Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet
Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet
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DOI：
10.1016/j.alit.2019.07.007
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发表时间：
2020-01-01
影响因子：
6.8
通讯作者：
Okamoto, Yoshitaka
中科院分区：
文献类型：
--
作者：
Gotoh, Minoru;Okubo, Kimihiro;Okamoto, Yoshitaka
背景：目前还没有关于舌下免疫疗法（SLIT）片剂双重给药治疗常年性和季节性过敏性鼻炎的研究。本试验（JapicCTI-184014）研究SQ屋尘螨（HDM）和日本雪松花粉（JCP）SLIT片剂双重治疗期间的安全性和免疫应答。方法：这是一项多中心、开放标签、随机试验，纳入109例HDM和JCP过敏性鼻炎患者，这些患者HDM和JCP特异性IgE检测阳性（>= 0.7 kU/L）。患者被分配接受HDM（N = 54）或JCP（N = 55）SLIT片剂单独治疗4周，随后接受8周的双重治疗，两种SLIT片剂在5分钟内给药。记录不良事件（AEs）、药物不良反应（ADRs）、HDM（Dermatophagoides farinae，Dermatophagoides pteronyssinus）和JCP特异性IgE和IgG 4。大多数AE和ADR的严重程度为轻度，未观察到严重事件。最常见的ADR是口腔局部事件。HDM特异性IgE和IgG 4水平（D. farinae、粉纹拟谷盗D.结论：HDM或JCP SLIT片单药治疗4周后，在5 min内给予两种SLIT片的双重治疗耐受性良好，并诱导了预期的免疫应答。Copyright（C）2019，日本变态反应学会制作和主办：Elsevier B. V.
Background: There have been no studies of dual administration of sublingual immunotherapy (SLIT) tablets for perennial and seasonal allergic rhinitis. This trial (JapicCTI-184014) was conducted to investigate the safety profile and immunological response during dual therapy with SQ house dust mite (HDM) and Japanese cedar pollen (JCP) SLIT tablets.Methods: This was a multicenter, open-label, randomized trial of 109 Japanese patients with coexisting HDM and JCP allergic rhinitis who had positive tests for HDM- and JCP specific IgE (>= 0.7 kU/L). Patients were allocated to receive HDM (N = 54) or JCP (N = 55) SLIT tablets alone for 4 weeks followed by 8 weeks of dual therapy with both SLIT tablets administered within 5 min of each other. Adverse events (AEs), adverse drug reactions (ADRs), and serum IgE and IgG4 specific for HDM (Dermatophagoides farinae, Dermatophagoides pteronyssinus) and JCP were recorded.Results: The percentage of subjects with AEs and ADRs was similar between the two groups and between the two periods of monotherapy and dual therapy. Most AEs and ADRs were mild in severity, and no serious events were observed. The most common ADRs were local events in the oral cavity. Levels of IgE and IgG4 specific for HDM (D. farinae, D. pteronyssinus) and JCP were increased after treatment with HDM and JCP SLIT tablets, respectively.Conclusions: Dual therapy with both SLIT tablets administered within 5 min after 4 weeks of monotherapy with HDM or JCP tablet was well tolerated and induced the expected immunological responses. Copyright (C) 2019, Japanese Society of Allergology. Production and hosting by Elsevier B.V.