地高辛血药浓度和不良反应影响因素分析  

Analysis of the concentration of digoxin and influential factors for ad-verse reaction

作　　者：肖雷[1] 曹灿 刘加涛[1] XIAO Lei;CAO Can;LIU Jiatao(Department of Pharmacy,the First Hospital Affiliated to Anhui Medical University/Third-grade Pharmaceu-tical Chemistry Laboratory of State Administration of Traditional Chinese Medicine,Hefei 230022,Anhui,China)

机构地区：[1]安徽医科大学第一附属医院药剂科/国家中医药管理局中药化学三级实验室,安徽合肥230022

出　　处：《中国临床药理学与治疗学》2024年第11期1280-1287,共8页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：安徽省自然科学基金(2008085MH257);安徽省高校优秀青年人才支持计划项目(gxyq2020008);安徽省高等学校自然科学研究项目(KJ2020A0177);安徽省“十三五”临床重点专科建设项目(卫科教秘[2017]529号)。

摘　　要：目的:探讨影响地高辛血药浓度的危险因素以及地高辛血药浓度水平与不良反应间的关系,为地高辛的安全、合理使用提供依据。方法:通过酶放大免疫测定技术监测地高辛血药浓度,并通过病案系统收集患者的基本资料、实验室指标、合并用药和不良反应等资料。结果:55例患者中分别有12.73%、76.36%和10.91%的患者使用<0.125 mg/d、0.125 mg/d和0.25 mg/d的地高辛,血清药物浓度随剂量递增而增加。有11例(20%)患者出现不良反应,最常见的是心律失常,发生不良反应的患者血清地高辛浓度为(2.55±1.59)ng/mL,显著高于无不良反应组的(0.93±0.63)ng/mL(P<0.000 1)。血肌酐升高者地高辛血药浓度高于肌酐正常者。重度肾功能损害患者血清地高辛浓度显著高于肾功能正常患者(P<0.05),不良反应发生率也高于肾功能正常患者。未观察到合并用药对地高辛血药浓度的影响。结论:地高辛血药浓度个体差异大,其血药浓度受给药剂量、肾功能等的影响,血药浓度越高,不良反应发生率越高。因此,应加强地高辛血药浓度监测,提高个体化给药水平。AIM:To investigate the risk factors af-fecting serum digoxin concentration and the rela-tionship between the level of the concentration and adverse reactions(ADR),and to provide a basis for the safe and rational use of digoxin.METHODS:The serum digoxin concentration(SDC)was moni-tored by enzyme amplification immunoassay tech-nology.The basic data,laboratory indicators,con-comitant medication and adverse reactions of pa-tients were collected through the medical record system.RESULTS:Among the 55 patients,12.73%,76.36%and 10.91%of the patients were treated with<0.125 mg/d,0.125 mg/d and 0.25 mg/d di-goxin,respectively.And the serum digoxin concen-tration increased in a dose dependent manner.Eleven patients(20%)developed ADR,the most common of which were arrhythmias.The SDC of patients with ADR was(2.55±1.59)ng/mL,which was significantly higher than that of the non-ADR group(0.93±0.63 ng/mL)(P<0.0001).The SDC in the patients with increased serum creatinine was higher than that in the normal creatinine group,and patients with severe renal impairment demon-strated significantly higher concentration of digoxin than that in patients with normal renal function(P<0.05).The effect of concomitant administration of other drugs on the SDCof digoxin was not ob-served.CONCLUSION:The SDC varies greatly among individuals,and is associated with dosage and renal function.The higher the concentration of digoxin in serum,the higher the incidence of ADR.Therefore,monitoring the SDC of digoxin should be strengthened,so as to improve the level of individ-ual treatment.

关 键 词：地高辛 治疗药物监测 血药浓度 不良反应 个体化治疗 

分 类 号：R969[医药卫生—药理学]