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万古霉素群体药代动力学在肾脏清除率增加患者中的临床验证

[Clinical verification of vancomycin population pharmacokinetics in patients with augmented renal clearance].

作者信息

Lu Haodi, Tang Lian, Xue Shengmin, Zhuang Zhiwei, Fang Jie, Zhao Fuli, Shang Erning

机构信息

Department of Pharmacy, Suzhou Hospital Affiliated to Nanjing Medical University, Suzhou 215002, Jiangsu, China (Lu HD, Tang L, Xue SM, Shang EN); Department of Emergency, Suzhou Hospital Affiliated to Nanjing Medical University, Suzhou 215002, Jiangsu, China (Zhuang ZW); Department of Pharmacy, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200025, China (Fang J); Department of Intensive Care Unit, Suzhou Hospital Affiliated to Nanjing Medical University, Suzhou 215002, Jiangsu, China (Zhao FL). Corresponding author: Shang Erning, Email:

出版信息

Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 May;30(5):444-448. doi: 10.3760/cma.j.issn.2095-4352.2018.05.010.

Abstract

OBJECTIVE

To evaluate the predictive value and to verify the clinical effect of JPKD-vancomycin for the trough concentration of vancomycin in patients with augmented renal clearance (ARC), and to provide a reference for clinical individualized drug therapy.

METHODS

A retrospective analysis was conducted. The clinical data of 48 adult patients with ARC using vancomycin and monitoring steady-state trough concentration of vancomycin admitted to Suzhou Hospital Affiliated to Nanjing Medical University from July 2013 to July 2017 were collected. A combination of classical Vancomycin Calculator software and JPKD-vancomycin software was used. Based on the individual conditions of patients [gender, age, height, weight, serum creatinine (SCr), disease status], Vancomycin Calculator software was used to obtain the recommended regimen and its steady-state trough concentration, and then JPKD-vancomycin software was used to predict the steady-state trough concentration of initial regimen. If the regimen was adjusted during the treatment, JPKD-vancomycin software was used to predict the steady-state trough concentration of the adjusted regimen. The measured values of steady-state trough concentration were recorded. The weight deviation between predicted concentration and measured concentration (WRES) was calculated. WRES < 30% was considered as good prediction, and the predictive value of JPKD-vancomycin software was evaluated for vancomycin trough concentration.

RESULTS

Forty-eight patients with ARC were enrolled, of whom 24 patients had adjusted the dosing regimen during the treatment. The initial concentration of blood samples was 48, after adjusting the dosage regimen, 24 blood samples were collected. The initial and adjusted daily dose of vancomycin was (2 000±500) mg/d and (2 500±600) mg/d, respectively, and the initial trough concentrations and adjusted trough concentrations was (8.4±7.3) mg/L and (9.1±4.3) mg/L, respectively. Only 14.6% and 25.0% of initial and adjusted trough concentrations reached the target range (10-20 mg/L) without significant difference (P > 0.05). The WRES value of adjusted trough concentrations predicted by JPKD-vancomycin software was significantly lower than that of initial regimen [10.6% (3.0%, 16.4%) vs. 14.3% (10.5%, 38.2%), P < 0.05], and the percentage of WRES < 30% also tended to increase [95.8% (23/24) vs. 70.8% (34/48), P < 0.05]. The well predictive rate of JPKD-vancomycin software for vancomycin trough concentration was 79.2% (57/72), but there were 15 patients with WRES > 30%.

CONCLUSIONS

JPKD-vancomycin software has good predictive value for the vancomycin trough concentration of ARC patients, especially for the trough concentration after adjusting the treatment regimen. JPKD-vancomycin can provide a reference for the design of clinical individualized application of vancomycin.

摘要

目的

评估JPKD-万古霉素软件对肾清除率增加(ARC)患者万古霉素谷浓度的预测价值并验证其临床效果,为临床个体化药物治疗提供参考。

方法

进行回顾性分析。收集2013年7月至2017年7月在南京医科大学附属苏州医院住院使用万古霉素并监测万古霉素稳态谷浓度的48例成年ARC患者的临床资料。采用经典的万古霉素计算器软件和JPKD-万古霉素软件相结合的方法。根据患者的个体情况[性别、年龄、身高、体重、血清肌酐(SCr)、疾病状态],使用万古霉素计算器软件获得推荐方案及其稳态谷浓度,然后使用JPKD-万古霉素软件预测初始方案的稳态谷浓度。如果治疗期间调整了方案,则使用JPKD-万古霉素软件预测调整后方案的稳态谷浓度。记录稳态谷浓度的测量值。计算预测浓度与测量浓度之间的权重偏差(WRES)。WRES<30%被认为预测良好,评估JPKD-万古霉素软件对万古霉素谷浓度的预测价值。

结果

纳入48例ARC患者,其中24例患者在治疗期间调整了给药方案。初始采血样本数为48例,调整剂量方案后采血样本数为24例。万古霉素初始和调整后的日剂量分别为(2000±500)mg/d和(2500±600)mg/d,初始谷浓度和调整后谷浓度分别为(8.4±7.3)mg/L和(9.1±4.3)mg/L。初始和调整后谷浓度仅分别有14.6%和25.0%达到目标范围(10~20mg/L),差异无统计学意义(P>0.05)。JPKD-万古霉素软件预测的调整后谷浓度的WRES值显著低于初始方案[10.6%(3.0%,16.4%)对14.3%(10.5%,38.2%),P<0.05],WRES<30%的比例也有增加趋势[95.8%(23/24)对70.8%(34/48),P<0.05]。JPKD-万古霉素软件对万古霉素谷浓度的良好预测率为79.2%(57/72),但有15例患者WRES>30%。

结论

JPKD-万古霉素软件对ARC患者万古霉素谷浓度具有良好的预测价值,尤其是对调整治疗方案后的谷浓度。JPKD-万古霉素可为临床万古霉素个体化应用方案设计提供参考。

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