中国临床药学杂志

目的 对美国食品药品监督管理局不良反应报告系统（FAERS）数据库中阿立哌唑的不良事件（ADE）报告进行数据挖掘，为临床安全用药提供参考依据。方法 采用报告比值（ROR）法和MHRA综合标准法对FAERS数据库2004年1月1日至2022年6月30日的阿立哌唑ADE报告进行数据挖掘，利用《国际医学用语词典》对挖掘到的风险信号进行分类和描述。结果 共检索到阿立哌唑相关ADE报告48 183份，去除社会环境、各类损伤、中毒、产品问题等与药物使用无关的ADE报告161份，挖掘出542个不良反应信号，其中有79个未在药品报告说明书中收录，严重的ADE主要分布在精神病类、神经系统疾病以及妊娠期等方面。系统器官分类（SOC）主要集中在精神病类、神经系统疾病以及各类检查等。通过对性别、年龄差异的相关ADE进一步分析，发现有性别差异的高危信号有23个，男性患者应警惕催乳素减少、恶性综合征及性欲增加等；女性患者应警惕催乳素异常、病感失认症、直立性高血压及凝视麻痹等；年龄差异的相关高危信号有17个，对于未成年患者，催乳素减少、动眼神经危象和流涎等是高危信号；对于成年患者，病感失认症、精神分裂症和躁狂症等是高危信号。结论 通过挖掘FAERS数据库中阿立哌唑的ADE报告，深入分析药品上市后的安全性，保障患者的用药安全。对本研究挖掘出的未在药品说明书中出现的及未在其他文献中报道过的新的不良反应信号应予以警示。

AIM To mine the adverse drug event(ADE) report of aripiprazole in FDA Adverse Event Reporting System(FAERS) database, and to provide reference frame for the clinical safety of drugs. METHODS Using methods of reporting odds ratio(ROR) and medicines and healthcare products regulatory agency(MHRA) to mine ADEs of aripiprazole from January 1, 2004 to June 30, 2022 in the FAERS database, and the risk signals which were mined would be classified and described by the International Dictionary of Medical terms. RESULTS A total of 48 183 ADEs related to aripiprazole were retrieved, 161 ADEs unrelated to drug use such as social environment, various injuries, poisoning and product problems were removed, and 542 signals were excavated, of which 79 were not included in the specification and severe ADEs were mainly in psychiatric and neurological diseases, as well as pregnancy, puerperium and perinatal periods. Through further analysis of the relevant ADEs of gender and age differences, it was found that there were 23high-risk signals with gender differences. Male patients should be vigilant against decreased blood prolactin, malignant syndrome, and increased libido. Female patients should be alert to abnormal blood prolactin, agnosia syndrome, orthostatic hypertension, and gaze paralysis. There were 17 high-risk signals with age differences, which were high-risk signals for juvenile patients with decreased blood prolactin, oculomotor nerve crisis, and salivation. For adult patients, agnosia syndrome, schizophrenia, mania, etc. were high-risk signals. CONCLUSION By mining the ADE report of aripiprazole in the FAERS database, post-marketing safety should be analyzed in depth to ensure the safety of patients. New adverse drug reaction signals unearthed in this study that did not appear in the specification and were not reported in other literature should be alerted.