中国临床药学杂志

目的 通过日本药品不良事件报告（JADER）数据库，检测和分析伏诺拉生潜在药品不良事件（ADE）信号，为临床合理安全使用提供参考。方法 采用比例失衡法中的报告比值比法（ROR）和MHRA综合标准法对JADER数据库中自2014年12月至2023年12月的伏诺拉生相关ADE报告进行数据挖掘。结果 共筛选得到伏诺拉生ADE报告2 192例，检测出比例失衡信号57个，涉及13个系统-器官分类（SOC）。ADE信号主要集中在胃肠系统疾病、皮肤及皮下组织类疾病和肝胆系统疾病。其中高胃泌素血症、胃黏膜肥大、血胃泌激素升高、Wernicke-Korsakoff综合征和嗜酸细胞型膀胱炎等首选术语（PT）的ADE信号较强，且未在药品说明书中记载。结论 该研究新发现的ADE信号，为现有药品说明书中的安全性信息提供了重要补充。同时，借助JADER数据库的深入挖掘，进一步提升了亚洲人群在药物应用安全性方面的认知水平，从而为保障患者的用药安全提供了有力支持。

AIM The potential adverse drug event(ADE) signals associated with vonoprazan were detected and analyzed using the Japanese Adverse Drug Event Report(JADER) database, to provide references for its rational and safe clinical use. METHODS The vonoprazan-related ADE reports in the JADER database from December 2014 to December 2023 were analyzed using the report odds ratio method and the comprehensive standard method from Medicines and Healthcare products Regulatory Agency(MHRA). RESULTS A total of 2 192 cases of vonoprazan-related ADE reports were analyzed, and 57 disproportionality signals were detected, involving 13 system organ classes. The ADE signals were primarily concentrated in gastrointestinal, skin, subcutaneous tissue and hepatobiliary disorders. Among these,strong ADE signals such as hypergastrinemia, gastric mucosal hypertrophy, elevated blood gastrin, Wernicke-Korsakoff syndrome, and eosinophilic cystitis were identified, which were not documented in the drug label. CONCLUSION The newly detected ADE signals in this study supplement current safety information in the drug label. Additionally, the understanding of drug safety in the Asian population is improved and the drug safety of patients is guaranteed by mining the JADER database.