經由科學方法及臨床確效以達到傳統中藥之現代化   全文下載

Modernization of Chinese Herbal Medicine through Scientific and Clinical Validations

傳統中藥產品本質上由不同藥材組成。因此在品質管制、品質保證及法規管理具諸多挑戰。現今市場上大部份中藥尚無法透過藥品審核程序證明其安全性與有效性。然為能得到大眾的信賴以及將其導入目前的醫療保健體系主流，研究人員、製造廠及管理部門等必須應用嚴謹的科學方法及臨床試驗以確保傳統中藥品質及批次間品質的均一性。因為最終產品的均一性難以界定，更甚的是中藥產程均不經純化步驟，故對產品品質及批次間之均一性端賴原料品質管制及其製程管制。應用現代科技係可監控中藥之品質及其均一性。亦即須設計一良好的臨床試驗方法以證明其安全性及有效性，且中藥製造者必須遵循優良藥品製造標準以及這些產品在執行人體臨床試驗前必須進行非臨床試驗。中藥臨床試驗之基本原則及設計亦應與單一化學成分之西藥相同。目前已有中藥方劑進行隨機、雙盲控制臨床試驗，而這些試驗已證實受試中藥之有效性及顯示無副作用。數千年來傳統的使用經驗能提供我們有關中藥方劑之選用、製備及應用的寶貴指南。因此必須應用如同西方醫學一樣的嚴謹之科學方法及臨床確效，方能被大眾接受。

Traditional herbal products are heterogeneous in nature. They impose a number of challenges to quality control, quality assurance and the regulatory process. Most herbal products on the market today have not been subjected to drug approval process to demonstrated their safety and effectiveness. To gain public trust and to bring these products into the mainstream of today's health care system, the researchers, the manufacturers and the regulatory agency must apply rigorous scientific methodologies and clinical trials to ensure the quality and lotto- lot consistency of the traditional herbal products. Since the identities of the final products are not well defined and there are essentially no purification steps involved in the production of herbal products, the quality and lot-to-lot consistency of the products rely mostly on the quality control of source materials and their manufacturing into final products. Using modern technologies, the quality and consistency of heterogeneous herbal products can be monitored. A well designed clinical trial is the method of choice to prove the safety and effectiveness of a therapeutical products. Manufacturers of the herbal products must adhere to the requirements of Good Manufacturing Practices ( GMPs ) and pre-clinical testing before these products can be tested on humans. The basic principle and design of the clinical trials for herbal products are the same as those for single component chemical products. A number of randomized, double blinded controlled studies have been carried out using herbal formulations. These studies have proven the effectiveness of the herbal products tested and shown little side effects. Thousands of years of traditional use can provide us with valuable guides to the selection, preparation and application of herbal formulations. To be accepted as viable alternatives to Western medicine, the same rigorous methods of scientific and clinical validations must be applied. 傳統中藥產品本質上由不同藥材組成。因此在品質管制、品質保證及法規管理具諸多挑戰。現今市場上大部份中藥尚無法透過藥品審核程序證明其安全性與有效性。然為能得到大眾的信賴以及將其導入目前的醫療保健體系主流，研究人員、製造廠及管理部門等必須應用嚴謹的科學方法及臨床試驗以確保傳統中藥品質及批次間品質的均一性。因為最終產品的均一性難以界定，更甚的是中藥產程均不經純化步驟，故對產品品質及批次間之均一性端賴原料品質管制及其製程管制。應用現代科技係可監控中藥之品質及其均一性。亦即須設計一良好的臨床試驗方法以證明其安全性及有效性，且中藥製造者必須遵循優良藥品製造標準以及這些產品在執行人體臨床試驗前必須進行非臨床試驗。中藥臨床試驗之基本原則及設計亦應與單一化學成分之西藥相同。目前已有中藥方劑進行隨機、雙盲控制臨床試驗，而這些試驗已證實受試中藥之有效性及顯示無副作用。數千年來傳統的使用經驗能提供我們有關中藥方劑之選用、製備及應用的寶貴指南。因此必須應用如同西方醫學一樣的嚴謹之科學方法及臨床確效，方能被大眾接受。