[关键词]
[摘要]
通过对奥曲肽不良反应信号的挖掘分析,以期为临床安全合理用药提供参考。采用比例失衡法中的比例报告比值法(PRR)和报告比值比法(ROR)对2018年1季度至2020年4季度美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)中奥曲肽的不良反应报告进行数据挖掘及分析。检索到148 469个以奥曲肽为首要怀疑药品的不良反应作为原始研究数据,分析处理数据后共得到786个有效信号,主要集中在各类检查(29.57%)、全身性疾病及给药部位各种反应(13.01%)和胃肠系统疾病(12.89%)等方面,发现说明书中未出现的信号累及器官系统有8个。使用奥曲肽前应做好用药评估,尤其当患者存在内分泌疾病、心血管疾病、胃肠系统疾病等基础疾病时,建议临床用药时定期监测相关指标,并注意给药部位反应,如发生不良反应或疾病进展,应及时采取相关干预措施,以确保安全合理用药。
[Key word]
[Abstract]
To provide the basis for rational and safe drug use in clinic, through the mining and analysis of adverse drug reaction (ADR) signals of Octreotide. The reporting odds ratio method (ROR) and proportional reporting ratio method (PRR) were used to mine and analyze the adverse reaction reports of octreotide which included 12 quarter from the first quarter of 2018 to the fourth quarter of 2020 of FDA adverse events reporting system (FAERS). Totally 148 469 ADRs with octreotide as the primary suspected drug were retrieved as the original data. After analyzing and processing the data, 786 effective signals were obtained, mainly focused on examination (29.57%), systemic diseases and administration site reactions (13.01%), gastrointestinal (12.89%) diseases and so on, and eight organ systems that did not appear in the instruction. Before using octreotide, drug evaluation should be performed well, especially when patients have basic diseases such as endocrine disease, cardiovascular disease, and gastrointestinal diseases. Indexs of correlation should be monitored on a regular basis. It was advised to take timely intervention measures when ADR or disease progression occurs so as to ensure safe and rational drug use.
[中图分类号]
R975
[基金项目]
四川省科技厅项目(2019JDR0163)