BACKGROUND:Timothy grass sublingual immunotherapy (SLIT) tablets are indicated for children with allergic rhinitis with or without conjunctivitis. OBJECTIVE:To use pooled analyses to assess the short- and long-term tolerability and safety of timothy grass SLIT-tablet in children. METHODS:Data from 9 double-blinded, randomized European or North American trials that included children with allergic rhinitis with or without conjunctivitis treated up to 3 years with once-daily timothy grass SLIT-tablet or placebo were pooled. RESULTS:In all, 1818 (timothy grass SLIT-tablet, n = 923; placebo, n = 895) subjects were included in the analysis. The frequency of treatment-emergent adverse events (AEs) was 86% in the SLIT-tablet group and 83% in the placebo group, and the frequency of treatment-related AEs (TRAEs) was 59% and 23%, respectively. Most (98%) TRAEs were mild to moderate in severity. The 2 most common TRAEs with SLIT-tablet were oral pruritus (33%) and throat irritation (19%), which had a median onset of 1 day and recurrence of 14.5 and 5 days, respectively. In all, 8% of subjects in the SLIT-tablet group and 2% in the placebo group discontinued because of AEs. There were 7 serious AEs assessed as related to SLIT-tablet, 1 systemic allergic reaction (severe with a drop in blood pressure), 3 epinephrine administrations, no eosinophilic esophagitis events, and no serious airway obstructions. The safety profile was similar in subjects across geographic regions and with and without asthma. CONCLUSIONS:Pooled data indicate that short- and long-term timothy grass SLIT-tablet is well tolerated in children, regardless of geographic region. AEs were generally local, mild, and transient allergic reactions.

译文

背景:蒂莫西草舌下免疫治疗(SLIT)片适用于患有或不患有结膜炎的过敏性鼻炎患儿。
目的:使用汇总分析来评估儿童提摩西草SLIT片剂的短期和长期耐受性和安全性。
方法:收集来自9项欧洲或北美双盲,随机试验的数据,该试验包括患有过敏性鼻炎的儿童(有或没有结膜炎),每天用一次速效草SLIT片剂或安慰剂治疗长达3年。
结果:总共纳入了1818名(蒂莫斯草SLIT片剂,n = 923;安慰剂,n = 895)受试者。 SLIT-片剂组出现治疗的不良事件(AEs)的频率为86%,安慰剂组为83%,与治疗相关的AEs(TRAEs)的频率分别为59%和23%。大多数(98%)TRAE的严重程度为轻度至中度。带有SLIT片剂的2种最常见的TRAE是口腔瘙痒(33%)和喉咙刺激(19%),它们的中位发作为1天,复发分别为14.5和5天。总之,SLAE片剂组中有8%的受试者和安慰剂组中有2%的受试者因AE停药。评估了与SLIT片剂相关的7种严重不良事件,1例全身性过敏反应(严重且血压下降),3次肾上腺素给药,无嗜酸性食管炎事件以及无严重气道阻塞。在有或没有哮喘的地区,受试者的安全性特征相似。
结论:汇总的数据表明,不论地理区域如何,儿童短期和长期食用提莫乐草SLIT片剂的耐受性都很好。 AE通常是局部,轻度和短暂的过敏反应。

+1
+2
100研值 100研值 ¥99课程
检索文献一次
下载文献一次

去下载>

成功解锁2个技能,为你点赞

《SCI写作十大必备语法》
解决你的SCI语法难题!

技能熟练度+1

视频课《玩转文献检索》
让你成为检索达人!

恭喜完成新手挑战

手机微信扫一扫,添加好友领取

免费领《Endnote文献管理工具+教程》

微信扫码, 免费领取

手机登录

获取验证码
登录