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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 detect the risk signals of liver injury related to anti-infectives by data mining methods and provide reference for the prevention and treatment of anti-infective drug-related liver injury. Methods: The reports of anti-infective drug-related liver injury in the ADR surveillance center database from 2009 to 2013 were retrieved. The age, , Report odds ratio method, the British National Institute of medicine and health product standard method and Bayesian confidence interval interval progressive neural network method of four kinds of data mining methods to detect anti-infectives associated liver injury risk signal. RESULTS: Of 67 145 ADR cases, 1 699 liver injury reports were reported, of which 572 were associated with anti-infective drug-related liver injury. The first three types of anti-infectives that caused the highest ADR frequency were anti-TB drugs, cephalosporins and antifungal drugs. Four kinds of data mining methods to detect, anti-TB drugs and anti-fungal drugs such as 15 kinds of liver injury-positive signals. Conclusion: Anti-TB drugs and antifungal drugs may be the main drugs that cause anti-infective drug-related liver injury. Clinicians should raise their awareness of anti-infective drug-related liver injury and strengthen prevention.