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Objectives The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus piperacillin/tazobactam (TZP) iv followed by oral amoxicillin/clavulanate (AMC). Patients and methods The study had a prospective, randomized, double-dummy, double-blind, multicentre design. Patients ≥18 years were prospectively stratified according to complicated skin and skin structure infection (cSSSI) subtype/diagnosis (major abscess, diabetic foot infection, wound infection or infected ischaemic ulcer), surgical intervention and severity of illness. Diagnoses and disease severity were based on predetermined criteria, documented by repeated photographs, and confirmed by an independent data review committee. Patients were randomized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7–21 days. The primary efficacy variable was clinical response at test of cure (TOC) for the per-protocol (PP) population. Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions. Clinical trials registry number: NCT 00402727. Results A total of 813 patients were randomized. Clinical success rates at TOC were similar for moxifloxacin and TZP–AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = 0.758] and intent-to-treat (ITT) [350/426 (82.2%) versus 305/377 (80.9%), respectively; P = 0.632] populations. Thus, moxifloxacin was non-inferior to TZP–AMC. Bacteriological success rates were high in both treatment arms [moxifloxacin: 432/497 (86.9%) versus TZP–AMC: 370/429 (86.2%), microbiologically valid (MBV) population]. Moxifloxacin was non-inferior to TZP–AMC at TOC in both the MBV and the ITT populations. Both treatments were well tolerated. Conclusions Once-daily iv/oral moxifloxacin monotherapy was clinically and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs. |
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木虫 (正式写手)
- 翻译EPI: 17
- 应助: 13 (小学生)
- 金币: 1897.4
- 散金: 88
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- 虫号: 1258721
- 注册: 2011-04-08
- 性别: MM
- 专业: 药物分析
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霜叶: 金币+60, 翻译EPI+1, ★★★★★最佳答案, 谢谢啦 2013-01-24 16:58:54
霜叶: 金币+60, 翻译EPI+1, ★★★★★最佳答案, 谢谢啦 2013-01-24 16:58:54
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RELIEF 研究的主要目的是评估两个序贯疗法—静脉注射（iv）/口服方案：莫西沙星iv /口服vs哌拉西林/他唑巴坦（TZP）iv，随后口服阿莫西林/克拉维酸（AMC）—的有效性和安全性。 患者和方法： 本研究采用前瞻性、随机、双模拟、双盲、多中心设计。根据复杂性皮肤和皮肤结构感染（cSSSI）亚型/诊断（主要为脓肿、糖尿病足感染、伤口感染或感染缺血性溃疡）、外科手术和病情的严重程度，将患者≥18岁进行前瞻性分层。诊断和疾病严重程度基于事先确定标准，由重复照片进行记录，并由一个独立数据审查委员会进行确认。患者随机分配接受400毫克莫西沙星每日一次iv、随后400毫克莫西沙星每日一次口服，或4.0/0.5克 TZP每日三次iv、随后875/125毫克AMC每日两次口服，持续7-21天。主要疗效变量是符合方案（PP）人群的在治愈试验时的临床反应。临床疗效评价由数据审查委员会基于重复的照片和病例说明进行评价。临床试验注册号：NCT00402727。 结果 总共有813例患者进行随机分配。莫西沙星和TZP-AMC的符合方案 [分别为320/361 (88.6%) vs 275/307 (89.6%)；P = 0.758] ]和“意图治疗” [分别为350/426 (82.2%) vs 305/377 (80.9%)； P = 0.632]人群在治愈试验（TOC）时的临床治愈率相似。因此，莫西沙星不劣于TZP-AMC。两个治疗组的细菌学治愈率均很高[莫西沙星：432/497 (86.9%) vs TZP–AMC: 370/429 (86.2%)，微生物有效（MBV）人群]。莫西沙星在MBV和ITT人群中的TOC不劣于TZP–AMC 。两种治疗均具有良好的耐受性。 结论 在cSSSI患者中，每日一次静脉注射/口服莫西沙星单药治疗的临床和细菌学疗效，不劣于TZP每天三次静脉注射、随后AMC每日两次口服。 |
2楼2013-01-24 14:05:24