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霜葉金蟲 (小有名氣)
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[求助]
幫忙翻譯一段摘要O(∩_∩)O謝謝
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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. |
木蟲 (正式寫手)
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RELIEF 研究的主要目的是評估兩個序貫療法—靜脈注射(iv)/口服方案:莫西沙星iv /口服vs哌拉西林/他唑巴坦(TZP)iv,隨后口服阿莫西林/克拉維酸(AMC)—的有效性和安全性。 患者和方法: 本研究采用前瞻性、隨機(jī)、雙模擬、雙盲、多中心設(shè)計(jì)。根據(jù)復(fù)雜性皮膚和皮膚結(jié)構(gòu)感染(cSSSI)亞型/診斷(主要為膿腫、糖尿病足感染、傷口感染或感染缺血性潰瘍)、外科手術(shù)和病情的嚴(yán)重程度,將患者≥18歲進(jìn)行前瞻性分層。診斷和疾病嚴(yán)重程度基于事先確定標(biāo)準(zhǔn),由重復(fù)照片進(jìn)行記錄,并由一個獨(dú)立數(shù)據(jù)審查委員會進(jìn)行確認(rèn)。患者隨機(jī)分配接受400毫克莫西沙星每日一次iv、隨后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、隨后875/125毫克AMC每日兩次口服,持續(xù)7-21天。主要療效變量是符合方案(PP)人群的在治愈試驗(yàn)時的臨床反應(yīng)。臨床療效評價由數(shù)據(jù)審查委員會基于重復(fù)的照片和病例說明進(jìn)行評價。臨床試驗(yàn)注冊號:NCT00402727。 結(jié)果 總共有813例患者進(jìn)行隨機(jī)分配。莫西沙星和TZP-AMC的符合方案 [分別為320/361 (88.6%) vs 275/307 (89.6%);P = 0.758] ]和“意圖治療” [分別為350/426 (82.2%) vs 305/377 (80.9%); P = 0.632]人群在治愈試驗(yàn)(TOC)時的臨床治愈率相似。因此,莫西沙星不劣于TZP-AMC。兩個治療組的細(xì)菌學(xué)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 。兩種治療均具有良好的耐受性。 結(jié)論 在cSSSI患者中,每日一次靜脈注射/口服莫西沙星單藥治療的臨床和細(xì)菌學(xué)療效,不劣于TZP每天三次靜脈注射、隨后AMC每日兩次口服。 |

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