新型抗糖尿病药吸入式胰岛素制剂Afrezza  

Technosphere insulin:a novel inhaled antidiabetic drug

作　　者：梁瑶[1,2] 谢铮铮[1] 孙路路[1] 

机构地区：[1]首都医科大学附属北京世纪坛医院药剂科,北京100038 [2]北京大学药学院药事管理与临床药学系,北京100191

出　　处：《中国新药杂志》2015年第12期1321-1325,共5页Chinese Journal of New Drugs

摘　　要：新型吸入式胰岛素制剂(technosphere insulin,TI,商品名:Afrezza),是一种经肺部给药的速效人胰岛素,2014年6月27日美国FDA批准其上市用于改善1型和2型糖尿病患者的血糖控制。与注射型胰岛素相比,Afrezza能更好地模拟健康人体胰岛素分泌,改善餐后血糖控制。临床研究表明,Afrezza降低糖化血红蛋白(Hb A1c)的效果与速效胰岛素(RAA)无差异,但可显著减少低血糖、体重增加的风险。该药可引起咳嗽、支气管痉挛等呼吸系统不良反应,对肺功能的长期影响有待进一步评估。本文对Afrezza的制剂特点、药动学、临床有效性研究、安全性评价等做一综述。Technosphere insulin （TI） , with brand name of Afrezza, is a rapid acting human insulin deliv- ered by a pulmonary drug delivery system. It was approved by the U.S. Food and Drug Administration on 27th June, 2014. Compared with other SC insulin products, Afrezza can mimic normal physiological insulin release and improve postprandial blood glucose control. Clinical studies presented no difference in the ability to reduce HbAlc between Afrezza and rapid-acting insulin analogs but the former had lower risk of hypoglycemia and weight gain. Respiratory adverse effects such as cough, bronchospasm can be caused by Afrezza, however its effects on long term pulmonary function has to be further evaluated. This paper summarized the preparation properties, pharmacokinet- ics, clinical efficacy studies and safety assessments of Afrezza.

关 键 词：Afrezza 吸入胰岛素 抗糖尿病药 餐时血糖 

分 类 号：R979.9[医药卫生—药品]