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铜绿假单胞菌所致肺炎:左氧氟沙星的临床试验经验

Pneumonia due to Pseudomonas aeruginosa: the levofloxacin clinical trials experience.

作者信息

Tennenberg Alan M, Davis Neelam B, Wu Shu-Chen, Kahn James

机构信息

Tibotec Therapeutics, Bridgewater, NJ 08869, USA.

出版信息

Curr Med Res Opin. 2006 May;22(5):843-50. doi: 10.1185/030079906X100195.

DOI:10.1185/030079906X100195
PMID:16709306
Abstract

Respiratory infections caused by Pseudomonas aeruginosa present significant treatment challenges, including that of overcoming intrinsic and adaptive resistance by these organisms. The fluoroquinolones may provide an effective option for treating these infections. In this analysis, we report on the efficacy of levofloxacin in the treatment of community-acquired pneumonia (CAP) and nosocomial pneumonia caused by P. aeruginosa using information from nine clinical studies supported by Johnson & Johnson Pharmaceutical Research and Development (Raritan, NJ) or Ortho-McNeil Pharmaceutical (Raritan, NJ). From these studies, a total of 36 patients were identified with pneumonia caused by P. aeruginosa and treated with levofloxacin (750 mg or 500 mg). For patients diagnosed with nosocomial pneumonia, levofloxacin treatment achieved a 64.7% (11/17) clinical success rate, compared with 41.2% (7/17) with comparator treatment (imipenem/cilastatin followed by ciprofloxacin) in the microbiologically evaluable population. Eradication rates were 58.8% with levofloxacin treatment vs. 29.4% with comparator (95% CI, -64.2 to 5.4). For levofloxacin-treated CAP patients with P. aeruginosa infections (n = 19), clinical success and microbiological eradication rates in the microbiologically evaluable population were 89.5% and 78.9%, respectively. Several limitations of this analysis exist including that this was a retrospective evaluation that pooled data from multiple studies with varying protocols, the number of patients included was limited, and the nosocomial pneumonia patients used adjunctive therapy with an antipseudomonal beta-lactam in most cases. Nonetheless, these findings suggest that levofloxacin may play a role in the treatment of these difficult respiratory infections.

摘要

由铜绿假单胞菌引起的呼吸道感染带来了重大的治疗挑战,包括克服这些病原体的固有耐药性和获得性耐药性。氟喹诺酮类药物可能为治疗这些感染提供一种有效的选择。在本分析中,我们利用强生制药研发公司(新泽西州拉里坦)或奥多-麦尼尔制药公司(新泽西州拉里坦)支持的9项临床研究信息,报告了左氧氟沙星治疗由铜绿假单胞菌引起的社区获得性肺炎(CAP)和医院获得性肺炎的疗效。从这些研究中,共确定了36例由铜绿假单胞菌引起肺炎并接受左氧氟沙星(750毫克或500毫克)治疗的患者。对于诊断为医院获得性肺炎的患者,在微生物学可评估人群中,左氧氟沙星治疗的临床成功率为64.7%(11/17),而对照治疗(亚胺培南/西司他丁随后环丙沙星)的成功率为41.2%(7/17)。左氧氟沙星治疗的根除率为58.8%,对照治疗为29.4%(95%CI,-64.2至5.4)。对于左氧氟沙星治疗的铜绿假单胞菌感染的CAP患者(n = 19),在微生物学可评估人群中的临床成功率和微生物学根除率分别为89.5%和78.9%。本分析存在若干局限性,包括这是一项回顾性评估,汇总了来自多项方案不同的研究数据,纳入的患者数量有限,并且大多数医院获得性肺炎患者在多数情况下使用了抗假单胞菌β-内酰胺类药物作为辅助治疗。尽管如此,这些发现表明左氧氟沙星可能在治疗这些难治性呼吸道感染中发挥作用。

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