470例维生素制剂不良反应分析  

Analysis of 470 Reports of ADR Induced by Vitamins

作　　者：刘梦婷 张昊文[1] 张锦文[1] 江莹 Liu Mengting;Zhang Haowen;Zhang Jinwen;Jiang Ying(Department of Pharmacy,Tongji Hospital,Tongji Medical college,Huazhong University of Science and Technology,Wuhan 430030,China;School of Pharmacy,Tongji Medical College,Huazhong University of Science and Technology;Center for ADR Monitoring of Wuhan City)

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,武汉430030 [2]华中科技大学同济医学院药学院 [3]武汉市药品不良反应监测中心

出　　处：《药物流行病学杂志》2022年第11期738-743,共6页Chinese Journal of Pharmacoepidemiology

摘　　要：目的:研究临床常用维生素制剂不良反应(ADR)的发生特点,为临床安全使用维生素制剂提供参考。方法:采用回顾性分析方法,收集2012年1月~2021年12月武汉市药品不良反应监测中心数据库中470例维生素制剂的ADR报告,统计分析患者性别、年龄、原患疾病、既往史和家族史,药品种类、联合用药,ADR诱导时间、类型、累及系统/器官与临床表现、转归等因素。结果:维生素制剂所致ADR主要发生于婴幼儿以及中老年患者,约有半数患者的ADR既往史和家族史不详。ADR涉及维生素制剂8种(注射剂6种,片剂2种),其中注射剂所致ADR 446例(94.09%)。在222例(47.23%)描述了ADR诱导时间的报告中,194例(78.37%)在用药30 min内发生。ADR临床表现以皮肤及其附件、全身性和心血管系统、呼吸系统损害为主(77.77%),严重者可导致过敏性休克。470例ADR中,新的一般的150例,严重的98例(含新的严重的41例),绝大多数病例痊愈或好转,但仍有1例患者死亡。结论:临床使用维生素制剂应详细询问患者既往史,加强对婴幼儿和老年人的用药监护,尽量避免维生素制剂超适应证用药,保证患者用药安全。Objective:To study the characteristics of ADR induced by commonly used vitamins and to offer a reference for rational use of vitamins in clinic.Methods:Using the method of retrospective analysis,470 cases of ADR related to vitamin reported by Center for ADR Monitoring of Wuhan City from January 2012 to December 2021 were analyzed in terms of patient’s gender,age,underlying diseases,past history and family history of the patients,type of drugs,drug combination,ADR induction time,system/organs injury,clinical manifestations,outcomes and other factors.Results:The case of ADR mainly occurred in infants and middle-aged and elderly people.About half of the patients’past and family history of ADR was not clear.Among 8 kinds of vitamin preparations(6 kinds for injections,2 kinds of tablets),446 ADR cases(94.09%)were caused by injection drug use.222 cases(47.23%)recorded the ADR induction time,194 cases(78.37%)of which ADR occurred as early as 30 minutes after administration.Their clinical manifestations mainly included systemic damage,skin and its appendage damage,cardiovascular system damage,and respiratory system damage.Severed ones could lead to even allergic reactions or anaphylactic shock.Among the 470 ADRs,there were 150 new and normal cases,and 98 severe cases(including 41 new cases),which were all cured or improved,but still 1 patient died.Conclusion:The ADR of vitamins are mainly allergic reactions,and ADR are related to age,allergy history and medication time.Therefore,medical personnel need to ask patients about their allergy history,avoid unreasonable drug combination,follow the drug instructions,and closely monitor the patients during medication to ensure their safety.

关 键 词：维生素 药品不良反应 报告 过敏反应 安全用药 

分 类 号：R977.2[医药卫生—药品]