Department M3/Internal Medicine IV, University of Medicine, Pharmacy, Science and Technology of Târgu Mureş, Târgu Mureş, Romania.
Diabetes, Nutrition and Metabolic Diseases Outpatient Unit, Emergency County Clinical Hospital, Târgu Mureş, Romania; and.
Am J Ther. 2020 Jan/Feb;27(1):e121-e132. doi: 10.1097/MJT.0000000000001076.
Insufficient insulin secretion is a core pathogenetic mechanism of diabetes mellitus and therefore, insulin therapy remains the cornerstone of management. Over the past 100 years, much progress has been made in the development of insulin therapy, including elaboration of novel insulin formulations and delivery methods.
Despite significant advances, there are still many barriers, challenges, and uncertainties involving insulin therapy. With newer pharmacological and technological approaches, there are many potential drawbacks to be addressed, such as immunogenicity, biocompatibility, degradation/clearance of delivery materials, stability, precision of dosing, reproducibility, predictability of performance, and safety over time, etc. In addition, the new formulations/delivery systems should be cost-effective and accessible.
A literature search of original and review articles, editorials, and meta-analyses in Medline/PubMed and Google Scholar has been performed. ClinicalTrials.gov website was searched for ongoing relevant clinical trials.
New insulin formulations (ultralong basal and ultrarapid analogues) were designed to obtain a prolonged, flatter profile, with less hypoglycemia and improvement of postprandial glucose control, respectively. The next generation of insulin therapy is probably best represented by the "smart" (glucose-responsive) insulins, which deliver it according to an endogenous glucose-sensing feedback mechanism. Another area of continuous advances includes insulin delivery systems with new jet injectors, smart pens, patch pumps, and other needle-free devices for subcutaneous administrations. Many alternative routes of insulin delivery (pulmonary, nasal, buccal, oral, and transdermal) have also been explored, with some reaching clinical use. The digitalization of diabetes care has made considerable progress in the past several years and will most probably make even more so in the near future.
The improved insulin formulations, newer delivery methods/routes, and digital technologies are rapidly becoming effective and have great potential to improve metabolic control as well as other outcomes, including quality of life of persons living with diabetes mellitus.
胰岛素分泌不足是糖尿病的核心发病机制,因此胰岛素治疗仍然是治疗的基石。在过去的 100 年里,胰岛素治疗在发展方面取得了很大进展,包括新型胰岛素制剂和给药方法的阐述。
尽管取得了重大进展,但胰岛素治疗仍存在许多障碍、挑战和不确定性。随着新的药理学和技术方法的出现,许多潜在的缺点需要解决,例如免疫原性、生物相容性、给药材料的降解/清除、稳定性、剂量精度、重现性、性能可预测性以及随着时间的推移的安全性等。此外,新的制剂/给药系统应该具有成本效益和可及性。
对 Medline/PubMed 和 Google Scholar 中的原始和综述文章、社论和荟萃分析进行了文献检索。在 ClinicalTrials.gov 网站上搜索了正在进行的相关临床试验。
新的胰岛素制剂(超长效基础和超快速类似物)旨在获得更持久、更平坦的曲线,分别减少低血糖和改善餐后血糖控制。下一代胰岛素治疗可能最好由“智能”(葡萄糖反应)胰岛素代表,根据内源性葡萄糖感应反馈机制输送胰岛素。胰岛素给药系统的另一个不断发展的领域包括新的喷射注射器、智能笔、贴片泵和其他用于皮下给药的无针装置。许多替代胰岛素给药途径(肺部、鼻腔、口腔、经皮和经皮)也已被探索,其中一些已达到临床应用。过去几年,糖尿病护理的数字化取得了相当大的进展,在不久的将来很可能会取得更大的进展。
改良的胰岛素制剂、更新的给药方法/途径和数字技术正在迅速变得有效,并具有极大的潜力改善代谢控制以及其他结果,包括糖尿病患者的生活质量。