Levofloxacin in the empirical treatment of patients with suspected bacteraemia/sepsis:: comparison with imipenem/cilastatin in an open, randomized trial
Levofloxacin in the empirical treatment of patients with suspected bacteraemia/sepsis:: comparison with imipenem/cilastatin in an open, randomized trial
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DOI：
10.1093/jac/44.6.799
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发表时间：
1999-12-01
影响因子：
5.2
通讯作者：
Nowotny, I
中科院分区：
文献类型：
--
作者：
Geddes, A;Thaler, M;Nowotny, I
采用开放、随机、多国、多中心研究方法，比较左氧氟沙星500 mg每日2次与亚胺培南/西司他丁1g静脉滴注每日3次治疗临床疑似菌血症/败血症住院患者的疗效、安全性和耐受性。如果败血症的临床症状和体征得到改善，左氧氟沙星患者可以在至少48小时的静脉治疗后从静脉注射转为口服。初步疗效分析基于临床终点的临床和细菌学反应。共有503名患者被随机分组，499名患者包括在意向治疗人群中。符合方案的人群包括287名细菌学证实感染的患者。临床终点时，意向治疗人群和按方案治疗人群的临床治愈率，左氧氟沙星分别为77%(184/239)和89%(125/140)，亚胺培南/西司他丁分别为68%(178/260)和85%(125/147)。随访时，左氧氟沙星组的治愈率为84%，亚胺培南/西司他丁组的治愈率为69%。两个人群的95%可信区间显示，左氧氟沙星与亚胺培南/西司他丁一样有效。临床终点时，87%(96/110)的左氧氟沙星患者和84%(97/116)的亚胺培南/西司他丁患者获得了满意的细菌学应答。74名(31%)左氧氟沙星患者和79名(30%)亚胺培南/西司他丁患者报告了可能与研究药物有关的不良事件。治疗组之间在临床上没有明显的差异。左氧氟沙星500 mg，每日两次，静脉注射或作为顺序静脉/口服治疗，在治疗疑似菌血症/败血症的住院患者中，与亚胺培南/西司他丁1g每日三次静脉注射同样有效和耐受性良好。
An open, randomized, multinational, multicentre study was conducted to compare the efficacy, safety and tolerability of levofloxacin 500 mg twice daily with imipenem/cilastatin 1 g iv three-times daily in the treatment of hospitalized adult patients with clinically suspected bacteraemia/ sepsis. Levofloxacin patients could change from iv to oral administration after a minimum of 48 h iv treatment if clinical signs and symptoms of sepsis had improved. The primary efficacy analysis was based on the clinical and bacteriological response at clinical endpoint. A total of 503 patients were randomized and 499 included in the intent-to-treat population. The perprotocol population comprised 287 patients with bacteriologically proven infection. Clinical cure rates at clinical endpoint in the intent-to-treat population and per-protocol population were 77% (184/239) and 89% (125/140), respectively, for levofloxacin and 68% (178/260) and 85% (125/147), respectively, for imipenem/cilastatin. At follow-up, the cure rates in the per-protocol population were 84% for levofloxacin and 69% for imipenem/cilastatin. The 95% confidence interval for both populations showed that levofloxacin was as effective as imipenem/cilastatin. A satisfactory bacteriological response was obtained in 87% (96/110) of levofloxacin patients and 84% (97/116) of imipenem/cilastatin patients at clinical endpoint. Adverse events possibly related to the study drug were reported in 74 (31%) levofloxacin patients and 79 (30%) imipenem/cilastatin patients. There were no clinically appreciable differences between the treatment groups. Levofloxacin 500 mg twice daily, either iv or as sequential iv/oral therapy, was as effective and well tolerated as imipenem/cilastatin 1 g iv three-times daily in the treatment of hospitalized patients with suspected bacteraemia/sepsis.