A Multicenter, Randomized, Controlled Clinical Trial on the Efficacy and Safety of Eucalyptol, Limonene, and Pinene Enteric Capsules in the Treatment of Chronic Rhinosinusitis With Nasal Polyps Postoperatively

作者：Yutong Sima, Jianfeng Liu, Jinfeng Liu, Gang Zheng, Yi Yang, Xiaolin Peng, Qi Yan, Xiaowei Wang, Xiaowei Wang, Yu Zhao, Yanjun Wang, Penglong Zhao, Jinming Zhao, Yuan Zhang, Ming Zheng, Chengyao Liu, Xiaohong Song, Yi Dong, Xia Gong, Wei Lv, Zhenlin Wang, Xiangdong Wang, Xiangdong Wang, Luo Zhang · 发表于：Clinical and Translational Allergy · 年份：2025 · DOI：10.1002/clt2.70123 · 被引用次数：1 · 研究领域：Sinusitis and nasal conditions、Allergic Rhinitis and Sensitization、Nasal Surgery and Airway Studies

BACKGROUND: Eucalyptol, limonene, and pinene enteric capsules (ELP) are typical mucoactive drugs used in chronic rhinosinusitis with nasal polyps (CRSwNP). However, reliable evidence regarding its efficacy in this population remains limited. This study aimed to evaluate the clinical efficacy and safety of ELP, particularly on nasal ciliary function and inflammatory biomarkers. METHODS: This prospective, randomized, controlled, multicenter clinical study enrolled CRSwNP patients who underwent endoscopic sinus surgery (ESS). Participants were randomly assigned at a 1:2 ratio to the intranasal corticosteroid (INCS) group or the ELP + INCS group. Clinical outcomes were assessed over 12 weeks using sinus computed tomography, nasal endoscopy, saccharin tests (STs) and the 22-item sinonasal outcome tests (SNOT-22). Local inflammation in nasal secretions were quantified via a Luminex assay, and adverse effects (AEs) was monitored throughout the study period. RESULTS: A total of 174 CRSwNP patients were included in the final analysis. Compared to the INCS group, the ELP + INCS group demonstrated significantly greater improvements in Lund-Mackay score (LMS) and Lund-Kennedy score (LKS) (p = 0.029 and 0.025, respectively). A higher proportion of patients in the ELP + INCS group also showed improvement in the runny nose score (weeks 8 and 12), cough score (week 4), and frustration score (week 8). Furthermore, STT was significantly shorter in the ELP + INCS group at week 4 (p = 0.015). Su...