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        氟康唑、酮康唑、伊曲康唑和伏立康唑上市后不良反應信號的挖掘與分析
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        篇名: 氟康唑、酮康唑、伊曲康唑和伏立康唑上市后不良反應信號的挖掘與分析
        TITLE:
        摘要: 目的:挖掘唑類抗真菌藥物氟康唑、酮康唑、伊曲康唑和伏立康唑上市后的安全警戒信號,為臨床合理用藥提供參考。方法:調取美國FDA不良事件報告系統(FAERS)數據庫2004年1月1日-2019年3月30日接收的氟康唑、酮康唑、伊曲康唑和伏立康唑藥品不良事件(ADE)報告,采用報告比值比(ROR)數據挖掘方法對這4種唑類藥物進行不良反應(ADR)信號挖掘,重點分析該類藥品說明書安全性信息所涉及的主要ADR。結果:提取FAERS數據庫信息得到氟康唑ADE報告27831例、酮康唑ADE報告5712例、伊曲康唑ADE報告5381例、伏立康唑ADE報告11333例。經ROR法檢測,上述4種唑類藥物在醫學檢查、血液和淋巴系統疾病、腎臟和泌尿系統疾病、內分泌疾病與肝膽疾病中均出現ADR強信號。其中,氟康唑、伏立康唑肝毒性ADR信號較強(氟康唑ROR=6.51,伏立康唑ROR=14.65);伊曲康唑類庫欣綜合征(ROR=24.86)和腎上腺抑制(ROR=44.06)ADR檢測結果顯示為強信號;酮康唑、伊曲康唑在腎上腺皮質功能不全中ADR信號較強(酮康唑ROR=15.64,伊曲康唑ROR=23.26),而酮康唑在皮膚及皮下組織疾病中ADR信號強度(ROR=2.81)明顯強于其他藥物。此外,氟康唑、伊曲康唑、伏立康唑引起出血性膀胱炎在其說明書中尚未收錄(氟康唑ROR=17.73,伊曲康唑ROR=31.43,伏立康唑ROR=17.06);氟康唑引起網狀青斑(ROR=10.50)在其說明書中尚未收錄。結論:臨床醫務人員應加強對氟康唑、酮康唑、伊曲康唑和伏立康唑相關主要ADR差異性的認識,在臨床使用過程中,對氟康唑、伊曲康唑、伏立康唑引起出血性膀胱炎,氟康唑引起網狀青斑等說明書中未提及、但真實世界發生率又較高的ADR,以及伊曲康唑導致的類庫欣綜合征和腎上腺抑制等雖然說明書中有提及、但檢測結果呈異常強信號的ADR應重點關注。
        ABSTRACT: OBJECTIVE:To excavate the safety warning signals induced by azole antifungal agents ,including fluconazole , ketoconazole,itraconazole and voriconazole after marketing ,and to provide references for rational drug use in the clinic. METHODS:Reporting odds ratio (ROR)data mining algorithm was used to investigate signals of adverse drug event (ADE)for fluconazole,ketoconazole,itraconazole and voriconazole from FDA Adverse Event Reporting System (FAERS)during January 1st,2004 to March 30th,2019. ROR data mining method was used to excavate the ADR signals of the drugs ,and main ADR involved in the safety information of azole antifungal agents instructions were analyzed. RESULTS :A total of 27 831,5 712, 5 381 and 11 333 reports were picked out for fluconazole ,ketoconazole,itraconazole and voriconazole ,respectively. All of these drugs had exhibited high-risk signals detection by ROR ,including medical examination ,blood and lymphatic system disorders , renal and urinary disorders ,endocrine diseases ,hepatobiliary disorders. The hepatotoxic-related ADR signals were mainly concentrated in fluconazole and voriconazole (fluconazole ROR =6.51,voriconazole ROR =14.65);ADR detection results of Cushing’s-like syndrome (ROR=24.86) and adrenal suppression (ROR=44.06) by itraconazole showed high-risk signals ; ketoconazole and itraconazole had showed a strong ADR signal in adrenocortical dysfunction (ketoconazole ROR =15.64, itraconazole ROR =23.26),and the signal intensity of ketoconazole (ROR=2.81)in skin and subcutaneous tissue disorders was significantly higher than that of other drugs . In addition ,hemorrhagic cystitis caused by fluconazole,itraconazole and voriconazole were not included in the drug instructions (fluconazole ROR =17.73,itraconazole ROR =31.43,voriconazole ROR =17.06); netted green spot caused by fluconazole (ROR=10.50)were not included in the drug instructions . CONCLUSIONS:Clinical staff should pay more attention to the differences in serious ADR related to fluconazole ,ketoconazole,itraconazole and voriconazole ; particularly some ADRs not mentioned in the drug instructions but have high incidence such as hemorrhagic cystitis caused by fluconazole,itraconazole,voriconazole and netted green spot caused by fluconazole ,as well as ADRs mentioned in the drug instructions but have abnormally high signal ,such as Cushing ’s-like syndrome and adrenal suppression caused by itraconazole .
        期刊: 2020年第31卷第09期
        作者: 劉海林,袁紅梅,王虎,刁俊林,周春巧,丁曉莉,張雪林,董志,王松
        AUTHORS: LIU Hailin,YUAN Hongmei, WANG Hu,DIAO Junlin,ZHOU Chunqiao,DING Xiaoli,ZHANG Xuelin,DONG Zhi,WANG Song
        關鍵字: 氟康唑;酮康唑;伊曲康唑;伏立康唑;不良反應;信號挖掘;報告比值比
        KEYWORDS: Fluconazole;Ketoconazole;Itraconazole;Voriconazole;ADR;Signal mining ;Reporting odds ratio
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