Department of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP; INSERM CIC9202; Université Paris 7, Paris, France.
Pediatr Infect Dis J. 2011 Feb;30(2):e29-37. doi: 10.1097/INF.0b013e3181fe353d.
ciprofloxacin has no marketing authorization for use in neonates worldwide but it is prescribed for the treatment of neonatal life-threatening infections, mainly in developing countries and in Europe. Given the concerns about its toxicity in this population and the necessity for its use in specific clinical situations, we conducted a systematic review of the use of ciprofloxacin in neonates.
we performed a systematic search of PubMed, Embase, and the Cochrane Database of Systematic Reviews and bibliographies of relevant articles. We included all studies, regardless of design, that reported efficacy, safety, and pharmacokinetics of ciprofloxacin for the treatment of any neonatal infectious condition. We excluded letters, editorials, preliminary reports, and abstracts.
observational cohort studies, case reports, and descriptions of patient series account for all literature reviewed. Ciprofloxacin was administrated in neonates as a salvage therapy for sepsis due to multidrug-resistant strains or with signs of clinical deterioration under first-line antibiotic treatment. Initial administration was always intravenous with variable dosing schedule. Clinical response to treatment was estimated at 64% and 91% in 2 cohort studies, with a median of 83% in case series. Of the 14 case reports, 12 yielded positive clinical outcomes. No serious adverse events, particularly joint toxicity, were observed, although evaluation was predominantly clinical and follow-up limited to few months after the end of treatment.
the current literature provides some information to support the use of ciprofloxacin in neonates. Additional high quality studies should be undertaken to provide reliable data on pharmacokinetics, efficacy, and long-term safety.
环丙沙星在全球范围内未获得用于新生儿的许可，但在发展中国家和欧洲，它被开给患有危及生命的新生儿感染的患者。鉴于人们对其在该人群中的毒性的担忧，以及在特定临床情况下使用它的必要性，我们对环丙沙星在新生儿中的使用进行了系统评价。
我们对 PubMed、Embase 和 Cochrane 系统评价数据库进行了系统检索，并查阅了相关文章的参考文献。我们纳入了所有研究，无论其设计如何，只要报告了环丙沙星治疗任何新生儿感染的疗效、安全性和药代动力学即可。我们排除了信件、社论、初步报告和摘要。
观察性队列研究、病例报告和病例系列描述构成了所有综述的文献。环丙沙星被用作多药耐药菌株引起的败血症的挽救性治疗，或在一线抗生素治疗下出现临床恶化迹象的新生儿。初始给药均为静脉内给药，剂量方案不同。在 2 项队列研究中，治疗的临床反应估计为 64%和 91%，病例系列的中位数为 83%。在 14 例病例报告中，有 12 例获得了阳性临床结果。虽然评估主要是临床的，并且在治疗结束后仅随访数月，但未观察到严重不良事件，特别是关节毒性。
目前的文献提供了一些支持环丙沙星在新生儿中使用的信息。应进行更多高质量的研究，以提供关于药代动力学、疗效和长期安全性的可靠数据。
