Medscape Infectious Diseases > Auwaerter on Infectious DiseasesCOMMENTARYFluoroquinolones Not First Line: FDA Advisory Reinforces Standard Practice in Ambulatory CarePaul G. Auwaerter, MDJune 02, 2016Hello. This is Paul Auwaerter, with Medscape Infectious Diseases and the Johns Hopkins University School of Medicine. The US Food and Drug Administration (FDA) recently announced[1] that it will upgrade its package warnings on fluoroquinolones to include instructions that they should not be used for routine respiratory tract infections or uncomplicated urinary tract infections unless there is no suitable alternative agent. 你好，我是Medscape感染性疾病专栏以及Johns Hopkins大学医学院的Paul Auwaerter。美国食品药品监督管理局(FDA)近期宣布将更新氟喹诺酮类药物的包装警示，说明中包括氟喹诺酮类药物不应用于常规呼吸道感染或非复杂性泌尿系感染的治疗，除非没有其他合适的替代药物。 Why these warnings are being reinforced at this point rests on several foundational issues. When I was a medical student the late 1980s, fluoroquinolones were embraced as 'wonder drugs.' We had ciprofloxacin, which offered oral treatment for Pseudomonas aeruginosa and was thought to be effective for Staphylococcus aureus, even in deep bone infections. Over time, these drugs have been widely embraced with new additions, such as levofloxacin and moxifloxacin. But a number of other drugs (eg, trovafloxacin, lomefloxacin, and others) have fallen to the wayside, deservedly, because of serious toxicities. 此时强调上述警示其实源于几个重要问题。上个世纪80年代，当我还是一名医学生时，氟喹诺酮被称为神奇的药物。当时我们有环丙沙星可供口服治疗铜绿假单胞菌，同时对金黄色葡萄球菌感染有效，即使对于深部骨髓感染而言。随着时间推移，这些药物又不断有新的成员加入，如左旋氧氟沙星和莫西沙星等。但是，很多其他药物（如trovafloxacin，lomefloxacin及其他）因严重的毒性反应宣告失败。 It seems to be true, however, that the fluoroquinolones remain broadly prescribed both by primary care practitioners and in hospital settings and skilled nursing facilities. Studies looking at the use of fluoroquinolones in ambulatory settings for uncomplicated urinary tract and respiratory infections show that over the past few years there has been little diminishment in the use of fluoroquinolones.[2] Because of their wide use and adoption, we are experiencing problems such as pathogen resistance. The fluoroquinolones are no longer recommended for gonorrhea because of widespread resistance. They are no longer recommended for routine first-line treatment of uncomplicated cystitis because of increased resistance of Escherichia coli to this class of drugs.[3] 然而，现实情况却是家庭医生以及医院内和安养院处方氟喹诺酮的情况非常普遍。对于门诊适用氟喹诺酮治疗非复杂性泌尿系感染及呼吸道感染的研究发现，在过去数年间，氟喹诺酮的使用仅有轻度减少。由于氟喹诺酮的广泛使用，我们目前面临很多难题如抗生素耐药。因为广泛耐药的缘故，不再推荐氟喹诺酮用于淋病的治疗。由于大肠杆菌对氟喹诺酮的耐药日益严重，因此也不再推荐氟喹诺酮作为非复杂性膀胱炎的常规一线治疗药物。 Another issue is that, over the years, the remaining fluoroquinolones have been associated with adverse effects, including increased risk for Clostridium difficile infection (compared with many other antibiotics), tendinopathy, arthropathy, QT prolongation, retinal issues, and central and peripheral nervous system toxicities.[4] These adverse effects have been reported, although perhaps not thoroughly vetted through careful analysis. However, the FDA now feels that owing to potential irreversible or permanent side effects, these drugs should not be used for first-line treatment. 另一个问题是，过去数年发现，其他的氟喹诺酮类药物伴随很多不良反应，包括难辨梭状芽孢杆菌感染（与很多其他抗生素相比）、肌腱病、关节病、QT间期延长、视网膜疾病以及中枢和周围神经系统毒性的风险增加。尽管没有经过系统的分析，但是这些不良反应时有报告。但是，FDA目前认为，由于上述不良反应可能无法逆转或永久存在，这些药物不应作为一线治疗的选择。 Many infectious diseases practitioners, out of concern about antibiotic resistance, have been broadly beating the drum for many years that these drugs should not be used in office settings and practices for mundane and pedestrian upper respiratory tract infections such as bronchitis or sinusitis, or for urinary tract infections. 除有关抗生素耐药的顾虑外，多年来很多感染科医生敲响了警钟，认为这些药物不应在门诊使用，也不应用于普通的上呼吸道感染（如支气管炎或鼻窦炎）或泌尿系感染。 So why are these drugs still so widely used? There is a perception (and perhaps a reality) that the fluoroquinolones are still quite safe. I have never seen a case of peripheral neuropathy although I have certainly seen C difficile infection, tendinopathy, and arthropathy. Obviously as drugs are getting more attention and being looked at in terms of adverse effects, it does not make sense to prescribe these drugs, which have quite broad-spectrum activity, to treat conditions that could be treated with a narrower-spectrum and more targeted drug. 那么，为什么这些药物仍然在广泛使用呢？人们感觉到（可能也是事实）氟喹诺酮仍然非常安全。我从未看到周围神经病变的病例，尽管我遇到过难辨梭状芽孢杆菌感染、肌腱病和关节病。很显然，随着药物的到更多关注，尤其在不良反应方面，我们不应将这些广谱药物用于治疗那些本应使用窄谱药物进行针对性治疗的疾病。 The FDA is upgrading its warnings about these drugs in spite of what practitioners are seeing. The diminished use of these broad-spectrum antibiotics for certain conditions is a worthy goal and probably will benefit patient care, either by avoiding the use of antibiotics altogether if appropriate, or targeting antibiotics, as recommended in guidance on sinusitis, bronchitis, exacerbations of bronchitis, and urinary tract infections. Thanks very much for listening. 尽管临床医生可能有不同观点，但是FDA更新了这些药物的警示。对于某些疾病减少上述广谱抗生素的使用可能是值得的，可能使得患者获益，如避免使用抗生素，或使用针对性的抗生素治疗，正如鼻窦炎、支气管炎、支气管炎加重及泌尿系感染的指南所推荐。 References1. US Food and Drug Administration. Fluoroquinolone antibacterial drugs. Drug Safety Communication - FDA advises restricting use for certain uncomplicated infections. Posted May 12, 2016. http://www./Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500665.htm Accessed May 15, 2016. 2. Lee GC, Reveles KR, Attridge RT, et al. Outpatient antibiotic prescribing in the United States: 2000 to 2010. BMC Med. 2014;12:96. 3. Kim M, Lloyd A, Condren M, Miller MJ. Beyond antibiotic selection: concordance with the IDSA guidelines for uncomplicated urinary tract infections. Infection. 2015;43:89-94. Abstract 4. Douros A, Grabowski K, Stahlmann R. Safety issues and drug-drug interactions with commonly used quinolones. Expert Opin Drug Metab Toxicol. 2015;11:25-39. Abstract  |
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