基于FAERS数据库美沙拉嗪不良反应信号挖掘与分析  

Mining and Analysis of Adverse Reaction Signals of Mesalazine Based on FAERS Database

作　　者：马丽娟[1,2] 高华 王青[3] 王钊[4] 马学琴 MA Lijuan;GAO Hua;WANG Qing;WANG Zhao;MA Xueqin(Department of Pharmacy,General Hospital of Ningxia Medical University,Yinchuan 750004,China;School of Pharmacy,Ningxia Medical University,Yinchuan 750004,China;Department of Pharmacy,The First People's Hospital of Yinchuan,Yinchuan 750001,China;Department of Pharmacy,Peking University First Hospital Ningxia Women and Children's Hospital,Ningxia Hui Autonomous Region Maternal and Child Health Hospital,Yinchuan 750001,China)

机构地区：[1]宁夏医科大学总医院药剂科,银川750004 [2]宁夏医科大学药学院,银川750004 [3]银川市第一人民医院药剂科,银川750001 [4]北京大学第一医院宁夏妇女儿童医院药剂科,宁夏回族自治区妇幼保健院,银川750001

出　　处：《宁夏医科大学学报》2024年第12期1242-1248,共7页Journal of Ningxia Medical University

基　　金：宁夏回族自治区重点研发计划重大(重点)项目(2018BCG01001)。

摘　　要：目的 通过对美国FAERS数据进行分析,探讨美沙拉嗪的不良反应(ADR),旨在为临床安全用药提供参考。方法 采用OpenVigil 2.1数据平台,收集2012年第1季度至2022年第3季度美沙拉嗪相关ADR数据,利用比例失衡法中的报告比值比(ROR)和贝叶斯可信传播神经网络(BCPNN)进行数据挖掘分析,得出ADR数量以及所涉及疾病等相关数据。结果 获得1 737个美沙拉嗪ADR报告中,有15 259例,共发现254个美沙拉嗪ADR信号涉及4 307个病例,22个系统器官分类(SOC)。其中胃肠系统疾病占47.1%,呼吸系统、胸及纵隔疾病占8.5%,各类检查占8.1%,心脏器官疾病占8.0%,血液及淋巴系统疾病占4.7%,感染及侵染类疾病占4.3%,血管和淋巴管类疾病占3.1%,免疫系统疾病占2.6%。新ADR信号包括各类检查、感染及侵染类疾病、血管和淋巴管类疾病、免疫系统疾病,后两者ADR信号尚未有相关报道。结论 临床工作中,除了关注美沙拉嗪引起的胃肠道ADR,还需警惕其可能引起的心脏、血管淋巴管和免疫系统ADR。Objective To explore the adverse reactions(ADR)of Mesalazine by analyzing FAERS data from the United States to provide a reference for clinically safe medication.Methods The OpenVigil 2.1 data platform was used to collect data on adverse reactions related to Mesalazine from the first quarter of 2012 to the third quarter of 2022.The reported odds ratio(ROR)and bayesian canfidence propagation neural network(BCPNN)in the proportional imbalance methods were used for data mining analysis to obtain the number of adverse reactions and related data on the diseases involved.Results Out of 1737 reports of Mesalazine ADR,15259 cases were reported,and 254 Mesalazine ADR signals were found.It was involving 4307 cases and 22 systemic organ classifications(SOC).Gastrointestinal diseases accounted for 47.1%,respiratory,thoracic,and mediastinal diseases for 8.5%,various types of examinations for 8.1%,cardiac diseases for 8.0%,hematologic and lymphatic system diseases for 4.7%,infectious and invasive diseases for 4.3%,vascular and lymphatic diseases for 3.1%,and immune system diseases for 2.6%.New ADR signals include those from various types of examinations,infectious and invasive diseases,vascular and lymphatic diseases,and immune system diseases,with the latter two categories of ADR signals not yet having been reported.Conclusion In clinical practice,in addition to paying attention to gastrointestinal ADR caused by Mesalazine,it is also necessary to be vigilant against its potential to cause cardiac,vascular,lymphatic,and immune system ADR.

关 键 词：FAERS数据库 美沙拉嗪 不良反应 比例失衡法 信号挖掘 

分 类 号：R969.3[医药卫生—药理学]