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低血糖症:新定义和监管影响。

Hypoglycemia: New Definitions and Regulatory Implications.

出版信息

Diabetes Technol Ther. 2018 Jun;20(S2):S250-S253. doi: 10.1089/dia.2018.0113. Epub 2018 Jun 6.

DOI:10.1089/dia.2018.0113
PMID:29873525
Abstract

Hypoglycemia is the limiting factor in controlling glucose levels in Diabetes. Rather than being a side effect, hypoglycemia is the mechanism of action for insulin therapy, with a very narrow therapeutic window. Until recently, regulatory bodies listed hypoglycemia only as an adverse effect of therapy; however, one insulin preparation is now recognized and labelled as reducing the risk of severe hypoglycemia. This paper describes internationally agreed upon definitions for hypoglycemia and proposed regulatory approaches for recognition and labeling of diabetes therapies to facilitate personalized care.

摘要

低血糖是控制糖尿病患者血糖水平的限制因素。低血糖不是一种副作用,而是胰岛素治疗的作用机制,其治疗窗非常狭窄。直到最近,监管机构仅将低血糖列为治疗的不良反应;然而,现在有一种胰岛素制剂被认为可以降低严重低血糖的风险。本文描述了国际上认可的低血糖定义,并提出了用于识别和标记糖尿病治疗方法的监管方法,以促进个性化护理。

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