Background and Objective

Amphotericin B deoxycholate (AMB-D) remains an antifungal agent with great therapeutic value in pediatric patients. The currrent consensus is that its use in neonates is safer than in older children. However, childhood presents different periods of development that deserve to be evaluated more precisely. Our goal was to assess the usage profile of AMB-D in stratified pediatric age groups, adapted according to the National Institute of Child Health and Human Development classification.

Methods

This retrospective cross-sectional observational study was conducted at a Brazilian tertiary children’s hospital between January 2014 and December 2019. Data of patients who received at least two doses of intravenous AMB-D while hospitalized were extracted from electronic health files. Information on patient demographics, underlying diseases and comorbidities, laboratory examinations, fungal infection diagnosis, and AMB-D use were gathered following specific criteria. Nonparametric tests were applied, such as the chi-square test to compare proportions and Fisher’s exact test to assess the association between categorical variables or contingency tables.

Results

One hundred and twenty-seven (127) medical records were stratified as preterm neonatal (birth <37 weeks postmenstrual age), term neonatal (birth–27 days), infants (28 days–12 months), toddlers (13 months–2 years), early childhood (3–5 years), middle childhood (6–11 years), and early adolescence (12–18 years). The criteria for the indication of AMB-D followed empirical use as the main indication (n = 74; 58.26%), proven and probable fungal infection (n = 39; 30.71%), and medical suspicion (n = 14; 11.02%). Candida spp. was the main etiologic agent isolated in cultures, with the highest frequency of C. albicans (n = 18; 40%), followed by Candida parapsilosis (n = 14; 31.11%), and Candida tropicalis (n = 6; 13.33%). Very few acute infusion-related adverse effects were observed during the administration of AMB-D in pediatric patients. We found an unfavorable impact of AMB-D use in patients from 13 months of age onwards suggesting this group as a turning point for a greater chance of adverse events, and not soon after the neonatal period.

Conclusions

Clinical or observational studies based on age stratification are essential to accurately elucidate whether potentially toxic drugs can be used safely in the pediatric population. Our search for a turning point was shown to contribute to the accuracy of the study, as it provided data on the impact of D-AMB in specific pediatric age groups.

中文翻译：

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儿科中的两性霉素 B：年龄分层分析表明，从 13 个月大起发生不良事件的可能性更大

背景与目的

两性霉素 B 脱氧胆酸盐 (AMB-D) 仍然是一种在儿科患者中具有重要治疗价值的抗真菌剂。目前的共识是，它在新生儿中的使用比在年龄较大的儿童中更安全。然而，童年呈现出不同的发展阶段，值得更准确地评估。我们的目标是评估 AMB-D 在分层儿科年龄组中的使用情况，根据美国国家儿童健康和人类发展研究所的分类进行调整。

方法

这项回顾性横断面观察研究于 2014 年 1 月至 2019 年 12 月在巴西一家三级儿童医院进行。从电子健康文件中提取了在住院期间接受至少两剂静脉注射 AMB-D 的患者的数据。按照特定标准收集有关患者人口统计学、基础疾病和合并症、实验室检查、真菌感染诊断和 AMB-D 使用的信息。应用了非参数检验，例如比较比例的卡方检验和评估分类变量或列联表之间的关联的 Fisher 精确检验。

结果

一百二十七 (127) 份医疗记录被分层为早产新生儿（出生<37 周后月经）、足月新生儿（出生-27 天）、婴儿（28 天-12 个月）、幼儿（13 个月-2 岁） )、儿童早期（3-5 岁）、儿童中期（6-11 岁）和青春期早期（12-18 岁）。AMB-D 适应症的标准遵循经验性使用作为主要适应症 ( n = 74; 58.26%)、证实和可能的真菌感染 ( n = 39; 30.71%) 和医学怀疑 ( n = 14; 11.02%) . 念珠菌属 是在培养物中分离出的主要病原体，白色念珠菌的频率最高（n = 18；40%），其次是近平滑念珠菌( n = 14; 31.11%) 和热带念珠菌( n = 6; 13.33%)。在儿科患者中使用 AMB-D 期间几乎没有观察到与急性输注相关的不良反应。我们发现在 13 个月大的患者中使用 AMB-D 会产生不利影响，这表明该组是不良事件发生几率更大的转折点，而且不会在新生儿期之后不久。

结论

基于年龄分层的临床或观察性研究对于准确阐明潜在毒性药物是否可以在儿科人群中安全使用至关重要。我们寻找转折点被证明有助于提高研究的准确性，因为它提供了有关 D-AMB 对特定儿科年龄组影响的数据。