Intelliject Inc, Richmond, Virginia, USA.
Ann Allergy Asthma Immunol. 2013 Aug;111(2):132-7. doi: 10.1016/j.anai.2013.06.002.
Epinephrine autoinjectors are underused for the treatment of anaphylaxis in community settings. Auvi-Q, a novel epinephrine autoinjector, was designed to be intuitive to use and reduce the potential for use-related errors.
To compare the bioavailability of 0.3 mg of epinephrine (adrenaline) injected with Auvi-Q and EpiPen in healthy adults.
In this randomized, single-blind, 2-treatment, 3-period, 3-sequence crossover study, healthy adults (18-45 years old) received a single injection of 0.3 mg of epinephrine with Auvi-Q in one period and with EpiPen in the other 2 periods. Blood samples were obtained before and 14 times during 6 hours after the dose. Outcomes included peak plasma concentration (Cmax), total epinephrine exposure (area under the concentration-time curve [AUC] from baseline to the last measurable concentration [AUC0-t] and extrapolated to infinity [AUCinf]), and adverse events.
Seventy-one volunteers (53 male, 74.6%), with a mean age of 33.2 years and a mean body mass index of 25.4, were randomized. Epinephrine peak concentration and total exposure were similar between Auvi-Q (Cmax = 0.486 ng/mL; AUC0-t = 0.536 ng·h/mL; AUCinf = 0.724 ng·h/mL) and EpiPen (Cmax = 0.520 ng/mL; AUC0-t = 0.466 ng·h/mL; AUCinf = 0.583 ng·h/mL). Cmax and AUC analyses demonstrated bioequivalence between Auvi-Q and EpiPen. Most treatment-emergent adverse events were mild (98%), and all resolved spontaneously. Rates of injection-site pain and bleeding were 13% and 5%, respectively, for Auvi-Q vs 24% and 10%, respectively, for EpiPen.
After a single injection of 0.3 mg of epinephrine, Auvi-Q and EpiPen had similar peak and total epinephrine exposure, were bioequivalent, and had similar safety profiles.
肾上腺素自动注射器在社区环境中用于治疗过敏反应的使用率较低。Auvi-Q 是一种新型肾上腺素自动注射器，设计初衷是易于使用，并降低与使用相关的错误风险。
比较健康成年人使用 Auvi-Q 和 EpiPen 注射 0.3 毫克肾上腺素（肾上腺素）的生物利用度。
在这项随机、单盲、2 种治疗、3 期、3 序列交叉研究中，健康成年人（18-45 岁）在一个时期内接受 Auvi-Q 单次注射 0.3 毫克肾上腺素，在另两个时期内接受 EpiPen 注射。在剂量后 6 小时内，共采集了 14 次血样。结果包括峰血浆浓度（Cmax）、总肾上腺素暴露量（从基线到最后可测量浓度的浓度-时间曲线下面积[AUC0-t]和外推至无穷大[AUCinf]）和不良事件。
71 名志愿者（53 名男性，74.6%），平均年龄 33.2 岁，平均体重指数 25.4，随机分组。Auvi-Q（Cmax=0.486ng/ml；AUC0-t=0.536ng·h/ml；AUCinf=0.724ng·h/ml）和 EpiPen（Cmax=0.520ng/ml；AUC0-t=0.466ng·h/ml；AUCinf=0.583ng·h/ml）的肾上腺素峰浓度和总暴露量相似。Cmax 和 AUC 分析表明 Auvi-Q 和 EpiPen 具有生物等效性。大多数治疗后出现的不良事件为轻度（98%），且均自行缓解。注射部位疼痛和出血的发生率分别为 Auvi-Q 组 13%和 5%，EpiPen 组为 24%和 10%。
单次注射 0.3 毫克肾上腺素后，Auvi-Q 和 EpiPen 的肾上腺素峰浓度和总暴露量相似，具有生物等效性，且安全性相似。
