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Purpose <p>To evaluate the factors influencing voriconazole (VRC) administration, clinical efficacy, and safety in children with hematological malignancies (HM) and invasive fungal infection (IFD).</p> Methods <p>This is a single-center, retrospective real-world study conducted between July 2018 and December 2023. Univariate and multivariate logistic regression analysis were used to analyze the affecting factors.</p> Results <p>A total of 167 patients were included in this study. Among them, 13.77% (23/167) of children under 2 years old received off-label use of VRC, with an initial maintenance dose higher than that of other groups (<i>P</i> &lt; 0.001). There were 8 cases (4.79%) of cured, 148 cases (88.62%) of improved, and 11 cases (6.59%) of ineffective. Thirty-eight cases experienced adverse drug reactions (ADR), with a highest incidence (10.2%) of hepatotoxicity. The concomitant proton pump inhibitors (PPIs), days of central venous catheterization and coagulopathy were independent influencing factors of ADR. Sixty-six patients underwent therapeutic drug monitoring (TDM), which increased the probability of achieving the target plasma trough concentration (C<sub>min</sub>). Among children &lt; 2 years old underwent TDM, 88.89% (8/9) achieved therapeutic concentration, and the probability was higher than that of the older groups. Days of VRC treatment had a positive but not statistically significant effect on achievement of target C<sub>min</sub>. Hypoalbuminemia and days of antimicrobials treatment were independent influencing factors of C<sub>min</sub> distribution.</p> Conclusion <p>Attention to the off-label use of VRC in children &lt; 2 years old, hypoalbuminemia and coagulopathy correction, potential drug interactions with VRC, and ADR monitoring is crucial for clinical efficacy and safety.</p>

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Voriconazole in the treatment of pediatric patients with hematologic malignancies and invasive fungal infections: a real-world study

  • 期刊论文

  • 发表日期：

    2025年3月9日

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  • Namei Wu,
  • Lili Cai,
  • Qingquan Zhang,
  • Yaxin Fan,
  • Zhihang Lin

摘要

Purpose

To evaluate the factors influencing voriconazole (VRC) administration, clinical efficacy, and safety in children with hematological malignancies (HM) and invasive fungal infection (IFD).

Methods

This is a single-center, retrospective real-world study conducted between July 2018 and December 2023. Univariate and multivariate logistic regression analysis were used to analyze the affecting factors.

Results

A total of 167 patients were included in this study. Among them, 13.77% (23/167) of children under 2 years old received off-label use of VRC, with an initial maintenance dose higher than that of other groups (P < 0.001). There were 8 cases (4.79%) of cured, 148 cases (88.62%) of improved, and 11 cases (6.59%) of ineffective. Thirty-eight cases experienced adverse drug reactions (ADR), with a highest incidence (10.2%) of hepatotoxicity. The concomitant proton pump inhibitors (PPIs), days of central venous catheterization and coagulopathy were independent influencing factors of ADR. Sixty-six patients underwent therapeutic drug monitoring (TDM), which increased the probability of achieving the target plasma trough concentration (Cmin). Among children < 2 years old underwent TDM, 88.89% (8/9) achieved therapeutic concentration, and the probability was higher than that of the older groups. Days of VRC treatment had a positive but not statistically significant effect on achievement of target Cmin. Hypoalbuminemia and days of antimicrobials treatment were independent influencing factors of Cmin distribution.

Conclusion

Attention to the off-label use of VRC in children < 2 years old, hypoalbuminemia and coagulopathy correction, potential drug interactions with VRC, and ADR monitoring is crucial for clinical efficacy and safety.