Hofmann Alison M, Scurlock Amy M, Jones Stacie M, Palmer Kricia P, Lokhnygina Yuliya, Steele Pamela H, Kamilaris Janet, Burks A Wesley
Division of Allergy and Immunology, Department of Pediatrics, Duke University Medical Center, Durham, NC 27710, USA.
J Allergy Clin Immunol. 2009 Aug;124(2):286-91, 291.e1-6. doi: 10.1016/j.jaci.2009.03.045. Epub 2009 May 27.
Oral immunotherapy (OIT) offers a promising therapeutic option for peanut allergy. Given that during OIT an allergic patient ingests an allergen that could potentially cause a serious reaction, the safety of OIT is of particular concern.
The purpose of this study was to examine safety during the initial escalation day, buildup phase, and home dosing phase in subjects enrolled in a peanut OIT study.
Skin, upper respiratory tract, chest, and abdominal symptoms were recorded with initial escalation day and buildup phase dosings. Subjects also maintained daily diaries detailing symptoms after each home dosing. A statistical analysis of these data was performed.
Twenty of 28 patients completed all phases of the study. During the initial escalation day, upper respiratory tract (79%) and abdominal (68%) symptoms were the most likely symptoms experienced. The risk of mild wheezing during the initial escalation day was 18%. The probability of having any symptoms after a buildup phase dose was 46%, with a risk of 29% for upper respiratory tract symptoms and 24% for skin symptoms. The risk of reaction with any home dose was 3.5%. Upper respiratory tract (1.2%) and skin (1.1%) symptoms were the most likely after home doses. Treatment was given with 0.7% of home doses. Two subjects received epinephrine after 1 home dose each.
Subjects were more likely to have significant allergic symptoms during the initial escalation day when they were in a closely monitored setting than during other phases of the study. Allergic reactions with home doses were rare.
口服免疫疗法（OIT）为花生过敏提供了一种有前景的治疗选择。鉴于在OIT期间，过敏患者摄入的过敏原可能会引发严重反应，OIT的安全性备受关注。
本研究旨在调查参加花生OIT研究的受试者在初始剂量递增日、累积阶段和家庭给药阶段的安全性。
在初始剂量递增日和累积阶段给药时记录皮肤、上呼吸道、胸部和腹部症状。受试者还需记录每日日记，详细描述每次家庭给药后的症状。对这些数据进行统计分析。
28名患者中有20名完成了研究的所有阶段。在初始剂量递增日，最常出现的症状是上呼吸道症状（79%）和腹部症状（68%）。初始剂量递增日出现轻度喘息的风险为18%。累积阶段给药后出现任何症状的概率为46%，上呼吸道症状的风险为29%，皮肤症状的风险为24%。家庭给药出现反应的风险为3.5%。家庭给药后最常出现的症状是上呼吸道症状（1.2%）和皮肤症状（1.1%）。0.7%的家庭给药进行了治疗。两名受试者在每次家庭给药1次后接受了肾上腺素治疗。
与研究的其他阶段相比，受试者在初始剂量递增日处于密切监测环境时更易出现明显的过敏症状。家庭给药引起的过敏反应很少见。
