基于山东省药品不良反应监测中心数据库的苯磺顺阿曲库铵不良反应分析

Analysis of adverse reactions caused by cisatracurium besylate based on the database of Shandong Provincial Center for Adverse Drug Reaction Monitoring

目的分析苯磺顺阿曲库铵不良反应及严重过敏反应的临床特征与治疗情况,为临床安全用药提供参考。方法检索2018年1月1日至2023年4月18日山东省药品不良反应监测中心数据库收集的苯磺顺阿曲库铵不良反应报告,对其进行回顾性分析。采用国际《医学用语词典》25.1版的首选术语和系统器官分类对不良反应用语进行标准化。筛选报告中的严重过敏反应,并进行分级,对各级严重过敏反应的特点及Ⅱ~Ⅳ级严重过敏反应的治疗方法进行分析。结果共纳入163例不良反应报告,涉及201个首选术语,涉及的系统器官分类排名前3位的为皮肤及皮下组织类疾病(133例,66.17%)、血管与淋巴管类疾病(14例,6.96%)、免疫系统疾病(14例,6.96%)。145例患者(89.0%)发生严重过敏反应,主要发生在用药10 min内(115例,79.3%)。145例严重过敏反应中37例(25.5%)为Ⅱ~Ⅳ级反应,最常见的首发过敏症状为循环系统症状(19例,51.4%),其次为皮肤症状(12例,32.4%);主要治疗药物包括糖皮质激素(27例,73.0%)、肾上腺素(17例,45.9%)和除肾上腺素外的其他升压药物(19例,51.4%)。所有患者经治疗后,症状好转或痊愈。结论苯磺顺阿曲库铵引起严重过敏反应多发生在用药10 min内,预后良好。对于分级为Ⅱ~Ⅳ级的严重过敏反应,急性期治疗药物主要包括糖皮质激素、肾上腺素和除肾上腺素外的其他升压药物。

Objective To analyze the clinical characteristics and treatments of adverse reactions and anaphylaxis induced by cisatracurium besylate,and provide reference for medication safety in clinic.Methods Adverse reaction reports of cisatracurium besylate in database of Shandong Provincial Center for Adverse Drug Reaction Monitoring between January 1,2008 and April 18,2023 were collected and analyzed retrospectively.The adverse reaction terminology was standardized using the preferred terms and system organ class(SOC)in the Medical Dictionary for Regulatory Activities 25.1.The cases of anaphylaxis were selected and graded.The characteristics of all anaphylaxis and treatments of anaphylaxis of gradeⅡ-Ⅳwere analyzed.Results A total of 163 adverse reaction reports were included for analysis,involving 201 preferred terms.The top 3 SOCs involved were mainly skin and subcutaneous tissue disorders(133 cases,66.17%),vascular disorders(14 cases,6.96%),and immune system disorders(14 cases,6.96%).One hundred and forty-five patients(89.0%)experienced anaphylaxis,mainly within 10 minutes after medication(115 cases,79.3%).Of them,37(25.5%)patients had anaphylaxis of gradeⅡ-Ⅳ.The most common initial symptom was circulation system symptoms(19 cases,51.4%),followed by skin or mucosal signs(12 cases,32.4%).The main therapeutic drugs included glucocorticoids(27 cases,73.0%),adrenaline(17 cases,45.9%),and other vasopressors other than adrenaline(19 cases,51.4%).All patients showed improvement or recovery in symptoms after treatments.Conclusions The anaphylaxis caused by cisatracurium besylate mainly occurred within 10 minutes after medication and have a good prognosis.For anaphylaxis classified as gradeⅡ-Ⅳ,the acute phase treatment drugs mainly include glucocorticoids,adrenaline,and other vasopres-sors other than adrenaline.