我院单唾液酸四己糖神经节苷脂钠注射液的临床应用监测研究
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篇名: 我院单唾液酸四己糖神经节苷脂钠注射液的临床应用监测研究
TITLE:
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。
ABSTRACT: OBJECTIVE: To explore the general rules and characteristics of ADR/ADE induced by Monosialotetrahexosylganglioside 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 statistically. RESULTS: A total of 621 patients were involved, including 393 male patients and 228 female patients with male-to-female ratio of 1.72 ∶ 1. The patients who were more than 61 years old were the majority (60.39%). GM1 was mainly used in neurology 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, understand the regularity and characteristics of GM1-induced ADR/ADE, so as to reduce the incidence of ADR/ADE and ensure safe, effective and economical drug use.
期刊: 2017年第28卷第29期
作者: 黄雪梅,吴伟,李琴,傅胜,徐坤,张明辉
AUTHORS: UANG Xuemei,WU Wei,LI Qin,FU Sheng,XU Kun,ZHANG Minghui
关键字: 单唾液酸四己糖神经节苷脂钠注射液;临床应用;重点监测;药品不良反应;药物不良事件
KEYWORDS: Monosialotetrahexosylganglioside sodium injection; Clinical application; Monitoring; ADR; ADE
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