Sterol/sterolins治療過敏性鼻炎之隨機雙盲安慰劑對照式臨床試驗

Efficacy and safety of sterols/sterolins in allergic rhinitis: a randomised double blind placebo-controlled clinical trial

全世界過敏性鼻炎盛行率因空氣品質與環境生態的改變於不斷攀升，雖然它不會造成生命上的威脅但對於生活品質、工作、學業、及生產力皆造成顯著影響，其免疫病理特徵已被證實與TH2細胞所分泌的細胞激素相關。Sterols/sterolins（Moducare(R)）在許多臨床前的研究中證實具有免疫調節及抗發炎的作用，使TH1/TH2趨向平衡，但並無針對過敏性鼻炎的臨床實驗曾發表過。本研究的目的在探討過敏性鼻炎的病人使用sterols/sterolins（Moducare(R)）的臨床療效與其安全性。本先導性隨機雙盲安慰劑對照組試驗共納入40位病人分別接受Moducare(R) 或安慰劑治療12週，並分別在第4、8、12週接受過敏性鼻炎嚴重度與生活品質評估問卷之調查與治療前後血清免疫學分析（IgE, eosinophil cationic protein, eosinophil）來評估其效果。Moducare(R)臨床治療效果採意圖治療分析法（intend-to treat analysis）評估，遺漏值之插補採用LVCF法（Last Value Carried Forward）。結果顯示Moducare(R)治療組中20位進入試驗，12位完成試驗，安慰劑組中20位進入試驗，16位完成試驗，兩組病人在過敏性鼻炎症狀評估表與生活品質評估表分數治療前後雖然都呈現下降趨勢但並無統計上意義，血清免疫學分析在兩組治療前後亦無統計上意義。安全性指標（creatinine, AST, ALT）中兩組病人皆在正常值範圍內，所有病人並無嚴重副作用或不良反應產生。由本研究中可知，Moducare(R)治療過敏性鼻炎的病人在12週的治療中雖然是安全的但並無顯著的臨床療效與血清免疫分析變化。

Objective: Sterols/sterolins (Moducare(R)) have demonstrated immunomodulation and anti-inflammatory effects in preclinical studies, but no clinical trial of patients with allergic rhinitis has yet been published. Thus, our aim was to investigate the safety and efficacy of sterols/sterolins in patients with allergic rhinitis. Methods: The framework was a pilot double-blind randomized controlled clinical trial. Forty patients were randomized to receive Moducare(R) capsules or placebos for 12 weeks. Patients were evaluated at weeks 4, 8 and 12 with symptom severity questionnaires and immunological assays, including: serum total immunoglobulin E (IgE), eosinophil, and eosinophil cationic protein (ECP). The primary efficacy endpoint indicated the mean change of the allergic rhinitis symptoms score in the therapeutic period at week 12; the secondary efficacy endpoints represented the changes of the Mini-Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) monthly score and the immunological assays of IgE, eosinophil and ECP at week 12. Results: A total of 28 patients (70%) completed the 12-week study, with eight patients dropping out of the Moducare(R) group and four patients dropping out of the placebo group. The results showed no significant adverse events of sterols/sterolins in this 12-week study. The results of the allergic rhinitis symptoms score, Mini-RQLQ, total IgE, eosinophil count and ECP value had no statistically significant changes in either group. Conclusions: While sterols/sterolins were well tolerated and safe in patients with allergic rhinitis, no significant clinical and immunological benefits were demonstrated in this 12-week pilot study.