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目的 检测和分析司美格鲁肽的安全信号，为司美格鲁肽的临床合理用药提供参考。方法 基于美国FDA不良事件呈报系统（FAERS），采用报告比值比（ROR）法和比例报告比值（PRR）法对FDA公开数据开放项目中于2018年1月到2020年12月上报的司美格鲁肽的药物不良反应（ADR）信号进行数据挖掘和分析。结果 以Semaglutide为药物名称进行检索，经筛选和去重后共纳入3 937份报告。其中，女性与男性比例相当；年龄主要在50～75岁；报告数量逐年增多；主要上报国家为美国；以ROR法和PRR法检测出134个共同信号，涉及系统器官21个，主要集中在胃肠系统疾病、各类检查和代谢及营养问题等方面。结论 司美格鲁肽可能会增加胰腺炎、胆石症、糖尿病性视网膜病和甲状腺髓样癌的发病风险，此类不良反应的高风险人群应慎用，用药时应积极监测相关指标。
Abstract：AIM To detect and analyze the safety signal of semaglutide, and to provide reference for rational drug use of semaglutide. METHODS Based on the FDA adverse event reporting system(FAERS), the adverse drug reaction(ADR) signals of semaglutide reported in the FDA open data project from January 2018 to December 2020 were mined and analyzed by using reporting odds ratio(ROR) method and proportional reporting ratio(PRR) method. RESULTS Semaglutide was used as the drug name, and 3 937 reports were included after screening and recallation. Among them, the proportion of women and men was equal, the age was mainly from 50 to 75 years old, the number of reports increased year by year, mainly from the United States, and 134 common signals were detected by ROR and PRR, involving 21 systemic organs, mainly focusing on gastrointestinal diseases, various examinations and metabolic and nutritional problems. CONCLUSION Semaglutide may increase the risk of pancreatitis, cholelithiasis, diabetic retinopathy and medullary thyroid carcinoma. People at high risk of such adverse reactions should be used with caution, and relevant indicators should be actively monitored during medication.
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基本信息:
DOI：10.19577/j.1007-4406.2022.02.002
中图分类号:R95
引用信息:
[1]屈涵,武正华,石晨阳,等.司美格鲁肽不良反应信号的检测和分析[J].中国临床药学杂志,2022,31(02):88-93.DOI:10.19577/j.1007-4406.2022.02.002.
2022-02-25
2022-02-25