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

IF 4.2 2区医学 Q2 ALLERGY

Clinical and Translational Allergy Pub Date : 2025-12-01 DOI:10.1002/clt2.70123

Yutong Sima, Jianfeng Liu, Jinfeng Liu, Gang Zheng, Yi Yang, Xiaolin Peng, Yan Qi, 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, Luo Zhang

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引用次数: 0

Abstract

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). Subgroup analysis revealed that the ELP + INCS group had significantly lower concentrations of granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-4, granulocyte colony-stimulating factor (G-CSF) and thrombopoietin (Tpo) compared to the INCS group. No significant difference was observed in the incidence of AEs between the two groups.

Conclusion

The combination of ELP and INCS represents an effective and well-tolerated treatment strategy for patients with CRSwNP following endoscopic sinus surgery.

Trial Registration

The trial was registered with the Chinese Clinical Trial Registry (www.chictr.org.cn; registration number ChiCTR2200055224)

Abstract Image

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桉叶精油、柠檬烯和蒎烯肠溶胶囊治疗慢性鼻窦炎术后鼻息肉的疗效和安全性的多中心、随机、对照临床试验

背景：桉树精油、柠檬烯和蒎烯肠溶胶囊（ELP）是治疗慢性鼻窦炎伴鼻息肉（CRSwNP）的典型黏液活性药物。然而，关于其在这一人群中的有效性的可靠证据仍然有限。本研究旨在评估ELP的临床疗效和安全性，特别是对鼻纤毛功能和炎症生物标志物的影响。方法：这项前瞻性、随机、对照、多中心临床研究纳入了接受内窥镜鼻窦手术（ESS）的CRSwNP患者。参与者按1:2的比例随机分配到鼻内皮质类固醇（INCS）组或ELP + INCS组。临床结果在12周内通过鼻窦计算机断层扫描、鼻内窥镜检查、糖精试验（STs）和22项鼻窦结局试验（SNOT-22）进行评估。通过Luminex检测对鼻分泌物局部炎症进行量化，并在整个研究期间监测不良反应（ae）。结果：最终共纳入174例CRSwNP患者。与INCS组相比，ELP + INCS组在lnd - mackay评分（LMS）和lnd - kennedy评分（LKS）方面表现出更大的改善（p分别= 0.029和0.025）。ELP + INCS组中较高比例的患者在流鼻涕评分（第8周和第12周）、咳嗽评分（第4周）和沮丧评分（第8周）方面也有改善。此外，ELP + INCS组在第4周的STT显著缩短（p = 0.015）。亚组分析显示，与INCS组相比，ELP + INCS组的粒细胞-巨噬细胞集落刺激因子（GM-CSF）、白细胞介素(IL)-4、粒细胞集落刺激因子（G-CSF）和血小板生成素（Tpo）浓度显著降低。两组间不良事件发生率无显著差异。结论：ELP联合INCS是内镜鼻窦手术后CRSwNP患者有效且耐受性良好的治疗策略。试验注册：在中国临床试验注册中心注册（www.chictr.org.cn；注册号ChiCTR2200055224）。

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来源期刊

Clinical and Translational Allergy Immunology and Microbiology-Immunology

CiteScore

7.50

自引率

4.50%

发文量

117

审稿时长

12 weeks

期刊介绍： Clinical and Translational Allergy, one of several journals in the portfolio of the European Academy of Allergy and Clinical Immunology, provides a platform for the dissemination of allergy research and reviews, as well as EAACI position papers, task force reports and guidelines, amongst an international scientific audience. Clinical and Translational Allergy accepts clinical and translational research in the following areas and other related topics: asthma, rhinitis, rhinosinusitis, drug hypersensitivity, allergic conjunctivitis, allergic skin diseases, atopic eczema, urticaria, angioedema, venom hypersensitivity, anaphylaxis, food allergy, immunotherapy, immune modulators and biologics, animal models of allergic disease, immune mechanisms, or any other topic related to allergic disease.