目的 利用美國FDA不良事件報告系統(tǒng)（FAERS）對奧馬環(huán)素進(jìn)行藥物不良反應(yīng)（ADR）高危信號挖掘，為臨床合理安全使用奧馬環(huán)素提供參考。方法 下載2018年第4季度至2023年第2季度共19個季度的數(shù)據(jù)的FAERS數(shù)據(jù)，采用報告比值比法（ROR）和綜合標(biāo)準(zhǔn)法（MHRA）對奧馬環(huán)素的相關(guān)ADR報告數(shù)據(jù)進(jìn)行信號挖掘。結(jié)果 共獲取以奧馬環(huán)素為首要懷疑藥物的ADR報告1 180例，ROR法和MHRA法獲得的奧馬環(huán)素ADR風(fēng)險信號基本一致，共獲得奧馬環(huán)素ADR信號35個，以植入物部位外滲和牙齒變色的ADR信號最強(qiáng)，且以胃腸道系統(tǒng)疾?。ㄈ鐞盒膰I吐）最為多見，有12個ADR未在奧馬環(huán)素藥品說明書中出現(xiàn)。結(jié)論 利用FAERS數(shù)據(jù)庫可對奧馬環(huán)素的ADR信號進(jìn)行挖掘與分析，可為臨床合理安全用藥提供依據(jù)。

Objective To provide guidance for the rational and safe use of omadacycline through mining and analyzing the adverse drug reaction (ADR) signals of omadacycline in FAERS. Methods A total of 19 quarters of FAERS data were downloaded from 2018 Q4 to 2023 Q2 and omadacycline related adverse events were extracted. The reporting odd ratio (ROR) and medicines and healthcare products regulatory agency (MHRA) method were used to detect the ADR signals. Results In the set period, FAERS received a total of 1 180 ADR reports with omadacycline as the primary suspected drug. The risk signals obtained by ROR method and MHRA method were basically the same, and a total of 35 omadacycline ADR signals were obtained. The ADR signals of implant site extravasation and tooth discolouration were the strongest, and the gastrointestinal system diseases (such as nausea and vomiting) were the most common. Totally 12 adverse event signals did not appear in the omadacycline drug instructions. Conclusion The data of FAERS can be used to analyze the ADR signals of omadacycline and provide evidence for clinical safety and rational drug use.

R978.1

廣東省教育廳研究生教育創(chuàng)新計劃項目（2023ANLK_046）；廣州市科技計劃項目（202103000002，201904010065）