异甘草酸镁注射液致过敏样反应27例分析

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。%OBJECTIVE:To explore the regularity and characteristics of anaphylactoid reactions induced by Magnesium iso-glycyrrhizinate 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. RE-SULTS:In the 27 cases,15 were male (55.56%) and 12 were female (44.44%),with percentage of 1.25∶1;ADR mainly oc-curred in patients with 41-60 years old(51.85%);involved organ/system were mainly skin and its appendages(35.85%)and sys-temic 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 in-duced by Magnesium isoglycyrrhizinate injection.