Mawal Yogesh, Critchley Ian A, Riccobene Todd A, Talley Angela K
a 1 Forest Laboratories, Inc., a subsidiary of Allergan plc (formerly Actavis plc) , New Jersey, USA.
b 2 Allergan plc , California, USA.
Expert Rev Clin Pharmacol. 2015;8(6):691-707. doi: 10.1586/17512433.2015.1090874. Epub 2015 Sep 30.
Treatment of complicated urinary tract infections and complicated intra-abdominal infections is increasingly difficult due to the rising prevalence of multidrug-resistant Gram-negative bacteria. Ceftazidime-avibactam is a combination of the established third-generation cephalosporin ceftazidime with avibactam, a novel non-β-lactam β-lactamase inhibitor, which restores the activity of ceftazidime against many β-lactamase-producing Gram-negative bacteria, including extended-spectrum β-lactamases and Klebsiella pneumoniae carbapenemases. Clinical and nonclinical studies supporting the safety and efficacy of ceftazidime-avibactam include microbiological surveillance studies of clinically relevant pathogens, in vivo animal models of infection, pharmacokinetic/pharmacodynamic target attainment analyses, Phase I clinical pharmacology studies, and Phase II/III studies in the treatment of complicated intra-abdominal infections and complicated urinary tract infections, including patients with ceftazidime-nonsusceptible Gram-negative infections.
由于多重耐药革兰氏阴性菌的患病率不断上升，治疗复杂性尿路感染和复杂性腹腔内感染变得越来越困难。头孢他啶-阿维巴坦是已有的第三代头孢菌素头孢他啶与新型非β-内酰胺β-内酰胺酶抑制剂阿维巴坦的组合，它恢复了头孢他啶对许多产β-内酰胺酶的革兰氏阴性菌的活性，包括超广谱β-内酰胺酶和肺炎克雷伯菌碳青霉烯酶。支持头孢他啶-阿维巴坦安全性和有效性的临床和非临床研究包括对临床相关病原体的微生物监测研究、感染的体内动物模型、药代动力学/药效学目标达成分析、I期临床药理学研究以及治疗复杂性腹腔内感染和复杂性尿路感染（包括对头孢他啶不敏感的革兰氏阴性感染患者）的II/III期研究。
