本文選題：莫西沙星 + 血藥濃度��； 參考：《中國藥學(xué)雜志》2015年22期

【摘要】：目的在中國健康受試者中評(píng)價(jià)連續(xù)4 d口服給藥莫西沙星對(duì)健康受試者QT間期的影響。方法篩選48名健康受試者(男女各24名)連續(xù)4 d口服400 mg莫西沙星。在給藥前、后按預(yù)設(shè)時(shí)間點(diǎn)各描記心電圖,使用儀器測(cè)量與人工測(cè)量方法測(cè)定QT間期;同時(shí)采集對(duì)應(yīng)時(shí)間點(diǎn)的血樣,用HPLC-MS/MS進(jìn)行血藥濃度測(cè)定;每周期結(jié)束時(shí)按方案要求進(jìn)行安全性檢查。結(jié)果 48名受試者入選本試驗(yàn),其中45名(男22,女23)完成試驗(yàn);連續(xù)4 d給予莫西沙星口服后可引發(fā)QT間期延長7,且給藥后血藥濃度與QT間期延長的量變關(guān)系為正相關(guān),莫西沙星給藥后對(duì)心臟安全性的危險(xiǎn)程度判定為可能危險(xiǎn)。結(jié)論莫西沙星連續(xù)4 d給藥可引發(fā)有意義與血藥濃度正相關(guān)的QT間期延長,故建議臨床在連續(xù)使用莫西沙星時(shí),應(yīng)結(jié)合莫西沙星藥代動(dòng)力學(xué)以及QT間期變化的特點(diǎn),慎重考慮患者尤其是心臟QT間期較長患者的用藥。
[Abstract]:Objective to evaluate the effect of oral moxifloxacin on QT interval in Chinese healthy volunteers for 4 days. Methods 48 healthy subjects (24 male and 24 male) were selected to take 400 mg moxifloxacin orally for 4 days. Before and after administration, electrocardiogram was recorded according to preset time points, QT interval was measured by instrument measurement and manual measurement, blood samples of corresponding time points were collected and blood concentration was measured by HPLC-MS/MS. Conduct security checks at the end of each cycle as required by the scheme. Results Forty-eight subjects (22 males and 23 females) completed the trial, and the QT interval was increased by 7 times after oral moxifloxacin for 4 days, and there was a positive correlation between serum concentration and QT interval prolongation after administration of moxifloxacin for 4 days. The risk of cardiac safety after the administration of moxifloxacin was determined to be potentially dangerous. Conclusion moxifloxacin administration for 4 days can induce significant prolongation of QT interval which is positively correlated with serum concentration. It is suggested that moxifloxacin pharmacokinetics and QT interval change should be combined with the clinical use of moxifloxacin continuously. Consider carefully the use of drugs in patients, especially in patients with longer QT intervals in the heart.
【作者單位】： 解放軍總醫(yī)院轉(zhuǎn)化醫(yī)學(xué)中心;
【基金】：國家科技重大專項(xiàng)子課題資助項(xiàng)目(2012ZX09303004-002)
【分類號(hào)】：R969.4

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本文編號(hào)：1844282