Postgraduate Program in Internal Medicine and Health Sciences, Federal University of Paraná (UFPR), 181, General Carneiro Street, Curitiba, Brazil.
Faculdades Pequeno Príncipe, Curitiba, Brazil.
Paediatr Drugs. 2022 Sep;24(5):513-528. doi: 10.1007/s40272-022-00523-0. Epub 2022 Jul 18.
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.
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.
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.
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.
两性霉素 B 去氧胆酸盐（AMB-D）在儿科患者中仍然是一种具有重要治疗价值的抗真菌药物。目前的共识是，其在新生儿中的使用比在年长儿童中更安全。然而，儿童期有不同的发育阶段，值得更精确地评估。我们的目标是根据国家儿童健康与人类发育研究所的分类，评估 AMB-D 在儿科年龄组中的使用情况。
这是一项在巴西一家三级儿童医院进行的回顾性横断面观察性研究，时间为 2014 年 1 月至 2019 年 12 月。从电子健康档案中提取至少接受两次静脉注射 AMB-D 的患者数据。根据具体标准收集患者人口统计学、基础疾病和合并症、实验室检查、真菌感染诊断和 AMB-D 使用信息。应用非参数检验，如卡方检验比较比例和 Fisher 确切检验评估分类变量或列联表之间的关联。
127 份病历分为早产儿（出生时<37 周胎龄）、足月儿（出生-27 天）、婴儿（28 天-12 个月）、幼儿（13 个月-2 岁）、学步儿（3-5 岁）、儿童（6-11 岁）和青少年（12-18 岁）。AMB-D 应用指征遵循经验使用（主要指征，n=74；58.26%）、确诊和可能的真菌感染（n=39；30.71%）和医学怀疑（n=14；11.02%）。在培养物中分离出的主要病原体为念珠菌属，其中白色念珠菌（n=18；40%）最多，其次为近平滑念珠菌（n=14；31.11%）和热带念珠菌（n=6；13.33%）。在儿科患者中使用 AMB-D 时，很少观察到急性输液相关不良事件。我们发现 13 个月及以上年龄组患者使用 AMB-D 有不利影响，表明该组发生不良事件的可能性更大，而不是在新生儿期之后。
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。我们寻找转折点有助于研究的准确性，因为它提供了关于 D-AMB 在特定儿科年龄组中影响的数据。
