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吸入型人胰岛素(依克苏泌):临床概况与患者考量

Inhaled human insulin (Exubera): clinical profile and patient considerations.

作者信息

Barnett Anthony H, Bellary Sri

机构信息

University of Birmingham and Heart of England National Health Service Foundation Trust (Teaching), Birmingham, UK.

出版信息

Vasc Health Risk Manag. 2007;3(1):83-91.

PMID:17583178
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1994047/
Abstract

Inhaled human insulin (Exubera) is a rapid-acting regular human insulin administered by oral inhalation before meals. It provides a non-invasive alternative to multiple subcutaneous injections for the treatment of hyperglycemia in adult patients with type 1 and type 2 diabetes. Compared with subcutaneous rapid-acting insulin analogs, Exubera provides equivalent HbA1c control. As a monotherapy or in combination with oral agents, Exubera also provides greater glycemic control than oral agents alone, at least in patients with high levels of HbA1c. Exubera demonstrates improved patient satisfaction compared with subcutaneous insulin or oral agents alone. When offered as a treatment option together with standard treatments in uncontrolled patients naive to insulin, Exubera increases acceptance of insulin therapy three-fold compared with patients offered standard regimens only. Exubera is well tolerated in comparison to subcutaneous insulin, with a similar incidence of mild to moderate hypoglycemia. Although cough is a common adverse effect early in therapy, this leads to treatment discontinuations in less than 1% of patients. Despite an increased incidence of insulin antibodies compared with subcutaneous administration, and a consistent but minor impact on pulmonary function, long-term safety data of up to 4 years continue to support the safety profile of Exubera.

摘要

吸入型人胰岛素(依克那肽)是一种速效常规人胰岛素,于餐前通过口腔吸入给药。它为1型和2型糖尿病成年患者治疗高血糖提供了一种非侵入性的替代多次皮下注射的方法。与皮下注射速效胰岛素类似物相比,依克那肽能使糖化血红蛋白(HbA1c)得到同等程度的控制。作为单一疗法或与口服药物联合使用时,依克那肽在控制血糖方面也比单独使用口服药物效果更好,至少在HbA1c水平较高的患者中如此。与单独使用皮下胰岛素或口服药物相比,依克那肽能提高患者满意度。当作为一种治疗选择与胰岛素初治的未控制患者的标准治疗一起提供时,与仅接受标准治疗方案的患者相比,依克那肽能使胰岛素治疗的接受度提高三倍。与皮下胰岛素相比,依克那肽耐受性良好,轻度至中度低血糖的发生率相似。尽管咳嗽是治疗早期常见的不良反应,但导致不到1%的患者停药。尽管与皮下给药相比,胰岛素抗体的发生率有所增加,且对肺功能有持续但轻微的影响,但长达4年的长期安全性数据仍支持依克那肽的安全性。

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本文引用的文献

1
Evaluation of risk factors for development of complications in Type II diabetes in Europe.评估欧洲 2 型糖尿病并发症发展的风险因素。
Diabetologia. 2002 Jul;45(Suppl 1):S23-S28. doi: 10.1007/s00125-002-0863-0.
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An open, randomized, parallel-group study to compare the efficacy and safety profile of inhaled human insulin (Exubera) with glibenclamide as adjunctive therapy in patients with type 2 diabetes poorly controlled on metformin.一项开放、随机、平行组研究,旨在比较吸入型人胰岛素(依克那肽)与格列本脲作为辅助治疗对二甲双胍治疗效果不佳的2型糖尿病患者的疗效和安全性。
Diabetes Care. 2006 Aug;29(8):1818-25. doi: 10.2337/dc05-1880.
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An open, randomized, parallel-group study to compare the efficacy and safety profile of inhaled human insulin (Exubera) with metformin as adjunctive therapy in patients with type 2 diabetes poorly controlled on a sulfonylurea.
一项开放、随机、平行组研究,比较吸入型人胰岛素(依克苏泌)与二甲双胍作为辅助治疗药物,对使用磺脲类药物血糖控制不佳的2型糖尿病患者的疗效和安全性。
Diabetes Care. 2006 Jun;29(6):1282-7. doi: 10.2337/dc05-1879.
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Postprandial glucose regulation: new data and new implications.餐后血糖调节:新数据与新启示
Clin Ther. 2005;27 Suppl B:S42-56. doi: 10.1016/j.clinthera.2005.11.020.
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The effect of smoking cessation and subsequent resumption on absorption of inhaled insulin.戒烟及随后恢复吸烟对吸入性胰岛素吸收的影响。
Diabetes Care. 2006 Feb;29(2):277-82. doi: 10.2337/diacare.29.02.06.dc05-1913.
6
Improving glucose management: ten steps to get more patients with type 2 diabetes to glycaemic goal.改善血糖管理:让更多2型糖尿病患者实现血糖目标的十个步骤。
Int J Clin Pract. 2005 Nov;59(11):1345-55. doi: 10.1111/j.1742-1241.2005.00674.x.
7
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.
8
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.
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Risking health to avoid injections: preferences of Canadians with type 2 diabetes.为避免注射而危及健康:2型糖尿病加拿大患者的偏好
Diabetes Care. 2005 Sep;28(9):2243-5. doi: 10.2337/diacare.28.9.2243.
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.