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豚草舌下含片治疗儿童变应性鼻结膜炎的随机安慰剂对照试验的疗效与安全性

Efficacy and Safety of Ragweed SLIT-Tablet in Children with Allergic Rhinoconjunctivitis in a Randomized, Placebo-Controlled Trial.

作者信息

Nolte Hendrik, Bernstein David I, Nelson Harold S, Ellis Anne K, Kleine-Tebbe Jörg, Lu Susan

机构信息

ALK, Bedminster, NJ.

Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, Ohio.

出版信息

J Allergy Clin Immunol Pract. 2020 Jul-Aug;8(7):2322-2331.e5. doi: 10.1016/j.jaip.2020.03.041. Epub 2020 Apr 15.

Abstract

BACKGROUND

Ragweed sublingual immunotherapy (SLIT) tablet reduces symptoms and symptom-relieving medication use in adults with allergic rhinitis with or without conjunctivitis (AR/C) but has not been evaluated in children.

OBJECTIVE

This international, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of ragweed SLIT-tablet in children with AR/C.

METHODS

Children (N = 1025; 77.7% polysensitized) aged 5 to 17 years with ragweed pollen-induced AR/C with or without asthma (FEV ≥80% predicted) were randomized 1:1 to daily ragweed SLIT-tablet (12 Amb a 1-Unit) or placebo for up to 28 weeks (NCT02478398). The primary end point was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary end points were TCS during the entire RPS, and DSS and DMS during the peak RPS.

RESULTS

Relative TCS (95% CI) improvements with ragweed SLIT-tablet versus placebo were -38.3% (-46.0% to -29.7%; least square [LS] mean difference, -2.73; P < .001) during peak RPS and -32.4% (-40.7% to -23.3%; LS mean difference, -1.86; P < .001) during the entire RPS. DSS and DMS during peak RPS improved with SLIT-tablet versus placebo by -35.4% (-43.2% to -26.1%; LS mean difference, -1.40; P < .001) and -47.7% (-59.8% to -32.5%; LS mean difference, -1.84; P < .001), respectively. Asthma DSS, short-acting β-agonist use, and nocturnal awakenings during peak RPS improved with SLIT-tablet versus placebo by -30.7%, -68.1%, and -75.1%, respectively (all nominal P ≤ .02). No events of anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions were reported.

CONCLUSIONS

Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.

摘要

背景

豚草舌下免疫疗法(SLIT)片剂可减轻患有或不患有结膜炎的过敏性鼻炎(AR/C)成人的症状并减少缓解症状药物的使用,但尚未在儿童中进行评估。

目的

这项国际多中心双盲安慰剂对照试验评估了豚草SLIT片剂在AR/C儿童中的疗效和安全性。

方法

年龄在5至17岁、患有豚草花粉诱导的AR/C且伴有或不伴有哮喘(预计第一秒用力呼气容积[FEV]≥80%)的儿童(N = 1025;77.7%为多敏体质)按1:1随机分组,每日服用豚草SLIT片剂(12个Amb a 1单位)或安慰剂,持续长达28周(NCT02478398)。主要终点是豚草花粉高峰期(RPS)期间的平均总综合评分(TCS;鼻结膜炎每日症状评分[DSS]与每日药物评分[DMS]之和)。关键次要终点是整个RPS期间的TCS,以及RPS高峰期的DSS和DMS。

结果

在RPS高峰期,与安慰剂相比,豚草SLIT片剂的相对TCS(95%CI)改善为-38.3%(-46.0%至-29.7%;最小二乘[LS]均值差异为-2.73;P <.001),在整个RPS期间为-32.4%(-40.7%至-23.3%;LS均值差异为-1.86;P <.001)。与安慰剂相比,SLIT片剂在RPS高峰期使DSS和DMS分别改善了-35.4%(-43.2%至-26.1%;LS均值差异为-1.40;P <.001)和-47.7%(-59.8%至-32.5%;LS均值差异为-1.84;P <.001)。与安慰剂相比,SLIT片剂使RPS高峰期的哮喘DSS、短效β受体激动剂使用和夜间觉醒分别改善了-30.7%、-68.1%和-75.1%(所有名义P≤.02)。未报告过敏反应、气道受损或严重的治疗相关全身性过敏反应事件。

结论

豚草SLIT片剂显著改善了豚草花粉诱导的AR/C儿童的症状,并减少了缓解症状药物的使用,且耐受性良好。

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