Department of Clinical Laboratory, Osaka Prefectural Hospital Organization Osaka Habikino Medical Center, Habikino City, Osaka 583-8588, Japan.
Secretariat, Osaka Prefectural Hospital Organization Osaka Habikino Medical Center, Habikino City, Osaka 583-8588, Japan.
Asian Pac J Allergy Immunol. 2022 Dec;40(4):386-392. doi: 10.12932/AP-050619-0575.
In allergic models, administration of rice that expresses a hybrid peptide consisting of 7 major T cell epitopes of Cry j 1 and Cry j 2 (7Crp), suppressed allergic symptoms, IgE elevation and specific T cell response to Japanese cedar pollen.
To evaluate the efficacy and safety of 7Crp-expressing rice in patients with Japanese cedar pollinosis.
A 24-week randomized, double-blind, placebo-controlled study was performed to see the efficacy of 7Crp on allergic symptoms using scoring systems, in which 45 patients were assigned to take either 5 g, 20 g test rice, or placebo daily. A 96-week open study was also conducted to determine its inhibitory effect on serum IgE and T cell proliferative response for Japanese cedar pollen, in which 10 patients consumed 5 g test rice daily.
No adverse events associated with the test rice occurred, and the intake rate was more than 96%. The test rice did not show suppression of symptoms related to Japanese cedar pollinosis within 24 weeks. However, intake of 5 g test rice led to a significant decrease in T cell response to Japanese cedar pollen during and after the second disperse season in a 96-week open trial, whereas the specific IgE titer remained unchanged.
Tolerability and safety of 7Crp-expressing rice was accepted. Daily intake of up to 20 g transgenic rice did not provide beneficial effects on Japanese cedar pollinosis within 24 weeks, however, continuous intake of 5 g rice might reduce allergen specific T cell response.
在过敏模型中，给予表达由 Cry j 1 和 Cry j 2 的 7 个主要 T 细胞表位组成的杂合肽的大米（7Crp），可抑制过敏症状、IgE 升高和对日本扁柏花粉的特异性 T 细胞反应。
评估表达 7Crp 的大米在日本扁柏花粉症患者中的疗效和安全性。
进行了一项为期 24 周的随机、双盲、安慰剂对照研究，使用评分系统评估 7Crp 对过敏症状的疗效，其中 45 名患者每天服用 5 g、20 g 试验大米或安慰剂。还进行了一项为期 96 周的开放性研究，以确定其对血清 IgE 和日本扁柏花粉 T 细胞增殖反应的抑制作用，其中 10 名患者每天食用 5 g 试验大米。
未发生与试验大米相关的不良事件，摄入率超过 96%。在 24 周内，试验大米并未显示对与日本扁柏花粉症相关症状的抑制作用。然而，在 96 周的开放性试验中，在第二次分散季节期间和之后，摄入 5 g 试验大米导致对日本扁柏花粉的 T 细胞反应显著下降，而特异性 IgE 滴度保持不变。
表达 7Crp 的大米具有良好的耐受性和安全性。每天摄入高达 20 g 的转基因大米在 24 周内对日本扁柏花粉症没有有益的效果，但是持续摄入 5 g 大米可能会降低过敏原特异性 T 细胞反应。
