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美国食品药品监督管理局批准的抗菌药物:2018 - 2019年

FDA approved antibacterial drugs: 2018-2019.

作者信息

Andrei Stefan, Droc Gabriela, Stefan Gabriel

机构信息

Department of Anesthesia and Intensive Care, Fundeni Clinical Institute, Bucharest, Romania.

Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.

出版信息

Discoveries (Craiova). 2019 Dec 31;7(4):e102. doi: 10.15190/d.2019.15.

Abstract

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.

摘要

细菌对现有抗菌疗法产生耐药性是一个国际公认的长期问题。年复一年,一直需要新型抗菌药物,而最近的研发努力仅产生了少数几种建议用于临床的新药或药物组合。本综述聚焦于过去两年(2018 - 2019年)美国食品药品监督管理局(US FDA)批准的新型抗菌药物。普拉佐米星、依拉环素、沙瑞环素、奥马环素、利福霉素(2018年)以及亚胺培南、西司他丁和瑞巴坦组合、普瑞玛尼、莱法莫林、头孢地尔(2019年)都是新的治疗选择。氨基糖苷类抗生素普拉佐米星针对肠杆菌科感染,主要用于治疗复杂性尿路感染。全合成氟环素依拉环素获批用于治疗复杂性腹腔内感染。四环素类衍生抗生素沙瑞环素可能是治疗非结节性中度至重度痤疮的有效策略,而另一种获批的四环素类衍生抗生素奥马环素可用于治疗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。已知的RNA合成抑制剂利福霉素现在也获批用于治疗非侵袭性大肠杆菌引起的旅行者腹泻。两种联合用药方案获批用于治疗复杂性尿路感染、复杂性腹腔内感染(亚胺培南、西司他丁和瑞巴坦)以及肺结核(普瑞玛尼与贝达喹啉和利奈唑胺联合使用)。莱法莫林是一种半合成截短侧耳素类抗生素,用于治疗社区获得性细菌性肺炎,而头孢地尔是一种头孢菌素类抗生素,是2019年获批的最后一种抗菌药物,用于治疗复杂性尿路感染。尽管有这些新进展,但仍迫切需要开发新的抗生素策略和药物,以克服细菌对抗生素的耐药性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/90f4/7086080/f348d7c53428/discoveries-07-102-g001.jpg

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