创新药品苯磺酸瑞马唑仑致过敏性休克风险分析及对策

Risk Analysis and Countermeasure of Anaphylactic Shock Induced by Innovative Drug Remimazolam Besylate

关键词:  苯磺酸瑞马唑仑  过敏性休克  严重药品不良反应  临床分析

Key words:  Remimazolam besylate  Anaphylactic shock  Severe adverse drug reaction  Clinical analysis

摘要:

目的 基于真实世界数据病例报告,分析苯磺酸瑞马唑仑过敏性休克的发生规律及特点,研究其影响因素及使用风险,为药品说明书的完善及临床麻醉用药提供依据。方法 查询2020～2024 年度国家药品不良反应监测系统海口数据库(以下简称“监测系统”),结合国外文献报道及美国食品药品监督管理局不良事件报告系统(FAERS)数据库,对监测系统收到的7例苯磺酸瑞马唑仑引起的过敏性休克严重药品不良反应(ADR)报告进行回顾分析,采用报告比值比(ROR)法和英国药品和保健产品管理局综合标准法(以下简称“MHRA”法)进行风险信号挖掘。结果 在真实世界中发生的7例过敏性休克ADR报告发生时间均在30分钟内,均为速发型超敏反应。临床表现为：血压下降、心率加快、皮肤潮红、血氧饱和度下降、发绀、心跳呼吸骤停等,严重低血压是7例过敏性休克报告的共同临床表现,也是过敏性休克的初始及主要证据。FEARS数据库共收到6份过敏性休克报告,占同期报告的10.0%,ROR法及MHRA法均挖掘出过敏性休克风险信号,信号强度排名第四。结论 使用苯磺酸瑞马唑仑时密切监测皮肤外观、血流动力学和气道通畅性等麻醉手术过程中患者的相关指标,减少过敏性休克的发生。

Abstract:

OBJECTIVE To analyze the occurrence regularity and characteristics of anaphylactic shock caused by remimazolam besylate based on the case report of real world data, study its influencing factors and drug risk, and provide references for the improvement of drug instructions and clinical anesthesia medication.METHODS The National Adverse Drug Reaction Monitoring System Haikou Database (hereinafter referred to as"monitoring system") from 2020 to 2024 was searched. combining with foreign literature reports and the FDA Adverse Event Reporting System(FAERS),7 cases of severe adverse drug reaction(ADR) reports of anaphylactic shock caused by remazolam besylate received from monitoring system were retrospectively analyzed.Risk signal mining was carried out by using the reporting odds ratio （ROR） method and the comprehensive standards method of theUK Medicines and Healthcare Products Regulatory Agency （hereinafter referred to as the “MHRA method”）. RESULTS 7 cases of anaphylactic shock ADR reports in the real world occurred within 30 minutes, all of which were immediate hypersensitivity reactions. The clinical manifestations were as follows:lowered blood pressure, accelerated heart rate,flushed skin, oxygen desaturation, cyanosis,cardiacrespiratory arrest,etc.Severe hypotension was the common clinical manifestation of 7 cases of anaphylactic shock, as well as the initial and main evidence of anaphylactic shock.There were 6 cases of adverse events of sanaphylactic shock received by the FAERS database, accounting for 10.0% of the total number of reports during the same period. ROR method and MHRA method both identified the risk signalof anaphylactic shock，ranking third among the strength of signals.CONCLUSIONS We should closely monitor the related indexes of patients during anesthesia operation,such as skin appearance, hemodynamics and airway patency when using remazolam besylate,so as to reduce the occurrence of anaphylactic shock .