基于开放数据的降血脂药物不良反应数据挖掘

Open access data-based adverse reaction data mining of anti-hyperlipidemia drugs

目的:分析降血脂药的主要不良反应及其可能的影响因素。方法:利用国家人口与健康科学数据共享平台,获取579名患者的降血脂药不良反应报告记录,药物名称统一用"药物名+剂型"格式进行规范,不良反应描述参照世界卫生组织创建的药品不良反应术语集(WHO Adverse Reaction Terminology,WHO-ART),构建不良反应匹配词典。随后利用数据挖掘方法对数据集进行多维度分析。结果:引起不良反应的给药途径以静脉滴注(75.4%)为主,主要不良反应表现为胸闷、瘙痒、呼吸困难;累及器官系统主要表现为全身性损害(61.1%),临床表现为发热、不适、厌食等。单因素分析和多因素logistic回归分析显示给药途径是影响不良反应严重程度的因素。结论:降血脂药的不良反应常涉及全身性损害、皮肤及其附件损害等多器官系统,给药途径对不良反应的影响程度最大。

Objective To analyze the major adverse reactions of anti-hyperlipidemia drugs and their influencing factors. Methods The adverse reactions of anti-hyperlipidemia drugs in 579 patients were retrieved from the National Population and Health Scientific Data Platform. An adverse reaction-matched dictionary was established by normalizing the names of anti-hyperlipidemia drugs according to the ＂drug name ＋ dosage form＂ and describing the adverse reactions according to the WHO adverse reaction terminology. The data set dimensions were analyzed by data mining. Results The adverse reaction rate of intravenous drip was 75.4% and manifested as chest distress, itching and dyspnea. The rate of adverse reaction involving organ systems was 61.1% and manifested as systemic injury, fever, discomfort and anorexia. Logistic regression analysis showed that the drug giving route was a factor influencing the severity of adverse reaction. Conclusion The adverse reactions of anti-hyperlipidemia drugs involve systemic, skin and its appendix injury. Drug giving route is the major factor influencing the severity of adverse reaction.