背景:胰高血糖素样肽-1受体激动剂(GLP-1RAs)由于其显着的降血糖和减肥作用而备受关注。以前的制剂只能皮下注射。口服GLP-1RAssemaglutide有助于拓宽治疗选择,但是它在现实世界中的安全性仍然需要观察。本研究基于FDA不良事件报告系统(FAERS)数据库,挖掘口服司马鲁肽的不良药物事件(ADE),为临床安全使用该药提供参考。
方法:为了分析口服司马鲁肽的信号质量,从2019年第三季度到2023年第三季度,FAERS数据库中使用的药物,我们收集了ADE数据,并使用不成比例分析进行了数据挖掘。然后,我们标准化了数据,并使用了各种信号量化技术,包括报告的赔率比(ROR),比例报告比率(PRR),贝叶斯信念传播神经网络(BCPNN),和多重经验贝叶斯伽马泊松收缩(MGPS),作进一步分析。
结果:我们筛选了2398份关于使用司马鲁肽片的报告,共涉及5653个ADE。这些报告主要由消费者提交,报告国主要是美国。总共为semaglutide片剂的信号开采了23种系统器官类别(SOC)和93种首选术语(PT)。三种最常见的SOC是胃肠道疾病,一般疾病和给药部位条件,和调查。在PT级别,代谢和营养失调表现出最高数量的信号,前三名是甲状腺囊肿,急性胆囊炎,和酮症。胃肠道疾病排名第二,主要涉及愤怒,胰腺炎,胃排空受损,和反流。此外,发生vith神经麻痹,信号强度高。
结论:我们的研究为口服司马鲁肽的安全性提供了更深入和更广泛的理解。ROR的结果,PRR,BCPNN,和MGPS算法表现出很高的一致性,与代谢和营养相关的疾病具有最高数量的信号。结论与产品的技术规格一致。值得注意的是,报告了其他意想不到的影响,包括急性胆囊炎,外展神经瘫痪,位置性眩晕.
BACKGROUND: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have attracted much attention because of their significant hypoglycemic and weight-loss effects. Previous preparations can only be subcutaneously injected. Oral administration of GLP-1RAs semaglutide helps to broaden treatment options, but its safety in the real world still needs to be observed. This study is based on FDA adverse event reporting system (FAERS) database to mine adverse drug events (ADE) of oral semaglutide, and provide references for the clinical safe use of this drug.
METHODS: To analyze the signal quality of oral semaglutide, which is a drug used in the FAERS database from the third quarter of 2019 to the third quarter of 2023, we collected ADE data and performed data mining by using disproportionate analysis. Then, we standardized the data and used a variety of signal-quantification techniques, including reported odds ratio (ROR), proportional reporting ratio (PRR), Bayesian belief propagation neural network (BCPNN), and multiple empirical Bayesian gamma Poisson contractions (MGPS), for further analysis.
RESULTS: We screened 2398 reports on the use of semaglutide tablets, involving a total of 5653 ADE. These reports were mainly submitted by consumers, and the reporting country was mainly the United States. A total of 23 system organ classes (SOC) and 93 preferred terms (PT) were mined for the signals of semaglutide tablets. The three most common SOC were gastrointestinal disorders, general disorders and administration site conditions, and investigations. At the PT level, metabolism and nutrition disorders exhibit the highest number of signals, with the top three being thyroid cyst, acute cholecystitis, and ketosis. Gastrointestinal disorders rank second, primarily involving eructation, pancreatitis, impaired gastric emptying, and regurgitation. In addition, vith nerve paralysis occurs and the signal intensity is high.
CONCLUSIONS: Our study provides a deeper and broader understanding of the safety of oral semaglutide. The results of the ROR, PRR, BCPNN, and MGPS algorithms exhibit high consistency, with metabolism and nutrition-related disorders having the highest number of signals. The conclusions align with the technical specifications of the product. Notably, other unexpected effects are reported, including acute cholecystitis, paralysis of the abducens nerve, and positional vertigo.