基于药品不良反应事件主动监测与智能评估预警系统的住院患者达托霉素用药合理性评价

Rational evaluation of daptomycin for hospitalized patients based on ADE active monitoring and intelligent assessment warning system

目的评估本院住院患者应用达托霉素的病例特点和用药情况,为临床优化应用达托霉素给药方案提供参考。方法基于"医疗机构药品不良事件主动监测与智能评估警示系统",对本院2014年1月1日至2017年12月31日期间使用达托霉素的住院患者进行回顾性分析,收集患者的年龄、性别、身高、体重、科室分布等基本资料,评估达托霉素抗感染疗效及药品不良反应等病例特点以及用药适应证、给药剂量、途径、溶媒、疗程等用药行为。结果共164例住院患者应用达托霉素抗感染治疗,平均年龄(48.61±18.43)岁。抗感染用药原因中仅64例次(35.96%)符合说明书批准的适应证;164例住院患者中149例(90.85%)给予达托霉素常规剂量0.5 g qd,另外15例(9.15%)基于肾功能和体重进行了个体化剂量调整。达托霉素给药前的微生物送检率为59.15%,抗感染治疗有效率66.46%,病历记载的ADR共2例;通过系统主动监测的人工关联性评价阳性的药源性肝损伤2例,达托霉素相关的肌酸激酸升高4例(2.44%),未发现药源性肾损伤阳性病例。结论达托霉素为特殊使用级抗菌药物,本院在使用中仍存在微生物送检率未达标、超适应证用药等问题,提示临床应进一步规范微生物标本送检并优化达托霉素给药方案。

Objective To evaluate the characteristics and prescription behaviors of daptomycin for inpatient in our hospital and to provide a reference for optimized administration of daptomycin.Methods By means of active monitoring and intelligent assessment warning system for adverse drug events(ADE)in medical institutions,the inpatients who were treated with daptomycin from Jan 1,2014 to Dec 31,2017 were retrospectively analyzed.Patients’age,gender,height,body weight,and ward distribution were collected.Anti-infection efficacy and adverse drug reactions were evaluated,as well as the indication,dosage,route,menstruum,and treatment course.Results Totally 164 inpatients were treated with daptomycin and the average age was(48.61±18.43)years.Only 64 patients(35.96%)conformed to the suggested indications of daptomycin,149(90.85%)were given the standard dose at 0.5 g qd,and the other 15 cases(9.15%)were given adjusted dose based on kidney function and body weight.The rate of microbiological examination before the administration of daptomycin was 59.15%,the anti-infection effective rate was 66.46%,and 2 ADR cases were recorded.In addition,2 cases of drug-induced liver injury and 4 cases of high creatine kinase related with daptomycin were monitored and no drug-induced kidney injury was found.Conclusion Daptomycin is a special antibacterial drug and problems still exist in microbiological examination rate and over-indication,suggesting it necessary to further standardize microbiological specimens and optimize dose regimen.