Fang Dandan, Zhang Xu, Li Jingyun, Zhang Luo, Zhang Yuan
Department of Allergy, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Department of Otolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Expert Rev Clin Immunol. 2025 Jun;21(6):731-743. doi: 10.1080/1744666X.2025.2504987. Epub 2025 May 14.
Allergic rhinitis (AR) is global health concern with an increasing prevalence. Among them, pollen-induced AR (PIAR) exhibits more severe and intense symptoms, decreased quality of life, prominent local inflammation, and is thus more challenging to control. Due to the difficulties in disease control, in recent years, an increasing number of treatment methods, including pharmacotherapy, allergen-specific immunotherapy, and newly developed biologics, have focused on PIAR. It has been shown that the pollen exposure has a significant impact on the symptoms of PIAR and the efficacy of intervention. From this perspective, clinical trials for PIAR need to take full account of pollen exposure, especially when assessing efficacy.
This review summarized the effect of pollen exposure on PIAR, including immune responses, symptoms and clinic visits. Current definitions for the pollen season (PS) and the peak pollen season (PPS) are discussed. Based on the previous PIAR-related clinical studies and the available recommendations for clinical trial design, a detailed account of trial protocols which fully considered pollen exposure is provided.
Pollen exposure has a significant impact on PIAR. With fully considering the pollen exposure in the clinical trial design for PIAR, future protocols for PIAR-related studies may be more objective and better harmonized and, therefore, comparable.
变应性鼻炎（AR）是一个日益受到全球关注的健康问题，其患病率不断上升。其中，花粉诱导的AR（PIAR）症状更为严重和强烈，生活质量下降，局部炎症突出，因此更具控制挑战性。由于疾病控制存在困难，近年来，越来越多的治疗方法，包括药物治疗、变应原特异性免疫治疗和新开发的生物制剂，都聚焦于PIAR。研究表明，花粉暴露对PIAR的症状和干预效果有显著影响。从这个角度来看，PIAR的临床试验需要充分考虑花粉暴露，尤其是在评估疗效时。
本综述总结了花粉暴露对PIAR的影响，包括免疫反应、症状和门诊就诊情况。讨论了花粉季节（PS）和花粉高峰期（PPS）的当前定义。基于以往与PIAR相关的临床研究以及临床试验设计的现有建议，详细介绍了充分考虑花粉暴露的试验方案。
花粉暴露对PIAR有显著影响。在PIAR的临床试验设计中充分考虑花粉暴露，未来与PIAR相关研究的方案可能会更加客观、协调一致，因此具有可比性。
