异甘草酸镁注射液致过敏样反应27例分析

Analysis of 27 Cases of Anaphylactoid Reactions Caused by Magnesium Isoglycyrrhizinate Injection

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。

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, chilis, 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.