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新型德谷胰岛素/门冬胰岛素复方制剂在 1 型糖尿病儿童和青少年患者中的疗效:在控制不佳和不依从患者中应用 IDegAsp 治疗 1 年的真实经验。

Efficacy of the Novel Degludec/Aspart Insulin Co-formulation in Children and Adolescents with Type 1 Diabetes: A Real-life Experience with One Year of IDegAsp Therapy in Poorly Controlled and Non-compliant Patients.

机构信息

Marmara University Faculty of Medicine, Department of Pediatric Endocrinology, İstanbul, Turkey

出版信息

J Clin Res Pediatr Endocrinol. 2022 Mar 3;14(1):10-16. doi: 10.4274/jcrpe.galenos.2021.2021.0113. Epub 2021 Aug 6.

DOI:10.4274/jcrpe.galenos.2021.2021.0113
PMID:34355879
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8900081/
Abstract

OBJECTIVE

To evaluate the efficacy of degludec/aspart (IDegAsp) insulin co-formulation in children and adolescents with poorly controlled type 1 diabetes (T1DM).

METHODS

Patients with poorly controlled T1DM on basal-bolus insulin regimes and having compliance problems related to insulin injections were switched to IDegAsp and were included. Data on hemoglobin A1c (HbA1c) levels, hypoglycemic episodes, frequency of diabetic ketoacidosis (DKA) and insulin doses were recorded at baseline and after one year of IDegAsp treatment.

RESULTS

Fifty patients (22 girls; 44%) were started on IDegAsp. The mean±standard deviation (range) age and duration of diabetes were 12.9±3.4 (4-18) and 5.2±3.1 (1.0-13.7) years, respectively. At the end of one year, 38 patients were still on IDegAsp, whereas 12 patients had opted to resume their original treatments. In those who continued on IDegAsp, HbA1c levels did not change, but the number of self-reported mild-moderate hypoglycemic episodes decreased significantly (p<0.05). In the year before switching to IDegAsp, 11 DKA attacks in 9 patients were observed, whereas this decreased to 4 DKA attacks in 4 patients after one year of IDegAsp therapy (p=0.06).

CONCLUSION

IDegAsp regimen may improve clinical management in poorly controlled basal-bolus insulin regimen T1DM patients who have frequent hypoglycemia and DKA attacks, as well as in those with poor compliance with multiple injections. Although a simplified basal-bolus IDegAsp regimen is an attractive option for patients with T1DM, some may not adapt to this treatment due to the fixed IAsp dose of IDegAsp.

摘要

目的

评估德谷胰岛素/门冬胰岛素(IDegAsp)联合制剂在血糖控制不佳的 1 型糖尿病(T1DM)患儿和青少年中的疗效。

方法

对接受基础-餐时胰岛素方案治疗但血糖控制仍不佳且存在与胰岛素注射相关的依从性问题的 T1DM 患者,转换为使用 IDegAsp 治疗,并记录其基线时和使用 IDegAsp 治疗 1 年后的糖化血红蛋白(HbA1c)水平、低血糖发作、糖尿病酮症酸中毒(DKA)发作频率和胰岛素剂量等数据。

结果

共有 50 例(22 例女性;44%)患者开始使用 IDegAsp。患者的平均(±标准差[范围])年龄和糖尿病病程分别为 12.9±3.4(4-18)岁和 5.2±3.1(1.0-13.7)年。在治疗 1 年后,38 例患者仍在继续使用 IDegAsp,而 12 例患者选择恢复原治疗方案。在继续使用 IDegAsp 的患者中,HbA1c 水平没有变化,但自我报告的轻度-中度低血糖发作次数明显减少(p<0.05)。在转换为 IDegAsp 之前的 1 年中,9 例患者共发生 11 次 DKA 发作,而在使用 IDegAsp 治疗 1 年后,4 例患者仅发生 4 次 DKA 发作(p=0.06)。

结论

对于低血糖发作和 DKA 发作频繁且多次注射依从性差的血糖控制不佳的基础-餐时胰岛素方案治疗的 T1DM 患者,以及对简化的基础-餐时 IDegAsp 方案治疗有吸引力的 T1DM 患者,IDegAsp 方案可能会改善其临床管理。然而,由于 IDegAsp 中门冬胰岛素的剂量固定,部分患者可能无法适应这种治疗。

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Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10.
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Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: A randomized trial.胰岛素德谷胰岛素/门冬胰岛素固定复方在 1 型糖尿病儿童和青少年中的疗效和安全性:一项随机试验。
Pediatr Diabetes. 2018 Nov;19(7):1263-1270. doi: 10.1111/pedi.12724. Epub 2018 Aug 16.
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Diabetes Control and Adherence in Adolescence.
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