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用于糖尿病患者的肺部胰岛素给药系统(艾可拓)的演变。

Evolution of a pulmonary insulin delivery system (Exubera) for patients with diabetes.

作者信息

Hollander Priscilla A

机构信息

Baylor University Medical Center, Endocrinology Center, Dallas, Texas, USA.

出版信息

MedGenMed. 2007 Mar 5;9(1):45.

PMID:17435648
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1925008/
Abstract

Many patients with diabetes fail to meet recommended glycemic goals regardless of the recognition of optimal glycemic control as a key component for improving clinical outcomes and quality of life in patients with diabetes. Patient- and physician-related barriers to the adoption of insulin therapy include fear and anxiety about injecting insulin, concerns about side effects, and personal health beliefs in regard to the use of insulin. There is an unmet need for an alternative insulin therapy that provides optimal glycemic control, is well tolerated, and improves patient adherence. Of the several inhaled insulin devices that are in various stages of development, the Exubera (INH) formulation is the first to be approved for use in the United States and in Europe. Exubera is a novel, rapid-acting inhaled human insulin formulation that has been developed for prandial insulin use. Clinical studies have shown that INH consistently improves glycemic control, in combination with longer-acting subcutaneous (SC) insulin regimens in patients with type 1 or type 2 diabetes, or is used to supplement or replace oral antidiabetic therapy in patients with type 2 diabetes. INH has demonstrated long-term safety and tolerability, with a risk for hypoglycemia similar to that of SC insulin, and no clinically meaningful changes in pulmonary function have been noted with its use. Patients treated with INH in clinical studies reported high levels of satisfaction with treatment, and many patients with diabetes choose inhaled insulin when it is offered as a treatment option. Taken together, these findings suggest that INH represents an important new development in the treatment of diabetes that may improve glycemic control in many patients with diabetes.

摘要

许多糖尿病患者未能达到推荐的血糖目标,尽管人们认识到最佳血糖控制是改善糖尿病患者临床结局和生活质量的关键组成部分。患者和医生方面与采用胰岛素治疗相关的障碍包括对注射胰岛素的恐惧和焦虑、对副作用的担忧以及关于胰岛素使用的个人健康观念。对于一种能提供最佳血糖控制、耐受性良好且能提高患者依从性的替代胰岛素疗法存在未满足的需求。在处于不同研发阶段的几种吸入式胰岛素装置中,Exubera(INH)制剂是首个在美国和欧洲获批使用的。Exubera是一种新型速效吸入式人胰岛素制剂,已被开发用于餐时胰岛素使用。临床研究表明,在1型或2型糖尿病患者中,INH与长效皮下(SC)胰岛素方案联合使用时能持续改善血糖控制,或者在2型糖尿病患者中用于补充或替代口服抗糖尿病治疗。INH已证明具有长期安全性和耐受性,低血糖风险与SC胰岛素相似,使用时未观察到肺功能有临床意义的变化。在临床研究中接受INH治疗的患者对治疗的满意度较高,并且当吸入式胰岛素作为一种治疗选择提供时,许多糖尿病患者会选择它。综上所述,这些发现表明INH代表了糖尿病治疗中的一项重要新进展,可能改善许多糖尿病患者的血糖控制。

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Evolution of a pulmonary insulin delivery system (Exubera) for patients with diabetes.用于糖尿病患者的肺部胰岛素给药系统(艾可拓)的演变。
MedGenMed. 2007 Mar 5;9(1):45.
2
Evaluation of inhaled insulin therapy for diabetes mellitus.吸入性胰岛素治疗糖尿病的评估。
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Inhaled insulin delivery--where are we now?吸入式胰岛素给药——我们目前处于什么阶段?
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Awake intranasal insulin delivery modifies protein complexes and alters memory, anxiety, and olfactory behaviors.清醒状态下经鼻给予胰岛素可改变蛋白质复合物,并影响记忆、焦虑和嗅觉行为。
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本文引用的文献

1
Exubera(®) (inhaled insulin): an evidence-based review of its effectiveness in the management of diabetes.艾可拓(®)(吸入式胰岛素):关于其在糖尿病管理中有效性的循证综述
Core Evid. 2005;1(2):89-101. Epub 2005 Jun 30.
2
Efficacy and safety of preprandial human insulin inhalation powder versus injectable insulin in patients with type 1 diabetes.1型糖尿病患者中餐前吸入型人胰岛素粉剂与注射用胰岛素的疗效及安全性比较
Diabetologia. 2006 May;49(5):891-9. doi: 10.1007/s00125-006-0161-3. Epub 2006 Feb 28.
3
Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study.患者及医疗服务提供者对胰岛素治疗的抗拒:跨国糖尿病态度、愿望与需求(DAWN)研究结果
Diabetes Care. 2005 Nov;28(11):2673-9. doi: 10.2337/diacare.28.11.2673.
4
Inhaled insulin improves glycemic control when substituted for or added to oral combination therapy in type 2 diabetes: a randomized, controlled trial.吸入胰岛素替代口服联合治疗或添加到口服联合治疗中时可改善2型糖尿病患者的血糖控制:一项随机对照试验。
Ann Intern Med. 2005 Oct 18;143(8):549-58. doi: 10.7326/0003-4819-143-8-200510180-00005.
5
Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem.2型糖尿病患者的心理性胰岛素抵抗:问题的范围
Diabetes Care. 2005 Oct;28(10):2543-5. doi: 10.2337/diacare.28.10.2543.
6
Dose response of inhaled dry-powder insulin and dose equivalence to subcutaneous insulin lispro.吸入型干粉胰岛素的剂量反应及与皮下注射赖脯胰岛素的剂量等效性。
Diabetes Care. 2005 Oct;28(10):2400-5. doi: 10.2337/diacare.28.10.2400.
7
The effect of insulin antibodies on the metabolic action of inhaled and subcutaneous insulin: a prospective randomized pharmacodynamic study.胰岛素抗体对吸入和皮下注射胰岛素代谢作用的影响:一项前瞻性随机药效学研究。
Diabetes Care. 2005 Sep;28(9):2161-9. doi: 10.2337/diacare.28.9.2161.
8
Efficacy of inhaled insulin in patients with type 2 diabetes not controlled with diet and exercise: a 12-week, randomized, comparative trial.
Diabetes Care. 2005 Aug;28(8):1922-8. doi: 10.2337/diacare.28.8.1922.
9
Impact of improved glycemic control on quality of life in patients with diabetes.
Endocr Pract. 2004 Nov-Dec;10(6):502-8. doi: 10.4158/EP.10.6.502.
10
Use of inhaled insulin in a basal/bolus insulin regimen in type 1 diabetic subjects: a 6-month, randomized, comparative trial.1型糖尿病患者在基础/餐时胰岛素治疗方案中使用吸入胰岛素:一项为期6个月的随机对照试验。
Diabetes Care. 2005 Jul;28(7):1630-5. doi: 10.2337/diacare.28.7.1630.