【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。更多还原

【Abstract】 Because of the vast diversity and complexity of skin and skin soft tissue infections,there are many difficulties in the clinical trial design of the antimicrobial drug for the treatment of these infections.Thus,we have tried to investigate the special consideration points on the clinical trial design in order to offer more reference to the development and evaluation of this kind of antimicrobial drugs.更多还原