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標題: | 生物共振波應用於改善糖尿病之研究 Study of Biological Resonance Waves applied to improving Diabetes Mellitus |
作者: | Wen-Chieh Chang 張文杰 |
指導教授: | 高成炎(Cheng-Yan Kao) |
關鍵字: | 生物共振波,微電流刺激,糖尿病,糖化血色素,臨床試驗, bRWs,MENS,Diabetes Mellitus,in vitro,in vivo,STZ,HbA1c,clinical trial, |
出版年 : | 2017 |
學位: | 博士 |
摘要: | 糖尿病(Diabetes Mellitus)是當前醫療重要的課題,依據世界衞生組織2017年最新的統計,全球75億總人口中,患病人口已逾4億人,約佔5.3%,就單一疾病而言,足見其盛行率。目前的糖尿病治療方式,主要有二種:口服藥物、胰島素注射,副作用大,易導致最終肝、腎功能衰竭。一種新的糖尿病療法,具輔助減藥、副作用小、不易影響肝、腎功能特質,是當務之急,也是糖尿病醫療領域所期待的。在此研究中,我們發展了名為生物共振波(bRWs, biological Resonance waves)的物理性、非侵入性輔助醫療裝置與技術,歷經從基礎的細胞、動物試驗,到人體臨床試驗,證實其效度有機會符合醫療領域目前的需求與應用。
本研究首先進行生物共振波技術之微電流電刺激(MENS, Microcurrent Electrical Nerve Stimulation)軟硬設計與驗證,在醫療安全規範上,通過了IEC 60601-1: 2005系列的認證,以為臨床試驗倫理審查之基礎。同時,針對生物共振波糖尿病頻率之探索,經過科學分析與歸納,研究出可以舒緩高血糖病況之內容,以進行後續之生物醫療驗證。這是一個由下而上的研究,最先利用HaCaT細胞進行體外試驗(In vitro),了解共振波對粒線體調節葡萄糖能力之影響,提供細胞層次之驗證;接著,就臨床前試驗部份(Pre-Clinical),以STZ誘發糖尿病鼠,比較其應用共振波療法後之糖化血色素(HbA1c)與口服血糖耐受度(OGTT)表現,提供體內安全與效度驗證(in vivo),並進行可能之機制探討;最後,經由正式的試驗倫理及衞福部審查,進行為期20個月宜蘭羅東聖母醫院之人體臨床試驗,收案人數達72人,實際驗證此新醫療輔助技術之療效。很欣慰地,此研究也促成了台大醫院為首的4家醫學中心聯合收案160人之查驗登記用臨床試驗,並在經濟部快速審查臨床試驗計畫的經費大力支持下,朝向生物共振波新醫療應用的目標邁進,期望能為台灣的生技醫療注入新血。 Diabetes Mellitus is an essential disease of metabolism for medicine nowadays, the patients of DM in 2017 will reach more than 400 million globally with a steady growth rate. The prevalence of this mono chronic disease would be about 5.3% among the population of total 7.5 billion in the world. The two main medical treatments of DM are oral drug and insulin injection which have apparent side effects and mostly derive to liver and kidney failures in the aftermath. Therefore, a novel treatment with less side-effect and with no harm for liver or kidney is in demand. In this study, we develop a non-invasive physical therapy of bRWs (biological Resonance Waves) including the device and treatment through different levels of verification from cell, animal, to clinical trial for the medical requirements. This thesis firstly focuses on the hardware and software design, and implementation of bRWs technology with MENS (MENS, Microcurrent Electrical Nerve Stimulation), as well as the essential frequencies applied for it are discovered from the data mining of scientific induction for optimization to biomedical efficacy. Based on a bottom-up strategy, HaCaT cell is applied to investigating energy utilization of mitochondria in vitro affected by bRWs to study the capability of glucose regulation. Then, the pre-clinical animal assay of DM induced by STZ method shows a great improvement in HbA1c and OGTT to help on the verification of in vivo efficacy for DM and provides the possible clues for toxicity and medical mechanism. Finally, a 20 month period and 72 enrollments of clinical trial permitted by IRB and TFDA to run for the last mile of this bRWs’ study proves a solid improvement of DM on the primary endpoint of HbA1c to achieve this systematic investigation of bRWs therapy. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/20596 |
DOI: | 10.6342/NTU201701685 |
全文授權: | 未授權 |
顯示於系所單位: | 生醫電子與資訊學研究所 |
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