3004例乌灵胶囊上市后安全性医院集中监测研究  

A Post-marketing Safety Study of Wuling Capsule in 3004 Cases of Centralized Monitoring in Hospital

作　　者：王嘉麟[1] 周莉[2] 王忠[3] 邢佳[1] 高翔[4] 焉石[5] 侯震[6] 刘小北 曹利民[8] 陆文惠[9] 单利华 吕莹 常和生[12] 郭蓉娟[13] WANG Jialin;ZHOU Li;WANG Zhong;XING Jia;GAO Xiang;YAN Shi;HOU Zhen;LIU Xiaobei;CAO Limin;LU Wenhui;SHAN Lihua;LYU Ying;CHANG Hesheng;Guo Rongjuan(Department of Rehabilitation,Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;The Second Department of Encephalopathy,Dongzhimen Hospital, Beijing University of Chinese Medicine,Beijing 100700,China;Institute of Basic Research in Clinical Medicine,Chinese Academy of Chinese Medical Sciences,Beijing 100700,China;The First Department of Neurology,the Affiliated Hospital of Medical School,Ningbo University,Ningbo 315000,China;Department of Traditional Chinese Medicine,Aviation General Hospital of China Medical University,Beijing 100012,China;Department of Traditional Chinese Medicine,Beijing Daxing District People's Hospital,Beijing102600,China;Department of Neurology,the NO.1 People's Hospital of Pinghu,Pinghu 314200,China;Department of Neurology,Xiaoshan Traditional Chinese Medicine Hospital,Hangzhou 311201,China;Department of Neurology,the First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China;Department of Neurology,Haining People's Hospital,Haining 314400,China;Department of Neurology,Chuiyangliu Hospital Affiliated to Tsinghua University,Beijing 100022,China;Department of Psychiatry,Beijing Fengtai Hospital,Beijing 100071,China;Office of the Party,Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]北京中医药大学东方医院康复科,北京100700 [2]北京中医药大学东直门医院脑病二科,北京100700 [3]中国中医科学院中医临床基础医学研究所,北京100700 [4]宁波大学医学院附属医院神经内一科,宁波315000 [5]中国医科大学航空总医院中医科,北京100012 [6]北京市大兴区人民医院中医科,北京102600 [7]平湖市第一人民医院神经内科,平湖314200 [8]杭州市萧山区中医院神经内科,杭州311201 [9]西安交通大学第一附属医院神经内科,西安710061 [10]浙江省海宁市人民医院神经内科,海宁314400 [11]清华大学附属垂杨柳医院神经内科,北京100022 [12]北京丰台医院精神科,北京100071 [13]北京中医药大学东方医院党院办,北京100700

出　　处：《医药导报》2022年第7期990-996,共7页Herald of Medicine

基　　金：国家自然科学基金面上项目(81072717)。

摘　　要：目的观察乌灵胶囊不良事件(ADE)和不良反应(ADR)发生率、性质和临床表现,为临床安全用药提供依据。方法采用多中心前瞻性、单臂医院集中监测的临床试验,监测2013年6月15日—2015年12月31日12家临床研究中心使用乌灵胶囊且符合伦理要求的患者,记录并分析所有ADR/ADE以及处理情况。结果共纳入患者3004例,其中发生ADE19例,发生率0.63%,发生ADR15例,发生率0.50%。ADR主要集中在消化系统及神经系统,包括食欲减退、口干、恶心、腹泻、胃部不适、心悸、头晕、头痛等症状,尚未发现与ADR/ADE相关的影响因素。结论乌灵胶囊的ADR发生率低,属于偶见,临床应用安全性较高。Objective To observe the incidence,nature,and clinical manifestations of adverse drug events(ADE)and adverse drug reactions(ADR)of Wuling capsule to provide a basis for clinical safe drug use.Methods A multicenter prospective,single-arm clinical trial of centralized monitoring in the hospital was used to monitor the patients who used the Wuling capsule in 12 clinical research centers from June 15,2013 to December 31,2015.All ADR/ADE and their treatment to them,were recorded and analyzed.Results A total of 3004 patients were included,19 of them had ADE(0.63%),15 had ADR(0.50%).ADR is mainly concentrated in the digestive and nervous system,including anorexia,dry mouth,nausea,diarrhea,stomach discomfort,palpitation,dizziness,headache and other symptoms.But no related influencing factors were found.Conclusion The incidence of ADR in Wuling capsules is uncommon,and its clinical application is safe.

关 键 词：乌灵胶囊 医院集中监测 中药上市后再评价 

分 类 号：R286[医药卫生—中药学] R969[医药卫生—中医学]