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美国食品药品监督管理局(FDA)新批准的抗菌药物:2015 - 2017年

New FDA approved antibacterial drugs: 2015-2017.

作者信息

Andrei Stefan, Valeanu Liana, Chirvasuta Radu, Stefan Mihai-Gabriel

机构信息

Intensive Care Unit, Centre Hospitalier Lyon Sud, Pierre Benite, France.

Department of Cardiac Anesthesia and Intensive care, Emergency Institute for Cardiovascular Diseases "Prof. C.C. Iliescu" Bucharest, Romania.

出版信息

Discoveries (Craiova). 2018 Apr 4;6(1):e81. doi: 10.15190/d.2018.1.

Abstract

Increasing bacterial resistance to antibiotics is a worldwide ongoing issue. Urgent need for new antibacterial agents has resulted in significant research efforts, with new molecules proposed for use in clinical practice. However, as highlighted by many groups this process does not have an optimal rhythm and efficacy, to fully combat highly adaptive germs, particularly in the intensive care units. This review focuses on the last three years of novel FDA approved antibacterial agents (2015-2017): ceftazidime/avibactam, obiltoxaximab, bezlotoxu-mab, delafloxacin, meropenem/vaborbactam, ozenoxacin. Ceftazidime/avibactam and meropenem/ vaborbactam are new players in the field of resistant bacteria treatment. Ceftazidime/avibactam is validated in selected patients with complicated urinary or intra-abdominal infections, hospital and ventilator-associated pneumonia. Meropenem/ vaborbactam gained approval for the cases of complicated urinary tract infections. Other potential indications are under investigation, widened and validated by future studies. Obiltoxaximab is a monoclonal antibody that can be used in the prevention and treatment of inhalational anthrax. Bezlotoxumab monoclonal antibody is an useful and specific tool for the management of recurrent Clostridium difficile infection. Delafloxacin is approved for patients with acute skin or skin structure infections. Despite recent progress, it is imperative to continue the development of new antibiotic drugs and new strategies to counteract resistance to antibiotics.

摘要

细菌对抗生素的耐药性不断增强是一个全球性的持续问题。对新型抗菌药物的迫切需求促使人们进行了大量研究,提出了一些新分子用于临床实践。然而,正如许多研究团队所强调的,这一过程缺乏最佳的节奏和效果,难以全面对抗高度适应性的病菌,尤其是在重症监护病房。本综述聚焦于过去三年中美国食品药品监督管理局(FDA)批准的新型抗菌药物(2015 - 2017年):头孢他啶/阿维巴坦、奥比妥珠单抗、贝佐妥珠单抗、德拉氟沙星、美罗培南/法硼巴坦、奥泽沙星。头孢他啶/阿维巴坦和美罗培南/法硼巴坦是耐药菌治疗领域的新成员。头孢他啶/阿维巴坦已在患有复杂性尿路感染或腹腔内感染、医院获得性肺炎和呼吸机相关性肺炎的特定患者中得到验证。美罗培南/法硼巴坦已获批用于治疗复杂性尿路感染。其他潜在适应症正在研究中,有待未来研究进一步拓展和验证。奥比妥珠单抗是一种单克隆抗体,可用于预防和治疗吸入性炭疽。贝佐妥珠单抗单克隆抗体是管理复发性艰难梭菌感染的一种有用且特异的工具。德拉氟沙星已获批用于治疗急性皮肤或皮肤结构感染。尽管最近取得了进展,但继续开发新的抗生素药物和对抗抗生素耐药性的新策略仍然势在必行。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c2e/7086068/34364edaf36c/discoveries-06-081-g001.jpg

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