摘要
目的：通过数据挖掘方法分析和检测抗感染药相关肝损伤风险信号,为防治抗感染药相关肝损伤提供参考。方法：调取2009~2013年解放军药品不良反应（ADR）监测中心数据库中抗感染药相关肝损伤报告,对患者的年龄、性别、引发ADR的药物类别与品种进行分析,并通过比例报告比法、报告比值比法、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种数据挖掘方法检测抗感染药相关肝损伤风险信号。结果：67 145例ADR报告中,共涉及1 699例肝损伤报告,其中抗感染药相关肝损伤为572例。引发ADR频次最高的前3类抗感染药分别为抗结核药、头孢菌素类药和抗真菌药。通过4种数据挖掘方法检测,抗结核药和抗真菌药等15种药物生成肝损伤的阳性信号。结论：抗结核药和抗真菌药可能是引发抗感染药相关肝损伤的主要药物。临床医务人员应提高对抗感染药相关肝损伤的认识,并加强防范。
Objective：To analyze and detecte the anti-infectious agents associated hepatic adverse drug reaction （ADR） signals using data mining methods, and provide reference for the prevention and treatment of anti-infective agents related hepatic ADRs. Methods： The hepatic ADR reports of anti-infective agents were collected from PLA ADR monitoring center during 2009 to 2013, and then analyzed in respect to age, gender and categories of suspected anti-infective agents. The relationships between anti-infectious agents and hepatic ADRs were assessed by 4 kinds of data mining methods, including the proportional reporting ratio（PRR）, the reporting odds ratio, combination X2 test-PRR measure used by the Medicines and Healthcare Products Regulatory Agency, and Bayesian Confidence Propagation Neural Network. Results： From 67 i45 reports submitted in our database, 1 699 cases regarded hepatic ADRs, and 572 were related to anti-infective agents. The most frequently drug classes inducing hepatic ADRs in anti-infective agents were anti-tubereulotics, cephalosporins, and antifungal drugs. Fifteen kinds of anti-infective agents, mainly including anti-tuberculosis drugs and antifungal drugs generated significant disproportionality using 4 kinds of data mining measures, indicating the post-marketing risk signals of liver injury. Conclusion：The anti-tuberculosis drugs and antifungal drugs were the most common suspects of the hepatic ADRs in anti-infective drugs. Clinicians must be aware of anti-infective drugs related liver injury and monitor patients when the prescription of these drugs.
出处
《药物流行病学杂志》
CAS
2016年第2期89-93,共5页
Chinese Journal of Pharmacoepidemiology
关键词
抗感染药
药源性肝损伤
药物警戒
药品不良反应
数据挖掘
Anti-infective drugs
Drug-induced liver injury
Pharmacovigilance
Adverse drug reaction
Data mining
