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基于openFDA数据库的胰高血糖素样肽1受体激动剂不良反应信号挖掘与分析
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| 篇名： | 基于openFDA数据库的胰高血糖素样肽1受体激动剂不良反应信号挖掘与分析 |
| TITLE： | Mining and analysis of glucagon-like peptide- 1 receptor agonists related adverse drug reaction signals based on openFDA database |
| 摘要： | 目的 挖掘并分析胰高血糖素样肽1受体激动剂（GLP-1RA）相关不良反应（ADR）的风险信号。方法收集美国食品药品监督管理局公共数据开放项目（OpenFDA）数据库2005年4月1日－2021年10月16日的GLP-1RA相关ADR数据，采用贝叶斯置信传播神经网络法进行数据挖掘；利用《国际医学用语词典》24.0版药物ADR术语集中的系统器官分类（SOC）对ADR进行分类和描述。结果与结论共检索到GLP-1RA相关的ADR报告175719份、ADR阳性信号140个，涉及艾塞那肽（ADR报告77027份，ADR阳性信号31个）、度拉糖肽（ADR报告45329份，ADR阳性信号26个）、利拉鲁肽（ADR报告42748份，ADR阳性信号32个）、司美格鲁肽（ADR报告8844份，ADR阳性信号27个）、利司那肽（ADR报告1771份，ADR阳性信号24个）。按照SOC分类，GLP-1RA致ADR涉及胃肠系统及肝胆系统、神经系统、泌尿及肾脏系统、内分泌系统、免疫系统及给药部位。胃肠系统中，以（急性）胰腺炎的发生风险较高，其风险高低排序依次为利拉鲁肽＞艾塞那肽＞司美格鲁肽＞度拉糖肽＞利司那肽；肝胆系统的ADR信号以胆石症较高，其风险高低排序依次为利拉鲁肽＞司美格鲁肽＞艾塞那肽＞利司那肽＞度拉糖肽。神经系统中，味觉障碍发生风险较高；与度拉糖肽、利司那肽相比，利拉鲁肽、艾塞那肽、司美格鲁肽更易引发头痛、头晕。泌尿及肾脏系统中，与艾塞那肽、度拉糖肽、利司那肽相比，利拉鲁肽、司美格鲁肽更易诱发急性肾损伤。内分泌系统中，低血糖发生风险较高，其风险高低排序依次为艾塞那肽＞利拉鲁肽＞利司那肽＞司美格鲁肽＞度拉糖肽。免疫系统中，利司那肽致荨麻疹发生风险较高，利拉鲁肽、度拉糖肽未出现相关ADR风险信号。艾塞那肽、度拉糖肽致给药部位ADR的风险较高，而司美格鲁肽致相关ADR的风险较低。临床在使用GLP-1RA时，应密切监测患者的肾功能、血糖，并关注突发上腹疼痛的患者；若发生相关ADR应及时采取干预措施，以保证患者用药安全、有效。 |
| ABSTRACT： | OBJECTIVE To mine and analyze the risk signal of glucagon- like peptide -1 receptor agonists （GLP-1RA）related adverse drug reaction （ADR）. METHODS ADR data related to GLP- 1RA from April 1，2005 to October 16，2021 in the openFDA database were collected ，and the Bayesian confidence propagation neoral network （BCPNN）method was used for data mining. ADR were classified and described by using systematic organ classification （SOC）of drug ADR terminology set in 24.0 edition of MedDRA. RESULTS & CONCLUSIONS A total of 175 719 ADR reports related to GLP- 1RA were retrieved ，with 140 ADR positive signals ，involving five drugs such as exenatide （77 027 cases of ADR and 31 ADR positive signals ），dulaglutide （45 329 cases of ADR and 26 ADR positive signals ），liraglutide （42 748 cases of ADR and 32 ADR positive signals ）， semaglutide（8 844 cases of ADR and 27 ADR positive signals ）and lixisenatide （1 771 cases of ADR and 24 ADR positive signals）. According to SOC classification ，GLP-1RA-induced ADR involved gastrointestinal system ，hepatobiliary system ，nervous system，urinary and renal system ，endocrine system ，immune system and administration site. In the gastrointestinal system ，the risk of （acute）pancreatitis was higher ，and the order of risk was liraglutide ＞exenatide＞semaglutide＞dulaglutide＞lixisenatide； ADR signal of hepatobiliary system was stronger for cholelithiasis ，and the order of risk was liraglutide ＞semaglutide＞exenatide＞ lixisenatide＞dulaglutide. In the nervous system ，the risk of taste disorder was higher ；compared with dulaglutide and lixisenatide ， liraglutide，exenatide and semaglutide were more likely to cause headache and dizziness. In urinary and renal system ， compared with exena tide，dulaglutide and lixisenatide ，liraglutide and semaglutide were more likely to cause acute renal injury. In the endocrine system ，the risk of hypoglycemia was higher ，and the order of risk was exenatide ＞liraglutide＞lixisenatide＞ semaglutide＞dulaglutide. In the immune system ，lixisenatide was more likely to develop urticaria than other drugs ，dulaglutide and liraglutide did not caused ADR signal. Among the administration sites ，the risk of ADR caused by exenatide and dulaglutide was higher，while the risk of related ADR caused by semaglutide was lower. When using GLP- 1RA clinically ，we should closely monitor the renal function and blood glucose of patients ，and pay attention to patients with sudden upper abdominal pain ；in case of relevant ADR ，timely intervention measures should be taken to ensure the safety and effectiveness of medication. |
| 期刊： | 2022年第33卷第12期 |
| 作者： | 董士超，王靖宇 |
| AUTHORS： | DONG Shichao ，WANG Jingyu |
| 关键字： | 胰高血糖素样肽1受体激动剂；FDA公共数据开放项目；药品不良反应；贝叶斯置信传播神经网络法；信号挖掘 |
| KEYWORDS： | glucagon-like peptide- 1 receptor agonists ；openFDA；adverse drug reaction ；BCPNN；signal mining |
| 阅读数： | 227 次 |
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