本帖最后由 感控雏鹰 于 2018-2-18 23:53 编辑
The Lancet：粘菌素单独与粘菌素加美洛培南治疗耐碳青霉烯革兰氏阴性菌引起的严重感染：一项随机对照试验
BackgroundColistin–carbapenem combinations are synergistic in vitro against carbapenem-resistant Gram-negative bacteria. We aimed to test whether combination therapy improves clinical outcomes for adults with infections caused by carbapenem-resistant or carbapenemase-producing Gram-negative bacteria. 背景粘菌素 - 碳青霉烯组合在体外对抗碳青霉烯耐药的革兰氏阴性细菌具有协同作用。我们旨在测试联合治疗是否能改善成人感染碳青霉烯耐药或产生碳青霉烯酶的革兰氏阴性菌引起的感染。 MethodsA randomised controlled superiority trial was done in six hospitals in Israel, Greece, and Italy. We included adults with bacteraemia, ventilator-associated pneumonia, hospital-acquired pneumonia, or urosepsis caused by carbapenem-non-susceptible Gram-negative bacteria. Patients were randomly assigned (1:1) centrally, by computer-generated permuted blocks stratified by centre, to intravenous colistin (9-million unit loading dose, followed by 4·5 million units twice per day) or colistin with meropenem (2-g prolonged infusion three times per day). The trial was open-label, with blinded outcome assessment. Treatment success was defined as survival, haemodynamic stability, improved or stable Sequential Organ Failure Assessment score, stable or improved ratio of partial pressure of arterial oxygen to fraction of expired oxygen for patients with pneumonia, and microbiological cure for patients with bacteraemia. The primary outcome was clinical failure, defined as not meeting all success criteria by intention-to-treat analysis, at 14 days after randomisation. This trial is registered at ClinicalTrials.gov, number NCT01732250, and is closed to accrual. 方法在以色列，希腊和意大利的六家医院进行了一项随机对照优势试验。包括成人患有菌血症，呼吸机相关性肺炎，医院获得性肺炎，或由碳青霉烯非敏感的革兰氏阴性菌引起的尿路感染。患者按中心随机分配（1：1），通过计算机产生的置换中心分层的块，静脉内施用粘菌素（9百万单位负荷剂量，随后每天两次4 500万单位）或粘菌素与美罗培南（2-长时间输注，每天三次）。该试验为开放标签，结果评估盲法。治疗成功被定义为生存，血液动力学稳定性，改善或稳定的顺序器官衰竭评估评分，肺炎患者动脉氧分压与呼气氧分压的比例稳定或改善，以及菌血症患者的微生物治疗。主要终点是临床失败，定义为在随机分组后14天内不满足意向治疗分析的所有成功标准。此试用版已注册于ClinicalTrials.gov，编号为NCT01732250，已关闭应计。 FindingsBetween Oct 1, 2013, and Dec 31, 2016, we randomly assigned 406 patients to the two treatment groups. Most patients had pneumonia or bacteraemia (355/406, 87%), and most infections were caused by Acinetobacter baumannii (312/406, 77%). No significant difference between colistin monotherapy (156/198, 79%) and combination therapy (152/208, 73%) was observed for clinical failure at 14 days after randomisation (risk difference ?5·7%, 95% CI ?13·9 to 2·4; risk ratio [RR] 0·93, 95% CI 0·83–1·03). Results were similar among patients with A baumannii infections (RR 0·97, 95% CI 0·87–1·09). Combination therapy increased the incidence of diarrhoea (56 [27%] vs 32 [16%] patients) and decreased the incidence of mild renal failure (37 [30%] of 124 vs 25 [20%] of 125 patients at risk of or with kidney injury). 发现在2013年10月1日和2016年12月31日之间，我们将406名患者随机分配到两个治疗组。大多数患者患有肺炎或菌血症（355/406，87％），大多数感染是由鲍曼不动杆菌引起的（312/406，77％）。在随机分组后14天观察到粘菌素单一疗法（156/198，79％）和联合疗法（152/208，73％）之间没有显着差异（风险差异-5.7％，95％CI -13· 9至2·4;危险比[RR] 0·93,95％CI 0·83-1·03）。A型鲍曼不动杆菌感染患者的结果相似（RR 0.97,95％CI 0.87-1.09）。联合治疗增加了腹泻的发生率（56 [27％] vs 32 [16％]），并降低了轻度肾功能衰竭的发生率（124例中有37例（30％）vs 125名患有或有肾损伤风险的患者中有25名[20％]）。 InterpretationCombination therapy was not superior to monotherapy. The addition of meropenem to colistin did not improve clinical failure in severe A baumannii infections. The trial was unpowered to specifically address other bacteria. 解释联合治疗并不优于单药治疗。美洛培南添加到粘菌素并不能改善严重鲍曼不动杆菌感染的临床失败。试验没有动力来专门处理其他细菌。 Funding
EU AIDA grant Health-F3-2011-278348 资金欧盟AIDA拨款Health-F3-2011-278348。 简译：感控雏鹰 原文：Colistin alone versus colistin plus meropenem for treatment of severe infections caused by carbapenem-resistant Gram-negative bacteria: an open-label, randomised controlled trial
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