Hengstler 增量型编码器产品说明书[8]资料.ppt

FDA Anesthetic Life Support Drugs Advisory Committee Sept. 10, 2003;Susstained-release hydromorphone (Palladone) --Risks vs. benefits discussion;Benefits Review sustained release opioids vs. IR opioids; IR oxycodone vs CR oxycodone Comparable Efficacy Safety Hale Clin J Pain 9/99 BACK PAIN Kaplan R J Clin Oncol 10/98 CANCER Stambauugh J.Clin Pharm 5/01 CANCER ;OxyContin--NDA--1995;OxyContin---NDA---1995 Summary of Efficacy “CR oxycodone appears to be a BID alternative to conventional QID oxycodone. Approval is recommended. Care should be taken to limit competitive promotion. This product has been shown to be as good as current therapy, but has not been shown to have a significant advantage beyond reduction in frequency of dosing.” --Curtis Wright, MRO ;The Medical Letter—9/17/01 “OxyContin is a q12h controlled-release formulation of oxycodone that can be used effectively in the treatment of pain due to cancer, and occasionally, other types of chronic pain. There is no evidence that oxycodone offers any advantage over appropriate doses of other opioids, and it appears to have the same potential for addiction as morphine.”;CR morphine vs CR oxycodone Comparable in Efficacy and Safety Heiskanen Pain 10/97 CANCER Mucci-LoRusso ’98 CANCER Bruera J. Clin Oncol 10/98 CANCER; IR hydromorphone vs CR hydromorphone (Q12hr) Comparable Efficacy and Safety Hayes Cancer 9/94 CANCER Bruera J. Clin Oncol 5/96 CANCER;CR oxycodone vs CR hydromorphone (Q12hrs) Comparable Efficacy Safety Hagen Cancer 4/97 CANCER;Summary 1. IR opioids and SR opioids are comparable in efficacy safety 2. SR preparations appear comparable in efficacy safety;Benefits: ---CONVENIENCE of bid or qd dosing ---Convenience of less pills ---for patients intolerant to other opioid preparations;Risks of sustained release