39例仙灵骨葆胶囊不良反应/事件分析  

Analysis of 39 Cases of Adverse Reactions/Events in Xianling Gubao Capsules

作　　者：李珊[1] 王秀娟[2] 庄伟[1] 刘琛[1] 赵业婷[3] 温若君 林晓兰[1] Li Shan;Wang Xiujuan;Zhuang Wei;Liu Chen;Zhao Yeting;Wen Ruojun;Lin Xiaolan(Department of Pharmacy,Xuanwu Hospital,Capital Medical University,Beijing 100053,China;School of Traditional Chinese Medicine,Capital Medical University;Beijing Center for ADR Mornitoring)

机构地区：[1]首都医科大学宣武医院药学部,北京100053 [2]首都医科大学中医药学院 [3]北京市药品不良反应监测中心

出　　处：《中国药师》2019年第6期1068-1071,共4页China Pharmacist

基　　金：北京市科委十病十药研发课题(编号:Z171100001717006);北京中医药科技发展资金学术创新项目(编号:JJ2016-10);首都中医药研究专项(编号:17ZY13)

摘　　要：目的:分析仙灵骨葆胶囊所致不良反应/事件(ADR/ADE),为仙灵骨葆胶囊临床安全使用提供依据。方法:采用回顾性研究方法,收集北京市药品不良反应监测中心2004年1月~2017年9月收到的仙灵骨葆胶囊ADR/ADE报告39例,从患者因素、药品因素、发生时间、反应类型与临床表现等方面进行综合分析。结果:39例ADR/ADE中,男7例(17.9%),女32例(82.1%);患者平均年龄(60.2±12.2)岁;27例ADR/ADE患者为正确用法用量,9例(23.08%)超剂量使用,3例用药剂量不足;单用仙灵骨葆胶囊25例(64.1%),联合其他药物14例(35.9%)。39例ADR/ADE中肝损伤17例(43.59%),其他消化系统损害12例(30.77%);严重ADR/ADE 10例(25.64%)。39例平均服用仙灵骨葆胶囊时间为(43.62±57.18)d;严重ADR/ADE患者平均用药时间为(85.30±60.92)d;肝损伤患者平均用药时间为(80.18±57.77)d。结论:仙灵骨葆胶囊广泛应用于临床,但也存在用药不当或不良反应情况,临床应用时应注意合理规范使用,辨证用药,加强监测,减少不良反应和事件的发生。Objective:To analyze the adverse reactions/events(ADR/ADE)caused by Xianling Gubao capsules,and to provide the basis for clinical safe use of Xianling Gubao capsules.Methods:Totally 39 cases of ADR/ADE reports of Xianling Gubao capsules received by Beijing ADR Monitoring Center from January 2004 to September 2017 were collected.The factors of patients,drugs,occurrence time,reaction types and clinical manifestations were comprehensively analyzed with the retrospective study.Results:Of the 39 cases of ADR/ADE,7 were males(17.9%)and 32 were females(82.1%).The age of the patients ranged from 28 to 82 years,with an average age of(60.2±12.2)years and a median age of 60 years.Among the 39 cases of ADR/ADE,27 cases used 3 tablets/bid correctly,9 cases(23.08%)were with overdose and 3 cases were with insufficient dose;25 cases(64.1%)used Xianling Gubao capsules alone and 14 cases(35.9%)were combined with other drugs.Among the 39 cases of ADR/ADE,17 cases(43.59%)had liver injury,12 cases(30.77%)had other digestive system damage,and 10 cases(25.64%)had severe ADR/ADE.The average administration time of Xianling Gubao capsules was(43.62±57.18)days in the 39 patients,(85.30±60.92)days in severe ADR/ADE patients and(80.18±57.77)days in liver injury patients.Conclusion:Xianling Gubao capsules are widely used in clinic,while there are still inappropriate use and adverse reactions.More attention should be payed to rational and standardized use of drugs in clinic,and monitoring should be strenghtened to reduce the occurrence of adverse reactions and events.

关 键 词：仙灵骨葆胶囊 药品不良反应/事件 肝损伤 

分 类 号：R286[医药卫生—中药学]