聚乙二醇洛塞那肽注射液对2型糖尿病患者安全性和耐受性评价  

Safety and Tolerance of Continuously Administered PEX168 Injection for Type 2 Diabetic Patients

作　　者：李楠[1] 雍小兰[1] 王蓝天[1] 黄娟[1] 杜晓琳[1] 冯仕银[1] 

机构地区：[1]成都军区总医院临床药学科,四川成都610083

出　　处：《解放军药学学报》2016年第5期440-443,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的评价聚乙二醇洛塞那肽注射液连续给药14周对2型糖尿病患者的安全性、耐受性。方法采用多中心、双盲、随机、平行组对照的设计。将符合条件的63例2型糖尿病患者按照随机原则平均分为3个剂量组。100μg组每周皮下注射100μg剂量,连续给药14周;200μg及300μg组第1、2周皮下注射100μg剂量,第3周起皮下注射200μg或300μg剂量,连续给药12周。结果聚乙二醇洛塞那肽注射液100、200和300μg组的总体不良反应发生率分别为52.38%、61.90%、90.38%,呈明显剂量依赖性,其中300μg组的不良反应发生率显著高于100μg组（P〈0.05）。100-300μg剂量下胃肠道的不良反应发生率和严重程度也呈剂量依赖性递增趋势,并可随治疗时间的延长逐步减轻。结论聚乙二醇洛塞那肽注射液连续给药14周的安全性、耐受性良好。Objective To evaluate the safety and tolerance of polyethylene glycol loxenatide injection（ PEX168） for type 2 diabetic patients by continuous administration for 14 weeks. Methods 63 patients with type 2diabetes mellitus were enrolled in a randomized,double blind,multi-center,and parallel controlled study. The patients were randomized into three groups. The 100 μg group was administered with 100 μg PEX168 weekly given via subcutaneous injection for 14 consecutive weeks. The 200 and 300 μg groups were administered with 100 μg PEX168 given via subcutaneous injection for the first 2 weeks,followed by 200 or 300 μg PEX168 via subcutaneous injection for the next 12 weeks. Results The adverse reaction rates of 100,200 and 300 μg groups were 52. 38%,61. 90% and 90. 38% respectively. The adverse reaction rates gradually increased in a distinctively dose-dependent manner. The incidence of adverse reactions in 300 μg group was significantly higher than that in 100 μg group（ P 〈0. 0167）. The incidence and severity of gastrointestinal adverse reactions gradually increased in a dose-dependent manner. The adverse reactions were gradually reduced with the extension of treatment time. Conclusion Continuous administration of PEX168 injection for 14 weeks in type 2 diabetic patients exhibits good safety and tolerability.

关 键 词：聚乙二醇洛塞那肽 2型糖尿病 安全性 耐受性 

分 类 号：R969.4[医药卫生—药理学]