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Lancet Infect Dis:酒精封管治疗或预防癌症儿童CLABSI是否有效?

发布日期:2018-09-03来源:Lancet Infect Dis官网发布人:感控雏鹰

酒精封管治疗小儿癌症中心线相关血流感染的治疗和二级预防:一项随机、双盲、对照试验

《Lancet Infect Dis》于2018年6月5日发表了关于一项关于酒精封管能否用于治疗和二级预防小儿癌症中心线相关血流感染的随机、双盲、安慰剂对照有效性试验

背景

中心线相关血流感染(CLABSI)影响约25%的患有癌症的儿童,并且治疗失败是常见的。辅助乙醇封管疗法可以预防治疗失败,但缺乏高质量的证据。我们评估了乙醇封管疗法作为癌症或血液病患儿CLABSI的治疗和二级预防。

方法

这项随机,双盲,安慰剂对照的优效性试验,在美国和澳大利亚的两家儿科医院进行了两项临时无效和疗效分析(在第一批46名和92名可评估参与者完成研究要求时完成)。患有癌症或血液病和新CLABSI的6个月至24岁患者符合条件。参与者被随机分配(1:1)接受乙醇封管疗法(70%乙醇)或安慰剂(肝素化盐水)每天每个流明2-4小时,持续5天(治疗阶段),然后最多3个非连续每周几天,持续24周(预防期)。主要的复合结果是治疗失败,包括可归因的导管拔除或死亡,新的或持续的(> 72 h)治疗期间感染或其他锁定疗法,以及预防期间复发的CLABSI。该试验已注册 ClinicalTrials.gov,编号NCT01472965。

结果

2011年12月14日至2016年9月12日期间,共有94名可评估参与者入组,其中48名接受乙醇封管治疗,46名接受安慰剂治疗。该研究在第二次中期分析中符合无效标准。治疗失败与乙醇封管疗法相似(48例中[21%[44%])和安慰剂组(46例中[20%[43%];相对危险度[RR] 1.0,95%CI 0.6-1.6; p = 0.98)。酒精封管(48例中28例[58%])中需要溶栓治疗的导管阻塞比安慰剂组(46例中15例[33%];RR 1.8,95% CI 1.1~2.9;p=0.012)更常见。酒精封管(48例中9例[19%])与安慰剂组(46例中10例[22%];p=0.72)由于不良影响或患者原因而造成封管中断的受试者比例相似。

结论

乙醇锁定疗法不能阻止CLABSI治疗失败,并且导管闭塞增加。不建议在该人群中进行常规乙封管定治疗或二级预防。

基金项目

美国黎巴嫩叙利亚联合慈善机构向圣犹达儿童研究医院和澳大利亚政府研究培训奖学金

Treatment and secondary prophylaxis with ethanol lock therapy for central line-associated bloodstream infection in paediatric cancer: a randomised, double-blind, controlled trial

Summary

Background

Central line-associated bloodstream infections (CLABSIs) affect about 25% of children with cancer, and treatment failure is common. Adjunctive ethanol lock therapy might prevent treatment failure but high-quality evidence is scarce. We evaluated ethanol lock therapy as treatment and secondary prophylaxis for CLABSI in children with cancer or haematological disorders.

Methods

This randomised, double-blind, placebo-controlled superiority trial, with two interim futility and efficacy analyses (done when the first 46 and 92 evaluable participants completed study requirements), was done at two paediatric hospitals in the USA and Australia. Patients aged 6 months to 24 years, inclusive, with cancer or a haematological disorder and new CLABSI were eligible. Participants were randomly assigned (1:1) to receive either ethanol lock therapy (70% ethanol) or placebo (heparinised saline) for 2–4 h per lumen daily for 5 days (treatment phase), then for up to 3 non-consecutive days per week for 24 weeks (prophylaxis phase). The primary composite outcome was treatment failure, consisting of attributable catheter removal or death, new or persistent (>72 h) infection, or additional lock therapy during the treatment phase, and recurrent CLABSI during the prophylaxis phase. This trial is registered with ClinicalTrials.gov, number NCT01472965.

Findings

94 evaluable participants were enrolled between Dec 14, 2011, and Sept 12, 2016, of whom 48 received ethanol lock therapy and 46 received placebo. The study met futility criteria at the second interim analysis. Treatment failure was similar with ethanol lock therapy (21 [44%] of 48) and placebo (20 [43%] of 46; relative risk [RR] 1·0, 95% CI 0·6–1·6; p=0·98). Some adverse events, including infusion reactions and catheter occlusion, were more frequent in the ethanol lock therapy group than in the placebo group. Catheter occlusion requiring thrombolytic therapy was more common with ethanol lock therapy (28 [58%] of 48) than with placebo (15 [33%] of 46; RR 1·8, 95% CI 1·1–2·9; p=0·012). Discontinuation of lock therapy because of adverse effects or patient request occurred in a similar proportion of participants in the ethanol lock therapy (nine [19%] of 48) and placebo groups (ten [22%] of 46; p=0·72).

Interpretation

Ethanol lock therapy did not prevent CLABSI treatment failure and it increased catheter occlusion. Routine ethanol lock therapy for treatment or secondary prophylaxis is not recommended in this population.

Funding

American Lebanese Syrian Associated Charities to St Jude Children's Research Hospital and an Australian Government Research Training Scholarship.

Published:June05,2018DOI:https://doi.org/10.1016/S1473-3099(18)30224-  

简译人:感控雏鹰