基于FAERS数据库的成人使用司美格鲁肽的临床研究

Clinical trial of semaglutide in adults based on the FAERS database

目的从整体、性别及年龄3个层面分析真实世界中司美格鲁肽不良事件发生情况,并比较不同性别及年龄患者不良事件发生情况的差异,为临床安全应用提供参考。方法用OpenVigil 2.1对美国食品药品监督管理局不良事件报告系统中司美格鲁肽相关不良事件进行检索,检索时间为自建库起至2023年4月。根据患者年龄及性别,分为18~64岁组及≥65岁组、男性组及女性组,并选取10个重点关注的不良事件(恶心、腹泻、呕吐、胰腺炎、胆囊炎、胆石症、低血糖、糖尿病视网膜病变、急性肾损伤、甲状腺癌/甲状腺髓样癌),用描述性分析对整体及各组司美格鲁肽不良事件进行统计分析。结果经处理共得到5330条个案信息,15558个不良事件。其中18~64岁组患者2935例,8553个不良事件;≥65岁组患者2395例,7005个不良事件。男性组患者2231例,6195个不良事件;女性组患者3059例,9277个不良事件;40例性别未知。恶心(1089例/7.00%)、呕吐(775例/4.98%)及腹泻(545例/3.50%)仍然是最常见的不良事件。18~64岁组患者胰腺炎的构成比显著高于≥65岁组患者(P<0.05);腹泻及胆石症的构成比均显著低于≥65岁组患者(均P<0.05)。男性组患者腹泻、呕吐、胰腺炎、胆囊炎、胆石症、糖尿病视网膜病变、急性肾损伤的构成比均显著高于女性组(均P<0.05)。结论恶心、腹泻及呕吐仍然是司美格鲁肽最常见不良事件。男性患者应该更加关注胃肠道、胰腺炎、胆囊事件、视网膜病变及急性肾损伤的发生,老年患者应该更加警惕腹泻及胆石症的发生。

Objective We aim to analyse semaglutide related adverse events in real-world,overall and by gender and age subgroups and compare the differences of different gender and age patients in adverse events,in order to supply references for security usage in the clinic.Methods OpenVigil 2.1 was used to search FDA Adverse Event Reporting System for semaglutide related adverse events from the establishment of the databases to April 2023.According to age and gender,patients were divided into 18-64 years old group and≥65 years old group,male group and female group.We selected ten adverse events which we interested(nausea,diarrhoea,vomiting,pancreatitis,cholecystitis,cholelithiasis,hypoglycaemia,diabetic retinopathy,acute kidney injury and thyroid cancer/medullary thyroid cancer)and analyzed overall and each group of semaglutide adverse events.Results A total of 5330 cases and 15558 adverse events were collected.2935 patients aged 18-64 old group years with 8553 adverse events;2395 patients age d≥65 years old group with 7005 adverse events.2231 male group patients with 6195 adverse events;3059 female group patients with 9277 adverse events.The sex of 40 patients was unknown.Nausea(1089 cases/7.00%),vomiting(775 cases/4.98%)and diarrhoea(545 cases/3.50%)remained the most common adverse events.The constituent ratio of pancreatitis was significantly higher in patients aged 18-64 years old group than in patients aged≥65 years old group(P<0.05);the constituent ratio of diarrhoeaand cholelithiasis was significantly lower in patients aged 18-64 years old group than patients aged≥65 years old group(P<0.05).The constituent ratio of diarrhoea,vomiting,pancreatitis,cholecystitis,cholelithiasis,diabetic retinopathy,and acute kidney injurywas significantly higher in male group patients than in female group(P<0.05).Conclusion Nausea,diarrhoea and vomiting remined the most common adverse events of semaglutide.Male should be more concerned about gastrointestinal,pancreatitis,gallbladder events,retinopathy and acute kidney injury.Elderly patients should be more alert diarrhoea and cholelithiasis.