Robertson Kara, Montazeri Nazanin, Shelke Urvashi, Jeimy Samira, Kim Harold
Clinical Immunology and Allergy, Department of Medicine, St. Joseph's Hospital, Western University, 268 Grosvenor Street, London, ON, N6A 4V2, Canada.
Department of Sociology and Legal Studies, Faculty of Arts, University of Waterloo, 200 University Avenue West, Waterloo, ON, N2L 3G1, Canada.
Allergy Asthma Clin Immunol. 2020 Nov 2;16(1):93. doi: 10.1186/s13223-020-00491-5.
Subcutaneous immunotherapy (SCIT) is the standard approach for treating patients with sensitizations to aeroallergens. However, immunotherapy can trigger severe systemic reactions if delivered inappropriately or to high risk patients. We sought to characterize and quantify SCIT systemic reactions requiring epinephrine administration during a 6-year period in a Canadian setting following the recommendations for components and dosages published in the 2010 Canadian Society of Allergy and Clinical Immunology (CSACI) Immunotherapy Manual.
A single centre retrospective chart review was performed for all patients with systemic reactions to subcutaneous immunotherapy requiring intramuscular epinephrine injection between January 2011 and October 2017. Each systemic reaction requiring epinephrine was reviewed for baseline patient characteristics, details of the reaction, and reaction severity. Research ethics approval was obtained through McMaster University.
28 of 380 patients experienced a systemic reaction requiring epinephrine administration, with an incidence rate of 1 per 1,047 injection visits (0.095%). 26 of the 28 reactions occurred within the mandatory 30-minute observation period post allergen immunotherapy. Of the 28 patients that experienced a systemic reaction to SCIT, 11 patients had asthma and 5 patients had a history of possible food allergy. All of the systemic reactions occurred during injections from vial number 4, and five patients reacted to their first shot of a re-ordered extract. 10 of the 28 patients required more than one intramuscular injection of epinephrine, and 20 of 28 patients were transferred to the hospital by ambulance.
This is the first Canadian study to review patients with systemic reactions to subcutaneous immunotherapy. Several best practice methods were employed throughout the study to optimize subcutaneous delivery of immunotherapy extract, and our recorded per injection incidence rate for systemic reactions was comparable or below the rate published in similar studies. The recommendations in the CSACI Immunotherapy Manual provide an approach to standardizing prescriptions for SCIT to maximize immunotherapy efficacy and reduce the risk of systemic reactions, though similar studies in larger multicenter settings are needed to confirm these observations. These observations provide important objective information to clinicians about the potential risks for systemic reactions in patients considering SCIT.
皮下免疫疗法(SCIT)是治疗对气传变应原致敏患者的标准方法。然而,如果给药不当或用于高危患者,免疫疗法可能引发严重的全身反应。我们试图根据2010年加拿大过敏与临床免疫学会(CSACI)免疫疗法手册中公布的成分和剂量建议,对加拿大6年期间需要使用肾上腺素治疗的SCIT全身反应进行特征描述和量化。
对2011年1月至2017年10月期间所有因皮下免疫疗法出现全身反应而需要肌内注射肾上腺素的患者进行单中心回顾性病历审查。对每例需要肾上腺素治疗的全身反应进行患者基线特征、反应细节和反应严重程度的审查。研究伦理批准通过麦克马斯特大学获得。
380例患者中有28例出现需要使用肾上腺素治疗的全身反应,发生率为每1047次注射就诊1例(0.095%)。28例反应中有26例发生在变应原免疫疗法后的强制30分钟观察期内。在28例经历SCIT全身反应的患者中,11例患有哮喘,5例有食物过敏史。所有全身反应均发生在从第4瓶注射时,5例患者对重新订购的提取物第一针有反应。28例患者中有10例需要多次肌内注射肾上腺素,28例患者中有20例通过救护车转至医院。
这是加拿大第一项对皮下免疫疗法全身反应患者进行审查的研究。在整个研究过程中采用了几种最佳实践方法来优化免疫疗法提取物的皮下给药,我们记录的全身反应每注射发生率与类似研究中公布的发生率相当或更低。CSACI免疫疗法手册中的建议提供了一种标准化SCIT处方的方法,以最大限度地提高免疫疗法疗效并降低全身反应风险,不过需要在更大的多中心环境中进行类似研究以证实这些观察结果。这些观察结果为临床医生提供了关于考虑接受SCIT治疗的患者发生全身反应潜在风险的重要客观信息。