Clerihew L, McGuire W
Tayside Institute of Child Health, Ninewells Hospital and Medical School, Dundee, UK, DD1 9SY.
Cochrane Database Syst Rev. 2004(1):CD003953. doi: 10.1002/14651858.CD003953.pub2.
Invasive fungal infection is an increasingly common cause of mortality and morbidity in preterm infants. In addition to amphotericin B, a variety of newer antifungal drugs and drug preparations are available for treatment. There is a need to assess their relative merits.
In preterm infants with suspected or confirmed invasive fungal infection, does treatment with newer systemic antifungal drugs or drug preparations, versus conventional amphotericin B alone, reduce mortality and adverse neurodevelopmental outcomes?
We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2003), MEDLINE (1966 - August 2003), EMBASE (1980 - August 2003), conference proceedings, and previous reviews.
Randomised and quasi-randomised control trials comparing one antifungal agent or combination of agents with another in preterm infants with suspected or confirmed invasive fungal infection.
We extracted the data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by each author, and synthesis of data using relative risk and risk difference. The pre-specified outcomes were death prior to hospital discharge, longer term neurodevelopment, and adverse drug reactions resulting in discontinuation of therapy.
We identified only one small trial. This study compared the use of fluconazole with amphotericin B (5-Fluorocytosine added if fungal meningitis present). Three of 11 infants who were treated with fluconazole died and four of 10 infants who were treated with amphotericin B died : Relative risk: 0.68 (95% confidence interval 0.20, 2.33), Risk Difference -0.13 (95% confidence interval -0.53, 0.27) There were not any data on longer term outcomes.
REVIEWER'S CONCLUSIONS: From this one small study there are insufficient data to favour one antifungal agent or combination to reduce mortality and adverse neurodevelopmental outcomes in preterm infants with suspected or confirmed invasive fungal infection. A large randomised controlled trial is required to compare the newer antifungal preparations with conventional amphotericin B. Further research may also determine the relative convenience and cost effectiveness of the available drugs.
侵袭性真菌感染是早产儿死亡和发病的一个日益常见的原因。除两性霉素B外，还有多种新型抗真菌药物和药物制剂可用于治疗。有必要评估它们的相对优点。
在疑似或确诊侵袭性真菌感染的早产儿中，与单独使用传统两性霉素B相比，使用新型全身性抗真菌药物或药物制剂进行治疗是否能降低死亡率和不良神经发育结局？
我们采用了Cochrane新生儿综述小组的标准检索策略。这包括检索Cochrane对照试验中央注册库（CENTRAL，《Cochrane图书馆》，2003年第3期）、MEDLINE（1966年 - 2003年8月）、EMBASE（1980年 - 2003年8月）、会议论文集以及以往的综述。
在疑似或确诊侵袭性真菌感染的早产儿中，比较一种抗真菌药物或药物组合与另一种抗真菌药物或药物组合的随机和半随机对照试验。
我们使用Cochrane新生儿综述小组的标准方法提取数据，每位作者分别评估试验质量和提取数据，并使用相对风险和风险差异对数据进行综合分析。预先设定的结局为出院前死亡、长期神经发育以及导致治疗中断的药物不良反应。
我们仅确定了一项小型试验。该研究比较了氟康唑与两性霉素B的使用情况（如果存在真菌性脑膜炎则加用5-氟胞嘧啶）。接受氟康唑治疗的11名婴儿中有3名死亡，接受两性霉素B治疗的10名婴儿中有4名死亡：相对风险：0.68（95%置信区间0.20，2.33），风险差异 -0.13（95%置信区间 -0.53，0.27）。没有关于长期结局的数据。
从这一项小型研究来看，没有足够的数据支持在疑似或确诊侵袭性真菌感染的早产儿中，使用一种抗真菌药物或药物组合优于另一种以降低死亡率和不良神经发育结局。需要进行一项大型随机对照试验来比较新型抗真菌制剂与传统两性霉素B。进一步的研究也可能确定现有药物的相对便利性和成本效益。
