注射用核糖核酸Ⅱ专项评价方法的构建与安全合理性

Special evaluation method and clinical rationality and safety evaluation of ribonucleic acid for injection Ⅱ

目的:探讨注射用核糖核酸Ⅱ安全与合理性专项评价研究。方法:本研究按月份分层随机抽取某院2016年9月-2017年8月临床使用核糖核酸Ⅱ的病例270份,药品说明书定量评价、药物利用研究及药品不良反应/事件Logistic回归分析综合评价方法,初步评价核糖核酸Ⅱ的安全合理性。结果:依据药品说明书评价结果提示合理性较高,其中给药剂量(100%),溶媒选择(100%),溶媒剂量(72.59%),给药浓度(74.07%),给药频次(98.15%),给药时间(100%),6项指标12个月内波动幅度与均值保持一致(90.80%);药物利用研究结果提示,存在超剂量、超浓度给药情况(aDDDs=5.68,aDDCs=7.37,dDUI=1.19,cDUI=1.53)。研究期内发现4例不良反应,均为一般不良反应,经Logistic回归分析提示与药物使用浓度有关。结论:此种评价方法可有效评价药物临床使用的安全合理性,应加强我院核糖核酸Ⅱ临床监测工作,尤其是超剂量、超浓度给药情况。

OBJECTIVE To study the special evaluation method and evaluation on clinical rationality and safety of ribonucleic acid for injection Ⅱ.METHODS Totally 270 medical records with ribonucleic acid for injection Ⅱ prescribed from September 2016 to August 2017 were selected randomly and evaluated by dispensatory,drug utilization index for dose and concentration（dDUI,cDUI）,average defined daily dose and concentration（aDDDs,aDDCs）,and ADR monitoring by logistic analysis method.RESULTS There were higher clinical rationality and safety for ribonucleic acid for injection Ⅱ,such as solvent selection,solvent dose,administration dose and concentration,administration frequency,administration duration.Four general adverse reactions about ribonucleic acid for injection Ⅱwere reported in the hospital during the study period.CONCLUSIONThis method is effective in evaluating the safety and efficacy of drugs.It should strengthen monitoring on ribonucleic acid for injection Ⅱin clinical practice,especially administration dose and concentration.