异甘草酸镁注射液致过敏样反应27例分析
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篇名: 异甘草酸镁注射液致过敏样反应27例分析
TITLE:
摘要: 目的:探讨异甘草酸镁注射液致过敏样反应发生的规律和特点,为临床合理用药提供参考。方法:对2014年1月-2015年3月期间湖南省药品不良反应(ADR)监测中心数据库收集到的27例异甘草酸镁注射液ADR报告进行回顾性分析。结果:27例异甘草酸镁注射液致过敏样反应的患者中,男性15例(55.56%),女性12例(44.44%),男女比例为1.25 ∶ 1;ADR多发生在41~60岁患者中(51.85%);累及器官/系统主要为皮肤及其附件(35.85%)和全身性损害(26.42%),主要临床表现为皮疹、瘙痒、呕吐、头晕、发热、寒战等;严重的ADR报告7例(25.92%),主要表现为寒战、高热等全身症状;大部分ADR经相关处理后痊愈(40.74%)或好转(55.56%)。结论:异甘草酸镁注射液说明书中未见有严重过敏反应的风险提示,需加强对异甘草酸镁注射液上市后的安全性监测,并进一步完善企业药品说明书,以防范异甘草酸镁致严重的ADR的风险。
ABSTRACT: OBJECTIVE: To explore the regularity and characteristics of anaphylactoid reactions induced by Magnesium isoglycyrrhizinate injection, and provide reference for clinical rational drug use. METHODS: 27 ADR reports induced by Magnesium isoglycyrrhizinate injection from Hunan Center for ADR Monitoring from Jan. 2014 to Mar. 2015 were retrospectively analyzed. RESULTS: In the 27 cases, 15 were male (55.56%) and 12 were female (44.44%), with percentage of 1.25 ∶ 1; ADR mainly occurred in patients with 41-60 years old (51.85%); involved organ/system were mainly skin and its appendages (35.85%) and systemic damage (26.42%), the main clinical manifestations were rash, itching, fever, chills, vomiting and dizziness; there were 7 severe ADR reports (25.92%), mainly showed chills, fever and other systemic symptoms; most ADR can be cured (40.74%) or relieved (55.56%) by related processing. CONCLUSIONS: There are no risk tips for severe allergic reactions in instruction, it is necessary to strengthen post-marketing surveillance and further improve the drug instructions to reduce the risk of severe ADR induced by Magnesium isoglycyrrhizinate injection.
期刊: 2016年第27卷第29期
作者: 罗佳,陈光建,杨立平,伍奕,曹丽芝
AUTHORS: LUO Jia,CHEN Guangjian,YANG Liping,WU Yi,CAO Lizhi
关键字: 异甘草酸镁注射液;过敏样反应;不良反应;分析
KEYWORDS: Magnesium isoglycyrrhizinate injection; Anaphylactoid reactions; Adverse drug reaction; Analysis
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