Tazobactam/piperacillin for moderate-to-severe pneumonia in patients with risk for aspiration: Comparison with imipenem/cilastatin

Tazobactam/piperacillin for moderate-to-severe pneumonia in patients with risk for aspiration: Comparison with imipenem/cilastatin
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DOI:
10.1016/j.pupt.2010.05.007
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发表时间:
2010-10-01
影响因子:
3.2
通讯作者:
Mishima, Michiaki
Mishima, Michiaki
中科院分区:
医学3区
文献类型:
--
作者:
Ito, Isao;Kadowaki, Seizo;Mishima, Michiaki

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背景:由于全球人口老龄化,吸入性肺炎的治疗已成为一个重要问题。他唑巴坦/哌拉西林(TAZ/PIPC)治疗吸入性肺炎的有效性尚不清楚。目的:比较TAZ/PIPC(1:4复方)与亚胺培南/西司他汀(IPM/CS)治疗中重度吸入性肺炎的临床疗效。患者和方法:在这项开放标签、随机研究中,对有吸入性肺炎风险的中重度社区获得性吸入性肺炎或疗养院获得性肺炎患者,每12小时静脉给予TAZ/PIPC 5 g或IPM/CS 1 g,平均持续11天。主要结局是在经过验证的perprotocol (VPP)人群中治疗结束时的临床缓解率(EOT)。次要结局是VPP组治疗期间(第4天和第7天)和研究结束时(EDS)的临床反应,以及改良意向治疗(MITI)组第30天的生存。结果:两组间主要及次要转归无差异。但TAZ/PIPC组腋窝温度(p < 0.05)和WBC计数(p = 0.01)改善明显更快。在革兰氏阳性菌感染患者中,TAZ/PIPC对VPP人群的EOT更有效(p = 0.03)。结论:TAZ/PIPC治疗中重度吸入性肺炎与IPM/CS一样安全有效。(C) 2010 Elsevier Ltd.版权所有。
Background: Treatment of aspiration pneumonia is becoming an important issue due to aging of populations worldwide. Effectiveness of tazobactam/piperacillin (TAZ/PIPC) in aspiration pneumonia is not clear.Purpose: To compare clinical efficacy between TAZ/PIPC (1:4 compound) and imipenem/cilastatin (IPM/CS) in patients with moderate-to-severe aspiration pneumonia.Patients and methods: In this open-label, randomized study either TAZ/PIPC 5 g or IPM/CS 1 g was intravenously administered every 12 h to patients with moderate-to-severe community-acquired aspiration pneumonia or nursing home-acquired pneumonia with risk for aspiration pneumonia for average 11 days. The primary outcome was clinical response rate at the end of treatment (EOT) in validated perprotocol (VPP) population. Secondary outcomes were clinical response during treatment (days 4 and 7) and at the end of study (EDS) in VPP population, and survival at day 30 in modified intention-to-treat (MITI) population.Results: There was no difference between the groups in primary or secondary outcome. However, significantly faster improvement as measured by axillary temperature (p < 0.05) and WBC count (p = 0.01) was observed under TAZ/PIPC treatment. In patients with gram-positive bacterial infection, TAZ/PIPC was more effective at EOT in VPP population (p = 0.03).Conclusion: TAZ/PIPC is as effective and safe as IPM/CS in the treatment of moderate-to-severe aspiration pneumonia. (C) 2010 Elsevier Ltd. All rights reserved.