Umasunthar T, Procktor A, Hodes M, Smith J G, Gore C, Cox H E, Marrs T, Hanna H, Phillips K, Pinto C, Turner P J, Warner J O, Boyle R J
Section of Paediatrics, Imperial College London, London, UK.
Imperial College Healthcare NHS Trust, St. Mary's Hospital, London, UK.
Allergy. 2015 Jul;70(7):855-63. doi: 10.1111/all.12628. Epub 2015 Apr 16.
Previous work has shown patients commonly misuse adrenaline autoinjectors (AAI). It is unclear whether this is due to inadequate training, or poor device design. We undertook a prospective randomized controlled trial to evaluate ability to administer adrenaline using different AAI devices.
We allocated mothers of food-allergic children prescribed an AAI for the first time to Anapen or EpiPen using a computer-generated randomization list, with optimal training according to manufacturer's instructions. After one year, participants were randomly allocated a new device (EpiPen, Anapen, new EpiPen, JEXT or Auvi-Q), without device-specific training. We assessed ability to deliver adrenaline using their AAI in a simulated anaphylaxis scenario six weeks and one year after initial training, and following device switch. Primary outcome was successful adrenaline administration at six weeks, assessed by an independent expert. Secondary outcomes were success at one year, success after switching device, and adverse events.
We randomized 158 participants. At six weeks, 30 of 71 (42%) participants allocated to Anapen and 31 of 73 (43%) participants allocated to EpiPen were successful - RR 1.00 (95% CI 0.68-1.46). Success rates at one year were also similar, but digital injection was more common at one year with EpiPen (8/59, 14%) than Anapen (0/51, 0%, P = 0.007). When switched to a new device without specific training, success rates were higher with Auvi-Q (26/28, 93%) than other devices (39/80, 49%; P < 0.001).
AAI device design is a major determinant of successful adrenaline administration. Success rates were low with several devices, but were high using the audio-prompt device Auvi-Q.
先前的研究表明患者普遍存在肾上腺素自动注射器（AAI）使用不当的情况。目前尚不清楚这是由于培训不足还是设备设计不佳所致。我们进行了一项前瞻性随机对照试验，以评估使用不同AAI设备注射肾上腺素的能力。
我们使用计算机生成的随机列表，将首次开具AAI的食物过敏儿童的母亲随机分配至使用Anapen或EpiPen，并根据制造商的说明进行了最佳培训。一年后，参与者被随机分配一种新设备（EpiPen、Anapen、新型EpiPen、JEXT或Auvi-Q），且未接受特定设备培训。我们在初次培训后的六周和一年以及更换设备后，在模拟过敏反应场景中评估了他们使用AAI注射肾上腺素的能力。主要结局是六周时由独立专家评估的肾上腺素注射成功情况。次要结局包括一年时的成功率、更换设备后的成功率以及不良事件。
我们将158名参与者随机分组。六周时，分配至Anapen的71名参与者中有30名（42%）成功注射，分配至EpiPen的73名参与者中有31名（43%）成功注射——相对危险度为1.00（95%置信区间为0.68-1.46）。一年时的成功率也相似，但一年时EpiPen（8/59，14%）的数字注射情况比Anapen（0/51，0%）更常见（P = 0.007）。在未接受特定培训而更换为新设备时，Auvi-Q的成功率（26/28，93%）高于其他设备（39/80，49%；P < 0.001）。
AAI设备设计是肾上腺素注射成功的主要决定因素。几种设备的成功率较低，但使用音频提示设备Auvi-Q时成功率较高。
