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319例次儿童霉酚酸血药浓度监测结果分析
Analysis of 319 Case times of Blood Concentration Monitoring of Mycophenolic Acid in Pediatric Patients
  
DOI:
中文关键词:  吗替麦考酚酯  霉酚酸  治疗药物监测  曲线下面积  药品不良反应
英文关键词:Mycophenolate mofetil  Mycophenolic acid  Therapeutic drug monitoring  Area under the curve  Adverse drug reactions
基金项目:中国世界卫生组织2016 2017双年度合作项目(编号:2016/647672 0);上海市卫生计生系统重要薄弱学科建设项目(编号:2016ZB0305)
作者单位
王广飞 李琴 朱逸清 陈也伟 朱琳 张旭晖 卢金淼 李智平 复旦大学附属儿科医院临床药学部 上海201102 
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中文摘要:
      摘 要 目的:分析复旦大学附属儿科医院2016年11月~2017年10月霉酚酸(MPA)血药浓度监测结果,促进临床安全用药。方法:采用酶放大免疫技术测定血清中游离MPA浓度,利用Mwphar+软件模拟MPA的药动学曲线,计算AUC0~12h值。收集患儿的临床资料,对患儿性别分布、疾病分类、血药浓度监测结果、药品不良反应(ADR)及转归情况进行分析。结果:纳入患儿237例,平均年龄为(10.70±3.61)岁,319例次MPA血药浓度监测结果。涉及到的疾病有14种,主要为系统性红斑狼疮(33.54%),肾病综合征(16.61%)和异体器官移植(15.05%)。MPA AUC0~12h值在30~60 mg·h·L-1的患儿约占48.28%。ADR主要涉及胃肠道(13.79%),所有发生ADR的患儿症状好转或消失。结论:结合Mwphar+软件拟合AUC代谢曲线,可更好地掌握患儿体内MPA的暴露量,提高临床疗效,保障儿童安全用药。
英文摘要:
      ABSTRACT Objective:Mycophenolic acid (MPA) therapeutic drug monitoring (TDM) of pediatric patients from Children’s Hospital of Fudan University during November 2016 to October 2017 was analyzed to improve clinical outcomes. Methods: Concentrations of serum MPA were determined by enzyme multiplied immunoassay technique, with the Mwphar+ software applied for the pharmacokinetic curve fitting analysis and calculation of the MPA–area under the concentration time curve (MPA AUC0 12h) based on the patients’ physiological conditions. The clinical data were collected, after which the patients’ gender, disease spectrum, MPA AUC0 12h, adverse drug reactions(ADR) and outcomes were analyzed.Results:A total of 237 pediatric patients treated by MMF participated in the study, with the average age at (10.70±3.61) years. The study included 319 case times of MPA TDM, and involved 14 diseases, in which systemic lupus erythematosus making the most proportion (33.54%), followed by nephrotic syndrome (16.61%) and allogeneic organ transplantation (15.05%). Of the 319 case times of MPA TDM, 48.28% of MPA exposure AUC0–12h was 30 60 mg·h·L-1. The gastrointestinal adverse effects were the most prevalent ADR, with a rate of 13.79%. All the patients with ADR were improved or recovered. Conclusion:When using MMF treating immune system diseases in pediatric patients, close attention must be paid. The Mwphar+ software is useful for the MPA pharmacokinetic curve fitting analysis, providing more accurate MPA exposure data, so as to improve clinical outcomes and ensure medication safety.
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