摘要
目的:探讨单唾液酸四己糖神经节苷脂钠注射液(GM1)致药品不良反应/药物不良事件(ADR/ADE)的一般规律、特点及相关风险因素,为临床安全、有效、经济用药提供参考。方法:通过医院局域网对2016年1-6月我院使用GM1的住院患者进行非干预集中监测,并对患者基本信息、用药情况、ADR/ADE发生情况和临床转归等进行统计分析。结果:共纳入患者621例,其中男性393例、女性228例,男女比例为1.72:1;年龄≥61岁的患者居多(60.39%)。该药主要集中应用于神经内科(71.18%)、急诊科(6.28%)、神经外科(6.12%)、全科医学科(4.67%)和中医康复科(4.03%)等5个科室。621例患者共发生ADR/ADE 28例,发生率为4.51%;超适应证用药的42例患者中发生ADR/ADE 3例,发生率为7.14%。男性ADR/ADE构成比(67.86%)高于女性(32.14%);联合用药3种及以上的有22例(78.57%);ADR/ADE主要为全身性损害(35.71%)和累及皮肤及其附件(28.57%)。579例符合适应证用药的患者中,治愈、好转、未愈的分别有165、405、9例。使用GM1的平均费用为5 108.08元,占总住院费用的9.07%,占药品总费用的23.33%。结论:加强GM1的合理用药与监测,掌握GM1致ADR/ADE的规律和特点,从而降低ADR/ADE的发生率,保障患者用药安全、有效、经济。
OBJECTIVE： To explore the general rules and characteristics of ADR/ADE induced by Monosialotetrahexosylgan- glioside sodium injection （GM1） as well as related risk factors, and to provide reference for safe, effective and economical drug use in clinic. METHODS： By hospital LAN, non-interventional centralized monitoring was conducted among patients receiving GM1 in our hospital from Jan.-Jun. 2016. The patients＇ information, drug use, ADR/ADE and clinical outcomes were analyzed sta- tistically. RESULTS： A total of 621 patients were involved, including 393 male patients and 228 female patients with male-to-fe- male ratio of 1.72 ： 1. The patients who were more than 61 years old were the majority （60.39%）. GM1 was mainly used in neurolo- gy department （71.18%） , emergency department （6.28%） , neurosurgery department （6.12%） , general practice department （4.67%） and TCM rehabilitation department （4.03%）. Among them, there were 28 ADR/ADE cases, with incidence of 4.51%. Among 42 patients with off-indication, 3 cases had ADR/ADE, with incidence of 7.14%. Meanwhile, the constituent ratio of ADR/ADE in male （67.86%） was higher than that in female （32.14%）. Twenty-two cases received more than three or more drugs （78.57%）. Furthermore, ADR/ADE mainly manifested as systemic damage （35.71%）, lesion of skin and its appendants （28.57%）. Among 579 patients met drug use with indication, there were 165 cured cases, 405 recovered cases and 9 uncured cases. In addition, the average expenditure of using GM1 was 5 108.08 yuan, accounting for 9.07% of total hospitalization cost and 23.33% of total drug cost. CONCLUSIONS： It is necessary to strengthen rational drug use and monitoring of GM1, under- stand the regularity and characteristics of GMl-induced ADR/ADE, so as to reduce the incidence of ADR/ADE and ensure safe, effective and economical drug use.
作者
黄雪梅
吴伟
李琴
傅胜
徐坤
张明辉
HUANG Xuemei WU Wei LI Qin FU Sheng XU Kun ZHANG Minghui(Dept. of Pharmacy, Tongren People＇s Hospital, Guizhou Tongren 554300, China Pharmaceutical Evaluation Center, Tongren Food and Drug Administration, Guizhou Tongren 554300, China)
出处
《中国药房》
CAS
北大核心
2017年第29期4085-4089,共5页
China Pharmacy
基金
贵州省药品评价中心科技计划项目[No.黔药监评价科研(2015)45-8]
作者简介
副主任药师。研究方向：临床药学。电话：0856-8169401。E-mail：577638713@qq．com
