米卡芬净与两性霉素B治疗早产儿侵袭性真菌感染的随机对照试验

Micafungin versus Amphotericin B in treatment of invasive fungal infection in preterm neonates: a randomized control trial.

作者信息

Ibrahim Mariam John Amin, Mohammed Fathy Marwa Saad, Ghobrial Mertte Ashraf Thabet, Mohamed Maha Hassan

机构信息

Pediatrics and Neonatology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Professor of Medical Microbiology and Immunology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

出版信息

Ital J Pediatr. 2025 Feb 27;51(1):61. doi: 10.1186/s13052-025-01852-9.

DOI:10.1186/s13052-025-01852-9

PMID:40016807

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11866894/

Abstract

BACKGROUND

Micafungin, Amphotericin B, and Fluconazole are the primary therapeutic agents employed to address invasive fungal candidiasis in neonates. Resistance to fluconazole is gradually developing in neonatal intensive care units. We aimed to conduct a comparative analysis of Micafungin and Amphotericin B in terms of their effectiveness and safety in the treatment of invasive fungal infections in neonates.

METHODS

Fifty-six preterm neonates with invasive fungal infection proven by fungal culture and who had received fluconazole for at least one week were included in our study and were divided randomly into two groups. Micafungin group: twenty-eight preterms received Micafungin at a dose of 8 mg/kg/day for 14 days. Amphotericin B group: twenty-eight preterms received amphotericin B at a dose of 1 mg /kg/day for 14 days. Clinical and laboratory follow up by fungal culture were performed after 14 days.

RESULTS

Neonates in the Micafungin group showed significant increased percentage for complete cure of the fungal infection compared to Amphotericin B group 18(64.3%) vs. 10(35.7%) respectively and decreased percentage of incomplete cure 10(35.7%) vs. 18(64.3%) respectively with p-value 0.030. A higher percentage of neonates were completely cured for both candida albicans (65.2%) and non-albicans (60%) in the micafungin group. Duration of respiratory and circulatory support was significantly shorter also. No additional drug side effects were observed with Micafungin except for mild hypomagnesemia. There was an increase in blood urea nitrogen with Amphotericin B.

CONCLUSION

Micafungin is effective and well tolerated for the treatment of invasive fungal infections in preterm neonates.

TRIAL REGISTRATION

The current study was approved by clinicaltrials.org and the protocol ID NCT06413056 was retrospectively registered in on 11th of march 2024. https://clinicaltrials.gov/study/NCT06413056?cond=micafungin%20in%20neonates&rank=2 .

摘要

背景

米卡芬净、两性霉素B和氟康唑是用于治疗新生儿侵袭性念珠菌病的主要治疗药物。在新生儿重症监护病房中，对氟康唑的耐药性正在逐渐增加。我们旨在对米卡芬净和两性霉素B在治疗新生儿侵袭性真菌感染方面的有效性和安全性进行比较分析。

方法

56例经真菌培养证实患有侵袭性真菌感染且已接受氟康唑治疗至少一周的早产儿被纳入我们的研究，并随机分为两组。米卡芬净组：28例早产儿接受米卡芬净治疗，剂量为8mg/kg/天，持续14天。两性霉素B组：28例早产儿接受两性霉素B治疗，剂量为1mg/kg/天，持续14天。14天后通过真菌培养进行临床和实验室随访。

结果

米卡芬净组新生儿真菌感染完全治愈的百分比显著高于两性霉素B组，分别为18例（64.3%）和10例（35.7%），不完全治愈的百分比分别下降，为10例（35.7%）和18例（64.3%），p值为0.030。米卡芬净组中白色念珠菌（65.2%）和非白色念珠菌（60%）完全治愈的新生儿百分比更高。呼吸和循环支持的持续时间也显著缩短。除轻度低镁血症外，未观察到米卡芬净有其他药物副作用。两性霉素B治疗后血尿素氮升高。