美国食品和药物管理局批准的抗菌药物:2018-2019 年。

Stefan Andrei, Gabriela Droc, Gabriel Stefan
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摘要

细菌对现有抗生素疗法的耐药性是国际公认的长期问题。年复一年,人们对新型抗菌药物的需求持续不断,而这种研发努力最近导致很少有新药或药物组合被提议用于临床。本综述重点关注近两年(2018-2019 年)美国 FDA 批准的新型抗菌药物。Plazomicin, eravacycline, sarecycline, omadacycline, rifamycin(2018 年)和 imipenem, cilastatin and relebactam combination, pretomanid, lefamulin, cefiderocol(2019 年)是新的治疗选择。Plazomicin 氨基糖苷类抗生素针对肠杆菌科感染,主要用于复杂的尿路感染。全合成氟环素埃拉伐环素获准用于复杂的腹腔内感染。四环素衍生抗生素沙瑞环素可能是治疗非结节性中重度痤疮的有效策略,而另一种已获批准的四环素衍生抗生素奥马他环素可用于急性细菌性皮肤和皮肤结构感染以及社区获得性细菌性肺炎患者。已为人熟知的 RNA 合成抑制剂利福霉素现在也被批准用于治疗由大肠杆菌引起的非侵袭性旅行者腹泻。针对复杂性尿路感染、复杂性腹腔内感染(亚胺培南、西司他丁和雷巴坦)和肺结核(pretomanid 与贝达喹啉和利奈唑胺联用)的两种组合策略获得批准。Lefamulin 是一种半合成胸腺嘧啶类抗生素,用于社区获得性细菌性肺炎,而头孢菌素类抗生素 cefiderocol 是 2019 年批准的最后一种抗菌药物,用于复杂性尿路感染。尽管取得了这些新进展,但目前仍迫切需要开发新型抗生素策略和药物,以克服细菌对抗生素的耐药性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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FDA approved antibacterial drugs: 2018-2019.

Bacterial resistance to existent antibiotherapy is a perpetual internationally-recognized problem. Year after year, there is a continuous need for novel antibacterial drugs and this research and development efforts recently resulted in few new drugs or combination of drugs proposed for the use into the clinic. This review focuses on the novel US FDA approved antibacterial agents in the last two years (2018-2019). Plazomicin, eravacycline, sarecycline, omadacycline, rifamycin (2018) and imipenem, cilastatin and relebactam combination, pretomanid, lefamulin, cefiderocol (2019) are new therapeutic options. Plazomicin aminoglycoside antibiotic targets Enterobacteriaceae infections, being mainly used for the complicated urinary tract infections. The fully synthetic fluorocycline eravacycline gained approval for the complicated intra-abdominal infections. The tetracycline-derived antibiotic sarecycline might be a useful strategy for the management of non-nodular moderate to severe acne, while the other tetracycline-derived antibiotic approved, omadacycline, may be used for the patients with acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. The already-known RNA-synthesis suppressor rifamycin is now also approved for noninvasive Escherichia Coli-caused travelers' diarrhea. Two combinatorial strategies were approved for complicated urinary tract infections, complicated intra-abdominal infections (imipenem, cilastatin and relebactam) and lung tuberculosis (pretomanid in combination with bedaquiline and linezolid). Lefamulin is a semisynthetic pleuromutilin antibiotic for community-acquired bacterial pneumonia, while cefiderocol, a cephalosporin antibiotic is the last antibacterial drug approved in 2019, for the use in complicated urinary tract infections. Despite of these new developments, there is an ongoing need and urgency to develop novel antibiotic strategies and drugs to overrun the bacterial resistance to antibiotics.

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