楊賢鴻 長庚大學
過敏性鼻炎為台灣重要的疾病，其盛行率約為20-30%1，且有逐年增加之趨勢，基於對疾病之病理機轉之認識，近代醫學已發展出許多種治療方法，但對於反覆再發且影響精神狀態與生活品質之患者，並無進一步較佳之方式。中藥之使用對於此階段的患者，已於臨床上發現有顯著的療效，且對於免疫功能有一定的調整作用2-5，其中，「補氣藥」佔有極為重要的角色，而其在細胞激素之研究方面，亦有部分進展。 但對於過敏反應中重要之抗原提交細胞作用，尤以樹突狀細胞為要，補氣藥作用於人體之反應，尚未有大規模之探討。故本試驗之目的在進行較大規模臨床試驗，以20歲至50歲之成年人為主，篩選出有過敏性鼻炎症狀之患者納入試驗，預計於兩年間收納110-120位個案，再進行隨機分配分成實驗組與對照組各50-60人，其中實驗組服用中藥補中益氣湯3gm，對照組服用安慰劑3gm，均為一天服用三次，於兩個月的期間內，定時監測症狀改善程度、生活品質改變與血液中免疫相關之T細胞、樹突狀細胞等功能與數量以及血中細胞激素IL-10、IL-12與塵?相關IgE濃度，評估與治療期間，受試者與負責評估之臨床醫師均無法得知其分配之組別，三個月後再行解密並統計分析補氣藥對於過敏性鼻炎之療效與其免疫機轉並加以性別分析與差異評估，以實證醫學精神進行補氣藥對過敏性鼻炎之療效評估與機轉探討。
關鍵詞：過敏性鼻炎，補氣藥，藥理機轉，臨床試驗，免疫機轉，性別分析
Effect of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis, a Double-blind, Randomized Control Trial
Yang Sien-Hung Chang Chung University
Allergic rhinitis is the type I hypersensitivity reaction of nasal mucosa to environmental allergen. It is characterized by one or more symptoms including sneezing, itching , rhinorrhea and nasal congestion. The prevalence of allergic rhinitis in Taiwan is approximately 20%-30% and increases annually. However, symptom relapse still bothered the majority of patients though there were certain advances in western medicine. In addition, side effects of western medicine, such as lethargy, mouth dryness after taking anti-histamine and immunosuppression after using steroid are also concerned by patient. Traditional Chinese medicine has been used widely in Taiwan for several disease, especially allergic diseases, such as allergic rhinitis. Among all Chinese herbal products, qi-tonifying regimen play a central role for allergic diseases control. Bu-zhong-yi-qi-tang (BZYQT), one of the famous qi-tonifying herbal products, has been proved to have immuno-modulation effect in previous studies. However, proof of clinical investigation of therapeutic efficacy and cellular level response are still lacking. In this study, a double-blinded, randomized, placebo control design is applied and total110- 120 intermittent allergic rhinitis patients will be enrolled in our study. All subjects will be divided into BZYQT and placebo control groups, each group will have 50-60 subjects. Subjects of BZYQT group will receive capsule of BZYQT, 3gm tid, 9gm a day, while control group will receive similar placebo capsule with same scheme. Total 2 month treatment course will be done. Clinical evaluation, including symptom severity, quality of life and chronic fatigue degree will be done once per month and one month after completed treatment. Additionally, various parameters for immunologic response will be checked before and after the treatment, including the total IgE amount, the ratio of CD4/CD8 of T lymphocytes, the profile of cytokine such as IL-4,IL-5,IL-8,IL-10,IL-13, IFN-γ as well as PGE2, LTC4, sICAM-1 , the mRNA expression of COX2 and neutrophil phagocytosis. Dendritic cell function, presumably the most important immune-response inducer, will also be checked through test for IL-10 and IL-12. Results will be analyzed statistically including gender analysis. We hope that therapeutic efficacy and possible cellular mechanism of immune-modulation will be elucidated after completing this clinical trial.
