968例药源性肾损伤分析及抗感染药物相关风险信号挖掘

968 Cases of Drug-induced Kidney Injury and Risk Signal Mining of Anti-infective Drugs

目的分析药源性肾损伤的发生特点及规律,挖掘抗感染药物致肾损伤的风险信号,为临床安全用药提供参考。方法回顾性分析解放军药品不良反应数据库中2016~2018年有效肾损伤报告,并通过报告比值比法、比例报告比法、英国药品和保健产品管理局的综合标准法和贝叶斯可信区间递进神经网络法4种数据挖掘方法进行风险信号挖掘。结果968例药源性肾损伤中,男633例(65.39%),女335例(34.61%),平均年龄(58.60±19.55)岁。出现频次最多的药物类别为抗感染药物269例(27.79%),位列前3的药物品种依次为万古霉素43例(4.44%)、甘露醇30例(3.10%)、碘克沙醇29例(3.00%)。经数据挖掘技术检测,万古霉素等11种抗感染药物生成肾损伤阳性风险信号。结论药源性肾损伤涉及药物种类较多,其中抗感染类药物发生频次最高,临床应用中应强化相关药物警戒意识,规范使用高肾毒性风险药物。

Objective To analyze the characteristics and regularity of occurrence of drug-induced kidney injury,and to explore the risk signals of kidney injury caused by anti-infective drugs so as to provide reference for safe clinical use.Methods Valid reports of kidney injury collected between 2016 and 2018 in the ADR database of the PLA were retrospectively analyzed,and risk signals mining was carried out using four data mining methods:the reporting odds ratio,proportional reporting ratio,combination x2 test-PRR measure used by the Medicines and Healthcare Products Regulatory Agency,and Bayesian Confidence Propagation Neural Network.Results Among the 968 cases of drug-induced kidney injury,633 cases(65.39%)involved males and 335 cases(34.61%)females,with an average age of 58.60±19.55 years.The most-frequently reported drugs were antiinfective drugs in 269 cases(27.79%),and the top three drugs were vancomycin in 43 cases(4.44%),mannitol in 30 cases(3.10%),and iodixanol in 29 cases(3.00%).After data mining,eleven types of anti-infective drugs,including vancomycin,generated positive risk signals of kidney injury.Conclusion T here are many k inds of drugs involved in drug-induced kidney injury,among which the frequency of anti-infective drugs is the highest.In clinical application,the awareness of relevant drug vigilance should be enhanced and the use of drugs with high risk of nephrotoxicity standardized.