diabetes type, disease duration, used diet, treatment incl. sulphonylurea or biguanide derivatives); personal data (age, height, weight, etc.); blood glucose level prior to and 2 hours postprandial; glycosuria; basic additional tests; basic lipid tests (total cholesterol, triglycerides); overall score of acarbose use (side effects, withdrawal, physicians and patients opinion on the drug). Fasting glycaemia was the criterion of inclusion into the analysis. Full data on this parameter were obtained in 480 patients (267 female and 213 male, aged 31-88 years). Acarbose was used as the only antidiabetic drug in 34% of the patients, combined with sulphonylurea in 44%, combined with sulphonylurea and biguanide (metformine) in 19% and combined with metformine only in several cases (3%). During the observation, significant weight and BMI loss, 3% reduction average (for both parameters), was observed in the whole studied group. Fasting and 2 hours postprandial glycaemia was markedly improved in the whole studied population (26.8% and 28.1% glucose level reduction, respectively), and particularly in those who was initially qualified into the group of bad diabetes control (29.4% and 32.4% glucose level decrease, respectively). The most favourable effect on glycaemia was observed for acarbose monotherapy (p < 0.005) when compared to combined treatment). No difference was found in glycaemic response referred to the initial body mass index (BMI). Tested lipid parameters improved during 8-week observation: serum cholesterol level decreased by 4.6% in the whole studied population, and by 8.9% in the group of bad diabetes control, respectively. Value differences did not reach, however, presumed statistical significance (p < 0.005). Significant improvement was noted in triglyceride levels: reductions by 17.5% in the whole group and by as much as 26.8% in the sub-group of bad diabetes control (initial level 200 mg/dl). Acarbose observational study performed in the routine treatment conditions confirmed efficacy of the drug in diabetes mellitus, for both--carbohydrate and lipid metabolism. The study showed low significance of side effects and high acceptation of the treatment by the patients and the physicians.
阿卡波糖（拜糖平，拜耳公司生产）是肠道α-葡萄糖苷酶的竞争性抑制剂，其作用机制是抑制碳水化合物的消化。本研究旨在前瞻性观察阿卡波糖在普通医疗保健中糖尿病患者的使用方案及其疗效和安全性。该研究在波兰各地的普通医疗保健中心进行。共有200名医生参与，每位医生被要求对3名患者使用阿卡波糖的情况进行监督。患者总数为600人。要求医生在使用阿卡波糖之前以及治疗4周和8周后，按照提供的表格进行记录：访谈数据（包括糖尿病类型、病程、饮食情况、治疗情况，如磺脲类或双胍类衍生物的使用）；个人数据（年龄、身高、体重等）；空腹及餐后2小时血糖水平；糖尿情况；基本附加检查；基本血脂检查（总胆固醇、甘油三酯）；阿卡波糖使用的总体评分（副作用、停药情况、医生和患者对药物的意见）。空腹血糖是纳入分析的标准。480名患者（267名女性和213名男性，年龄31 - 88岁）获得了该参数的完整数据。34%的患者将阿卡波糖作为唯一的抗糖尿病药物使用，44%的患者与磺脲类药物联合使用，19%的患者与磺脲类药物和双胍类（二甲双胍）联合使用，仅有少数病例（3%）与二甲双胍单独联合使用。在观察期间，整个研究组观察到体重和体重指数（BMI）显著下降，平均下降3%（两个参数均如此）。整个研究人群的空腹和餐后2小时血糖均有明显改善（血糖水平分别降低26.8%和28.1%），特别是那些最初被判定为糖尿病控制不佳的患者（血糖水平分别降低29.4%和32.4%）。与联合治疗相比，阿卡波糖单药治疗对血糖的影响最为显著（p < 0.005）。在血糖反应方面，未发现与初始体重指数（BMI）存在差异。在为期8周的观察期间，所检测的血脂参数有所改善：整个研究人群的血清胆固醇水平下降了4.6%，糖尿病控制不佳组下降了8.9%。然而，这些数值差异未达到假定的统计学显著性（p < 0.005）。甘油三酯水平有显著改善：整个组降低了17.5%，糖尿病控制不佳亚组降低了高达26.8%（初始水平为200mg/dl）。在常规治疗条件下进行的阿卡波糖观察性研究证实了该药物在糖尿病治疗中对碳水化合物和脂质代谢均有效。该研究表明副作用的显著性较低，患者和医生对该治疗的接受度较高。
