癫痫患儿血药浓度监测依从性对丙戊酸有效性和安全性的影响  

The Influence of Therapeutic Drug Monitoring Compliance on Efficiency and Safety about Valproic Acid in Epileptic Children

作　　者：徐善森 张媞[1] 刘美[1] 肇丽梅[1] 

机构地区：[1]中国医科大学附属盛京医院药学部,沈阳110004

出　　处：《中国药学杂志》2015年第20期1829-1832,共4页Chinese Pharmaceutical Journal

基　　金：辽宁省自然科学基金资助项目(2013021079)

摘　　要：目的通过考查患儿对血药浓度监测的依从性,评价丙戊酸钠用药的有效性及安全性,为癫痫患儿的个体化用药提供参考。方法收集应用丙戊酸钠单用药或联合其他抗癫痫药治疗,并进行丙戊酸血药浓度监测的患儿病例,对资料进行回顾性分析。结果共有1 507例患儿纳入研究。49.44%患儿只测定了1次丙戊酸血药浓度,测定4次以上血药浓度的患儿仅占5.24%;首次进行丙戊酸血药浓度监测患儿的达治疗窗率仅为51.63%,超治疗窗者占3.58%;不同监测次数之间患儿年龄、日给药剂量、血药浓度、控制率差异均有统计学意义(P<0.05);不同年龄组之间丙戊酸血药浓度差异有统计学意义(P<0.001);丙戊酸钠单用组与合并用药组之间日给药剂量(P<0.001)、血药浓度(P=0.001)、达治疗窗率(P=0.004)有统计学差异;而不同监测次数之间,肝功能异常发生率无差异。结论丙戊酸血药浓度个体间差异大,需定期监测血药浓度,进行个体化给药,降低不良反应的发生,提高药物疗效。OBJECTIVE To evaluate the efficiency and safety of sodium valproate by testing the compliance of therapeutic drug monitoring（ TDM） in epileptic children so as to provide a reference for rational and individual treatment. METHODS A retrospective analysis of clinical data of children with epilepsy was performed. The patients were treated with sodium valproate or combined with other AEDs. RESULTS A total 1 507 children were included in the study. It was found that the 49. 44% of children had taken TDM only once and the children who had TDM for over 4 times merely took up 5. 24%. The first time performed TDM data within therapeutic window only took up 51. 63%,and 3. 58% exceeding the window as well. There were statistical difference between age,daily dosage,valproate plasma concentration and control rate among different times in TDM（ P〈0. 001）. And difference was also statistical significance between valproate plasma concentration in age groups. Comparing sodium valproate monotherapy to sodium valproate combined with other AEDs,daily dosage（ P〈0. 001）,the valproate serum concentration（ P = 0. 001） and the rate within therapeutic window（ P = 0. 004） were all in statistical difference. However,there was no difference in abnormal liver function rate among TDM times.CONCLUSION Since the great difference among individuals,it need to take individual therapy based on the results of TDM and to reduce the adverse reaction so as to improve the efficiency and rational use of drugs on clinic.

关 键 词：丙戊酸 血药浓度监测 依从性 有效性 安全性 

分 类 号：R969.3[医药卫生—药理学]