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[Lancet Infect Dis在线发表]:洗必泰清洁尿道口能够减少导管相关泌尿系感染
2019年07月03日 时讯速递, 进展交流 暂无评论

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Chlorhexidine for meatal cleaning in reducing catheter-associated urinary tract infections: a multicentre stepped-wedge randomised controlled trial

Oyebola Fasugba, Prof Allen C Cheng, Victoria Gregory, et al

Lancet Infect Dis Published: April 12, 2019 DOI: https://doi.org/10.1016/S1473-3099(18)30736-9

Summary

Background 背景

Evidence for the benefits of antiseptic meatal cleaning in reducing catheter-associated urinary tract infection (UTI) is inconclusive. We assessed the efficacy of 0·1% chlorhexidine solution compared with normal saline for meatal cleaning before urinary catheter insertion in reducing the incidence of catheter-associated asymptomatic bacteriuria and UTI.

有关采用消毒剂清洁尿道口减少导管相关泌尿系感染(UTI)的证据并不明确。我们比较了在留置尿管前使用0.1%洗必泰溶液或生理盐水清洁尿道口,对于减少导管相关无症状性菌尿及UTI的影响。

Methods 方法

A cross-sectional, stepped-wedge, open-label, randomised controlled trial was undertaken in Australian hospitals. Eligible hospitals were Australian public and private hospitals, with an intensive care unit and more than 30 000 hospital admissions per year. Hospitals were randomly assigned to an intervention crossover date using a computer-generated randomisation system. Crossover dates occurred every 8 weeks; during the first 8 weeks of the study, no hospitals were exposed to the intervention (control phase), after which each hospital sequentially crossed over from the control to the intervention every 8 weeks. Patients requiring a urinary cathetwer were potentially eligible for inclusion in this hospital-wide study. Participants were excluded if they were younger than 2 years, had a medical reason preventing the use of the chlorhexidine, had the catheter inserted in theatre, did not have the catheter insertion date documented, required in-and-out or suprapubic catheterisation, had symptoms and signs suggestive of UTI at the time of catheter insertion, or were currently undergoing treatment for UTI. The intervention was the use of 0·1% chlorhexidine solution for meatal cleaning before urinary catheterisation with 0·9% normal saline used in the control phase. Masking of hospitals was not possible because it was not feasible to mask staff administering the intervention. The co-primary outcomes were the number of cases of catheter-associated asymptomatic bacteriuria and UTI per 100 catheter-days and were assessed within 7 days of catheter insertion in the intention-to-treat population. This trial is registered with Australian New Zealand Clinical Trials Registry, number ACTRN12617000373370.

我们在澳大利亚的医院中进行了一项横断面、阶梯设计、开放标签、随机对照试验。医院入选标准为澳大利亚的公立及私立医院,设置ICU,且医院年收治30000名以上住院患者。将医院随机分组,根据计算机生成的随机化系统确定干预措施交叉日期。每8周进行一次交叉;在研究的最初8周内,所有医院均未采取干预措施(对照阶段),此后每8周均有一家医院序贯从对照阶段进入干预阶段。在医院内,需要留置尿管的患者可以纳入研究。排除标准包括年龄不足2岁,有医学因素导致无法使用洗必泰,在手术室留置尿管,未记录置管日期,需要留置耻骨上导管,置管时已有症状和体征提示存在UTI,或正在接受UTI治疗。干预措施为在留置尿管前使用0.1%洗必泰溶液进行尿道口清洁,对照阶段使用0·9%生理盐水。由于不能对采取干预措施的医务人员进行隐藏,因此无法实现医院的隐藏。联合主要预后终点为每100个导管日的导管相关无症状性菌尿和UTI病例数,针对一项治疗人群在留置导管7天内进行评估。试验在澳大利亚新西兰临床试验注册网站注册,注册号ACTRN12617000373370。

Findings 结果

21 hospitals were assessed for eligibility between Jan 5, 2017, and May 1, 2017; of these, three were successfully enrolled and randomised to one of three intervention crossover dates. 1642 participants in these hospitals were included in the study between Aug 1, 2017, and March 12, 2018, 697 (42%) in the control phase and 945 (58%) in the intervention period. In the control period, 13 catheter-associated UTI and 29 catheter-associated asymptomatic bacteriuria events in 2889 catheter-days (0·45 catheter-associated UTI cases and 1·00 catheter-associated asymptomatic bacteriuria cases per 100 catheter-days) were recorded compared with four catheter-associated UTI and 16 catheter-associated asymptomatic bacteriuria events in 2338 catheter-days (0·17 catheter-associated UTI cases and 0·68 catheter-associated asymptomatic bacteriuria cases per 100 catheter-days) during the intervention period. The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08–0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01–0·32, p=0·00080). There were no reported adverse events.

2017年1月5日至5月1日间,共对21家医院进行评估;其中,3家医院成功纳入研究,并随机分配至3个干预交叉日期之一。在2017年8月1日至2018年3月12日期间,共有1642名患者纳入研究,其中对照阶段697名(42%),干预阶段945名(58%)。在对照阶段的2889个导管日中发生13例导管相关UTI和29例导管相关无症状性菌尿(每100个导管日0·45 导管相关 UTI 及 1·00 导管相关无症状性菌尿),干预阶段2338个导管日共发生4例导管相关UTI 和 16例导管相关无症状性菌尿(每100个导管日0·17例导管相关UTI和0·68例导管相关无症状性菌尿)。干预措施伴随导管相关无症状性菌尿发生率减少74% (发生率比值 0·26, 95% CI 0·08–0·86, p=0·026),导管相关UTI发生率减少94% (0·06, 95% CI 0·01–0·32, p=0·00080)。无不良事件报告。

Interpretation 结论

The use of chlorhexidine solution for meatal cleaning before catheter insertion decreased the incidence of catheter-associated asymptomatic bacteriuria and UTI and has the potential to improve patient safety.

在留置尿管前使用洗必泰溶液清洁尿道口能够降低导管相关无症状性菌尿及UTI的发生率,并可能增进患者安全。

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