抗感染药物临床用药进展推荐.pptVIP

抗病毒药物2005~2007 作用 中文名 英文名 年份 指 证 核苷类HIV逆转录酶抑制剂 (1) 恩曲他滨 替诺福韦酯合剂 Emtricitabine Tenofovir DF (Coformulation) 2006 单用或与其他抗逆转录病毒药物合用治疗成人HIV感染 HIV蛋白酶抑制剂 (2) 替拉那韦 Tipranavir 2005 与利托那韦合用治疗成人HIV感染(已治疗者或对蛋白酶抑制剂耐药) Darunavir ethanolate 2006 同上 侵入型抑制剂 (1) Maraviroc 2007.8 合用治疗对抗逆转录病毒药物多重耐药HIV感染 抑制HIV-1整合酶 (1) Raltegravir 2007.10 合用治疗已治疗HIV感染或多重耐药病毒感染 核苷类似物 (2) 恩替卡韦 Enticavir 2005 慢性乙肝的治疗 替比夫定 Telbivudine 2006 慢性乙肝的治疗 * Thank you * * * The search for a new medicine This pipe represents the long road that has to be traveled to discover and develop a new medicine. Many projects have to be initiated before a medicine is discovered. For each project, hundreds of molecules frequently have to be synthesized and tested in biological models. In preclinical pharmacology, research is conducted to understand how substances are absorbed, converted and metabolized, and then finally excreted from the body, all in relation to time. The safety of the substance must also be minutely evaluated in various models. The development of a medicine is a selection process at each successive phase. The problem here is that many substances fall by the wayside at a late stage of development and have to be discarded for all kinds of reasons: insufficient activity, bioavailability, safety, etc. The purpose of all these preclinical tests is to predict what might be expected in clinical research, in other words in the human body. Ideally, it would be better if the substances that do not meet the criteria could be identified at an early stage. That would save a lot of time and money. Clinical pharmacology and safety account for a very substantial part of the development time. These trials in humans are conducted in various phases and take five to seven years to complete. * * * * 抗感染药物临床应用进展 王明贵 复旦大学华山医院抗生素研究所 卫生部抗生素临床药理重点实验室 主要内容 抗菌药物 抗菌药研发存在的问题 近年上市或完成Ⅲ期临床试验的新抗菌药 新抗菌药开发新思路 近3年上市新抗真菌药 近3年上市抗病毒药 * 主要内容 抗菌药物 抗菌药研发存在的问题 已上市或完成Ⅲ期临床试验的新抗菌药 新抗菌药开发新思路 近3年上市新抗真菌药 近3年上市抗病毒药 * 美国批准上市的新抗菌药物1983-2007 Modified from