艾塞那肽在非糖尿病肥胖人群中应用的安全性

The Safety of Exenatide Administered in Non-diabetic Obese Population

目的:探讨艾塞那肽在非糖尿病肥胖受试者中应用的安全性。方法:以非糖尿病肥胖自愿者为研究对象,年龄>18岁,体质指数(BMI)>25 kg/m2,腰围男>90 cm,女>85 cm。测定基线及应用艾塞那肽7 d后的空腹与早餐后2 h血浆血糖,行72 h动态血糖监测,每日8点指尖血糖监测。结果:29例受试者均完成临床观察。基线与艾塞那肽应用后,空腹血糖为(5.2±0.3)mmol/L与(4.7±0.3)mmol/L(P<0.01),早餐后2 h血糖为(6.2±1.1)mmol/L与(5.9±1.0)mmol/L(P>0.05),体重为(80.6±7.6)kg与(79.5±7.7)kg(P<0.01);72 h连续动态血糖监测血糖低值3.1 mmol/L,血糖高值8.7 mmol/L。最常见不良事件为轻度或中度消化道症状,其中9例出现恶心、3例呕吐、2例腹胀,另有3例头晕,无严重低血糖事件发生。结论:艾塞那肽短期应用于非糖尿病肥胖人群低血糖风险小,主要不良事件为轻中度消化道症状。

Objective： To investigate the initial safety of exenatide administered in Non-diabetic obese population. Methods： Non-diabetic obese volunteers, 〉18 years old, BMI〉25 kg/m^2, waistline （male〉90 cm and female〉85 cm）. Baseline and 7 days after application of exenatide, fasting plasma glucose, 2 h postprandial plasma glucose, and 72 h dynamic blood glucose were measured. Results： 29 Cases completed the clinical observation. Baseline and after application of exenatide, the fasting plasma glucose were （5.2± 0.3） mmol/L and （4.7± 0.3） mmol/L （P〈0.01）. The 2 h plasma glucose were （6.2± 1.1） mmol/L and （5.9±1.0） mmol/L （P〉0.05）. The body weight were （80.64± 7.6） kg and （79.5± 7.7） kg （P〈0.01）. The 72 h dynamic blood glucose monitoring shows the low-value was 3.1 mmol/L and the high-value was 8.7 mmol/L. The most frequent adverse events was mild or moderate alimentary symptoms, nausea 9 cases, vomiting 3 cases and abdominal distension 2 cases. Other adverse event was dizziness （3 cases）. No hypoglycemia event. Conclusions： Exenatide short-term applied to non-diabetic obese population hasn＇t the risk of hypoglycemia, mild to moderate alimentary symptoms is the main adverse events.