口服制霉菌素预防极低出生体重早产儿系统性真菌感染：一项随机对照试验。
Oral nystatin prophylaxis to prevent systemic fungal infection in very low birth weight preterm infants: a randomized controlled trial.
作者信息
Rundjan Lily, Wahyuningsih Retno, Oeswadi Chrissela Anindita, Marsogi Miske, Purnamasari Ayu
机构信息
Division of Neonatology, Department of Pediatrics, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital, Jalan Diponegoro 71, DKI Jakarta, 10430, Indonesia.
Division of Mycology, Department of Parasitology, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital, DKI Jakarta, Indonesia.
出版信息
BMC Pediatr. 2020 Apr 17;20(1):170. doi: 10.1186/s12887-020-02074-0.
BACKGROUND
Systemic fungal infection (SFI) is one of leading causes of morbidity and mortality in very low birth weight (VLBW) preterm infants. Because early diagnosis of SFI is challenging due to nonspecific manifestations, prophylaxis becomes crucial. This study aimed to assess effectiveness of oral nystatin as an antifungal prophylaxis to prevent SFI in VLBW preterm infants.
METHODS
A prospective, open-labelled, randomized controlled trial was performed in a neonatal intensive care unit (NICU) of an academic hospital in Indonesia. Infants with a gestational age ≤ 32 weeks and/or birth weight of ≤ 1500 g with risk factors for fungal infection were assessed for eligibility and randomized to either an intervention group (nystatin) or control group. The intervention group received 1 ml of oral nystatin three times a day, and the control group received a dose of 1 ml of sterile water three times a day. The incidence of fungal colonization and SFI were observed and evaluated during the six-week study period. Overall mortality rates and nystatin-related adverse drug reactions during the study period were also documented.
RESULTS
A total of 95 patients were enrolled. The incidence of fungal colonization was lower among infants in nystatin group compared to those in control group (29.8 and 56.3%, respectively; relative risk 0.559; 95% confidence interval 0.357-0.899; p-value = 0.009). There were five cases of SFI, all of which were found in the control group (p-value = 0.056). There was no difference in overall mortality between the two groups. No adverse drug reactions were noted during the study period.
CONCLUSIONS
Nystatin is effective and safe as an antifungal prophylactic medication in reducing colonization rates in the study population. Whilst the use of nystatin showed a potential protective effect against SFI among VLBW preterm infants, there was no statistical significant difference in SFI rates between groups.
TRIAL REGISTRATION
NCT03390374. Registered 4 January 2018 - Retrospectively registered.
背景
系统性真菌感染（SFI）是极低出生体重（VLBW）早产儿发病和死亡的主要原因之一。由于SFI的早期诊断因非特异性表现而具有挑战性，因此预防至关重要。本研究旨在评估口服制霉菌素作为抗真菌预防措施对预防VLBW早产儿SFI的有效性。
方法
在印度尼西亚一家学术医院的新生儿重症监护病房（NICU）进行了一项前瞻性、开放标签、随机对照试验。对胎龄≤32周和/或出生体重≤1500g且有真菌感染风险因素的婴儿进行资格评估，并随机分为干预组（制霉菌素）或对照组。干预组每天口服3次1ml制霉菌素，对照组每天口服3次1ml无菌水。在为期六周的研究期间观察和评估真菌定植和SFI的发生率。还记录了研究期间的总体死亡率和与制霉菌素相关的药物不良反应。
结果
共纳入95例患者。制霉菌素组婴儿的真菌定植发生率低于对照组（分别为29.8%和56.3%；相对风险0.559；95%置信区间0.357 - 0.899；p值 = 0.009）。有5例SFI病例，均在对照组中发现（p值 = 0.056）。两组的总体死亡率无差异。研究期间未观察到药物不良反应。
结论
制霉菌素作为抗真菌预防药物在降低研究人群的定植率方面有效且安全。虽然使用制霉菌素对VLBW早产儿的SFI显示出潜在的保护作用，但两组之间的SFI发生率无统计学显著差异。
试验注册
NCT03390374。2018年1月4日注册 - 回顾性注册。
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