首页|药源性肾损伤高风险药物研究:基于武汉市10年药品不良反应监测数据

药源性肾损伤高风险药物研究:基于武汉市10年药品不良反应监测数据

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目的:探讨武汉地区药源性肾损伤(drug-induced kidney injury,DIKI)的临床特点及发生规律,挖掘DIKI高频次药物品种,以期为临床合理用药提供参考。方法:采用回顾性研究方法,收集2012-2022年武汉市ADR自发呈报系统数据库中DIKI相关报告,采用描述性方法对报告信息、患者人口学特征、涉及药物及种类分布等进行分析,采用报告比值比法(ROR)、比例报告比值法(PRR)、综合标准法(MHRA)和贝叶斯置信度递进神经网络法(BCPNN)挖掘风险信号。结果:共纳入1 504例DIKI报告,数量呈逐年上升趋势,报告类型为"严重"的占比达38。43%;患者主要集中在60~79年龄段,男女构成比为1。58∶1,多发生在用药后2~7d;报告共涉及19类417种药物,出现频次最多的药物类别为抗感染药物(27。73%),其次是血液系统用药(12。50%)和泌尿系统用药(8。31%),位列前3的药物品种依次为山莨菪碱、甘露醇和万古霉素。经数据挖掘技术检测,8种药物生成肾损伤强阳性风险信号。结论:DIKI临床表现形式多样,涉及药物种类繁多,抗感染类药物发生频次最高,老年男性患者为高危人群,提示临床需重点关注,尽量避免超适应证超剂量用药,加强监测肾功能,以减少高危人群DIKI的发生。
Study of high-risk agents for drug-induced kidney injury:monitoring data of 10-year spontaneous reports in Wuhan Municipality
OBJECTIVE To explore the clinical characteristics and occurrence patterns of drug-induced kidney injury(DIKI)in Wuhan Municipality and identify the risk signals of kidney injury caused by high-frequency agents to provide references for rational use of drugs in clinical practices.METHODS For this retrospective study,all DIKI-related reports were collected from Wuhan ADR spontaneous reporting system database during 2012 to 2022.Demographic profiles,distribution/type of drugs and clinical manifestations were recorded with descriptive statistics.Risk signal mining was further conducted with reporting odds ratio(ROR)and proportional reporting ratio(PRR)through the databases of Medicines and Healthcare Products Regulatory Agency(MHRA)and Bayesian Confidence Propagation Neural Network(BCPNN).RESULTS A total of 1 504 DIKI cases were obtained with an annual increase in the number of cases.The degree of DIKI was mostly"general"and"serious"accounted for 38.43%.The subjects predominated in 60-79 age group with a male-to-female ratio of 1.58∶1.A large majority of DIKI reports occurred at Days 2-7 post-dosing.A total of 19 categories and 417 types of drugs were involved.The most frequently reported drugs were antibiotics(27.73%),hematological agents(12.50%)and urinary system drugs(8.31%).Top three drugs were scopolamine,mannitol and vancomycin.Further data mining revealed eight drugs with strong positive risk signals for kidney injury.CONCLUSION DIKI is associated with a large variety of drugs.Antibiotics are the most frequent.Due to diverse clini-cal manifestations of DIKI,high-risk senior males should be closely monitored.Drugs should be dosed strictly according to the indications and doses of package insert.And kidney functions shall be watched for minimizing the occurrence of DIKI in high-risk populations.

drug-induced kidney injuryadverse drug eventspontaneous reporting systempharmacovigilancedata mining

江莹、漆建军、李田、姚梦迪、何凯霞、柳莹、王璐、刘东、贡雪芃、魏安华

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武汉市药品不良反应监测中心,湖北武汉 430000

华中科技大学同济医学院附属同济医院药学部,湖北武汉 430033

药源性肾损伤 药品不良事件 自发呈报系统 药物警戒 数据挖掘

2024

中国医院药学杂志
中国药学会

中国医院药学杂志

CSTPCD北大核心
影响因子:1.198
ISSN:1001-5213
年,卷(期):2024.44(7)
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