Weill Cornell Medical College, New York, NY, USA.
Clin Pharmacokinet. 2019 Sep;58(9):1149-1153. doi: 10.1007/s40262-019-00767-z.
On 27 August, 2018, the US Food and Drug Administration approved eravacycline, a fluorocycline antimicrobial agent within the tetracycline class of antibacterial drugs, for the treatment of complicated intra-abdominal infections in patients aged 18 years and older. This decision was based on substantial clinical and pre-clinical data, including rigorous pharmacokinetic and pharmacodynamic work. This paper examines the in-vivo pharmacokinetic/pharmacodynamic work that led to the approval of eravacycline and explores how this important new antibiotic may be used to treat aggressive multidrug-resistant infections in the years ahead.
2018 年 8 月 27 日，美国食品药品监督管理局批准了依拉环素，一种氟环素类抗菌药物，用于治疗 18 岁及以上患者的复杂性腹腔内感染。这一决定基于大量的临床前和临床数据，包括严格的药代动力学和药效学研究。本文探讨了导致依拉环素批准的体内药代动力学/药效学研究，并探讨了这种重要的新型抗生素在未来几年如何用于治疗侵袭性、多重耐药感染。
