Mersal Ali, Alzahrani Ibrahim, Azzouz Mahasen, Alsubhi Adel, Alsawaigh Heba, Albshri Nouf, Bajammal Manal, Avand Ghazal, Almahbosh Abdulmajid
Neonatal Intensive Care Unit, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia.
J Clin Neonatol. 2013 Apr;2(2):88-92. doi: 10.4103/2249-4847.116408.
Fluconazole has shown to be effective in reducing both colonization and invasive Candida infection (ICI) in ELBW neonates; we conducted a randomized trial to compare oral nystatin with intravenous fluconazole for prophylaxis against invasive Candidiasis in high risk neonates.
By using SPSS, preterm less than 30 weeks gestation and/or birth weight 1200 grams or less assigned to receive either intravenous Fluconazole (6 mg/kg q72 hr for 1(st) week then q48 h for 6 wks) or oral Nystatin (100,000 unit q8 hr for 6 wks). The medications commenced at one week of age after obtaining the base line investigations and check for Candida colonization by urine culture and rectal swab; subsequently all lab work and the clinical data were monitered regularly. Risk factors were assessed. The data collected prospectively looking for primary end point the invasive Candida infection (ICI) and 2 ndry outcomes include medication safety, tolerance and cost.
65 neonate randomly assigned however only 57 neonates comleted the study 33/57 (57%) to intravenous fluconazole group and 24/57 (42%) to oral nystatin group. No differences in birth weights Nystatin (1.15 Kg) Fluconazole (1.01 Kg), gender males (26/57), female (32/57), Gestational age (29.28 vs l28.22) or risk factors between the two groups. Rectal swab Colonization occurred in 2/24 (8%) in Nystatin group and 4/33 (12%) in the Fluconazole group, but none of the neonates developed ICI or side effects, although in the Fluconazole group transient transaminase elevation 2SD standard deviation above the mean was observed. Central line duration was 2 SD above the mean for fluconazole group, The cost of the Fluconazole treated group (7,581 SAR) 106.4 US/pt double the cost of Nystatin treated group (3,375 SAR) 50 US/pt.
Intravenous Fluconazole and oral Nystatin at the prophylactic doses are equally effective and safe in preventing (ICI) in preterm neonates, however oral Nystatin is readily available, easily administered with lower cost per neonate.
氟康唑已被证明可有效减少极低出生体重儿的念珠菌定植和侵袭性念珠菌感染（ICI）；我们进行了一项随机试验，比较口服制霉菌素与静脉注射氟康唑预防高危新生儿侵袭性念珠菌病的效果。
使用SPSS软件，将孕周小于30周和/或出生体重1200克或更低的早产儿随机分为两组，分别接受静脉注射氟康唑（第1周6毫克/千克，每72小时一次，之后6周每48小时一次）或口服制霉菌素（100,000单位，每8小时一次，共6周）。在获得基线检查结果并通过尿培养和直肠拭子检查念珠菌定植情况后，于出生后1周开始用药；随后定期监测所有实验室检查结果和临床数据。评估危险因素。前瞻性收集数据，寻找主要终点侵袭性念珠菌感染（ICI），次要结局包括药物安全性、耐受性和成本。
65例新生儿被随机分组，但仅57例完成研究，其中33/57（57%）进入静脉注射氟康唑组，24/57（42%）进入口服制霉菌素组。两组在出生体重（制霉菌素组1.15千克，氟康唑组1.01千克）、性别（男26/57，女32/57）、孕周（29.28对28.22）或危险因素方面无差异。直肠拭子检查显示，制霉菌素组2/24（8%）出现定植，氟康唑组4/33（12%）出现定植，但两组均无新生儿发生ICI或出现副作用，不过氟康唑组观察到转氨酶短暂升高超过平均值2个标准差。氟康唑组的中心静脉置管时间超过平均值2个标准差。氟康唑治疗组的成本为7581沙特里亚尔（106.4美元/例），是制霉菌素治疗组（成本3375沙特里亚尔，50美元/例）的两倍。
预防性剂量的静脉注射氟康唑和口服制霉菌素在预防早产儿侵袭性念珠菌感染（ICI）方面同样有效且安全，然而口服制霉菌素易于获得，给药方便，且每例新生儿的成本较低。
