心血管疾病中药材循证应用的必威体育精装版进展-英文.pptVIP

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心血管疾病中药材循证应用的必威体育精装版进展-英文.ppt

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心血管疾病中药材循证应用的必威体育精装版进展-英文

17th Oct 2006 Disposition Pathways ofDrugs and Chinese Herbal Medicines Challenges for Herbal Clinical trials Dosage formulation: standardized or individualized? Biomarkers? Safety profiles? Pharmacokinetics data? 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: Underestimated Patients: 70% do not reveal their herbal use to their doctors/pharmacists in Western countries Legal issue: rigorous preclinical and clinical assessments not required Difficulties in the studies; poor clinical studies Lack of ADR reporting system Types of Clinical Reports on Herb-Drug Interactions What Herbs Interact with Drugs? What Drugs Interact with Herbs? Toxicity due to Herb-Drug Interactions SJW-Drug Interactions Antidepressants: amitriptyline; SSRIs (sertraline – Zoloft) Anticancer drug: irinotecan (CPT-11) Anticoagulants: warfarin (coumadin), phenprocoumon Antihistamine: fexofenadine Anti-HIV agents: PI: indinavir; RTI: nevirapine Bronchodilator: theophylline Hypoglycemics: tolbutamide Cardiovascualr drugs: digoxin, simvastatin Opiates: methadone, loperamide Oral contraceptives Sedatives: alprazolam midazolam Immunosuppressants: cyclosporine tacrolimus Mechanisms for Herb-Drug Interactions Herb-CYP Interactions Herb-PgP Interactions Herbal Labeling What: identity, quantity of contents, identified active ingredient by common name or proprietary blend. How to use: route, dose daily, etc Who: name and place of manufacturer, packer or distributor. What to claim ? “This statement has not been evaluated by the Food and Drug Administration”. ? “This product is not intended to diagnose, treat, cure, or prevent any diseases”. - “It is not advisable to use in combination with…” ** RMIT University 10th SCICC, Guangzhou, China, 2008 Recent Prog