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首页> 外文期刊>Allergology international: official journal of the Japanese Society of Allergology >Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet
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Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet

机译：室内尘螨片和日本雪松花粉片双重舌下免疫疗法的安全性和免疫应答

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BackgroundThere 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.MethodsThis 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.ResultsThe 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.ConclusionsDual 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.
机译：背景尚无针对常年性和季节性变应性鼻炎双重给药舌下免疫疗法（SLIT）片剂的研究。该试验（JapicCTI-184014）旨在研究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，随机对照试验109名日本人同时存在HDM和JCP过敏性鼻炎，他们的HDM-和JCP特异性IgE（≥0.7？kU / L）呈阳性。患者被分配为单独接受HDM（N？=？54）或JCP（N？=？55）SLIT片剂，持续4周，然后进行8周双重治疗，两种SLIT片剂均在5分钟内彼此给药。记录不良反应（AEs），药物不良反应（ADRs）以及对HDM（Fererophaeides farinae，Dermatophagoides pteronyssinus）和JCP特异的血清IgE和IgG4。结果两组之间以及两组之间AEs和ADR的受试者百分比相似单一疗法和双重疗法两个时期。大多数AE和ADR的严重程度均较轻，未观察到严重事件。最常见的ADR是口腔局部事件。 HDM和JCP SLIT片治疗后，分别对HDM（D.?farinae、D.?pteronyssinus）和JCP的IgE和IgG4含量升高。结论单一治疗4周后，在5？min内同时给予SLIT片双重治疗用HDM或JCP片剂耐受性良好，并诱导了预期的免疫反应。

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