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Background <p>Aminoglycoside pharmacokinetics is expected to change in premature infant. However, the PK profile of amikacin in Chinese premature infants has not been characterized. The aim of this study was to assess the safety and describe the pharmacokinetics properties of amikacin in Chinese premature infants.</p> Methods <p>This was a two-center, retrospective, pharmacokinetic study. Phoenix NLME was used to construct a pharmacokinetics model. Monte Carlo simulations were performed to screen the optimal dosage regimen.</p> Results <p>A total of 54 amikacin concentrations from 23 patients were available for population pharmacokinetic analysis. The patients received an amikacin total daily dose (median(range)) of 14.32 (10.34–19.70) mg/kg. The distribution of C<sub>min</sub> (median(range)) was 4.07 (1.01–30.99)µg/mL, and C<sub>max</sub> (median(range)) was 17.45 (4.56-164.72) µg/mL. There were 14 patients achieved target C<sub>min</sub>, and 6 infants achieved C<sub>max</sub>. There were 3 cases occurred acute kidney injury, with C<sub>max</sub> and C<sub>min</sub> all exceeded the recommended range. A one-compartment model with first-order elimination best described the amikacin concentration-time data. The estimated typical values of clearance and volume of distribution for amikacin were 1.43&#xa0;L/h/70kg and 30.97&#xa0;L/70kg, respectively. Covariate analyses revealed that statistically significant relationships between amikacin clearance and weight, postmenstrual age and renal function, while there was a statistically significant relationship between volume of distribution and weight. Based on the model-based simulations, the initial recommend dosage regimens prior to therapeutic drug monitoring were suggested as 13&#xa0;mg/kg q24h, 12&#xa0;mg/kg q36h and q48h for serum creatinine between 15–22µmol/L; 23–36 and 37–60µmol/L, respectively.</p> Conclusion <p>Weight, postmenstrual age and renal function have significant influence on the PK of amikacin in Chinese premature infants. The optimal dosage regimens might provide an alternative choice for premature infants in China in the therapy of amikacin.</p>

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Therapeutic drug monitoring of amikacin in Chinese premature infant: a population pharmacokinetic analysis and dosage optimization

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月6日

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  • Jia-hui Li,
  • Jin-hui Xu,
  • Yan Huang,
  • Mi Zhou,
  • Zu-ming Yang,
  • Jing-jing Li,
  • Zong-tai Feng,
  • Qian Zhang,
  • Yan-xia Yu,
  • Lu-fen Duan,
  • Lian Tang

摘要

Background

Aminoglycoside pharmacokinetics is expected to change in premature infant. However, the PK profile of amikacin in Chinese premature infants has not been characterized. The aim of this study was to assess the safety and describe the pharmacokinetics properties of amikacin in Chinese premature infants.

Methods

This was a two-center, retrospective, pharmacokinetic study. Phoenix NLME was used to construct a pharmacokinetics model. Monte Carlo simulations were performed to screen the optimal dosage regimen.

Results

A total of 54 amikacin concentrations from 23 patients were available for population pharmacokinetic analysis. The patients received an amikacin total daily dose (median(range)) of 14.32 (10.34–19.70) mg/kg. The distribution of Cmin (median(range)) was 4.07 (1.01–30.99)µg/mL, and Cmax (median(range)) was 17.45 (4.56-164.72) µg/mL. There were 14 patients achieved target Cmin, and 6 infants achieved Cmax. There were 3 cases occurred acute kidney injury, with Cmax and Cmin all exceeded the recommended range. A one-compartment model with first-order elimination best described the amikacin concentration-time data. The estimated typical values of clearance and volume of distribution for amikacin were 1.43 L/h/70kg and 30.97 L/70kg, respectively. Covariate analyses revealed that statistically significant relationships between amikacin clearance and weight, postmenstrual age and renal function, while there was a statistically significant relationship between volume of distribution and weight. Based on the model-based simulations, the initial recommend dosage regimens prior to therapeutic drug monitoring were suggested as 13 mg/kg q24h, 12 mg/kg q36h and q48h for serum creatinine between 15–22µmol/L; 23–36 and 37–60µmol/L, respectively.

Conclusion

Weight, postmenstrual age and renal function have significant influence on the PK of amikacin in Chinese premature infants. The optimal dosage regimens might provide an alternative choice for premature infants in China in the therapy of amikacin.