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Piperacillin/Tazobactam vs Imipenem/Cilastatin in the Treatment of Nosocomial Pneumonia-a Double Blind Prospective Multicentre Study.

机译:哌拉西林/他唑巴坦与亚胺培南/西拉他汀在医院内肺炎的治疗中的应用-双盲前瞻性多中心研究。

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BACKGROUND: Piperacillin/tazobactam (P/T) with its broad spectrum of antibacterial activity is used widely for the treatment of moderate to severe polymicrobial nosocomial infections. PATIENTS AND METHODS: The efficacy and safety of P/T was compared with imipenem/cilastatin (I/C) in patients with established nosocomial pneumonia. This multicentre study took place from January 1999 to December 2001. Due to difficulties in recruiting sufficient patients it was terminated prematurely. In all, 221 patients were randomly assigned to either P/T at 4 g/0.5 g (n = 110) or I/C at 1 g/1 g (n = 111). Additional aminoglycoside therapy was mandatory if Pseudomonas aeruginosa was present. The ITT population (107 P/T and 110 I/C patients) was used for the analysis of efficacy. RESULTS: The clinical efficacy was equally good for the P/T and I/C groups; 71% [95% CI 61.3, 79.2] vs 77.3% [95% CI 68.1, 84.5] at the end of therapy, 66.4% [95% CI 56.5, 75] vs 70% [95% CI 60.4, 78.2] on day 3, a nd 59.8% [95% CI 49.9, 69] vs66.4% [95% CI 56.6, 74.9] on day 14 after therapy, respectively. Proven or assumed bacterial eradication at the end of therapy was 45.8% (P/T) and 52.7% (I/C). Treatment-related adverse events (AE) were recorded in 30% of P/T patients and 25.2% I/C patients. There were ten serious treatment-related AEs in the P/T group and five in the I/C group. CONCLUSION: Although numbers were inadequate for full statistical evaluation, P/T and I/C were similarly effective in the treatment of severe nosocomially acquired pneumonia.
机译:背景:哌拉西林/他唑巴坦(P / T)具有广泛的抗菌活性,被广泛用于治疗中度至重度的微生物医院感染。患者和方法:将P / T与亚胺培南/西司他丁(I / C)在已确诊的医院内肺炎患者中的疗效和安全性进行比较。这项多中心研究于1999年1月至2001年12月进行。由于招募足够的患者有困难,该研究提前终止。总共有221名患者被随机分配为4 g / 0.5 g(n = 110)的P / T或1 g / 1 g(n = 111)的I / C。如果存在铜绿假单胞菌,则必须进行额外的氨基糖苷治疗。使用ITT人群(107名P / T和110名I / C患者)进行疗效分析。结果:P / T和I / C组的临床疗效均相同。治疗结束时分别为71%[95%CI 61.3、79.2]和77.3%[95%CI 68.1、84.5],当日为66.4%[95%CI 56.5、75]与70%[95%CI 60.4、78.2] 3,治疗后第14天分别为59.8%[95%CI 49.9,69]和66.4%[95%CI 56.6,74.9]。治疗结束时已证实或假定的细菌清除率为45.8%(P / T)和52.7%(I / C)。在30%的P / T患者和25.2%的I / C患者中记录了与治疗相关的不良事件(AE)。 P / T组有10例与治疗相关的严重不良事件,I / C组有5例。结论:尽管尚不足以进行全面的统计评估,但P / T和I / C在重症医院内获得性肺炎的治疗中同样有效。

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