Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Department of Otorhinolaryngology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
Sci Rep. 2017 Apr 11;7:46142. doi: 10.1038/srep46142.
Current allergen-specific immunotherapy (AIT) for pollinosis requires long-term treatment with potentially severe side effects. Therefore, development of an AIT that is safe and more convenient with a shorter regimen is needed. This prospective, double-blind, placebo-controlled trial randomized 55 participants with Japanese cedar pollinosis (JCP) to active or placebo groups to test the safety and efficacy of short-term oral immunotherapy (OIT) with Cry j 1-galactomannan conjugate for JCP. Mean symptom-medication score as the primary outcome in the active group improved 27.8% relative to the placebo group during the entire pollen season. As the secondary outcomes, mean medication score in active group improved significantly, by 56.2%, compared with placebo during the entire pollen season. Mean total symptom score was similar between active and placebo groups during the entire pollen season. There were no severe treatment-emergent adverse events in the active and placebo groups. Therefore short-term OIT with Cry j 1-galactomannan conjugate is safe, and effective for reducing the amount of medication use for JCP.
目前针对花粉症的变应原特异性免疫疗法（AIT）需要长期治疗，且可能存在严重的副作用。因此，需要开发一种更安全、更方便、疗程更短的 AIT。本前瞻性、双盲、安慰剂对照试验将 55 名日本扁柏花粉症（JCP）患者随机分为活性组或安慰剂组，以测试 Cry j 1-半乳甘露聚糖缀合物的短期口服免疫疗法（OIT）治疗 JCP 的安全性和有效性。在整个花粉季节，活性组的主要结局——症状-药物评分的平均改善率相对安慰剂组提高了 27.8%。作为次要结局，在整个花粉季节，活性组的药物评分平均改善了 56.2%，显著优于安慰剂组。在整个花粉季节，活性组和安慰剂组的总症状评分相似。活性组和安慰剂组均未发生严重的治疗相关不良事件。因此，Cry j 1-半乳甘露聚糖缀合物的短期 OIT 是安全有效的，可以减少 JCP 的用药量。
