Allergology Service, University Hospital Virgen del Rocío, Sevilla, Spain.
Immunotherapy. 2013 Dec;5(12):1295-303. doi: 10.2217/imt.13.133.
Few studies have compared cluster immunotherapy and conventional administration regimens. The aim of this study was to establish the safety profile of these different regimens in patients with allergic respiratory diseases who received index-of-reactivity (IR)-standardized allergen extracts by the subcutaneous route.
MATERIALS & METHODS: The safety of subcutaneous immunotherapy (SCIT), administered by means of a 4-week cluster titration schedule (cluster-SCIT) or by an 8-week short conventional titration schedule (SC-SCIT), both with a target dose of 8 IR, was assessed in a retrospective, observational, multicenter study.
A total of 658 patients (339 cluster-SCIT and 319 SC-SCIT) were recruited from 92 sites in Spain. Injection site reactions occurred in 25.1 and 27.3% of patients treated with cluster-SCIT and SC-SCIT, respectively. Systemic reactions (European Academy of Allergy and Clinical Immunology criteria) were reported for 0.2% of doses and 1.5% of patients with cluster-SCIT, and 0.7% of doses and 4.4% of patients with SC-SCIT. Most reactions were mild and there were no grade 3 or 4 systemic reactions. No life-threatening systemic reactions, anaphylactic shock, or adverse events leading to therapy discontinuation were reported.
The safety profile of the cluster regimen supports the use of accelerated SCIT schedules with IR-standardized allergen extracts compared with short conventional schedules, particularly if similar extracts and application methods are used.
鲜有研究比较过集群免疫疗法和常规给药方案。本研究旨在确定这些不同方案在接受皮下途径给予指数反应(IR)标准化过敏原提取物的过敏性呼吸道疾病患者中的安全性特征。
通过 4 周集群滴定方案(集群-SCIT)或 8 周短常规滴定方案(SC-SCIT)以 8IR 为目标剂量对皮下免疫疗法(SCIT)的安全性进行评估,这两种方案均采用皮下途径。这两种方案均采用皮下途径。这是一项回顾性、观察性、多中心研究。
共招募了 658 名患者(集群-SCIT339 例,SC-SCIT319 例),他们来自西班牙 92 个地点。集群-SCIT 和 SC-SCIT 治疗的患者中分别有 25.1%和 27.3%出现注射部位反应。报道了 0.2%的剂量和 0.2%的患者出现集群-SCIT 的全身反应(欧洲过敏与临床免疫学会标准),以及 0.7%的剂量和 4.4%的患者出现 SC-SCIT 的全身反应。大多数反应为轻度,无 3 级或 4 级全身反应。未报告危及生命的全身反应、过敏性休克或导致治疗中断的不良事件。
集群方案的安全性特征支持与短期常规方案相比,使用 IR 标准化过敏原提取物加速 SCIT 方案,特别是如果使用类似的提取物和应用方法。