Division of Geographic Medicine and Infectious Diseases, Tufts University School of Medicine and Tufts Medical Center, Boston, MA, USA.
Clin Infect Dis. 2013 Jun;56(12):1685-94. doi: 10.1093/cid/cit152. Epub 2013 Apr 17.
Infections caused by antibiotic-resistant bacteria, especially the "ESKAPE" pathogens, continue to increase in frequency and cause significant morbidity and mortality. New antimicrobial agents are greatly needed to treat infections caused by gram-negative bacilli (GNB) resistant to currently available agents. The Infectious Diseases Society of America (IDSA) continues to propose legislative, regulatory, and funding solutions to this continuing crisis. The current report updates the status of development and approval of systemic antibiotics in the United States as of early 2013. Only 2 new antibiotics have been approved since IDSA's 2009 pipeline status report, and the number of new antibiotics annually approved for marketing in the United States continues to decline. We identified 7 drugs in clinical development for treatment of infections caused by resistant GNB. None of these agents was included in our 2009 list of antibacterial compounds in phase 2 or later development, but unfortunately none addresses the entire spectrum of clinically relevant GNB resistance. Our survey demonstrates some progress in development of new antibacterial drugs that target infections caused by resistant GNB, but progress remains alarmingly elusive. IDSA stresses our conviction that the antibiotic pipeline problem can be solved by the collaboration of global leaders to develop creative incentives that will stimulate new antibacterial research and development. Our aim is the creation of a sustainable global antibacterial drug research and development enterprise with the power in the short term to develop 10 new, safe, and efficacious systemically administered antibiotics by 2020 as called for in IDSA's "10 × '20 Initiative."
由抗生素耐药菌引起的感染，尤其是“ESKAPE”病原体，其发病率和死亡率持续上升。非常需要新的抗菌药物来治疗目前可用药物耐药的革兰氏阴性菌（GNB）引起的感染。美国传染病学会（IDSA）继续提出立法、监管和资金解决方案来应对这一持续的危机。本报告更新了截至 2013 年初美国全身用抗生素的开发和批准状况。自 IDSA 2009 年的药物管道状况报告以来，仅批准了 2 种新抗生素，美国每年批准上市的新抗生素数量继续下降。我们发现了 7 种用于治疗耐药 GNB 感染的临床开发药物。这些药物都没有列入我们 2009 年处于 2 期或更后期开发阶段的抗菌化合物名单中，但遗憾的是，没有一种药物能解决所有与临床相关的 GNB 耐药问题。我们的调查表明，针对耐药 GNB 感染开发新抗菌药物方面取得了一些进展，但进展仍然令人担忧。IDSA 强调我们坚信，抗生素管道问题可以通过全球领导人的合作来解决，制定有创意的激励措施将刺激新的抗菌药物研究和开发。我们的目标是创建一个可持续的全球抗菌药物研究和开发企业，在短期内有能力开发 10 种新的、安全有效的全身用抗生素，以实现 IDSA 的“10ב20 倡议”的目标。
