Caminati Marco, Dama Anna Rita, Djuric Ivana, Montagni Marcello, Schiappoli Michele, Ridolo Erminia, Senna Gianenrico, Canonica Giorgio Walter
Allergy Unit, Verona University and General Hospital, Verona, Italy.
Expert Rev Clin Immunol. 2015 Feb;11(2):233-45. doi: 10.1586/1744666X.2015.988143. Epub 2014 Dec 6.
Fatal reactions related to subcutaneous allergen immunotherapy are rare: one event in 2.5 million injections has been reported in the USA and none in Europe. The prevalence of very severe systemic reactions (systemic adverse events [SAEs]) is one in 1 million injections. Though the serious events rate is decreasing and the majority of SAEs (∼0.2% per injection) are moderate and reversible, they still represent a major concern. Uncontrolled asthma, long-term therapy with β-blockers and high degree of allergen sensitivity are generally considered risk factors. The relevance of other conditions, like previous local reactions, the use of extracts conjugated with adjuvants and accelerated build-up schedules is controversial, as well as the role of preventative strategies. A careful risk assessment of patients and optimal administration procedures may significantly decrease the risk of SAEs. However, more uniform safety data are required and an accurate safety profile should be provided for every allergen product.
在美国,每250万次注射中有1例此类事件报告,欧洲则无相关报告。非常严重的全身反应(全身性不良事件[SAEs])的发生率为每100万次注射中有1例。尽管严重事件发生率在下降,且大多数SAEs(每次注射约0.2%)为中度且可逆,但它们仍是一个主要问题。未控制的哮喘、β受体阻滞剂长期治疗以及高度变应原敏感性通常被视为危险因素。其他情况的相关性,如既往局部反应、使用与佐剂结合的提取物以及加速递增方案,以及预防策略的作用,都存在争议。对患者进行仔细的风险评估和采用最佳给药程序可能会显著降低SAEs的风险。然而,需要更统一的安全数据,并且应为每种变应原产品提供准确的安全概况。