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首页> 外文期刊>Antimicrobial agents and chemotherapy. >Randomized Noninferiority Trial of Cefoperazone-Sulbactam versus Cefepime in the Treatment of Hospital-Acquired and Healthcare-Associated Pneumonia
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Randomized Noninferiority Trial of Cefoperazone-Sulbactam versus Cefepime in the Treatment of Hospital-Acquired and Healthcare-Associated Pneumonia

机译：Cefoperazone-sulbactam的随机非血小效性试验与治疗医院收购和医疗保健相关肺炎的头脑

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Cefoperazone, a third-generation cephamycin with broad-spectrum antibacterial activity and the ability to permeate bacterial cell membranes, is active against commonly encountered multidrug-resistant pathogens for hospital-acquired pneumonia (HAP) and health care-associated pneumonia (HCAP). To clarify the clinical effects of cefoperazone-sulbactam in the treatment of HAP and HCAP, we conducted an open label, randomized, noninferiority trial that recruited patients aged >= 18 years suffering HAP/HCAP. Participants were randomly assigned to the cefoperazone-sulbactam (2g of each per 12 h) or cefepime (2g per 12 h) arm. Clinical and microbiological responses were evaluated at early posttherapy and test-of-cure visits. Recruited patients were allocated to subpopulations for intent-to-treat (n = 154), per-protocol (n = 147), and safety (n = 166) analyses. Intent-to-treat analysis demonstrated that (i) at the early posttherapy visit, 87.3% of patients receiving cefoperazone-sulbactam and 84.3% of patients receiving cefepime achieved clinical improvement or cure (risk difference of 3.0%; 95% confidence interval [CI], -9.0% to 15.0%), and (ii) at the test-of-cure visit, 73.1% of patients receiving cefoperazonesulbactam and 56.8% of patients receiving cefepime were assessed as cured (risk difference of 16.3%; 95% CI, 0.0% to 33.0%). These results indicated the noninferiority of cefoperazone-sulbactam to cefepime, which was confirmed by per-protocol analysis. The chest radiographic consolidation/infiltration resolution rate, microbiological eradiation rate, and percentage of adverse events were comparable in both groups. Serious adverse events were rare, and none was judged to be related to the study drugs. Cefoperazone-sulbactam at 2 g every 12 h was noninferior to cefepime at 2 g every 2 h for patients with HCAP.
机译：Cefoperazone，具有广谱抗菌活性的第三代Cephamycin和渗透细菌细胞膜的能力，对常见的抗性肺炎（HAP）和医疗保健相关肺炎（HCAP）具有常见的多药物抗性病原体。为了阐明头孢哌酮-Surbactam在治疗Hap和Hcap中的临床疗效，我们进行了开放的标签，随机，非流动性试验，征聘患者患者患者= 18年的HAP / HCAP。将参与者随机分配给Cefoperazone-sulbactax（每12小时的2g）或头孢隙（每12小时2g）臂。在早期后治疗和治愈性测试中评估了临床和微生物反应。募集患者被分配给群体，用于治疗（n = 154），每种方案（n = 147），以及安全性（n = 166）分析。意图对治疗分析表明，（i）在早期后治疗，87.3％的患者接受头孢哌酮-Ulbactam和84.3％的接受头孢隙的患者临床改善或治愈（风险差异为3.0％; 95％置信区间[CI [9.0％至15.0％]，（ii）在治愈性试验中，73.1％的接受头孢唑氮杂作用的患者和56.8％的患者被评估为治愈（风险差为16.3％; 95％CI） ，0.0％至33.0％）。这些结果表明头孢哌酮-Hybactam至头孢酰胺的不可取性，通过每种方案分析证实。两组的胸部射线照相固结/渗透分辨率，微生物消失率和不良事件的百分比相当。严重的不良事件是罕见的，没有被判断与研究药物有关。每12小时每12小时，每12小时的头孢唑唑胺-2克，每2克为每2克为HCAP患者的每2克。

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