284例甘油果糖注射液致不良反应/不良事件报告分析

摘要

目的：探讨甘油果糖注射液致不良反应（ADR）/不良事件（ADE）的一般规律和特点，为临床合理用药提供参考。方法：检索河南省ADR监测中心2004年1月1日－2014年10月31日收到的甘油果糖注射液致ADR/ADE病例报告，就收集到的284例ADR/ADE相关信息进行统计和分析，并与国内11家药品生产企业的药品说明书进行对比分析。结果：甘油果糖注射液致ADR/ADE与性别有关，成年男性居多；用药30 min内发生ADR/ADE；临床主要表现为皮肤及其附件损害、用药部位损害和全身性损害。11家药品生产企业的药品说明书中注意事项描述差异较大。结论：临床应加强对甘油果糖注射液ADR/ADE的监测，并完善药品说明书，尽量避免或减少ADR/ADE的发生，确保临床用药安全。%OBJECTIVE:To explore the general rules and characteristics of ADR/ADE induced by Glycerol fructose injection and provide reference for clinical ration drug use. METHODS:284 cases of ADR/ADE induced by Glycerol fructose injection from Jan. 2004 to Oct. 2014 in Drug ADR Monitoring Center of Henan Province were statistically analyzed and comparatively analyzed with the drug instructions in 11 domestic drug manufacturing enterprises. RESULTS:ADR/ADE induced by Glycerol fructose injec-tion was related to gender,mainly adult male,and ADR/ADE might occurred within 30 min;main clinical manifestations were skin and its appendages damages,medication site damage and systemic damage. There were larger differences among the notes de-scription in the package inserts from 11 drug manufact urers. CONCLUSIONS:The clinic should strengthen the monitoring of ADR/ADE induced by Glycerol fructose injection,try to avoid or reduce the incidence of ADR,improve the drug instructions and ensure medication safety.