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【文摘发布】AIR吸入型胰岛素在慢性阻塞性肺病
DOI: 10.2337/dc06-2284
TITLE: AIR® Inhaled Insulin in Subjects with Chronic Obstructive Pulmonary Disease: Pharmacokinetics, Glucodynamics, Safety, and Tolerability
AUTHOR: Klaus Rave, MD, Amparo de la Peña, PhD, Fabián S. Tibaldi, PhD, Liping Zhang, PhD, Bernard Silverman, MD, Michaela Hausmann, MD, Lutz Heinemann, PhD and Douglas B. Muchmore, MD
ABSTRACT
OBJECTIVE---: In this open-label, randomized, crossover study, pharmacokinetic and glucodynamic responses were compared in healthy subjects versus subjects with moderate COPD, following administration of 12 units-equivalent AIR® Inhaled Insulin versus 12 units subcutaneous (SC) insulin lispro.
RESEARCH DESIGN AND METHODS---: Three nonsmoking groups (n=15 each)---healthy subjects (baseline mean ± SD: aged 38±13 years, FEV1 4.06±1.04 L), subjects with chronic bronchitis (aged 53±9 years, FEV1 2.14±0.60 L), and subjects with pulmonary emphysema (aged 58±6 years, FEV1 1.67±0.61 L)---were randomly assigned to one of three treatment sequences. Three euglycemic glucose clamp procedures were performed.
RESULTS---: In subjects with chronic bronchitis and emphysema, AIR Inhaled Insulin administration resulted in reduced insulin exposure (AUC0-t') (55.7%, P = 0.13 and 78.5%, P < 0.001, respectively) and reduced total insulin effect (GIRtot) (60.4%, P < 0.01 and 67.1%, P < 0.01, respectively) relative to healthy subjects. SC insulin lispro administration resulted in similar responses across study groups for insulin exposure and metabolic effect. Intra-subject pharmacokinetic and glucodynamic variability ranged from 17--52% across groups. No significant differences were shown for pre- and post-clamp pulmonary function tests. During clamps, FEV1 and FVC declined modestly in both COPD groups with no difference between AIR Insulin and SC insulin lispro.
CONCLUSIONS---: Short-time exposure with AIR Inhaled Insulin was well tolerated by COPD subjects, showing similar time-exposure and time-action profiles, but with reduced insulin absorption and metabolic effect compared with healthy subjects. Further clinical evaluation is warranted in patients with comorbid diabetes and COPD. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 RESOURCE: Diabetes Care Publish Ahead of Print published online ahead of print April 24, 2007
来源：Diabetes Care Publish Ahead of Print published online ahead of print April 24, 2007
DOI: 10.2337/dc06-2284
AUTHOR: Klaus Rave, MD, Amparo de la Peña, PhD, Fabián S. Tibaldi, PhD, Liping Zhang, PhD, Bernard Silverman, MD, Michaela Hausmann, MD, Lutz Heinemann, PhD and Douglas B. Muchmore, MD
TITLE: AIR® Inhaled Insulin in Subjects with Chronic Obstructive Pulmonary Disease: Pharmacokinetics, Glucodynamics, Safety, and Tolerability
题目：AIR®吸入胰岛素在慢性阻塞性肺病患者中的应用：药物代谢动力学，血糖效应，安全性和耐受性
作者：Klaus Rave, MD, Amparo de la Peña, PhD, Fabián S. Tibaldi, PhD, Liping Zhang, PhD, Bernard Silverman, MD, Michaela Hausmann, MD, Lutz Heinemann, PhD and Douglas B. Muchmore, MD
ABSTRACT
摘要
OBJECTIVE: In this open-label, randomized, crossover study, pharmacokinetic and glucodynamic responses were compared in healthy subjects versus subjects with moderate COPD, following administration of 12 units-equivalent AIR® Inhaled Insulin versus 12 units subcutaneous (SC) insulin lispro.
目的：在这项开放，随机和交叉研究中，对健康受试者与中度慢性阻塞性肺病患者交叉服用相当12单位AIR®吸入胰岛素和12单位皮下注射insulin lispro后的药物代谢动力学和血糖效应进行研究。
RESEARCH DESIGN AND METHODS: Three nonsmoking groups (n=15 each)---healthy subjects (baseline mean ± SD: aged 38±13 years, FEV1 4.06±1.04 L), subjects with chronic bronchitis (aged 53±9 years, FEV1 2.14±0.60 L), and subjects with pulmonary emphysema (aged 58±6 years, FEV1 1.67±0.61 L)---were randomly assigned to one of three treatment sequences. Three euglycemic glucose clamp procedures were performed.
研究设计与方法：研究可分为三个实验组（每组15名，均为不吸烟受试者）-----健康受试者：年龄38±13岁，FEV1 (Forced Expiratory Volume in the first second) 4.06±1.04 L；慢性支气管炎患者：年龄53±9岁，FEV1 2.14±0.60 L；肺气肿患者：年龄58±6 岁，FEV1 1.67±0.61 L。每组随机使用三种治疗顺序中的一种。在试验过程中应用了正常葡萄糖钳夹技术。
RESULTS: In subjects with chronic bronchitis and emphysema, AIR Inhaled Insulin administration resulted in reduced insulin exposure (AUC0-t') (55.7%, P = 0.13 and 78.5%, P < 0.001, respectively) and reduced total insulin effect (GIRtot) (60.4%, P < 0.01 and 67.1%, P < 0.01, respectively) relative to healthy subjects. SC insulin lispro administration resulted in similar responses across study groups for insulin exposure and metabolic effect. Intra-subject pharmacokinetic and glucodynamic variability ranged from 17--52% across groups. No significant differences were shown for pre- and post-clamp pulmonary function tests. During clamps, FEV1 and FVC declined modestly in both COPD groups with no difference between AIR Insulin and SC insulin lispro.
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作者:admin@医学,生命科学 2010-11-03 05:11
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