頁籤選單縮合
題名 | 教學醫院成立中藥臨床試驗中心=The Plan of Teaching Hospital to Estableish Clinical Trial Center of Traditional Chinese Medicine |
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作者 | 蔡金川; | 書刊名 | 中醫藥年報 |
卷期 | 3 2014.12[民103.12] |
頁次 | 頁(105)1-(105)38 |
分類號 | 414.53 |
關鍵詞 | 義大醫院; 中藥臨床試驗中心; 中藥新藥開發; E-Da Hospital; Clinical trail center for Chinese medicine; Exploition of new Chinese medicine; |
語文 | 中文(Chinese) |
中文摘要 | 本計畫之目的是藉由義大醫院中藥臨床試驗中心之成立,以建置符合國際規範之臨床試驗環境,並提昇中醫藥臨床試驗能力與品質、提供中藥新藥開發與藥品療效再評估、及確認中醫醫療器材安全與效能的臨床科學性驗證。在發展目標的導向上,建置中藥臨床試驗中心環境及培育臨床試驗中心人才,定期辦理各專業領域之教育訓練課程。 本中心目前實際執行工作項目說明如下:完成中藥臨床試驗中心的軟硬體擴建及修繕;完成中藥臨床試驗中心申請研究案招募之人才需要;進行第一年理中湯改善大腸激躁症候群患者,收集目標病例人數到達30 人以上;完成本中心將以GMP 藥廠為目標,與傳統藥廠進行藥品的新開發研究;完成臨床試驗教育訓練課程之規劃至少1~2 場。 中藥臨床試驗中心的軟硬體擴建及修繕方面:目前完成相關建設擴建,包含軟硬體設備配置與修改臨床試驗的標準作業程序,添購電子高低溫濕度計兩台、血壓計、溫度計乙台、中醫藥研究叢書等設備配置;中藥臨床試驗中心研究人才之招募方面:本中心101-102 年度承接衛生福利部委託計畫「推動傳統醫藥(材)生技研發類」並聘請一位專案研究助理及工讀生協助計畫執行;本院臨床試驗中心執行兩案以上之中藥臨床試驗案件方面:102 年度中心接受衛生福利部補助執行理中湯改善大腸激躁症候群及預防復發的效果及香砂六君子湯改善胃食道逆流及預防復發的效果臨床試驗,針對理中湯之收案,目前接受治療的11 位受試者(含治療組及對照組)中,有4 位已完成8 週的第一階段治療,有3 位退出試驗,有4 位尚在進行中,3 位完成第二階段追蹤;本研究試驗案為兩年期之雙盲隨機試驗,至目前研究尚進行中無法進行解碼,因此,目前尚無法提供成果分析;臨床試驗教育訓練課程之規畫方面:本中心共辦理4 場臨床試驗教育訓練課程並派員參加院外2 場的臨床試驗相關課程或研討會;本中心将已GMP 藥廠為目標,輔導傳統藥廠對既有成方進行療效確認方面:協助本院內部醫護人員、院外研究人員加入中醫藥臨床試驗研究進行中西醫結合臨床試驗規劃。並接受國內、外醫療機構參訪促進彼此的了解,增進未來國際合作的機會。 為了整合院內臨床試驗之作業流程與規範,由具有中西醫學、藥學、統計學等實務背景之專業人員組織「中藥臨床試驗委員會」,並明訂本中心作業辦法、組織規程、中心組織章程。為了使外界了解本中心的作業辦法及組織架構,設立專屬網站並於6 月完成更新。另外,積極接洽並輔導傳統藥廠對既有成方進行療效確認及新開發等臨床試驗。本中心亦與各大學及其他醫療機構密切合作,以開拓中醫新診斷儀器與醫療器材的開發,提升中醫藥的療效與功能性。 |
英文摘要 | The purpose of this study is to set up the clinical trail center for Chinese Medicine in order to fellow the regulations for environment of clinical trail. Then, we can improve the abilities and qualities of clinical trail, provide the evulations of new medicine development and medicine effectiveness, and confirm the scientific safety and efficency of Chinese medicine equipments. The targets of development of clinical trail center are to provide the trail environment, to do talent cultivation, and to conduct education training programs. Currently, this center implements the working projects, such as to finish the improvement and extention of software and hardware, to finish the requirement of research talent, to enroll the 30 patients with irritable bowel syndrome into the Li Chung Tong treatment program in first year, to develop the new Chinese medicine researches from the traditional and GMP pharmaceutical factories, and to conduct the education training programs of clinical trail at least twice. About hardware and software development and renovation, this Trail Center had already finished some issues, such as to arrange the hardware and software equipments, to edit standard operating procedures of clinical trail, to buy new electronic hyprothermograph and hamnatodynamometer, and to buy new medical research reference books. About the talent recuritment, this center involved the “Promoting Traditional Medicine and Biotechnolgy Research Project” from Ministry of Health and Welfare. In addition, the center hired one research assistant and one part-time employee to assist this project. For Chinese Medicine Clinical Trail, this center finished two trails this year, such as “the effects of Li Chung Tong to improve symptoms and to prevent the recurrence of irritable bowel syndrome” and “the effects of Xiangsha-liujunzi-tang to improve symptoms and to prevent the recurrence of reflux esophagitis”. About the trail of“the effects of Li Chung Tong to improve symptoms and to prevent the recurrence of irritable bowel syndrome”, we had 11 participants: 4 participants already finished the first treatment period, 3 participants drawed out, 4 participants is still attending the trail, 3 participants already finished the second treatment period. This project is two-year trail and uses by double blind method ; in addition, it is not already finished to do the data decoding of results. This year, we conducted 4 education training courses of clinical trail. Also we sent our employees to attend the training courses and conferences. Therefore, this center tried to assist doctors, nurses, researches to join Chinese medicine researches and to plan clinical trail projects. Otherwise, we received the foreign visiting groups and institiutes in order to improve the cooperated opportunities. We integrated the processes and regulations of clinical trail inside hospital by professionals who are the members of Chinese Medicine Clinical Trail Committee. In order to let people know about this center, we also set up and revise the exclusive network frontpage. Besides, we contact and train the traditional pharmaceutical factories to develop the new clinical trails and to confirm the effectiveness of traditional medicines. In fact, the center is also to cooperate with other universities and healthcare institiues in order to develop the new diagnose equipments and therapy materials and to promote the functionality and effectiveness of Chinese medicines. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。