皮肤及皮肤软组织感染抗菌药物临床试验设计与评价的特殊考虑  

Special considerations on the clinical trial design and evaluation of skin and skin soft tissue infection

作　　者：谢松梅[1] 符世平[2] 杨进波[1] 孙涛[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038 [2]洛阳市中心医院外科,洛阳471009

出　　处：《中国新药杂志》2009年第16期1493-1495,共3页Chinese Journal of New Drugs

摘　　要：皮肤及皮肤软组织感染的巨大多样性和复杂性使该类抗菌药物的临床试验设计在疾病分类、病例入选和排除、致病菌的确定、细菌培养阳性率、给药方案、统计学评价等方面存在较多难点和疑点,因此,本文在药品审评中心起草的《抗菌药物临床试验技术指导原则》一般性要求的基础上,对该类感染性疾病抗菌药物临床试验设计的特殊考虑进行探讨,以期对该类药物的研发和评价提供有益的参考。Because of the vast diversity many difficulties in the clinical trial design of the have tried to investigate the special consideration to the development and evaluation of this kind of and complexity of skin and skin soft tissue infections, there are antimicrobial drug for the treatment of these infections. Thus, we points on the clinical trial design in order to offer more reference antimicrobial drugs.

关 键 词：皮肤及皮肤软组织感染 抗菌药物 临床试验 设计 

分 类 号：R978[医药卫生—药品] R969[医药卫生—药学]