Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial
Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial
复制标题
DOI：
10.1016/s0140-6736(15)00126-9
复制
发表时间：
2015-11-07
期刊：
影响因子：
168.9
通讯作者：
Rebollo-Mesa, Irene
中科院分区：
文献类型：
--
作者：
Kalra, Lalit;Irshad, Saddif;Rebollo-Mesa, Irene
背景卒中后肺炎与死亡率增加和功能预后不良相关。本研究评估了有效的抗生素预防减少肺炎患者吞咽困难后急性strok.Methods我们做了一个前瞻性的，多中心的，集群随机，开放标签对照试验与掩蔽终点评估的患者年龄大于18岁的吞咽困难后，新的中风招募48中风单位在英国，认可，并列入英国国家中风审计。我们排除了有抗生素禁忌症、既往存在吞咽困难或已知感染或预计生存时间不会超过14天的患者。我们通过计算机随机分配单元（1：1），给予预防性抗生素7天加标准卒中单元护理或仅对卒中发作48小时内聚集在单元中的患者进行标准卒中单元护理。我们进行了随机化，最小化了住院人数和专科护理的分层。患者和进行评估和分析的工作人员对卒中单元分配设盲。主要结局是前14天卒中后肺炎，在意向治疗人群中采用基于标准的分层算法和医生诊断进行评估。本试验不对新参与者开放，并在isrctn.com注册，编号ISRCTN37118456.Findings在2008年4月21日至2014年5月17日期间，我们将48个卒中单元（以及单元内聚集的1224名患者）随机分配到两个治疗组：24名抗生素治疗组和24名仅标准治疗组（对照组）。11个单位和7名患者在随机化后14天内退出，剩下37个单位的1217名患者进行意向治疗分析（抗生素组615名患者，对照组602名患者）。预防性使用抗生素并不影响算法定义的卒中后肺炎的发生率（抗生素组564例患者中71例[13%] vs对照组524例患者中52例[10%];边际调整比值比[OR] 1.21 [95%CI 0.71-2.08]，p=0.489，组内相关系数[ICC] 0.06 [95%CI 0.02-0.17]。由于数据缺失，129例（10%）患者无法确定脑卒中后肺炎。此外，我们注意到两组间医生诊断的卒中后肺炎无差异（615例患者中的101例[16%] vs 602例患者中的91例[15%]，调整后OR 1.01 [95%CI 0.61-1.68]，p=0.957，ICC 0.08 [95%CI 0.03-0.21]）。最常见的不良事件是与卒中后肺炎无关的感染（主要是尿路感染），抗生素组的发生率较低（22/615 [4%] vs 45/602 [7%]; OR 0.55 [0.32-0.92]，p=0.02）。腹泻阳性艰难梭菌发生在两名患者（
Background Post-stroke pneumonia is associated with increased mortality and poor functional outcomes. This study assessed the effectiveness of antibiotic prophylaxis for reducing pneumonia in patients with dysphagia after acute stroke.Methods We did a prospective, multicentre, cluster-randomised, open-label controlled trial with masked endpoint assessment of patients older than 18 years with dysphagia after new stroke recruited from 48 stroke units in the UK, accredited and included in the UK National Stroke Audit. We excluded patients with contraindications to antibiotics, pre-existing dysphagia, or known infections, or who were not expected to survive beyond 14 days. We randomly assigned the units (1: 1) by computer to give either prophylactic antibiotics for 7 days plus standard stroke unit care or standard stroke unit care only to patients clustered in the units within 48 h of stroke onset. We did the randomisation with minimisation to stratify for number of admissions and access to specialist care. Patient and staff who did the assessments and analyses were masked to stroke unit allocation. The primary outcome was post-stroke pneumonia in the first 14 days, assessed with both a criteria-based, hierarchical algorithm and by physician diagnosis in the intention-to-treat population. Safety was also analysed by intention to treat. This trial is closed to new participants and is registered with isrctn.com, number ISRCTN37118456.Findings Between April 21, 2008, and May 17, 2014, we randomly assigned 48 stroke units (and 1224 patients clustered within the units) to the two treatment groups: 24 to antibiotics and 24 to standard care alone (control). 11 units and seven patients withdrew after randomisation before 14 days, leaving 1217 patients in 37 units for the intention-to-treat analysis (615 patients in the antibiotics group, 602 in control). Prophylactic antibiotics did not affect the incidence of algorithm-defined post-stroke pneumonia (71 [13%] of 564 patients in antibiotics group vs 52 [10%] of 524 in control group; marginal adjusted odds ratio [OR] 1.21 [95% CI 0.71-2.08], p=0.489, intraclass correlation coefficient [ICC] 0.06 [95% CI 0.02-0.17]. Algorithm-defined post-stroke pneumonia could not be established in 129 (10%) patients because of missing data. Additionally, we noted no differences in physician-diagnosed post-stroke pneumonia between groups (101 [16%] of 615 patients vs 91 [15%] of 602, adjusted OR 1.01 [95% CI 0.61-1.68], p=0.957, ICC 0.08 [95% CI 0.03-0.21]). The most common adverse events were infections unrelated to post-stroke pneumonia (mainly urinary tract infections), which were less frequent in the antibiotics group (22 [4%] of 615 vs 45 [7%] of 602; OR 0.55 [0.32-0.92], p=0.02). Diarrhoea positive for Clostridium difficile occurred in two patients (