我院154份静脉滴注药品说明书调查分析

Investigation and Analysis of 154 Package Inserts of Intravenous Infusion Drugs in Our Hospital

目的:为规范静脉滴注药品说明书提供参考。方法:抽取我院154份静脉滴注药品说明书,对静脉滴注药品说明书的药品规格、配制溶媒、输液浓度、输液速度、药物相互作用、药动学、药物代谢酶、药物配制后的贮存、特殊人群用药等进行调查分析。结果:准确标注药品规格且适合药品配制的占93.5%,明确标注配制溶媒的占83.8%,有明确标注或可明确计算出配制浓度范围的占54.5%,明确标注输液速度的占59.1%。标注药物相互作用、药动学参数、药物代谢酶的分别占76.0%、74.7%和2.6%;说明药物配制后贮存条件和时间的占20.8%;注明老人、儿童、孕妇及哺乳期妇女用药信息的分别占60.4%、59.7%和73.4%;标明肝脏、肾脏功能不全时用药的分别占15.6%和39.0%。结论:部分国产静脉滴注药品说明书存在信息量不足,描述不准确等问题,应进一步完善其说明书。

OBJECTIVE：To provide reference for regulating the package inserts of intravenous infusion drugs.METHODS：154 package inserts of intravenous infusion drugs were analyzed in respects of drug specifications,preparation of solvent,infusion concentration,infusion velocity,drug interaction,pharmacokinetics,drug metabolizing enzymes,drug storage after preparation,drug use in specific populations.RESULTS：Accurate specifications labeled accounted for 93.5%,preparation of solvent labeled clearly accounted for 83.8%,preparation concentration labeled clearly accounted for 54.5%,infusion rate for 59.1%,drugs interaction for 76.0%,pharmacokinetic parameters for 74.7%,drug metabolizing enzymes for 2.6%,storage conditions after drug preparation for 20.8%,drug use information for elderly,children,pregnant and lactating women respectively for 60.4%,59.7%,and 73.4%,liver and renal dysfunction for 15.6% and 39.0% respectively.CONCLUSION：Now there are some problems about package inserts of some domestic intravenous injections,such as inadequate information and inaccurate description.To ensure safe,effective and economical use of intravenous infusion drugs,package inserts of injection should be further improved.