抗菌导管并不能有效降低尿路感染的发病率

　　背景：

　　导管相关尿路感染（CAUTI）是一种可预防的造成住院患者伤害的原因。本文旨在研究与标准聚四氟乙烯（PTFE）尿管相比，短期常规使用抗菌导管是否会降低导管相关尿路感染的发生风险。

　　方法：

　　进行一项平行、三组、多中心、随机对照的优效试验，招募来自英国24家医院需要短期（≤14天）置入尿管的成年（≥16岁）患者。按照1:1:1的比例通过远程计算机将受试者随机分配至接受银合金涂层尿管组、呋喃西林浸染尿管组或聚四氟乙烯尿管组（对照组）。接受计划外尿管置入的患者也被纳入，并回顾性地获取知情同意。

　　受试者和试验人员均对治疗分配知情。由试验人员收集数据，并收集随机化后6周患者的问卷报告。主要终点指标为6周中接受抗生素处方的有症状尿道感染的发生率。研究假定如果导管相关尿路感染能绝对减少3.3%，则表明常规使用抗菌尿管可充分获益。本研究的注册号为ISRCTN75198618。

　　结果：

　　7102例被随机分配的受试者中有708例（10%）没有**尿管，未签署知情同意或中途退出，他们都没有被纳入主要分析中。对照组2144例患者中有271（12.6%）例发生主要终点事件，银合金涂层尿管组的2097例患者有263例（12.5%）发生主要终点事件（差异 ??0.1% [95% CI ??2.4～2.2]），呋喃西林浸染尿管组的2153例患者中有228例（10.6%）出现主要终点事件（??2.1% [??4.2～0.1]）。呋喃西林浸染尿管组的导管相关不适率高于其他组。

　　解释：

　　银合金涂层导管并不能有效降低导管相关的症状性尿路感染的发生率。呋喃西林浸染导管对尿道感染的降低并没有显著的临床意义。本试验不支持常规使用抗菌导管

　　Summary

　　Background

　　Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm for patients in hospital. We aimed to establish whether short-term routine use of antimicrobial catheters reduced risk of CAUTI compared with standard polytetrafluoroethylene (PTFE) catheterisation.

　　Methods

　　In our parallel, three group, multicentre, randomised controlled superiority trial, we enrolled adults (aged ≥16 years) requiring short-term (≤14 days) catheterisation at 24 hospitals in the UK. Participants were randomly allocated 1:1:1 with a remote computer allocation to receive a silver alloy-coated catheter, a nitrofural-impregnated catheter, or a PTFE-coated catheter (control group).

　　Patients undergoing unplanned catheterisation were also included and consent for participation was obtained retrospectively. Participants and trial staff were unmasked to treatment assignment. Data were collected by trial staff and by patient-reported questionnaires for 6 weeks after randomisation. The primary outcome was incidence of symptomatic urinary tract infection for which an antibiotic was prescribed by 6 weeks.

　　We postulated that a 3·3% absolute reduction in CAUTI would represent sufficient benefit to recommend routine use of antimicrobial catheters. This study is registered, number ISRCTN75198618.

　　Findings

　　708 (10%) of 7102 randomly allocated participants were not catheterised, did not confirm consent, or withdrew, and were not included in the primary analyses. Compared with 271 (12·6%) of 2144 participants in the control group, 263 (12·5%) of 2097 participants allocated a silver alloy catheter had the primary outcome (difference ??0·1% [95% CI ??2·4 to 2·2]), as did 228 (10·6%) of 2153 participants allocated a nitrofural catheter (??2·1% [??4·2 to 0·1]). Rates of catheter-related discomfort were higher in the nitrofural group than they were in the other groups.

　　Interpretation

　　Silver alloy-coated catheters were not effective for reduction of incidence of symptomatic CAUTI. The reduction we noted in CAUTI associated with nitrofural-impregnated catheters was less than that regarded as clinically important. Routine use of antimicrobial-impregnated catheters is not supported by this trial.

　　Funding

　　UK National Institute for Health Research Health Technology Assessment Programme.