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低剂量和高剂量缓慢口服鸡蛋免疫疗法治疗鸡蛋过敏的疗效和安全性:单中心非劣效性随机试验

Efficacy and safety of low- and high-dose slow oral egg immunotherapy for hen's egg allergy: Single-center non-inferiority randomized trial.

作者信息

Takaoka Yuri, Ito Yoichi M, Kumon Junko, Yamaguchi Tomohiro, Ueno Rumi, Tsurinaga Yuki, Nakano Tamana, Fukasawa Yohei, Shigekawa Amane, Yoshida Yukinori, Kameda Makoto, Doi Satoru

机构信息

Department of Pediatrics, Osaka Habikino Medical Center, Osaka, Japan.

Data Science Center, Promotion Unit, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, Hokkaido, Japan.

出版信息

Asian Pac J Allergy Immunol. 2023 Apr 17. doi: 10.12932/AP-130722-1411.

DOI:10.12932/AP-130722-1411
PMID:37061933
Abstract

BACKGROUND

Low-dose oral immunotherapy (OIT) is a safe treatment for hen's egg allergy; however, comparison of its therapeutic effects with those of high-dose OIT has not been reported.

OBJECTIVE

To compare the efficacy of low- and high-dose boiled egg-white (EW) OIT for hen's egg allergy.

METHODS

Patients with hen's egg allergy were randomly assigned to two groups: OIT using hard-boiled EW with a maximum maintenance dose of 2 and 20 g in the low-dose (L-D) and high-dose (H-D) groups, respectively. The intake dose was ingested twice a week, increased by approximately 20% per week until reaching the target maintenance dose (2 or 20 g hard-boiled EW), and maintained thereafter according to the schedule. The threshold was confirmed via oral food challenge (OFC) after 6 months, and the difference in the proportion of subjects passing the exit OFC between groups was evaluated.

RESULTS

Fifty-two patients (L-D, n = 23; H-D, n = 29) were enrolled. Thirty-three patients (L-D, n = 17; H-D, n = 16) completed the 6-month OIT and underwent an exit OFC. In total, three (L-D, 3/17; H-D, 3/16) patients in each group tested negative for an exit OFC with a 20-g reactive dose (p = 1.000). EW-specific IgE levels in both groups decreased significantly after OIT (L-D, p < 0.001; H-D, p = 0.002).

CONCLUSIONS

A threshold-elevating effect was observed in the L-D group, not inferior to that in the H-D group. Low-dose OIT may be appropriate to treat hen's egg allergy for the first 6 months.

摘要

背景

低剂量口服免疫疗法(OIT)是治疗鸡蛋过敏的一种安全疗法;然而,其与高剂量OIT治疗效果的比较尚未见报道。

目的

比较低剂量和高剂量煮蛋清(EW)OIT治疗鸡蛋过敏的疗效。

方法

鸡蛋过敏患者被随机分为两组:低剂量(L-D)组和高剂量(H-D)组,分别使用最大维持剂量为2克和20克的煮硬蛋清进行OIT。摄入剂量每周服用两次,每周增加约20%,直至达到目标维持剂量(2克或20克煮硬蛋清),此后按计划维持。6个月后通过口服食物激发试验(OFC)确认阈值,并评估两组间通过末次OFC的受试者比例差异。

结果

共纳入52例患者(L-D组,n = 23;H-D组,n = 29)。33例患者(L-D组,n = 17;H-D组,n = 16)完成了6个月的OIT并接受了末次OFC。每组各有3例(L-D组,3/17;H-D组,3/16)患者在20克激发剂量的末次OFC中检测为阴性(p = 1.000)。两组OIT后EW特异性IgE水平均显著下降(L-D组,p < 0.001;H-D组,p = 0.002)。

结论

L-D组观察到阈值升高效应,不低于H-D组。低剂量OIT可能适合在最初6个月治疗鸡蛋过敏。

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