地佐辛注射液致ADR/ADE报告1 290例分析
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篇名: 地佐辛注射液致ADR/ADE报告1 290例分析
TITLE:
摘要: 目的:了解地佐辛注射液致药品不良反应/事件(ADR/ADE)的一般规律和特点,为指导临床安全、合理用药提供参考。方法:检索2009年1月-2016年8月江苏省ADR数据库,对地佐辛注射液致ADR/ADE的患者性别与年龄、药品用法用量、ADR累及器官/系统及临床表现和转归等进行统计分析。结果:共纳入1 290例地佐辛注射液致ADR/ADE报告,其中严重的ADR/ADE报告40例(3.10%);报告单位以医疗机构为主(1 276例,98.91%)。ADR/ADE患者女性多于男性,男女比例为1 ∶ 1.45;ADR/ADE发生比例最高的年龄段为45~65岁(43.49%)。给药途径以静脉用药为主(1 137例,88.14%);初始剂量超剂量用药577例(50.75%)。ADR/ADE主要累及胃肠系统(54.99%)、中枢及外周神经系统(24.72%)和全身性损害(5.20%);严重的ADR/ADE表现为过敏性休克、心悸、呼吸困难等,其中过敏性休克等在说明书中未提及。1 283例(99.46%)ADR/ADE转归结果为痊愈和好转。结论:应加强地佐辛注射液上市后的药品安全性再评价,完善药品说明书,加强患者宣传教育,以减少和避免ADR/ADE的发生。
ABSTRACT: OBJECTIVE: To investigate general regularity and characteristics of adverse drug reactions/events (ADR/ADE) induced by Dezocine injection, and to provide reference for safe and rational drug use in clinic. METHODS: Retrieved from Jiangsu Province ADR Database during Jan. 2009-Aug. 2016, ADR/ADE induced by Dezocine injection was analyzed statistically in respects of patient’s gender and age, usage and dosage, organs/systems involved in ADR, clinical manifestations and outcome. RESULTS: Among 1 290 ADR/ADE induced by Dezocine injection, there were 40 cases of severe ADR/ADE (3.10%); medical institutions were main reporting units (1 276 cases, 98.81%). In ADR/ADE cases, female was more male, with ratio of male to female was 1 ∶ 1.45. ADR/ADE mostly occurred in 45-65 age group (43.49%). Intravenous medication was main route of administration (1 137 cases, 88.14%). Initial dose of 577 cases was excessive dose (50.75%). ADR/ADE mainly involved gastrointestinal system (54.99%), central and peripheral nervous system (24.72%) and systemic lesions (5.20%). Severe ADR/ADE manifested as anaphylactic shock, palpitation and dyspnea, etc. But anaphylactic shock was not mentioned in drug package inserts. 1 283 ADR/ADE (99.46%) were cured or improved . CONCLUSIONS: It is necessary to strengthen drug safety reevaluation of Dezocine injection after being on the market, improve drug package inserts and enhance patients education as so as to reduce and avoid the occurrence of ADR/ADE.
期刊: 2017年第28卷第26期
作者: 于丹丹,孙骏,李明,马丹华,陈永飞
AUTHORS: YU Dandan,SUN Jun,LI Ming,MA Danhua,CHEN Yongfei
关键字: 地佐辛注射液;药品不良反应;药品不良事件;合理用药
KEYWORDS: Dezocine injection; Adverse drug reaction; Adverse drug event; Rational drug use
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