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Cry j 1-半乳甘露聚糖缀合物短期口服免疫疗法新方案治疗日本雪松花粉症的安全性和有效性:一项前瞻性、随机、开放标签研究。

Safety and efficacy of a new regimen of short-term oral immunotherapy with Cry j 1-galactomannan conjugate for Japanese cedar pollinosis: a prospective, randomized, open-label study.

作者信息

Murakami Daisuke, Sawatsubashi Motohiro, Kikkawa Sayaka, Ejima Masayoshi, Saito Akira, Kato Akio, Komune Shizuo

机构信息

Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Department of Otorhinolaryngology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.

Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

出版信息

Allergol Int. 2015 Apr;64(2):161-8. doi: 10.1016/j.alit.2014.10.009. Epub 2015 Jan 12.

DOI:10.1016/j.alit.2014.10.009
PMID:25838092
Abstract

BACKGROUND

Short-term oral immunotherapy (OIT) using the Cry j1-galactomannan conjugate for Japanese cedar pollinosis may be effective and relatively safe. However, a treatment regimen has not been established. In the present study, we examined a new OIT regimen with a build-up phase and extended the maintenance phase of OIT to the peak period of the pollen season to enhance the therapeutic effect and safety of OIT.

METHODS

A prospective, randomized, open-label trial was conducted over a period of 4 months. Participants were randomly divided into two groups. The OIT group comprised 23 subjects. The build-up phase was initiated 1 month before the expected pollen season. The maintenance phase was continued for 51 days during the peak pollen season. The control group comprised 24 subjects. The symptoms and medication score, levels of allergen-specific serum antibodies throughout the pollen season, and adverse effects with OIT were evaluated.

RESULTS

Participants receiving OIT showed significant improvements in total symptom scores, medication score, and total symptom-medication scores throughout the pollen season compared with the control group. The levels of allergen-specific serum IgG4 were significantly increased in the OIT group but not in the control group throughout the cedar pollen season. Importantly, no severe adverse effects were observed with OIT.

CONCLUSIONS

The new regimen of short-term OIT using the Cry j1-galactomannan conjugate for Japanese cedar pollinosis is effective, relatively safe and induces immune tolerance. Thus, OIT using allergen-galactomannan conjugates may provide a rapid, effective, and thus convenient immunotherapy for pollinosis instead of SLIT or SCIT.

摘要

背景

使用Cry j1-半乳甘露聚糖缀合物进行短期口服免疫疗法(OIT)治疗日本雪松花粉症可能有效且相对安全。然而,尚未确立治疗方案。在本研究中,我们研究了一种具有递增期的新OIT方案,并将OIT的维持期延长至花粉季节的高峰期,以提高OIT的治疗效果和安全性。

方法

进行了一项为期4个月的前瞻性、随机、开放标签试验。参与者被随机分为两组。OIT组包括23名受试者。递增期在预期花粉季节前1个月开始。维持期在花粉高峰期持续51天。对照组包括24名受试者。评估了整个花粉季节的症状和用药评分、过敏原特异性血清抗体水平以及OIT的不良反应。

结果

与对照组相比,接受OIT的参与者在整个花粉季节的总症状评分、用药评分和总症状-用药评分方面有显著改善。在整个雪松花粉季节,OIT组的过敏原特异性血清IgG4水平显著升高,而对照组则没有。重要的是,OIT未观察到严重不良反应。

结论

使用Cry j1-半乳甘露聚糖缀合物进行短期OIT治疗日本雪松花粉症的新方案有效、相对安全且可诱导免疫耐受。因此,使用过敏原-半乳甘露聚糖缀合物的OIT可能为花粉症提供一种快速、有效且方便的免疫疗法,替代舌下免疫疗法(SLIT)或皮下免疫疗法(SCIT)。

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