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4种个体化给药工具对万古霉素血药浓度的预测准确性与临床适用性比较
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| 篇名： | 4种个体化给药工具对万古霉素血药浓度的预测准确性与临床适用性比较 |
| TITLE： | Comparison of predictive accuracy and clinical applicability among four vancomycin individualized dosing tools |
| 摘要： | 目的 比较4种个体化给药工具（SmartDose、ClinCalc、Gulou、Pharmado）对万古霉素血药浓度的预测准确性及临床适用性，为临床合理用药提供依据。方法采用回顾性队列研究设计。回顾性收集2022年1月1日至2024年6月30日于复旦大学附属中山医院厦门医院住院接受静脉注射万古霉素治疗并监测稳态谷浓度的479例成年患者资料纳入分析研究。以平均误差、平均绝对误差、平均百分比误差、平均绝对百分比误差、绝对百分比误差＜30%的患者比例、95%一致性界限及预测值与实测值的总体相对百分差值为指标，评估各工具的预测准确性。以可获得性、患者管理、多方案推荐等为指标，评价各工具对所有患者的临床适用性；以血药浓度预测值与实测值的准确度差异为指标，评价各工具对不同肾功能亚组（亢进、正常、轻度损伤、中度损伤、重度损伤）患者的临床适用性。结果在预测准确性方面，SmartDose的平均绝对百分比误差为46.40%，绝对百分比误差＜30%的患者比例最高（46.56%）。Bland-Altman分析结果显示，SmartDose预测值的总体相对百分差值最小（－7.25%），但各工具的95%一致性界限均较宽（上下限差值均大于200%）。在临床适用性方面，4种工具均为免费开放，可获得性良好；其中，SmartDose和Pharmado提供了最全面的解决方案，包括患者管理、多方案推荐和药物浓度-时间曲线图等功能。肾功能亚组分析结果显示，Pharmado对肾功能亢进患者预测效果最优（平均差值为0.11mg/L），SmartDose和ClinCalc在肾功能正常及轻度损伤患者中的表现相对更优（平均差值分别为0.37、0.51mg/L及－1.13、－1.33mg/L），SmartDose在肾功能中度损伤患者中表现最佳（平均差值为－2.60mg/L），而Pharmado和Gulou在肾功能重度损伤患者中的预测偏差较小（平均差值分别为1.52、－0.23mg/L）。结论4种个体化给药工具在万古霉素血药浓度初始预测中的准确性均有限，其中SmartDose的整体预测准确性最高，且具备完善的临床管理功能。建议肾功能亢进患者优先选用Pharmado，肾功能正常或轻度损伤患者选用SmartDose或ClinCalc，肾功能中度损伤患者选用SmartDose，肾功能重度损伤患者选用Pharmado或Gulou。 |
| ABSTRACT： | OBJECTIVE To compare the predictive accuracy and clinical applicability of four vancomycin individualized dosing tools （SmartDose， ClinCalc， Gulou， Pharmado） and provide a basis for rational clinical medication use. METHODS A retrospective cohort study was conducted， enrolling 479 adult patients who received vancomycin therapy and underwent steady-state trough concentration monitoring in Zhongshan Hospital， Fudan University （Xiamen Branch） from January 1， 2022， to June 30， 2024. The predictive accuracy of each tool was evaluated using indicators， such as mean error （ME）, mean absolute error （MAE）， mean percentage error （MPE）， mean absolute percentage error （MAPE）， the proportion of patients with an absolute percentage error （APE） of less than 30%， the 95% limits of agreement， and the overall relative percentage difference between predicted and measured values. Using indicators such as accessibility， patient management， and recommendation of multiple treatment options， the clinical panxso@163.com applicability of the tools for all patients was evaluated； using the discrepancy in accuracy between the predicted and actual measured blood drug concentrations as an indicator， the clinical applicability was assessed for patients in different renal function subgroups （hyperfunction， normal， mild impairment， moderate impairment， and severe impairment）. RESULTS In terms of accuracy， SmartDose demonstrated the best overall performance with an MAPE of 46.40% and a proportion of APE ＜30% （46.56%）. Bland-Altman analysis indicated that SmartDose had the smallest overall relative percentage difference （－7.25%）， although the 95% limits of agreement were broad for all tools， with differences between the upper and lower limits exceeding 200%. In terms of applicability， all four dosing tools were freely accessible and demonstrated good availability； SmartDose and Pharmado provided the most comprehensive solutions， offering features such as patient management， multiple regimen recommendations， and drug concentration-time curve plotting. Stratified analysis based on renal function revealed that Pharmado showed optimal prediction for hyperfiltration patients （mean difference： 0.11 mg/L）. SmartDose and ClinCalc showed relatively better performance in normal and mild renal impaiment （mean difference： 0.37， 0.51 mg/L and －1.13， －1.33 mg/L，respectively）. SmartDose performed best in moderate renal impairment （mean difference： －2.60 mg/L）. Pharmado and Gulou had smaller prediction biases in severe renal impairment （mean differences： 1.52 mg/L and －0.23 mg/L， respectively）. CONCLUSIONS The four individualized dosing tools demonstrated limited accuracy in the initial prediction of vancomycin concentrations. Among them， SmartDose demonstrates the highest overall prediction accuracy and possesses comprehensive clinical management features. It is recommended that Pharmado be preferred for patients with renal hyperfiltration； SmartDose or ClinCalc can be used for patients with normal or mildly impaired renal function； SmartDose is recommended for patients with moderately impaired renal function； Pharmado or Gulou may be considered for patients with severely impaired renal function. |
| 期刊： | 2025年第36卷第22期 |
| 作者： | 陈沭；卢艳钦；沈赟；曹畅；潘坤明；李晓宇；吕迁洲 |
| AUTHORS： | CHEN Shu，LU Yanqin，SHEN Yun，CAO Chang，PAN Kunming，LI Xiaoyu，LYU Qianzhou |
| 关键字： | 万古霉素；个体化给药工具；治疗药物监测；血药浓度；肾功能；方案预测 |
| KEYWORDS： | vancomycin； individualized dosing tools； therapeutic drug monitoring； plasma concentration； renal function； plan |
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