通過對(duì)奧曲肽不良反應(yīng)信號(hào)的挖掘分析，以期為臨床安全合理用藥提供參考。采用比例失衡法中的比例報(bào)告比值法（PRR）和報(bào)告比值比法（ROR）對(duì)2018年1季度至2020年4季度美國食品藥品監(jiān)督管理局（FDA）不良事件報(bào)告系統(tǒng)（FAERS）中奧曲肽的不良反應(yīng)報(bào)告進(jìn)行數(shù)據(jù)挖掘及分析。檢索到148 469個(gè)以奧曲肽為首要懷疑藥品的不良反應(yīng)作為原始研究數(shù)據(jù)，分析處理數(shù)據(jù)后共得到786個(gè)有效信號(hào)，主要集中在各類檢查（29.57%）、全身性疾病及給藥部位各種反應(yīng)（13.01%）和胃腸系統(tǒng)疾?。?2.89%）等方面，發(fā)現(xiàn)說明書中未出現(xiàn)的信號(hào)累及器官系統(tǒng)有8個(gè)。使用奧曲肽前應(yīng)做好用藥評(píng)估，尤其當(dāng)患者存在內(nèi)分泌疾病、心血管疾病、胃腸系統(tǒng)疾病等基礎(chǔ)疾病時(shí)，建議臨床用藥時(shí)定期監(jiān)測相關(guān)指標(biāo)，并注意給藥部位反應(yīng)，如發(fā)生不良反應(yīng)或疾病進(jìn)展，應(yīng)及時(shí)采取相關(guān)干預(yù)措施，以確保安全合理用藥。

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.

R975

四川省科技廳項(xiàng)目（2019JDR0163）