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背景:基于数项非劣效性临床试验结果,美国FDA分别在2005年与2009年批准替加环素用于治疗复杂性腹腔内感染(cIAIs),复杂性皮肤软组织感染(cSSTIs)与社区获得性肺炎(CAP)。2010年9月,FDA发布安全警告并更新了药物标签,提出随机对照临床研究表明替加环素可增加患者的死亡风险。
Background: Based on several noninferiority clinical trials, the FDA approved tigecycline in 2005 and 2009 for the treatment of complicated intra-abdominal infections (cIAIs), complex skin and soft tissue infections (cSSTIs) and community-acquired Pneumonia (CAP). In September 2010, the FDA issued a safety warning and updated the drug label, proposing that randomized controlled clinical studies indicate that tigecycline increases the risk of death in patients.