過敏性鼻炎患者經絡電傳導之臨床試驗設計研究

A Clinical Investigational Design for the study of Ryodoraku on Allergic Rhinitis Patients

鄭雅菁(Ya-Ching Cheng)

指導教授 ： 張炎林

中原大學/工學院/生物醫學工程學系/碩士(2009年)

https://doi.org/10.6840/cycu200900458

摘要

過敏性鼻炎是一項全球性的健康議題，其患者約佔世界人口的15%至30%，且罹患人口仍不斷在上升。以台灣而言，過敏性鼻炎是台灣最常見的過敏性疾病，約有1/3的兒童患有此疾病，常見的併發症如氣喘，因此是值得研究與探討的一個重要議題。
日本京都大學中古義雄（Dr. Yoshio Nakatani）教授於1949年開始研究皮膚電阻與病狀之關係，發現許多內臟疾病的患者都會出現特定的皮膚電阻反應模式，在皮膚上排列許多容易通電的反應點（良導點），而這些良導點與中醫針灸學的經穴位置幾乎是一致的。
本研究收集48位過敏性鼻炎的病患，在療程開始前需簽立同意書，確立診斷後接受第一次的良導絡測試並填寫RSOM-31評估量表，給予受試者第二代抗組織胺口服藥Cetirizine 10mg，每日一次，於回診時接受經絡電位測量儀之量測，採自我用藥前後對照試方式為期二週。所有紀錄之資料經由整理統計後，再進行分析比較治療前後之經絡電傳導。
根據治療前後填寫RSOM-31評估量表，結果統計有顯著差異水準(p <0.05)；以整體十二經絡治療前後來比較發現手厥陰心包經和足太陰脾經達顯著差異水準(p < 0.05)。
本研究參照醫療器材優良臨床試驗基準執行臨床試驗，且已通過署立桃園醫院人體試驗委員會之核准，並依赫爾辛基宣言的精神及國內相關法令的規定，確保試驗對象之生命、健康、個人隱私及尊嚴，並依計畫書內容執行國內相關法令的規定通報嚴重不良反應事件，提供所需的所有相關資訊給人體試驗委員會，以作確保受試者權益。

關鍵字

良導絡 ； 醫療器材優良臨床試驗 ； 人體試驗委員會 ； 過敏性鼻炎

並列摘要

The allergic rhinitis is a global health issue. There are about 15% to
30% patients of the world population suffered from this disease, and the
trend is getting raised constantly. In Taiwan, the allergic rhinitis is the most
common allergic disease, and there are nearly 1/3 Taiwanese children
suffering from this disease. It’s common to see that Asthma is coming with
the complications. Therefore, it’s an important topic for us to study.
Dr. Yoshio Nakatani, professor of the Kyoto University in Japanese,
began to study the relationship between the skin resistance and the
symptom of the allergic rhinitis in 1949. He found that there were a lot of
patients of the viscera disease present a specific skin resistance；these
conductive points shown on the skin almost match with the Chinese
medicine acupuncture points.
In this research we collected 48 patients, who were suffered from
allergic rhinitis, into the clinical investigation. The patients needed to sign
the consent letter before the course of the treatment. We offered the
experimenters an oral medicine (Cetirizine) 10mg once a day, and the
course of the treatment were lasting for two weeks. We measured the
meridian conduction value(via the medical equipment: Ryodoraku). All the
measured data would be analyzed and compared .
According to the before and after the treatment to fill in the RSOM-31
evaluation, the results show that there are significant difference in
“Pericardium meridian of Hand-Jueyin” ， “Spleen meridian of
Foot-Taiyin” (p <0.05 ) among the 12 meridians.
This research followed the Good Clinical Practice of medical devices
in Taiwan and was approved by the IRB in the Tao-Yuan General
Hospital .Also followed by the spirit of the Declaration of Helsinki, and
related regulations had followed to insure patient's life, health , personal
privacy and dignity. It was also according to the related regulations to
notify serious adverse reactions in order to ensure patients’ rights.

並列關鍵字

Ryodoraku ； Good Clinical Practice ； IRB ； Allergic rhinitis

參考文獻

30. 陳修宜、徐茂銘，過敏性鼻炎的治療原則，當代醫學，28:10=336，p9-14， 2001

31. 李正廷、王興萬，過敏性鼻炎的診斷，中華民國耳鼻喉科醫學會， 36(5)，p29-31，2001

5. Bousquet J，Bullinger M，Fayol C，et al: Assessment of quality of life in patients with perennial allergic rhinitis with the French version of the SF-36 Health Status Questionnaire. J Allergy Clin Immunol 1994; 94:182-8.

7. Artur Fedorowaki,Andrzej Steciwko,and Edward Ziobro,Variability of electric skin conductivity on selected points as a potential diagnostic and prognostic test in asthmatic children”,2nd International Conference on Bioelectromagnetism,AUSTRALIA:169-170,1998

9. A. B. Kay，“Allergy and allergic diseases”. First of two parts， N. Engl. J. Med. vol. 344，no. 1，pp. 30-37，Jan. 2001.