Lu Zhiqiang Kevin, Yuan Jing, Li Minghui, Sutton S Scott, Rao Gowtham A, Jacob Sony, Bennett Charles L
University of South Carolina, South Carolina College of Pharmacy, Clinical Pharmacy and Outcomes Sciences Department , 715 Sumter Street, CLS Building, Room 311G, Columbia, SC 29208 , USA +1 803 777 2653 ; +1 803 777 2820 ;
Expert Opin Drug Saf. 2015 Feb;14(2):295-303. doi: 10.1517/14740338.2015.989210. Epub 2014 Dec 10.
Azithromycin and levofloxacin have been shown to be efficacious in treating infections. The adverse drug events associated with azithromycin and levofloxacin were considered rare. However, the US FDA released warnings regarding the possible risk of QT prolongation with azithromycin and levofloxacin.
Case reports/case series, observational studies and clinical trials assessing cardiovascular risks associated with azithromycin and levofloxacin were critically reviewed, including 15 case reports/series, 5 observational studies and 5 clinical trials that investigated the cardiac risks associated azithromycin and levofloxacin.
Results are discordant. Two retrospective studies utilizing large databases demonstrated an increased risk of cardiovascular death with azithromycin, when azithromycin was compared with amoxicillin. Two other retrospective studies found no difference in cardiovascular death associated with azithromycin and other antibiotics. For levofloxacin, the increased risk of cardiovascular death was only found in one retrospective study. Therefore, the risks and benefits of antibacterial therapies should be considered when making prescription decisions. This study should not preclude clinicians from avoiding azithromycin and levofloxacin. If a patient has an indication to receive an antibiotic and if azithromycin or levofloxacin is needed, it may be used, but the potential risks must be understood.
阿奇霉素和左氧氟沙星已被证明在治疗感染方面有效。与阿奇霉素和左氧氟沙星相关的药物不良事件被认为很少见。然而,美国食品药品监督管理局(US FDA)发布了关于阿奇霉素和左氧氟沙星可能导致QT间期延长风险的警告。
对评估阿奇霉素和左氧氟沙星相关心血管风险的病例报告/病例系列、观察性研究和临床试验进行了严格审查,包括15份调查阿奇霉素和左氧氟沙星心脏风险的病例报告/系列、5项观察性研究和5项临床试验。
结果不一致。两项利用大型数据库的回顾性研究表明,与阿莫西林相比,使用阿奇霉素时心血管死亡风险增加。另外两项回顾性研究发现,阿奇霉素与其他抗生素在心血管死亡方面没有差异。对于左氧氟沙星,仅在一项回顾性研究中发现心血管死亡风险增加。因此,在做出处方决定时应考虑抗菌治疗的风险和益处。本研究不应阻止临床医生避免使用阿奇霉素和左氧氟沙星。如果患者有使用抗生素的指征且需要使用阿奇霉素或左氧氟沙星,则可以使用,但必须了解其潜在风险。