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家长和儿童对随机对照花生口服免疫治疗试验中生活质量的感知。

Parent and child perception of quality of life in a randomized controlled peanut oral immunotherapy trial.

机构信息

Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.

Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

出版信息

Pediatr Allergy Immunol. 2019 Sep;30(6):638-645. doi: 10.1111/pai.13066. Epub 2019 Jul 25.

Abstract

BACKGROUND

Improved quality of life (QoL) after oral immunotherapy (OIT) in peanut allergic children is often reported by their parents, while the child's perspective is less clear.

OBJECTIVE

We aimed to explore whether 2 years of OIT improved QoL in children with peanut allergy and to identify factors influencing change in QoL.

METHODS

In the open-labeled TAKE-AWAY peanut OIT trial including children with anaphylaxis to peanuts, 57 were randomized to OIT and 20 to observation. The Pediatric Quality of Life Inventory Version 4.0 was completed by parents and children at enrollment (Y ), after 1 year (end of updosing; Y ) and after 2 years (Y ) of OIT. Minimally clinically important difference (MCID) is ≥5.3. Perceived treatment burden was recorded by visual analogue scales, including adverse events (AEs). An open food challenge (OFC) was performed at Y .

RESULTS

At Y , 18 children had discontinued OIT and 2 of 39 OIT children refused OFC, while 35 of 37 were desensitized to 7500 mg peanut protein. From Y to Y the mean change (95% confidence intervals) in QoL was 4.4 (0.5, 8.3) among child self-reports and twice as large among parental proxy reports (9.3 [4.3, 14.3]; both P < 0.0001), without significant improvement among the controls. The change in QoL was significantly different from the controls for the parental proxy reports only (P = 0.002). Neither treatment burden nor AEs significantly predicted changes in QoL.

CONCLUSION

Two years of OIT improved child-QoL as reported by parents, but not by the children, suggesting that parents may overestimate improvement in child-QoL by OIT.

摘要

背景

接受口服免疫治疗(OIT)后,花生过敏儿童的生活质量(QoL)通常会得到其父母的改善报告,而儿童自身的看法则不太明确。

目的

我们旨在探讨 OIT 是否能改善花生过敏儿童的 QoL,并确定影响 QoL 变化的因素。

方法

在一项包括对花生过敏发生过敏反应的儿童的 TAKE-AWAY 花生 OIT 试验中,57 名儿童被随机分配至 OIT 组,20 名儿童被分配至观察组。在 OIT 开始时(Y )、1 年(结束剂量递增;Y )和 2 年后(Y ),父母和儿童使用儿童生活质量量表第四版(PedsQL)完成问卷调查。最小临床重要差异(MCID)为≥5.3。通过视觉模拟量表记录治疗负担,包括不良事件(AEs)。在 Y 时进行开放食物挑战(OFC)。

结果

在 Y 时,18 名儿童已停止 OIT,39 名 OIT 儿童中有 2 名拒绝进行 OFC,而 37 名儿童中有 35 名对 7500mg 花生蛋白脱敏。与 Y 相比,Y 时儿童自评的 QoL 平均变化(95%置信区间)为 4.4(0.5,8.3),而父母代评报告的变化则是儿童自评报告的两倍(9.3 [4.3,14.3];均 P<0.0001),对照组则没有显著改善。只有父母代评报告的 QoL 变化与对照组有显著差异(P=0.002)。治疗负担和 AEs 均与 QoL 变化无显著相关性。

结论

2 年 OIT 可改善父母报告的儿童 QoL,但不能改善儿童自身报告的 QoL,这表明父母可能高估了 OIT 对儿童 QoL 的改善。

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