参麦注射液不良反应流行病学特点分析  

Epidemiological characteristics of ADR caused by Shenmai injection

作　　者：祁麟 文彦丽[2] 

机构地区：[1]中国医学科学院血液病医院,天津300020 [2]中国药科大学药物代谢与动力学研究中心,南京210009

出　　处：《天津药学》2014年第5期31-34,共4页Tianjin Pharmacy

摘　　要：目的:探讨参麦注射液发生不良反应的规律和特点,提出参麦注射液临床合理使用建议,以达到个体优化治疗及安全使用参麦注射液的目的。方法:检索2002—2012年间国内公开发行的医学期刊所报道的使用参麦注射液后发生不良反应的病例共102例,并分别对患者的人群特征、不良反应出现时间、给药途径、用法用量、原患疾病、临床表现、累及系统-器官等进行统计与分析,总结参麦注射液不良反应流行病学特点。结果:参麦注射液导致不良反应多发于中老年患者(86.27%)。不良反应以即发型和速发型为主,发生时间集中在用药过程中,其中用药过程中10 min内不良反应发生率最高,为73.53%,用药中30 min累计发生率为84.31%。不良反应临床表现多样化,主要表现为皮肤及附件损害(37.50%),表现形式主要为过敏反应;其次为心血管系统损害(32.14%)。结论:临床医师、药师在临床应用参麦注射液时应辨证用药,用药前应详细询问患者的过敏史,对本品所含成份过敏者禁用,过敏体质者慎用。在给药期间应对患者密切观察,特别是中老年患者,一旦出现过敏症状,则应立即停药并给予适当救治措施。Objective： To investigate the epidemiological characteristics of adverse drug reaction（ ADR） caused by Shenmai injection,raising reasonable proposals for clinical use of Shenmai injection and to achieve a both individualized and safe treatment.Methods： The information on adverse drug reactions to Shenmai injection in 102 cases retrieved from Chinese medical journals issued during 2002 to 2012 was analyzed and statistically processed by patients＇ population characteristics,the onset time for the ADR,administration route,usage and dosage,diseases,clinical manifestations,and involved system and organs. Then the epidemiological characeristics of the ADR were summed up. Results： The elderly patients were likely to be the victims of the ADRs（ 86.27%）. Most ADR occurred immediately in the course of drug administration. The onset of ADR was usually within the first 10 min during the infusion（ 73. 53%）,and the events occurring during the first 30 min of drug administration accounted for 84. 31%of the total ADR. Most ADR happened in the skin and the adnexa,showing hypersensitive ones（ 37. 50%）,and the others affected cardiovascular systems（ 32. 14%）. Conclusions： Clinical pharmacists and doctors should know about the patient＇s history of allergies in detail,and be careful to prescribe the injection to the patients with allergy. The patients should be closely observed during the administration. Once the allergy symptoms were observed,the administraion of the injection should be discontinued immediately and appropriate rescue meassures should be given.

关 键 词：参麦注射液 不良反应 流行病学特点 

分 类 号：R97[医药卫生—药品]