Sheikh Aziz, Simons F Estelle R, Barbour Victoria, Worth Allison
Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK.
Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD008935. doi: 10.1002/14651858.CD008935.pub2.
Anaphylaxis is a serious hypersensitivity reaction that is rapid in onset and may cause death. Adrenaline (epinephrine) auto-injectors are recommended as the initial, potentially life-saving treatment of choice for anaphylaxis in the community, but they are not universally available and have limitations in their use.
To assess the effectiveness of adrenaline (epinephrine) auto-injectors in relieving respiratory, cardiovascular, and other symptoms during episodes of anaphylaxis that occur in the community.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 1), MEDLINE (Ovid SP) (1950 to January 2012), EMBASE (Ovid SP) (1980 to January 2012 ), CINAHL (EBSCO host) (1982 to January 2012 ), AMED (EBSCO host) (1985 to January 2012 ), LILACS, (BIREME) (1980 to January 2012 ), ISI Web of Science (1950 to January 2012 ). We adapted our search terms for other databases. We also searched websites listing on-going trials: the World Health Organization International Clinical Trials Registry Platform, the UK Clinical Research Network Study Portfolio, and the meta Register of Controlled Trials; and contacted pharmaceutical companies who manufacture adrenaline auto-injectors in an attempt to locate unpublished material.
Randomized and quasi-randomized controlled trials comparing auto-injector administration of adrenaline with any control including no intervention, placebo, or other adrenergic agonists were eligible for inclusion.
Two authors independently assessed articles for inclusion.
None of the 1328 studies that were identified satisfied the inclusion criteria.
AUTHORS' CONCLUSIONS: Based on this review, we cannot make any new recommendations on the effectiveness of adrenaline auto-injectors for the treatment of anaphylaxis. Although randomized, double-blind, placebo-controlled clinical trials of high methodological quality are necessary to define the true extent of benefits from the administration of adrenaline in anaphylaxis via an auto-injector, such trials are unlikely to be performed in individuals experiencing anaphylaxis because of ethical concerns associated with randomization to placebo. There is, however, a need to consider trials in which, for example, auto-injectors of different doses of adrenaline and differing devices are compared in order to provide greater clarity on the dose and device of choice. Such trials would be practically challenging to conduct. In the absence of appropriate trials, we recommend that adrenaline administration by auto-injector should still be regarded as the most effective first-line treatment for the management of anaphylaxis in the community. In countries where auto-injectors are not commonly used, it may be possible to conduct trials to compare administration of adrenaline via auto-injector with adrenaline administered by syringe and ampoule, or comparing the effectiveness of two different types of auto-injector.
过敏反应是一种严重的超敏反应，起病迅速，可能导致死亡。肾上腺素自动注射器被推荐为社区中过敏反应初始的、可能挽救生命的首选治疗方法，但并非普遍可得，且在使用上存在局限性。
评估肾上腺素自动注射器在缓解社区发生的过敏反应发作期间的呼吸、心血管及其他症状方面的有效性。
我们检索了Cochrane对照试验中心注册库（CENTRAL）（《Cochrane图书馆》2012年第1期）、MEDLINE（Ovid SP）（1950年至2012年1月）、EMBASE（Ovid SP）（1980年至2012年1月）、CINAHL（EBSCO主机）（1982年至2012年1月）、AMED（EBSCO主机）（1985年至2012年1月）、LILACS（BIREME）（1980年至2012年1月）、ISI科学网（1950年至2012年1月）。我们对检索词进行了调整以适用于其他数据库。我们还检索了列出正在进行试验的网站：世界卫生组织国际临床试验注册平台、英国临床研究网络研究组合以及对照试验元注册库；并联系了生产肾上腺素自动注射器的制药公司，试图找到未发表的资料。
比较肾上腺素自动注射器给药与任何对照（包括无干预、安慰剂或其他肾上腺素能激动剂）的随机和半随机对照试验符合纳入标准。
两位作者独立评估文章是否纳入。
所识别的1328项研究中无一符合纳入标准。
基于本综述，我们无法就肾上腺素自动注射器治疗过敏反应的有效性提出任何新的建议。尽管方法学质量高的随机、双盲、安慰剂对照临床试验对于确定通过自动注射器给予肾上腺素在过敏反应中的真正获益程度是必要的，但由于与随机给予安慰剂相关的伦理问题，此类试验不太可能在经历过敏反应的个体中进行。然而，有必要考虑进行例如比较不同剂量肾上腺素自动注射器和不同装置的试验，以便更清楚地了解首选剂量和装置。此类试验实施起来具有实际挑战性。在缺乏适当试验的情况下，我们建议通过自动注射器给予肾上腺素仍应被视为社区中过敏反应管理最有效的一线治疗方法。在自动注射器不常用的国家，有可能进行试验以比较通过自动注射器给予肾上腺素与通过注射器和安瓿给予肾上腺素的情况，或者比较两种不同类型自动注射器的有效性。
