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一项随机双盲对照试验,评估牛磺罗定-柠檬酸盐导管封管液在预防血液透析患者菌血症中的作用。

A randomized double-blind controlled trial of taurolidine-citrate catheter locks for the prevention of bacteremia in patients treated with hemodialysis.

机构信息

Renal Unit, Lancashire Teaching Hospitals, Royal Preston Hospital, Lancashire, UK.

出版信息

Am J Kidney Dis. 2010 Jun;55(6):1060-8. doi: 10.1053/j.ajkd.2009.11.025. Epub 2010 Mar 6.

Abstract

BACKGROUND

Bacteremia is a major cause of morbidity in patients using intravascular catheters. Interdialytic locking with antibiotics decreases the incidence of bacteremia, but risks antibiotic resistance. Taurolidine is a nontoxic broad-spectrum antimicrobial agent that has not been associated with resistance. Preliminary evidence suggests that taurolidine-citrate locks decrease bacteremia, but cause flow problems in established catheters.

STUDY DESIGN

Double-blind randomized controlled trial.

INTERVENTION

Interdialytic locking with taurolidine and citrate (1.35% taurolidine and 4% citrate) compared with heparin (5,000 U/mL) started at catheter insertion.

SETTING & PARTICIPANTS: 110 adult hemodialysis patients with tunneled cuffed intravascular catheters inserted at 3 centers in Northwest England.

OUTCOMES & MEASUREMENTS: Primary end points were time to first bacteremia episode from any cause and time to first use of thrombolytic therapy.

RESULTS

There were 11 bacteremic episodes in the taurolidine-citrate group and 23 in the heparin group (1.4 and 2.4 episodes/1,000 patient-days, respectively; P = 0.1). There was no significant benefit of taurolidine-citrate versus heparin for time to first bacteremia (hazard ratio, 0.66; 95% CI, 0.2-1.6: P = 0.4). Taurolidine-citrate was associated with fewer infections caused by Gram-negative organisms than heparin (0.2 vs 1.1 infections/1,000 patient-days; P = 0.02); however, there was no difference for Gram-positive organisms (1.1 vs 1.2 infections/1,000 patient-days; P = 0.8). There was a greater need for thrombolytic therapy in the taurolidine-citrate versus heparin group (hazard ratio, 2.5; 95% CI, 1.3-5.2; P = 0.008).

LIMITATIONS

Small sample size. The study included bacteremia from all causes and was not specific for catheter-related bacteremia.

CONCLUSIONS

Taurolidine-citrate use did not decrease all-cause bacteremia and was associated with a greater need for thrombolytic treatment. There was a decrease in infections caused by Gram-negative organisms and a trend to a lower frequency of bacteremia, which warrants further study.

摘要

背景

菌血症是使用血管内导管的患者发病的主要原因。使用抗生素进行透析间封管可降低菌血症的发生率,但存在抗生素耐药的风险。牛磺罗定是一种无毒的广谱抗菌药物,尚未与耐药性相关联。初步证据表明,牛磺罗定-柠檬酸盐封管可降低菌血症的发生率,但会导致已建立的导管出现血流问题。

研究设计

双盲随机对照试验。

干预措施

在导管插入时开始使用牛磺罗定和柠檬酸盐(1.35%牛磺罗定和 4%柠檬酸盐)与肝素(5000 U/mL)进行透析间封管。

地点和参与者

英格兰西北部的 3 个中心的 110 名成年血液透析患者,使用隧道带套的血管内导管。

主要结果和测量指标

主要终点是首次因任何原因发生菌血症的时间和首次使用溶栓治疗的时间。

结果

牛磺罗定-柠檬酸盐组发生 11 次菌血症,肝素组发生 23 次(分别为 1.4 和 2.4 次/1000 患者天;P = 0.1)。与肝素相比,牛磺罗定-柠檬酸盐对首次菌血症的时间没有显著益处(风险比,0.66;95%CI,0.2-1.6:P = 0.4)。与肝素相比,牛磺罗定-柠檬酸盐引起的革兰氏阴性菌感染较少(0.2 比 1.1 次/1000 患者天;P = 0.02),但革兰氏阳性菌感染无差异(1.1 比 1.2 次/1000 患者天;P = 0.8)。与肝素相比,牛磺罗定-柠檬酸盐组更需要溶栓治疗(风险比,2.5;95%CI,1.3-5.2;P = 0.008)。

局限性

样本量小。该研究包括所有原因引起的菌血症,并非专门针对导管相关菌血症。

结论

牛磺罗定-柠檬酸盐的使用并未降低所有原因引起的菌血症,并且与更需要溶栓治疗相关。革兰氏阴性菌感染减少,菌血症的频率有降低趋势,这需要进一步研究。

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