摘要
目的基于真实世界评价依达拉奉右莰醇的安全性。方法采用回顾性研究方法,利用中国医院药物警戒系统(China Hospital Pharmacovigilance System,CHPS)对聊城市人民医院2021年3月1日至2022年2月28日应用依达拉奉右莰醇的所有患者的人群特征和相关不良反应(Adverse drug reaction,ADR)的临床资料进行分析。结果共纳入应用依达拉奉右莰醇的患者3236例次,收集到158例ADR病例,ADR发生率为4.88%。不良反应包括天冬氨酸转氨酶(AST)升高、丙氨酸转氨酶(ALT)升高、血钾降低、皮疹、γ-谷氨酰转移酶(γ-GGT)升高等。其中AST升高的发生率为1.82%、ALT升高的发生率为1.58%、血钾降低的发生率为1.58%。相关性评价为“可能”的144例(91.14%),均为一般不良反应,均未对原患疾病造成影响。ADR发生时间最早在用药当天即出现,高发期为用药后的2~8 d(64.56%)。ADR发生后未停药+对症处理的113例(71.52%),所占比例最高。结论真实世界中依达拉奉右莰醇的安全性良好,但仍应加强监测,及时发现ADR并采取措施,保障用药安全。
Objective To evaluate the safety of edaravone dexcamphenol in the real world.Methods A retrospective study was conducted to analyze the population characteristics and the related adverse drug reactions of all patients who used edaravone dexcamphorol from March 1,2021 to February 28,2022 in Liaocheng People's Hospital using the CHPS platform.Results A total of 3236 patients were included in the study.There were 158 ADR reports,with an incidence of 4.88%.The ADR included elevated AST,elevated ALT,reduced potassium,skin rashes,elevatedγ-GGT,and so on.The incidence of elevated AST was 1.82%,that of elevated ALT was 1.58%,and that of reduced potassium was 1.58%.The correlation was evaluated as possible in 144 cases(91.14%),all being general ADRs and having no impact on the original disease.ADRs occurred as early as the day of medication and occurred more frequently(64.56%)during 2~8 days after medication.After the occurrence of ADRs,the medication was not stopped in 113 cases,which were given symptomatic treatment,accounting for the highest proportion.Conclusion The edaravone dexcamphenol in the real world had a good safety profile,but clinical monitoring should be strengthened to find ADRs in time and measures should be taken to ensure the safety of drug use.
作者
孙倩
杨雪
张帆
Sun Qian;Yang Xue;Zhang Fan(Department of Clinical Pharmacy,Liaocheng People's Hospital,Liaocheng 252000,China)
出处
《实用药物与临床》
CAS
2024年第7期510-513,共4页
Practical Pharmacy and Clinical Remedies
基金
中国卒中学会脑血管病全程管理项目-启航基金
山东省药学会医院合理用药天际健康中青年科研学术活动项目(第二期)(hlyy2024-08)。
关键词
依达拉奉右莰醇
安全性
中国医院药物警戒系统
不良反应
Edaravone dexcamphenol
Safety
Chinese hospital pharmacovigilance system
Adverse drug reaction
