协和专家临床药理学讲座药物治疗课件.pptVIP

Adverse Reactions: A Potential Consequence of Drug Therapy Audrey F. Jakubowski, Ph. D. November 30, 1999 Outline What is a drug? Drug therapy: Benefit and Risk Monitoring adverse drug reactions Studying new drugs Regulatory Definitions Pharmacovigilance Definition of a Drug Chemical substance or natural product Can prevent, diagnose or treat disease Can alter pharmacologic function Available in a stable dosage form Works by interacting with tissues, organs, cells, receptors, enzymes, transport channels History of Drugs Ancient civilizations used a mixture of magic, religion and drugs to treat disease Most drugs in antiquity came from plant and animal parts or fluids Understanding of drug mechanisms increased in parallel with knowledge of anatomy, physiology, biochemistry and chemistry Drug Therapy has Benefit and Risk Benefit cure/improve disease or symptoms reduce morbidity increase quality of life Risk adverse effects unpleasant, e.g. nausea serious, e.g. death costs Physician’s Dilemma Many drugs available Chinese traditional medicines Western drugs Choose the drug with the greatest potential to treat or cure disease For this Patient: Do the risks associated with this drug outweigh the benefits? Impact more than the therapeutic site Metabolites may have activity Drugs can induce or inhibit the metabolism of other drugs Age and race impact drug metabolism Children metabolize more rapidly than adults Elderly often have impaired metabolism Racial differences 5-10% Asians vs. 50% Caucasians are slow acetylators Cytochrome P-450 isoform patterns differ among Asians and Caucasians Detecting Adverse Events Consider whether any effect associated with the use of a drug is caused by the drug Dramatic AEs are easier to detect anaphylactic reaction within minutes of injection of penicillin AEs that mimic disease or occur after prolonged treatment are more difficult phocomelia after thalidomide treatment Types of Adverse Effects (1) Known to occur f