文献类型：期刊文献

中文题名：基于真实世界的银杏酮酯滴丸用药安全性研究

英文题名：Safety evaluation of Ginkgo-ketone Dropping Pills based on real world

作者：迟航[1];刘凯[1];赵英强[2];邢永发[2];路美娟[2];何晓清[3];张栋蔚[4]

第一作者：迟航

机构：[1]甘肃中医药大学,甘肃兰州730000;[2]天津中医药大学第二附属医院心内科,天津300250;[3]广州医科大学附属第三医院心内科,广东广州510140;[4]上海市第五人民医院中医科,上海200240

第一机构：甘肃中医药大学

年份：2022

卷号：53

期号：9

起止页码：2768

中文期刊名：中草药

外文期刊名：Chinese Traditional and Herbal Drugs

收录：CSTPCD;;Scopus;北大核心:【北大核心2020】；CSCD:【CSCD2021_2022】；

语种：中文

中文关键词：银杏酮酯滴丸;不良事件;药物不良反应;转归;安全性

外文关键词：Ginkgo-ketone Dropping Pills;adverse events;adverse drug reactions;prognosis;safety

摘要：目的研究真实世界银杏酮酯滴丸用药的安全性,为银杏酮酯滴丸临床大规模推广应用提供依据。方法采用前瞻性、非干预、多中心、开放性、大样本真实世界研究的方法,收集银杏酮酯滴丸适用人群药物不良事件(adverse event,AE)和药物不良反应(adverse drug reaction,ADR)发生情况及相关因素、发生与转归特点。结果纳入天津中医药大学第二附属医院等29家机构的1084患者。其中99例患者发生139例次AE,发生率为9.1%,发生率最高的AE为感染及侵染类疾病(3.3%);相关因素分析发现女性、60~70岁患者、冠心病心绞痛(血瘀证)、社区医院、合并代谢及营养类疾病的患者银杏酮酯滴丸AE发生率较高。共有7例患者发生11例次ADR,总发生率为1.0%,胃肠系统疾病为ADR发生率最高,女性、70岁以上患者、冠心病心绞痛(血瘀证)、社区医院和合并高血压的患者银杏酮酯滴丸ADR发生率最高。针对AE采取相对措施,其中保持剂量不变131例次,导致降低剂量的AE 2例次、暂停用药的AE 3例次、永久停药的AE 3例次;105例次AE转归为已恢复且不伴后遗症,22例次AE未恢复,未知的12例次。针对ADR采取相对措施,其中保持剂量不变7例次,剂量降低的ADR 2例次,暂停用药的ADR 2例次,所有ADR转归为已恢复并不伴后遗症。结论真实世界患者服用银杏酮酯滴丸安全性良好,临床应加强银杏酮酯滴丸AE和ADR的监测,保障用药安全。
Objective To study the safety of Ginkgo-ketone Dropping Pills(银杏酮酯滴丸) in the real world,and to provide basis for large-scale clinical application of Ginkgo-ketone Dropping Pills.Methods The adverse event(AE) and adverse drug reaction(ADR) occurrence and their related factors,occurrence and outcome characteristics of Ginkgo-ketone Dropping Pills were collected by prospective,non-intervention,multi-center,open and large-sample real world study.Results A total of 1084 patients from 29institutions including the Second Affiliated Hospital of Tianjin University of Chinese Medicine were enrolled.There were 139 cases of AE in 99 patients,with an incidence of 9.1%.The highest incidence of AE was infection and infectious disease(3.3%).Correlation analysis showed that female patients,60—70 years old patients,coronary heart disease angina pectoris(blood stasis syndrome),community hospitals,patients with metabolic and nutritional diseases had the highest AE incidence of Ginkgo-ketone Dropping Pills.There were 11 cases of ADR in seven patients,with an incidence of 1.0%.The highest incidence of ADR was gastrointestinal disease.Correlation analysis showed that female patients,patients over 70 years old,coronary heart disease and angina pectoris(blood stasis syndrome),community hospitals and patients complicated with hypertension had the highest ADR incidence of Ginkgo-ketone Dropping Pills.Relative measures were taken for AE,including 131 cases with unchanged dose,two cases with reduced dose,three cases with drug suspension,and three cases with permanent withdrawal of AE.A total of 105 cases of AE were recovered without sequelae,and 22 cases of secondary AE were not recovered,and 12 cases were unknown.Relative measures were taken for ADR,including seven cases with unchanged dose,two cases with reduced dose and two cases with drug suspension.All ADRs were recovered without sequelae.Conclusion Ginkgo-ketone Dropping Pills have good safety in real world patients.Clinical monitoring of AE and ADR of Ginkgo-ketone Dropping Pills should be strengthened to ensure drug safety.