Tamma Seetha M, Hsu Alice J, Tamma Pranita D
Department of Biomedical Sciences, Long Island University, Long Island, New York, NY, USA.
Department of Pharmacy, Johns Hopkins Hospital, Baltimore, MD, USA.
Paediatr Drugs. 2016 Feb;18(1):1-11. doi: 10.1007/s40272-015-0157-x.
Antibiotics are arguably the greatest medical development of the 20th century but these precious resources are being threatened by the continued rise in infections caused by multidrug-resistant bacteria. There is concern that we are on the precipice of a 'post-antibiotic era'. The situation is exacerbated by a stagnation in the pharmaceutical industry in developing new antibiotics, particularly those with activity against some of the most resistant Gram-negative organisms because of significant economic, scientific, and regulatory barriers. One of the products of recent initiatives to reinvigorate the antibiotic pipeline is the agent ceftolozane/tazobactam. Ceftolozane/tazobactam was approved in December 2014 by the US Food and Drug Administration for the treatment of complicated urinary tract infections and complicated intra-abdominal infections for patients 18 years of age and older. The safety and effectiveness of ceftolozane/tazobactam in pediatric patients has not been established in clinical studies. However, with the rise of highly drug-resistant Gram-negative organisms in children and the current climate of ongoing, multiple, and simultaneous antibiotic shortages--particularly of broad-spectrum antibiotics, the potential off-label role of ceftolozane/tazobactam for children needs to be explored while pediatric studies are ongoing. The objective of this opinion piece is to discuss what is currently known about ceftolozane/tazobactam and its potential implications for use in the pediatric population.
抗生素可以说是20世纪最伟大的医学发展成果，但这些宝贵资源正受到多重耐药菌导致的感染持续增加的威胁。人们担心我们正处于“后抗生素时代”的边缘。制药行业在开发新抗生素方面停滞不前，这使得情况更加恶化，特别是那些对一些耐药性最强的革兰氏阴性菌有活性的抗生素，因为存在重大的经济、科学和监管障碍。最近旨在振兴抗生素研发渠道的举措之一是头孢洛扎/他唑巴坦制剂。头孢洛扎/他唑巴坦于2014年12月获得美国食品药品监督管理局批准，用于治疗18岁及以上患者的复杂性尿路感染和复杂性腹腔内感染。头孢洛扎/他唑巴坦在儿科患者中的安全性和有效性尚未在临床研究中得到证实。然而，随着儿童中高度耐药革兰氏阴性菌的增加以及当前持续、多重和同时出现的抗生素短缺情况——特别是广谱抗生素短缺，在儿科研究进行期间，需要探索头孢洛扎/他唑巴坦在儿童中潜在的超说明书用药作用。这篇观点文章的目的是讨论目前关于头孢洛扎/他唑巴坦的已知信息及其在儿科人群中使用的潜在影响。
