9441例注射用复方三维B(Ⅱ)的合理用药评价

Evaluation of rational drug use in 9441 cases of compound trivitamin B for injection(Ⅱ)

目的:了解我院注射用复方三维B(Ⅱ)的使用情况,并总结该药所致ADR/ADE的规律、特点,为临床合理用药提供参考。方法:采用回顾性研究方法,对我院2015年度9441例注射用复方三维B(Ⅱ)使用的溶媒、用药剂量及上报国家药品不良反应监测中心的22例发生ADR/ADE的病例进行统计分析。结果:超药品说明书规定溶媒和剂量使用的病例共计2291例和403例,占用药的28.54%;2014–2015年发生的22例ADR/ADE主要累及皮肤及其附件损害(37.50%)、全身性损害(25.00%)等,病例中严重ADR/ADE表现为呼吸困难、排尿困难及全身麻木等,说明书中未提示,其中超说明书使用药品造成ADR/ADE共计8例(36.36%)。结论:应严格按照药品说明书规定的溶媒和剂量使用注射用复方三维B(Ⅱ),重视说明书中未提示的ADR发生风险,以减少严重ADR/ADE的发生。

Objective： To analyze the utilization of compound trivitamin B for injection （ Ⅱ ） used in our hospital, and find out the regulation and characteristics of irrational drug use and ADR/ADE, and provide references for clinical rational drug use. Methods： A retrospective study was conducted to evaluate 9441 cases of compound trivitamin B for injection （Ⅱ） in solvent, dosage and 22 cases of ADR/ADE reported to the National Adverse Drug Reaction Monitoring Center. Results： Over drug instructions using solvent and dosage cases were 2291 and 403 respectively, accounted for 28.54%. The 22 ADR/ADE cases occurred between 2014 and 2015 were mainly involved in the skin and its appendages （37.50%） and systemic damage （25.00%）, in which 8 ADR/ADE cases （36.36%） were caused by ultra manual, severe ADR/ADE showed difficulty in breathing, urinating difficulty and body numbness, which the instructions are not prompted. Conclusion： According to solvent and dosage instructions provided for the use of compound trivitamin B for injection （ Ⅱ）, and paying attention to the risk of adverse reactions which not mentioned in specification will reduce the occurrence of serious ADR/ADE.