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一项卡泊芬净与两性霉素 B 治疗新生儿侵袭性念珠菌病的随机、双盲、前瞻性研究。

A randomized, double-blind, prospective study of caspofungin vs. amphotericin B for the treatment of invasive candidiasis in newborn infants.

机构信息

Department of Pediatrics, Faculty of Medicine, El-Minya University, El-Minya, Egypt.

出版信息

J Trop Pediatr. 2012 Feb;58(1):25-30. doi: 10.1093/tropej/fmr025. Epub 2011 Feb 25.

DOI:10.1093/tropej/fmr025
PMID:21355042
Abstract

BACKGROUND

Caspofungin is an echinocandin agent with fungicidal activity against Candida species.

OBJECTIVE

To assess the efficacy, safety and tolerability of caspofungin relative to amphotericin B in neonates with invasive candidiasis.

PATIENTS AND METHODS

Thirty-two neonates with invasive candidiasis were randomly assigned to receive either caspofungin (n = 15) or amphotericin B (n = 17). Efficacy was evaluated, with a successful outcome defined as fulfilling all the components of a prespecified five-part composite endpoint. Evaluation of safety was done by monitoring drug-related adverse events.

RESULTS

At the end of intravenous therapy, evaluation showed that caspofungin was superior, with a favorable response in 86.7% of patients as compared with 41.7% of those who received amphotericin B (p = 0.04). There were significantly fewer adverse events in the caspofungin group than in the amphotericin B group.

CONCLUSION

Caspofungin is more effective, safer and alternative to amphotericin B for the treatment of invasive candidiasis in newborn infants.

摘要

背景

卡泊芬净是一种棘白菌素类抗真菌药物,具有抗念珠菌属真菌的杀菌活性。

目的

评估卡泊芬净相对于两性霉素 B 在治疗新生儿侵袭性念珠菌病中的疗效、安全性和耐受性。

患者和方法

32 例侵袭性念珠菌病新生儿被随机分配接受卡泊芬净(n=15)或两性霉素 B(n=17)治疗。通过评估符合预先指定的五部分综合终点的所有组成部分的成功治疗结局来评估疗效。通过监测与药物相关的不良事件来评估安全性。

结果

静脉治疗结束时的评估显示,卡泊芬净的疗效更优,86.7%的患者有良好的反应,而接受两性霉素 B 治疗的患者中仅有 41.7%有良好的反应(p=0.04)。卡泊芬净组的不良事件明显少于两性霉素 B 组。

结论

卡泊芬净在治疗新生儿侵袭性念珠菌病方面比两性霉素 B 更有效、更安全,是一种替代两性霉素 B 的选择。

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