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    Please use this identifier to cite or link to this item: http://ir.cnu.edu.tw/handle/310902800/32539

    標題: Randomized Noninferiority Trial of Cefoperazone-Sulbactam versus Cefepime in the Treatment of Hospital-Acquired and Healthcare-Associated Pneumonia
    作者: Liu, Jien-Wei
    Chen, Yen-Hsu
    Lee, Wen-Sen
    Lin, Jung-Chung
    Huang, Ching-Tai
    Lin, Hsi-Hsun
    Liu, Yung-Ching
    Chuang, Yin-Ching
    Hung-Jen Tang(湯宏仁)
    Chen, Yao-Shen
    Ko, Wen-Chien
    Lu, Min-Chi
    Wang, Fu-Der
    貢獻者: Kaohsiung Chang Gung Mem Hosp, Dept Internal Med, Div Infect Dis
    Chang Gung Univ, Coll Med
    Kaohsiung Med Univ Hosp, Dept Internal Med, Div Infect Dis
    Kaohsiung Med Univ, Coll Med
    Wan Fang Med Ctr, Dept Internal Med, Div Infect Dis
    Taipei Med Univ, Sch Med, Dept Internal Med
    Triserv Gen Hosp, Natl Def Med Ctr, Dept Internal Med, Div Infect Dis & Trop Med
    Chang Gung Mem Hosp, Dept Internal Med, Div Infect Dis
    I Shou Univ, E Da Hosp, Dept Internal Med
    Taipei Med Univ, Shuang Ho Hosp, Div Infect Dis
    Chi Mei Hosp, Dept Internal Med
    Chi Mei Med Ctr, Dept Med
    Chia Nan Univ Pharm & Sci, Dept Hlth & Nutr
    Natl Yang Ming Univ, Sch Med
    Kaohsiung Vet Gen Hosp, Dept Internal Med
    Natl Cheng Kung Univ Hosp, Dept Internal Med
    Natl Cheng Kung Univ, Coll Med
    Chung Shan Med Univ Hosp, Dept Internal Med, Div Infect Dis
    Chung Shan Med Univ, Sch Med, Dept Microbiol & Immunol
    Taipei Vet Gen Hosp, Dept Med, Div Infect Dis
    China Med Univ Hosp
    China Med Univ, Sch Med, Dept Microbiol & Immunol
    關鍵字: cefoperazone-sulbactam
    healthcare-associated pneumonia
    hospital-acquired pneumonia
    noninferiority trial
    日期: 2019-08
    上傳時間: 2020-07-29 13:49:03 (UTC+8)
    摘要: 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.
    關聯: Antimicrobial Agents and Chemotherapy, v.63, n.8, e00023-19
    Appears in Collections:[保健營養系(所) ] 期刊論文

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