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作 者:王广飞[1] 李琴[1] 朱逸清[1] 陈也伟[1] 朱琳[1] 张旭晖[1] 卢金淼[1] 李智平[1] Wang Guangfei;Li Qin;Zhu Yiqing;Chen Yewei;Zhu Lin;Zhang Xuhui;Lu Jinmiao;Li Zhiping(Department of Clinical Pharmacy, Children' s Hospital of Fudan University, Shanghai 201102, China)
机构地区:[1]复旦大学附属儿科医院临床药学部,上海201102
出 处:《药物流行病学杂志》2018年第6期396-399,共4页Chinese Journal of Pharmacoepidemiology
基 金: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)
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-AUC0~12h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。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-AUC0-12h) based on the patients' physiological conditions. The clinical data were collected, alter which the patients' gender, disease spectrum, MPA-AUC0-12h, adverse drug reactions(ADR) and outcomes were analyzed. Re- suits: 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 AUC0-12h 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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