Safety and onset time of modified Yupingfeng nasal spray versus mometasone furoate nasal spray on house dust mites-induced moderate to severe allergic rhinitis: A prospective, multicenter, randomized, open-label, parallel-group clinical trial

IF 5.4 2区医学 Q1 CHEMISTRY, MEDICINAL Journal of ethnopharmacology Pub Date : 2025-03-26 Epub Date: 2025-03-01 DOI:10.1016/j.jep.2025.119574

Huan Wang , Ting Liu , Chao Liao , Fangqi Liang , Li Tian

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Abstract

Ethnopharmacological relevance

House dust mite (HDM)-induced allergic rhinitis (AR) is a significant global health issue, leading to considerable illness and disability worldwide. In traditional Chinese medicine, Modified Yupingfeng Nasal Spray (MYN) is believed to support defense systems, and regulate immune defense systems.

Aim of the study

Previous research has shown that both MYN and mometasone furoate nasal spray (MFN) can alleviate symptoms of HDM-induced AR. However, the safety and onset time of MYN compared to MFN for treating HDM-induced AR remain unclear. This study aimed to explore the onset time, safety, and potential mechanisms of MYN and MFN in the treatment of HDM-induced AR.

Methods

In a multicenter, randomized, open-label, parallel-arm trial, 207 patients with AR who tested positive for HDMs allergens (≥2+) were randomly assigned to receive either MYN or MFN treatment. The primary endpoint was the onset time of AR remission. Additionally, 9 patients were randomly selected from each group to investigate potential mechanisms.

Results

Compared to MFN (12.05 ± 1.07 days), MYN (21.56 ± 1.92 days) had a slower onset time in controlling AR symptoms. However, there was no significant difference in cumulative remission of AR between MYN and MFN after 77 days of treatment. At the end of the study, no significant difference in disease control rates was observed between MYN (89.00%) and MFN (96.04%) (P > 0.05). MYN treatment significantly increased PTEN mRNA levels in nasal mucosal epithelial cells and serum IL-10, while reducing NF-κΒ and TSLP levels in nasal lavage fluid, as well as serum IL-6 and TNF-α (P < 0.05).

Conclusions

Both MYN and MFN effectively reduce AR symptoms; however, MFN acts more quickly than MYN in relieving these symptoms, while MYN is associated with fewer side effects. The therapeutic effects of MYN may be linked to the regulation of the PTEN/NF-κB/TSLP signaling pathway.

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改良雨屏风鼻喷雾剂与糠酸莫米松鼻喷雾剂治疗屋尘螨致中重度变应性鼻炎的安全性和起效时间：一项前瞻性、多中心、随机、开放标签、平行组临床试验

民族药理学相关性：屋尘螨（HDM）引起的过敏性鼻炎（AR）是一个重要的全球健康问题，在世界范围内导致相当多的疾病和残疾。在中医中，改良玉屏风鼻喷雾剂（MYN）被认为是支持防御系统，调节免疫防御系统。研究目的：既往研究表明，MYN和糠酸莫米松鼻喷雾剂（MFN）均可缓解hdm诱导的AR症状。然而，与MFN相比，MYN治疗hdm诱导AR的安全性和起效时间尚不清楚。本研究旨在探讨MYN和MFN治疗hdm诱导AR的起效时间、安全性和潜在机制。方法：在一项多中心、随机、开放标签、平行对照试验中，207例hdm过敏原（≥2+）检测呈阳性的AR患者被随机分配接受MYN或MFN治疗。主要终点是AR缓解的开始时间。另外，每组随机抽取9例患者，探讨可能的发病机制。结果：与MFN（12.05±1.07天）相比，MYN（21.56±1.92天）在控制AR症状方面起效时间较慢。然而，在治疗77天后，MYN和MFN之间的AR累积缓解没有显著差异。研究结束时，MYN组（89.00%）和MFN组（96.04%）的疾病控制率无显著差异（P < 0.05）。MYN治疗显著提高鼻黏膜上皮细胞PTEN mRNA水平和血清IL-10水平，降低鼻灌洗液NF-κΒ和TSLP水平以及血清IL-6和TNF-α水平(结论：MYN和MFN均能有效减轻AR症状；然而，MFN在缓解这些症状方面比MYN更快，而MYN的副作用更少。MYN的治疗作用可能与PTEN/NF-κB/TSLP信号通路的调控有关。

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来源期刊

Journal of ethnopharmacology 医学-全科医学与补充医学

CiteScore

10.30

自引率

5.60%

发文量

967

审稿时长

77 days

期刊介绍： The Journal of Ethnopharmacology is dedicated to the exchange of information and understandings about people''s use of plants, fungi, animals, microorganisms and minerals and their biological and pharmacological effects based on the principles established through international conventions. Early people confronted with illness and disease, discovered a wealth of useful therapeutic agents in the plant and animal kingdoms. The empirical knowledge of these medicinal substances and their toxic potential was passed on by oral tradition and sometimes recorded in herbals and other texts on materia medica. Many valuable drugs of today (e.g., atropine, ephedrine, tubocurarine, digoxin, reserpine) came into use through the study of indigenous remedies. Chemists continue to use plant-derived drugs (e.g., morphine, taxol, physostigmine, quinidine, emetine) as prototypes in their attempts to develop more effective and less toxic medicinals.