某医院硫辛酸注射液不良反应29例回顾性分析  

Retrospective Analysis of 29 Cases of Adverse Reactions to Lipoic Acid Injection in A Hospital

作　　者：杨秀婷 陈红红[1] 刘桂凤 熊国营 蔡红[1] YANG Xiuting;CHEN Honghong;LIU Guifeng;XIONG Guoying;CAI Hong(Nanchang First Hospital,Nanchang Jiangxi 330008,China;Jiangxi Institute for Drug Control Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)

机构地区：[1]南昌市第一医院,江西南昌330008 [2]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《药品评价》2021年第22期1402-1405,共4页Drug Evaluation

摘　　要：目的:探讨硫辛酸注射液不良反应发生的类型及相关因素,预防或减少不良反应(ADR)的发生,为临床合理安全使用硫辛酸注射液提供参考。方法:收集2019年1月1日至2021年5月1日南昌市第一医院上报的硫辛酸注射液不良反应29例并对其发生情况进行分析总结。结果:硫辛酸注射液在使用时发生瘙痒反应的比例达63.4%,其中发生瘙痒病例中,注射部位皮肤瘙痒比例达46.2%;其次ADR临床表现还包括灼热、皮疹、胸闷、高热、寒战、头昏、恶心、呕吐、疼痛、红肿、心悸等,此外还可引起呼吸困难、严重腹泻及全身风疹等少见的严重ADR,主要发生在用药后5~10 min,采取停药、减慢滴速及对症治疗后多数转归良好。结论:硫辛酸使用过程中发生ADR与多种因素有关,临床在使用硫辛酸注射液时应注意监测患者尤其是合并有心血管疾病患者的用药反应,合理地使用硫辛酸注射液可减少其不良反应的发生。Objective:To explore the types and related factors of adverse reactions of lipoic acid injection,to prevent or reduce the occurrence of adverse reactions (ADR),and to provide reference for rational and safe use of lipoic acid injection in clinic.Methods:A total of 29 cases of adverse reactions to lipoic acid injection reported in Nanchang First Hospital from January 1,2019 to May 1,2021 were collected,and their occurrence was analyzed and summarized.Results:The proportion of pruritus in lipoic acid injection was 63.4%,among which,the proportion of pruritus in injection site was 46.2%.Secondly,ADR clinical manifestations include heat,skin rashes,chest tightness,high fever,chills,dizziness,nausea,vomiting,pain,redness,heart palpitations,flustered,moreover,lipoic acid injection also can cause breathing difficulties,such as severe diarrhea and systemic rubella rare severe ADR which mainly occurred (5-10) min after administration.Taking drug withdrawal,slowing down drip rateand symptomatic treatment bring good outcome mostly.Conclusion:The occurrence of ADR during the use of lipoic acid is related to a variety of factors.In clinical use of lipoic acid injection,attention should be paid to the monitoring of patients especially patients with cardiovascular diseases drug reaction.Rational use of lipoic acid injection can reduce the occurrence of adverse reactions.

关 键 词：硫辛酸注射液 药物相关性副作用和不良反应 瘙痒 注射部位 

分 类 号：R969[医药卫生—药理学]