心血管疾病中药材循证应用的最新进展-英文PPT.ppt

* RMIT University 10th SCICC, Guangzhou, China, 2008 Recent Progress in the Evidence-Based Application of Herbal Medicines for Cardiovascular Diseases Professor Shufeng Zhou, MD, PhD School of Health Sciences WHO Collaborating Center for Traditional Medicine RMIT University, Bundoora, Victoria 3083 Australia Phone: Tel: +61 3 9925 7794; Fax: +61 3 9925 7178 Email: shufeng.zhou@rmit.edu.au 11 April 2008 An Overview of Global Herbal Use All folk medicine includes the use of plant products. 11,145 species of herbal plants worldwide; 534 species of plants for Chinese Medicine. WHO definition – botanical origin, without adulteration of any synthetic drugs. Legal status: food supplements (FDA TGA) – “DSHEA”; drugs/health foods (SFDA of China). US$25 billion; market value ?10?15%/per year. 2 billion in Australia. 40% Caucasian and 80% Asians use or used herbs. Active Components Biotransformation Excretion Absorption Response/Toxicity ?? ?? ?? ?? Preclinical Stage Phase I Phase II Phase III Phase IV Clinical Trials of Herbal Medicines General acceptance of humans Safety and Efficacy More data on safety and Efficacy Challenges for Herbal Clinical trials Dosage formulation: standardized or individualized? Biomarkers? Safety profiles? Pharmacokinetics data? OMEGA FINAL ESTIMATE RSE (%) 95% CONFIDENCE INTERVAL CV (%) LBOUND UBOUND 1，1 0.132 30.2 0.054 0.210 36.3 2，2 0.0318 46.5 0.00279 0.0608 17.8 3，3 0.0001 …. …. …. 1.00 4，4 0.363 47.5 0.0249 0.703 60.3 RESIDUAL VARIABILITY (SIGMA；CV% if proportional, S.D. if additive) 1，1 0.00752 39.6 0.00168 0.0134 8.67 2，2 1.00e-005 …. …. …. SD=0.00316 Dosage (mg/kg) PT TT fib APTT Injection rate (mg/min) PT TT Fib APTT Integrated Conc. (μg/ml) PT PT TT Fib APTT Herbal medicines as multi-component therapeutics It is possible to integrate PK and PD for herbal medicines. Challenges: multi-component therapeutics? Which marker compounds to measure? How to determine therapeutic window? Herb-Drug Interactions: Underest