吸入胰岛素粉雾剂Afrezza:新型抗糖尿病药  

Insulin human inhalation powder Afrezza: A new antidiabetic drug

作　　者：何光杰[1] 李宏[2] 李静[1] 韩英 马红霞 HE Guang-jie LI Hong LI jing HAN Ying MA Hong-xia(Tianjin Pharmceutical Group Co., Ltd., 300171, China Marketing Department, Tianjin Biochemical Pharmaceutical Co., Ltd., Tianjin 300308, China Tianjin Kinovata Pharmceutical Co., Ltd., 300400, China)

机构地区：[1]天津药业集团有限公司,天津300171 [2]天津生物化学制药有限公司销售部,天津300308 [3]天津信诺制药有限公司,天津300400

出　　处：《药物评价研究》2016年第5期899-908,共10页Drug Evaluation Research

摘　　要：人胰岛素Afrezza粉雾剂是由Mann Kind公司研发上市的速效吸入型胰岛素,即Technosphere胰岛素(TI),是药物和第二代吸入器的组合产品。人胰岛素粉雾剂是一种有效及耐受良好的降糖药物,用于1型糖尿病(T1DM)和2型糖尿病(T2DM)患者餐前给药降糖,提供了一种解决胰岛素初始治疗时诸如注射恐惧症、担忧体质量增加和低血糖风险的替代疗法。吸入TI的降糖疗效虽然低于皮下注射,但是低血糖和体质量增加的发生率更低,其长期疗效和安全性需要进一步深入研究。探讨了吸入TI粉雾剂的原理、药理作用、治疗T1DM和T2DM的临床疗效、安全性和耐受性等内容。Afrezza（human insulin） inhalation powder developed by Mann Kind Corporation is a drug and device combination product consisting of Technosphere insulin（TI） and an oral inhaler device（the Gen2 inhaler）. Inhaled TI is an effective and generally well-tolerated agent for the prandial treatment of hyperglycaemia in T1 DM and T2 DM patients and may provide a solution to insulin initiation barriers such as injection phobia, which concerns of bodyweight gain and hypoglycaemia. Glycaemic efficacy of TI is lower than that of sc insulin, but inhaled insulin has a lower risk of severe hypoglycaemia and weight gain. Long-term outcomes and safety with TI should be further investigated. This review discusses the rationale for pulmonary delivery of insulin, pharmacological, efficacy, safety, and tolerability data relevant to the use of TI in T1 DM and T2 DM.

关 键 词：Afrezza 吸入胰岛素 糖尿病 药动学 临床试验 有效性 安全性 

分 类 号：R977.15[医药卫生—药品]