Efficacy of house dust mite sublingual tablet in the treatment of allergic rhinoconjunctivitis: A randomized trial in a pediatric population.
Efficacy of house dust mite sublingual tablet in the treatment of allergic rhinoconjunctivitis: A randomized trial in a pediatric population.
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DOI：
10.1111/pai.12984
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发表时间：
2019-03
期刊：
影响因子：
--
通讯作者：
Masuyama K
中科院分区：
文献类型：
--
作者：
Okamoto Y;Fujieda S;Okano M;Hida H;Kakudo S;Masuyama K
在一项双盲、随机、安慰剂对照研究（JAPIC CTI-152981）中，评估了300片屋尘螨（HDM）过敏原提取物的反应指数（IR）片剂在日本过敏性鼻炎（AR）儿童（5 - 16岁）患者中的疗效和安全性。患者以1：1的比例随机接受HDM舌下含片或安慰剂，每日一次，持续52周。主要终点为第48 - 52周期间分析的平均校正症状评分（AASS;每日鼻炎总症状评分的平均值，包括喷嚏、流涕、鼻塞和鼻瘙痒，根据补救药物使用情况进行校正）（重复测量的混合效应模型）。在438例随机化患者中，403例（92%; 193例活性药物，210例安慰剂）完成了研究。第48 - 52周期间，活性药物组的AASS（最小二乘[LS]均值[SE]）显著（P = 0.0005）低于安慰剂组（6.32 [0.20] vs 7.27 [0.19];相对LS均值差，−13%）。与安慰剂组相比，活性组的免疫应答（特异于两种HDM抗原的IgE和IgG 4抗体）显著更高（P < 0.0001）。几乎所有患者均发生轻度或中度不良事件（AE）。最常见的治疗相关AE为口腔瘙痒、口腔水肿、咽喉刺激和耳部瘙痒。1例患者发生严重假组（声门下喉炎），已恢复。没有死亡或过敏反应需要使用注射肾上腺素。HDM片剂显著改善了HDM诱导的常年性AR的症状，并与显著的免疫应答相关。儿童患者的安全性特征与成人一致，无新的安全性问题。
The efficacy and safety of 300 index of reactivity (IR) tablets of house dust mite (HDM) allergen extracts in Japanese pediatric (5‐16 years old) patients with allergic rhinitis (AR) were assessed in a double‐blind, randomized, placebo‐controlled study (JAPIC CTI‐152981). Patients were randomized 1:1 to HDM sublingual tablets or placebo once daily for 52 weeks. The primary end‐point was average adjusted symptom score (AASS; average of daily Rhinitis Total Symptom Scores, comprising sneezing, rhinorrhea, nasal congestion, and nasal pruritus, adjusted for rescue medication use), analyzed during Weeks 48‐52 (mixed‐effects model for repeated measures). Of 438 patients randomized, 403 (92%; 193 active, 210 placebo) completed the study. AASS (least‐squares [LS] mean [SE]) during Weeks 48‐52 was significantly (P = 0.0005) lower in the active group compared with placebo (6.32 [0.20] vs 7.27 [0.19]; relative LS mean difference, −13%). Immunological responses (IgE and IgG4 antibodies specific to antigens of two HDM species) were significantly greater in the active group compared with placebo (P < 0.0001). Almost all patients experienced mild or moderate adverse events (AEs). The most common treatment‐related AEs were oral pruritus, mouth edema, throat irritation, and ear pruritus. One patient experienced serious pseudocroup (subglottic laryngitis) that recovered. There were no deaths or anaphylaxis requiring the use of injectable adrenaline. The HDM tablet significantly improved symptoms of HDM‐induced perennial AR and was associated with a significant immunological response. The safety profile in pediatric patients was consistent with that in adults, with no new safety concerns.
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影响因子：
12.4
作者：
Okamoto Y;Fujieda S;Okano M;Yoshida Y;Kakudo S;Masuyama K
通讯作者：
Masuyama K
影响因子：
14.2
作者：
Bergmann, Karl-Christian;Demoly, Pascal;Zeldin, Robert K.
通讯作者：
Zeldin, Robert K.
影响因子：
1.7
作者：
Masuyama, Keisuke;Goto, Minoru;Fujieda, Shigeharu
通讯作者：
Fujieda, Shigeharu
影响因子：
6.1
作者：
Grouin, J-M.;Vicaut, E.;Devillier, P.
通讯作者：
Devillier, P.
DOI：
10.1136/adc.2010.183095
发表时间：
2011-06-01
影响因子：
1
作者：
Fiocchi, Alessandro;Fox, Adam T.
通讯作者：
Fox, Adam T.