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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。
The huge diversity and complexity of skin and soft tissue infections have led to the design of clinical trials of this class of antimicrobial agents in terms of disease classification, case selection and exclusion, identification of pathogens, positive rates of bacterial culture, dosing schedules, and statistical evaluation There are many difficulties and doubts. Therefore, based on the general requirements of “Guiding Principles for Antibacterials Clinical Trial” drafted by the Center for Drug Evaluation, this article discusses the special considerations of clinical trial design for such antimicrobials of infectious diseases, In order to provide a useful reference for the research and development and evaluation of these drugs.