TM02®治疗过敏性鼻炎的临床疗效：症状显著缓解与IL-5下调和过敏性炎症减轻相关。
Clinical Efficacy of TM02® in Allergic Rhinitis: Significant Symptom Alleviation Associated with IL-5 Downregulation and Reduced Allergic Inflammation.
文献信息
| PMID | 42793253 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Hao-Dong Tan |
| 作者单位 | Medicinal Mushroom Research Group (MMRG), Department of Molecular Medicine, Faculty of Medicine, Universiti Malaya, Kuala Lumpur 50603, Malaysia. |
| 期刊 | Current issues in molecular biology |
| SCI 分区 | Q2 |
| IF | 3.9 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 鼻科 |
中文摘要
背景： 过敏性鼻炎（AR）是一种慢性炎症性疾病，严重影响生活质量。尽管现有治疗方法可用，但由于治疗负担，症状控制仍不理想。培养的斜生褐孔菌菌核（TM02®）以其抑制过敏的生物活性而闻名，是一种有前景的AR辅助治疗方法。方法：在108名AR患者中进行了一项随机、双盲临床试验，患者接受TM02®或安慰剂治疗30天。主要结局包括总鼻症状评分（TNSS），反映过去12小时和2周的情况（TNSS12hrs和TNSS2wks），以及过敏性鼻炎控制测试（ARCT）。次要终点是外周免疫生物标志物：IgE、IFNγ、IL-4、IL-5和IL-13。安全性通过不良事件（AEs）和全血细胞计数分析进行评估。统计分析使用广义估计方程（GEE）在改良符合方案集（mPP）中进行。结果：mPP分析（N_TM02® = 25；N_安慰剂 = 31）显示TM02®在总TNSS12hrs、总TNSS2wks和ARCT方面具有显著治疗效果（分别为β = -3.70，p值 < 0.001；β = -4.44，p值 < 0.001；和β = 3.89，p值 = 0.017）。次要终点分析未显示显著变化。然而，在TNSS2wks和IL-5水平变化之间观察到正相关模式（β = 14.94；p值 = 0.003）。治疗组之间在AE发生率和实验室安全性生物标志物方面无显著差异。结论：本研究表明，TM02®减轻了AR症状严重程度，且不良反应最小。其潜在机制可能涉及调节IL-5水平和过敏性炎症。总体而言，TM02®是持续性症状AR的一种潜在辅助或补充治疗选择。
英文摘要
Allergic rhinitis (AR) is a chronic inflammatory disease that substantially affects quality of life. Despite available therapies, symptom control remains suboptimal owing to treatment burden. Cultivated sclerotium of Lignosus rhinocerus (TM02®), known for its allergy-dampening bioactivities, is a promising adjunctive AR treatment. A randomized, double-blinded clinical trial was conducted in 108 AR patients, who received either TM02® or placebo for 30 days. Primary outcomes consisted of Total Nasal Symptom Score (TNSS), reflective of past 12 h and 2 weeks (TNSS12hrs and TNSS2wks), and the Allergic Rhinitis Control Test (ARCT). The secondary endpoints were the peripheral immune biomarkers: IgE, IFNγ, IL-4, IL-5 and IL-13. Safety was assessed with adverse events (AEs) and full blood-counting analyses. Statistical analysis was performed using generalized estimating equation (GEE) in the modified per-protocol (mPP). mPP analysis (N_TM02® = 25; N_placebo = 31) demonstrated significant treatment effectiveness of TM02® in total TNSS12hrs, total TNSS2wks, and ARCT (β = -3.70, p-value < 0.001; β = -4.44, p-value < 0.001; and β = 3.89, p-value = 0.017, respectively). Secondary endpoint analysis did not reveal significant changes. However, a positive associative pattern (β = 14.94; p-value = 0.003) was observed between TNSS2wks and IL-5 level changes. There were no significant differences in AE incidences and laboratory safety biomarkers between treatment arms. The present study revealed that TM02® reduced AR symptom severity with minimal adverse effects. The underlying mechanism may involve the modulation of IL-5 levels and allergic inflammation. Overall, TM02® is a potential adjunctive or complementary treatment option for AR with persistent symptoms.