[關(guān)鍵詞]
[摘要]
目的 挖掘5-羥色胺和去甲腎上腺素再攝取抑制劑相關(guān)不良事件的風(fēng)險(xiǎn)信號(hào),為該類藥物的臨床安全使用提供參考。方法 利用美國(guó)食品藥品監(jiān)督管理局不良事件報(bào)告系統(tǒng)(FAERS)數(shù)據(jù)庫(kù),使用OpenVigil 2.1數(shù)據(jù)平臺(tái),收集文拉法辛、度洛西汀、左旋米那普侖從FAERS建庫(kù)或在美國(guó)上市至2023年6月30日的不良事件報(bào)告。采用報(bào)告比值比法(ROR)聯(lián)合貝葉斯可信區(qū)間遞進(jìn)神經(jīng)網(wǎng)絡(luò)法(BCPNN)進(jìn)行數(shù)據(jù)挖掘,并分別按照發(fā)生頻次和信號(hào)強(qiáng)度進(jìn)行排序。結(jié)果 共檢索到相關(guān)不良事件報(bào)告9 376份,風(fēng)險(xiǎn)信號(hào)1 419個(gè),其中文拉法辛(4 564份,791個(gè))、度洛西汀(4 411份,585個(gè))、左旋米那普侖(401份,43個(gè))。按發(fā)生頻次排序,文拉法辛和度洛西汀發(fā)生頻次較多的停藥綜合征、惡心、頭暈以及左旋米那普侖發(fā)生頻次較多的血壓升高、多汗等均可見于其藥品說(shuō)明書;從信號(hào)強(qiáng)度來(lái)看,文拉法辛對(duì)子代的影響、度洛西汀與文拉法辛共有的低鈉血癥以及左旋米那普侖的腎功能損害都是相關(guān)性較強(qiáng)并且罕見的不良事件。結(jié)論 臨床在使用上述藥物時(shí),應(yīng)關(guān)注患者的電解質(zhì)水平、腎功能、精神異常以及妊娠周期和狀態(tài),若發(fā)生相關(guān)不良事件,應(yīng)及時(shí)采取干預(yù)措施,以保障患者用藥安全。
[Key word]
[Abstract]
Objective To excavate the risk signals of adverse events related to serotonin-norepinephrine reuptake inhibitor (SNRI), and to provide reference for clinical safe use of these drugs. Methods Using the FDA adverse event reporting system (FAERS) database and OpenVigil 2.1 data platform, the adverse events reports for venlafaxine, duloxetine, and levomilnacipran were collected from FAERS established the database or approved by FDA to the June 30th, 2023. The ROR method combined with BCPNN was used for data mining and sorted according to the occurrence frequency and signal strength respectively. Results A total of 9 376 adverse events reports related to SNRI were retrieved, with 1 419 risk signals, including venlafaxine (4 564 reports, 791 signals), duloxetine (4 411 reports, 585 signals) and levomilnacipran (401 reports, 43 signals). According to the occurrence frequency, withdrawal syndrome, nausea and dizziness which occur more frequently with venlafaxine and duloxetine, as well as elevated blood pressure and excessive sweating, which occur more frequently with levomilnacipran, can be found in their drug instructions. According to the signal strength, the effects of venlafaxine on infants and children, the hyponatremia shared by duloxetine and venlafaxine, and the renal impairment of levomilnacipran are all highly relevant and rare adverse events reports. Conclusion When SNRIs were used clinically, the electrolyte levels, renal function, psychiatric abnormalities and pregnancy cycle of patients should be paid attention to. If related adverse events occurred, timely intervention measures should be taken to ensure the medication safety of patients.
[中圖分類號(hào)]
R971
[基金項(xiàng)目]
中央高?;究蒲袠I(yè)務(wù)費(fèi)專項(xiàng)資金資助項(xiàng)目(2042022kf1077);湖北省衛(wèi)生健康委員會(huì)面上項(xiàng)目(WJ2021M147);湖北省自然科學(xué)基金資助項(xiàng)目(2023AFB239)