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地特胰岛素:治疗严重低血糖的有效药物。

Dasiglucagon: an effective medicine for severe hypoglycemia.

机构信息

College of Pharmacy, University of South China, No. 28, Changsheng West Road, Zhengxiang District 421001, Hengyang, Hunan, China.

出版信息

Eur J Clin Pharmacol. 2021 Dec;77(12):1783-1790. doi: 10.1007/s00228-021-03183-0. Epub 2021 Jul 5.

Abstract

PURPOSE

Patients with type 1 diabetes mellitus (T1DM) receiving insulin therapy commonly suffer from insulin-mediated hypoglycemia and require glucagon for glycemic control to achieve normal plasma glucose (PG) levels. Severe hypoglycemia will endanger the life of patients and require intervention. Stable glucagon analog dasiglucagon was approved for the treatment of patients with severe hypoglycemia and is administered via Zegalogue autoinjector/Zegalogue prefilled syringe. The main purpose of this review article is to review the basic properties and clinical effects of dasiglucagon.

METHOD

We search related literature on CNKI, Web of Science and PubMed by keywords dasiglucagon, hypoglycemia, type 1 diabetes, glucagon. Carry out a careful review of the included literature. Dasiglucagon information on clinicaltrials.gov and https://www.fda.gov/ has been adopted.

RESULTS AND CONCLUSION

Dasiglucagon is a novel peptide analog of human glucagon, which can effectively rescue insulin-induced severe hypoglycemia in patients with T1DM and rapidly increase glycemic levels in a small dose under normal and hypoglycemic conditions. It has been proven that dasiglucagon has definite stability and solubility in aqueous formulations. Dasiglucagon has a higher absorption rate and longer plasma elimination half-life than traditional reconstituted glucagon. In three randomized, double-blind, placebo-controlled trials in children aged 6 to 17 years and adults with T1DM the median time to glycemic recovery in 10 min after dasiglucagon administration was significantly faster than placebo and 99% of patients recovered within 15 min after subcutaneous injection of dasiglucagon in the key phase 3 clinical trial. The most common adverse reactions in these phase 3 trials were vomiting, nausea, diarrhea, headache, and injection site pain.

摘要

目的

接受胰岛素治疗的 1 型糖尿病(T1DM)患者常发生胰岛素介导的低血糖,并需要胰高血糖素来控制血糖以达到正常的血浆葡萄糖(PG)水平。严重低血糖会危及患者生命,需要进行干预。稳定的胰高血糖素类似物地特胰岛素获批用于治疗严重低血糖,通过 Zegalogue 自动注射器/预填充注射器给药。本文主要综述地特胰岛素的基本特性和临床疗效。

方法

检索中国知网、Web of Science 和 PubMed 数据库中关于地特胰岛素、低血糖、1 型糖尿病、胰高血糖素的相关文献,关键词为 dasiglucagon、hypoglycemia、type 1 diabetes、glucagon。对纳入文献进行仔细评价。采用临床研究.gov 和 https://www.fda.gov/ 上的地特胰岛素信息。

结果与结论

地特胰岛素是一种新型人胰高血糖素肽类似物,可有效挽救 T1DM 患者因胰岛素导致的严重低血糖,并可在正常和低血糖条件下小剂量快速升高血糖水平。已证实地特胰岛素在水性制剂中具有确切的稳定性和溶解性。地特胰岛素的吸收率高于传统重组胰高血糖素,其血浆消除半衰期长于传统重组胰高血糖素。在 3 项针对 6-17 岁儿童和 T1DM 成人的随机、双盲、安慰剂对照试验中,地特胰岛素给药后 10 min 血糖恢复的中位数时间明显快于安慰剂,在关键的 3 期临床试验中,99%的患者在皮下注射地特胰岛素后 15 min 内恢复血糖。这些 3 期试验中最常见的不良反应为呕吐、恶心、腹泻、头痛和注射部位疼痛。

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