Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
J Korean Med Sci. 2012 May;27(5):476-83. doi: 10.3346/jkms.2012.27.5.476. Epub 2012 Apr 25.
The efficacy and safety of ertapenem, 1 g once daily, were compared with that of ceftriaxone, 2 g once daily, for the treatment of adults with acute pyelonephritis (APN) and complicated urinary tract infections (cUTIs) in a prospective, multicenter, double-blinded, randomized study. After ≥ 3 days of parenteral study therapy, patients could be switched to an oral agent. Of 271 patients who were initially stratified by APN (n = 210) or other cUTIs (n = 61), 66 (48.9%) in the ertapenem group and 71 (52.2%) in the ceftriaxone group were microbiologically evaluable. The mean duration of parenteral and total therapy, respectively, was 5.6 and 13.8 days for ertapenem and 5.8 and 13.8 days for ceftriaxone. The most common pathogen was Escherichia coli. At the primary efficacy endpoint 5-9 days after treatment, 58 (87.9%) patients in the ertapenem group and 63 (88.7%) in the ceftriaxone had a favorable microbiological response. When compared by stratum and severity, the outcomes in the two groups were equivalent. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. The results indicate that ertapenem is highly effective and safe for the treatment of APN and cUTIs.
厄他培南 1 g 每日 1 次与头孢曲松 2 g 每日 1 次治疗成人急性肾盂肾炎(APN)和复杂性尿路感染(cUTI)的疗效和安全性在一项前瞻性、多中心、双盲、随机研究中进行了比较。在接受至少 3 天的静脉研究治疗后,患者可转为口服药物。在最初按 APN(n = 210)或其他 cUTI(n = 61)分层的 271 例患者中,66 例(48.9%)厄他培南组和 71 例(52.2%)头孢曲松组可进行微生物学评估。厄他培南组和头孢曲松组分别有 5.6 天和 13.8 天的平均静脉和总治疗时间。最常见的病原体是大肠埃希菌。在治疗后 5-9 天的主要疗效终点,厄他培南组 58 例(87.9%)和头孢曲松组 63 例(88.7%)患者的微生物学反应良好。按分层和严重程度比较,两组的结果相当。两组的药物相关不良事件的频率和严重程度通常相似。结果表明,厄他培南治疗 APN 和 cUTI 非常有效且安全。