Botero-Calderon Lorena, Benjamin Daniel K, Cohen-Wolkowiez Michael
Universidad del Valle , Calle 4B # 36-00, Cali , Colombia.
Expert Opin Pharmacother. 2015 May;16(7):1035-48. doi: 10.1517/14656566.2015.1031108. Epub 2015 Apr 5.
Invasive candidiasis is responsible for ∼ 10% of nosocomial sepsis in very-low-birth-weight infants and is associated with substantial morbidity and mortality. Over the last two decades, the antifungal armamentarium against Candida spp. has increased; however, efficacy and safety studies in this population are lacking.
We reviewed the medical literature and extracted information on clinical and observational studies evaluating the use of antifungal agents in neonates with invasive candidiasis.
Efficacy and safety data for antifungals in neonates are lacking, and the majority of studies conducted to date have concentrated on pharmacokinetic/pharmacodynamic evaluations. Unlike other anti-infective agents, efficacy data in the setting of neonatal candidiasis cannot be extrapolated from adult studies due to differences in the pathophysiology of the disease in this population relative to older children and adults. Data for amphotericin B deoxycholate, fluconazole, and micafungin suggest that these are the current agents of choice for this disease in neonates until data for newer antifungal agents become available. For prophylaxis, data from fluconazole randomized controlled trials will be submitted to the regulatory agencies for labeling. Ultimately, the field of therapeutics for neonatal candidiasis will require multidisciplinary collaboration given the numerous challenges associated with conducting clinical trials in neonates.
侵袭性念珠菌病导致极低出生体重儿约10%的医院获得性败血症,且与严重的发病率和死亡率相关。在过去二十年中,针对念珠菌属的抗真菌药物储备有所增加;然而,该人群中关于其疗效和安全性的研究尚缺。
我们查阅了医学文献,并提取了有关评估抗真菌药物在侵袭性念珠菌病新生儿中应用的临床和观察性研究的信息。
新生儿抗真菌药物的疗效和安全性数据尚缺,且迄今为止进行的大多数研究都集中在药代动力学/药效学评估上。与其他抗感染药物不同,由于该人群与大龄儿童及成人疾病病理生理学存在差异,新生儿念珠菌病的疗效数据无法从成人研究中推断得出。去氧胆酸两性霉素B、氟康唑和米卡芬净的数据表明,在有更新抗真菌药物数据可用之前,这些是目前治疗新生儿该疾病的首选药物。对于预防,氟康唑随机对照试验的数据将提交给监管机构用于标签标注。鉴于在新生儿中开展临床试验存在诸多挑战,新生儿念珠菌病治疗领域最终将需要多学科协作。