摘要

　　背景：

　　導管相關尿路感染（CAUTI）是一種可預防的造成住院患者傷害的原因。本文旨在研究與標準聚四氟乙烯（PTFE）尿管相比，短期常規(guī)使用抗菌導管是否會降低導管相關尿路感染的發(fā)生風險。

　　方法：

　　進行一項平行、三組、多中心、隨機對照的優(yōu)效試驗，招募來自英國24家醫(yī)院需要短期（≤14天）置入尿管的成年（≥16歲）患者。按照1:1:1的比例通過遠程計算機將受試者隨機分配至接受銀合金涂層尿管組、呋喃西林浸染尿管組或聚四氟乙烯尿管組（對照組）。接受計劃外尿管置入的患者也被納入，并回顧性地獲取知情同意。

　　受試者和試驗人員均對治療分配知情。由試驗人員收集數據，并收集隨機化后6周患者的問卷報告。主要終點指標為6周中接受抗生素處方的有癥狀尿道感染的發(fā)生率。研究假定如果導管相關尿路感染能絕對減少3.3%，則表明常規(guī)使用抗菌尿管可充分獲益。本研究的注冊號為ISRCTN75198618。

　　結果：

　　7102例被隨機分配的受試者中有708例（10%）沒有**尿管，未簽署知情同意或中途退出，他們都沒有被納入主要分析中。對照組2144例患者中有271（12.6%）例發(fā)生主要終點事件，銀合金涂層尿管組的2097例患者有263例（12.5%）發(fā)生主要終點事件（差異 ??0.1% [95% CI ??2.4～2.2]），呋喃西林浸染尿管組的2153例患者中有228例（10.6%）出現主要終點事件（??2.1% [??4.2～0.1]）。呋喃西林浸染尿管組的導管相關不適率高于其他組。

　　解釋：

　　銀合金涂層導管并不能有效降低導管相關的癥狀性尿路感染的發(fā)生率。呋喃西林浸染導管對尿道感染的降低并沒有顯著的臨床意義。本試驗不支持常規(guī)使用抗菌導管

　　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.