基于FAERS数据库挖掘分析他汀类药物不良反应

Analysis of adverse drug reactions of statins based on FAERS database mining

目的:利用美国食品药品监督管理局不良事件报告系统开展他汀类药物的不良反应风险分析。方法:采用报告比值比法与贝叶斯置信区间传播神经网络法对他汀类药物的不良反应信号进行分析。结果:新发现他汀类药物部分共性不良反应(大于4种他汀类药物存在的新发不良反应)12种,且他汀类药物糖尿与新发糖尿病之间存在较强的关联性。结论:他汀类药物较为确定的不良反应是血压降低以及新发糖尿病,在骨骼和呼吸系统方面他汀类药物的不良反应与文献报道存在争议,他汀类药物对血液、精神、神经、消化系统、肾脏及泌尿系统方面造成的风险尚未有足够循证医学证据支撑。对他汀类药物的应用后续要持续监测安全性风险,同时要积极合理地使用,提高风险获益水平。

OBJECTIVE The U.S.Food and Drug Administration Adverse Drug Event Reporting System was used to conduct adverse drug reaction risk analysis of statins.METHODS The reporting odds ratio method and Bayesian confidence interval propagation neural network method were used to analyze the signal of suspected adverse reactions of statins.RESULTS Some common suspected adverse reactions(new suspected adverse reactions with more than 4 statins)were newly identified for statins, and there was a strong association between statin and new-onset diabetes mellitus.CONCLUSION The adverse reactions of statins are lower blood pressure and new-onset diabetes mellitus.The adverse reactions of statins in bone and respiratory system are controversial with those reported in the literature.There is insufficient evidence-based medical evidence to support the risks of statins on blood, psychiatric, neurological, digestive, renal and urinary systems.The use of statins should be followed by continuous monitoring of safety risks, and active and rational use to improve the level of risk and benefit.