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替尔泊肽不良事件信号挖掘与分析
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| 篇名： | 替尔泊肽不良事件信号挖掘与分析 |
| TITLE： | Signal mining and analysis of adverse drug events of tirzepatide |
| 摘要： | 目的 基于FDA不良事件报告系统（FAERS）数据库，对替尔泊肽相关药物不良事件（ADE）信号进行挖掘分析，为临床安全用药提供参考。方法通过FAERS数据库提取2022年5月1日至2024年6月30日替尔泊肽为首要怀疑药物的ADE报告，并利用《国际医学用语词典》对筛选后的ADE的系统器官分类（SOC）和首选术语进行系统归纳，再通过报告比值比法和比例报告比值法对上述ADE进行信号挖掘及分析。结果共获得替尔泊肽相关ADE报告39229份，严重ADE报告3934份（10.03%），严重的ADE报告以导致住院/住院时间延长为主（3.82%），涉及131个ADE阳性信号；已报告患者性别和患者年龄的ADE报告中，女性26195份（66.77%），男性7869份（20.06%），年龄以18～64岁为主（54.26%）。发生频次排名前3位的ADE分别为注射部位疼痛、恶心和注射部位出血。信号较强且并未被替尔泊肽说明书提及的ADE分别为注射部位发凉、饥饿性酮症酸中毒、注射部位出血、饥饿、肾上腺素升高、注射部位皮肤开裂、贪食、皮肤松解、肠脓毒症、饱腹感缺乏和痛觉异常。患者性别和年龄亚组分析结果表明，不同性别和年龄段患者的ADE报告数在不同SOC下所占比例存在差异，男性或≥65岁患者在胃肠系统疾病的风险大于女性或＜65岁患者。结论临床应用替尔泊肽时，除了关注药品说明书中记载的ADE外，还应关注注射部位发凉、饥饿性酮症酸中毒、注射部位出血、肾上腺素升高、肠脓毒症等药品说明书未提及的ADE，以保障患者安全用药。 |
| ABSTRACT： | OBJECTIVE To identify and analyze adverse drug event （ADE） signals associated with tirzepatide based on the FDA Adverse Event Reporting System （FAERS） database， providing a reference for clinical medication safety. METHODS ADE reports from January 1， 2022， to June 30， 2024， with tirzepatide as the primary suspected drug， were extracted from the FAERS database. Medical Dictionary for Regulatory Activities was used to systematically categorize the selected system organ class （SOC） and preferred term of ADE. Signal mining and analysis were performed using the reporting odds ratio method and the proportional reporting ratio method. RESULTS A total of 39 229 ADE reports related to tirzepatide were obtained， including 3 934 severe ADE reports （10.03%）. The majority of severe ADE reports were related to hospitalization or prolonged hospitalization （3.82%）， involving 131 positive ADE signals. Among the reports with documented patient gender and age， 26 195 were female （66.77%）， 7 869 were male （20.06%）， and the majority of patients were aged 18-64 years （54.26%）. The top three most frequently reported ADE were injection site pain， nausea， and injection site hemorrhage. Strong ADE signals not mentioned in the tirzepatide instruction included injection site coldness， starvation ketoacidosis， injection site hemorrhage， hunger， elevated adrenaline， injection site skin cracking， binge eating， skin laxity， intestinal sepsis， lack of satiety， and dysesthesia. Subgroup analysis for patient’s gender and age showed differences in the proportion of ADE reports across different SOC. Male patients or those aged≥65 years had a higher risk of gastrointestinal system disorders compared to female patients or those aged ＜65 years. CONCLUSIONS In clinical use of tirzepatide， in addition to monitoring ADE listed in the instruction， attention should also be paid to ADE not mentioned in the instruction， such as injection site coldness， starvation ketoacidosis， injection site hemorrhage， elevated adrenaline， and intestinal sepsis， to ensure patient safety. |
| 期刊： | 2025年第36卷第08期 |
| 作者： | 谢泽宇；梁焯茹；郑桂梅；曹伟灵；陈吉生 |
| AUTHORS： | XIE Zeyu，LIANG Zhuoru，ZHENG Guimei，CAO Weiling，CHEN Jisheng |
| 关键字： | 替尔泊肽；FDA不良事件报告系统；药物不良事件；信号挖掘 |
| KEYWORDS： | tirzepatide； FDA Adverse Event Reporting System； adverse drug event； signal mining |
| 阅读数： | 1 次 |
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