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    题名: 杞菊地黃丸對乾眼症之臨床療效評估
    其它题名: Clinical Evaluation of the Traditional Chinese Prescription
    作者: 張永賢(Chang,Yung-Hsien)
    贡献者: 中醫學院中西醫結合研究所;中國附醫中醫針灸科
    关键词: 乾眼症;杞菊地黃丸;Dry edy;Chi-ju-di-huang-wan
    日期: 2001-12-31
    上传时间: 2009-09-01 13:32:02 (UTC+8)
    摘要: 乾眼症(Dry eye)是現代人眼科最常見的疾病之一,由於現代人長期待在有中央空調的空間當中,空氣乾燥、濕度降低、淚液蒸發快,而室外空氣污染嚴重,更易導致眼瞼及結膜發炎。眼睛便常常容易感到乾澀,再加上資訊時代的來臨、人口的老化,藥物的濫用,電腦終端機的普及,隱形眼鏡的風行等等,的確讓乾眼症成為一種現代人的流行文明病。由於乾眼症的發生率,在48到91歲的正常人約有14.4%,而男性11.4%,女性16.7%有乾眼症,小於60歲佔8.4%,大於80歲佔19.0%。在總人口中,乾眼症的病人很多,常造成乾澀、疼痛、異物感、畏光等不適,嚴重者會影響日常生活及人際關係。在西醫中,目前是給予人工淚液,或抗自體免疫反應的藥(如:cyclosporin),或有用手術將淚管出口阻塞,以使淚液能保留在眼內的時間加強,但效果均有限。有鑑於此,中國醫藥學院附設醫院中醫部與眼科擬以進行『中藥方劑對乾眼症治療』之研究,採用中藥固有劑杞菊地黃丸治療乾眼症之療效評估。本計劃擬收集90位大於20歲至75歲願意簽立「同意書」之符合乾眼症診斷的病人,隨機分為二組,二組皆接受人工淚液,但實驗組接受中藥(杞菊地黃丸),對照組接受安慰劑,並針對兩者對於乾眼症(Dry eye)之療效作觀察與比較。並以杞菊地黃丸這個常用之眼科中藥處方進行符合GCP的中藥臨床試驗,以印證醫藥典籍對中醫藥處方療效的記載。

    Dry eye is a very common disease in the modern society owing to the long-time staying in the air-conditioned environment, the dry air, decreasing humidity and fast vaporization of tears. Moreover, the state of air pollution, the aging of society, over-using of drugs, increasing the popularization of personal computers and terminals as well as the fashion of contact lens all make the symptom of dry eye getting even worse. Dry can easily causes inflammation of eyelid, conjuntiva and cornea. Dry eye had become a very popular disease in modern civilization. The incidence of dry-eye in the population aged from 48 to 91 is about 8.4%, among which male is 11.4% and female16.7%. They are suffering from eye dryness, pain, intrusive foreign body sensation and photophobia. If the condition is getting worse, it will influence the patient’s normal life and social relationship. Medicines used now include artificial tear and immunosuppressive medicine such as cyclosporin. As for operations, they seal the putumn of canalicular in order to keep tears staying for a longer time in the eyes, but the effects are limited. Therefore, the Department of Chinese Medical Science and Ophthalmology in the China Medical College Hospital are planning to do a research on the therapeutic effects of Chinese herbal pharmaceutical treatment for dry-eye patients. Chi-ju-di-huang-wan is the commonly used Chinese herbal medicine for eye therapy but there are no therapeutic reports on the effect of chi-ju-di-huang-wan so far. In our study, 90 dry-eye patients will be enrolled. Every patient will informed and sign the agreements before engaging in the experiment. The patients randomly divided into two groups. The experimental group will be treated with topical eye drop and Chinese herbal medicine. The control group will be dealt with topical eye drop and placebo. Both groups will be observed and the results are compared to find the therapeutic effects of the different medical treatments. Chi-ju-di-huang-wan will be u sed in the experiment conforming GCP standards in order to prove its therapeutic effects ever recorded in the Chinese medical books.
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