长效胰岛素类似物的安全性回顾:从成人2型糖尿病到妊娠期高血糖  

Retrospective Insight on Safety of Long-acting Insulin Analogues:from Adult Type 2 Diabetes to Gestational Hyperglycemia

作　　者：吴红花[1] WU Honghua(Peking University First Hospital,Beijing 100034,China)

机构地区：[1]北京大学第一医院,北京100034

出　　处：《药品评价》2023年第8期911-915,共5页Drug Evaluation

摘　　要：长效胰岛素类似物进入中国市场已有20年,临床应用中得到普遍认可且积累了长足的经验。以德谷胰岛素和甘精胰岛素U300为代表的新型超长效胰岛素也先后进入中国市场,在起效时间、峰值时间、作用持续时间上,更接近生理性基础胰岛素分泌模式,变异性更低,低血糖风险更小,安全性更高。EXPECT研究证实了德谷胰岛素妊娠期应用的疗效和安全性,最新版说明书已做出修订,指出“如果临床需要,可以考虑在妊娠期间使用德谷胰岛素进行治疗”。因此,本文将从临床研究、指南角度,对比分析四种长效胰岛素类似物的特点,解析德谷胰岛素与多个长效胰岛素类似物在临床应用的安全性,尤其是妊娠期高血糖使用德谷胰岛素的安全性。Long-acting insulin analogues have entered the Chinese market to treat diabetes for two decades,and its clinical efficacy and safety in adults deserve affirmation.Degludec insulin and glargine U300,the ultra-long-acting insulins analogue,are more closely resembles physiological insulin secretion in the timing of onset,peak,and duration of action,which resulted in lower variability and lower risk of hypoglycemia and improved safety.The efficacy and safety of the use of insulin during pregnancy have been verified in the EXPECT study,and the latest version of the manual has been revised to state that"if clinically necessary,the use of insulin during pregnancy can be considered."Therefore,this article will compare and analyze the characteristics of four long-acting insulin analogues from the perspective of clinical studies and guidelines,and analyze the safety comparison between degludec insulin and multiple long-acting insulin analogues in clinical application,especially the safety of degludec insulin used for Gestational hyperglycemia.

关 键 词：胰岛素 长效 妊娠期高血糖 糖尿病 2型 德谷胰岛素 长效胰岛素类似物 

分 类 号：R587.1[医药卫生—内分泌]