奥氮平和齐拉西酮不良事件信号挖掘与分析

Signal Mining and Analysis of Adverse Drug Events of Olanzapine and Ziprasidone

目的促进临床合理使用奥氮平和齐拉西酮。方法检索美国食品和药物管理局不良事件报告系统(FAERS)数据库中2004年1月1日至2020年9月30日收录的药品不良事件(ADE)报告,采用报告比值比法分析2种目标药品上报频数排名前30位的ADE及指定医疗事件(DME)信号。结果2种药品的高频ADE多分布于神经系统疾病。奥氮平以糖尿病性昏迷、代谢紊乱及神经抑制性恶性综合征信号较显著;齐拉西酮以肥胖、神经抑制性恶性综合征及2型糖尿病信号较显著。两者共同检出的DME信号所属疾病包括横纹肌溶解、心源性猝死、胰腺炎、急性胰腺炎、尖端扭转型室性心动过速、粒细胞缺乏症、粒细胞减少症、肝坏死等。结论基于真实世界的ADE信号挖掘有助于开展奥氮平和齐拉西酮的安全性评价,降低临床用药风险。

Objective To promote the clinical rational use of olanzapine and ziprasidone.Methods The adverse drug event(ADE)reports collected in the FDA Adverse Event Reporting System(FAERS)database from January 1,2004 to September 30,2020 were searched.The reporting odd ratio(ROR)method was used to analyze the top 30 reported ADE and designated medical event(DME)signals of the two target drugs.Results The high-frequency ADEs of the two drugs were mostly distributed in nervous system diseases.Olanzapine showed significant signs of diabetic coma,metabolic disturbance and neuroleptic malignant syndrome.Ziprasidone showed significant signs of obesity,neuroleptic malignant syndrome and type 2 diabetes mellitus(T2DM).The common DME of the two drugs were rhabdomyolysis,sudden cardiac death,acute pancreatitis,torsade de pointe ventricular tachycardia,agranulocytosis,granulocytopenia,hepatonecrosis and so on.Conclusion Signal mining of ADEs based on the real world is helpful to carrying out the safety evaluation of olanzapine and ziprasidone and reducing the risk of clinical medication.