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FDA批准上市获得QIDP认证的新药概况

Review of New Drugs with QIDP Certification Approved by FDA
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摘要 目的了解FDA批准上市的QIDP认证的8种新抗菌药概况。方法查阅近年来国内外相关文献75篇,对其进行归纳、总结和分析。结果目前全球已上市8种QIDP认证的抗菌药,适用于治疗由耐药致病菌引起的严重感染,抗菌谱广,抗菌活性强,耐受性良好。结论 FDA批准上市的8种QIDP认证抗菌药在全球面临耐药菌的威胁下值得进一步研究。 ObjectiveTo overview the 8 new antibacterials with QIDP certification approved by the FDA. Methods The relevant 75 papers about 8 FDA approved QIDP antibacterial drugs were summarized and analyzed. Results At present, 8 antibacterial drugs with QIDP qualification have been marketed and are suitable for the treatment of serious infections caused by drug-resistant pathogens. They have the characteristics of broad antibacterial spectrum, strong antibacterial activity, and good tolerance. Conclusion Facing with the challenge of global drug resistance, the 8 antibacterial drugs with QIDP certification approved by the FDA are worthy of more research.
作者 牛亚平 梁蓓蓓 孙湃 王睿 贾晋生 NIU Yaping;LIANG Beibei;SUN Pai;WANG Rui;JIA Jinsheng(Department of Pharmacy,Shanxi Medical University,Shanxi Taiyuan 030001,China;Center of Medicine/Medical Devices Clinical Research,Chinese People's Liberation Army General Hospital,Beijing 100853,China;Shanxi Medical University Affiliated Jinmei Group General Hospital,Shanxi Jincheng 048006,China)
出处 《中国药物警戒》 2018年第9期564-571,共8页 Chinese Journal of Pharmacovigilance
关键词 QIDP认证 达巴万星 泰地唑胺磷酸酯 奥利万星 头孢他啶/阿维巴坦 头孢洛扎/他唑巴坦 硫酸艾莎康唑 德拉沙星 美罗培南/ vaborbactam QIDP dalbavancin tedizolid phosphate oritavancin ceftolozane/tazobactam ceftazidime/avibactam
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