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30%柠檬酸钠与肝素作为血液透析患者导管封管液的随机临床试验比较

Randomized, clinical trial comparison of trisodium citrate 30% and heparin as catheter-locking solution in hemodialysis patients.

作者信息

Weijmer Marcel C, van den Dorpel Marinus A, Van de Ven Peter J G, ter Wee Pieter M, van Geelen Jos A C A, Groeneveld Johannes O, van Jaarsveld Brigitte C, Koopmans Marjon G, le Poole Caatje Y, Schrander-Van der Meer Anita M, Siegert Carl E H, Stas Koen J F

机构信息

Department of Nephrology, Free University Medical Center, Amsterdam, The Netherlands.

出版信息

J Am Soc Nephrol. 2005 Sep;16(9):2769-77. doi: 10.1681/ASN.2004100870. Epub 2005 Jul 20.

Abstract

Interdialytic hemodialysis catheter-locking solutions could contribute to a reduction of catheter-related complications, especially infections. However, they can cause side effects because of leakage from the tip of the catheter. Recently, trisodium citrate (TSC) has been advocated because of its antimicrobial properties and local anticoagulation. In a multicenter, double-blind, randomized, controlled trial, TSC 30% was compared with unfractionated heparin 5000 U/ml for prevention of catheter-related infections, thrombosis, and bleeding complications. The study was stopped prematurely because of a difference in catheter-related bacteremia (CRB; P < 0.01). Of 363 eligible patients, 291 could be randomized. The study included 98 tunneled cuffed catheters and 193 untunneled. There were no significant differences in patient and catheter characteristics on inclusion. In the heparin group, 46% of catheters had to be removed because of any complication compared with 28% in the TSC group (P = 0.005). CRB rates were 1.1 per 1000 catheter-days for TSC versus 4.1 in the heparin group (P < 0.001). For tunneled cuffed catheters, the risk reduction for CRB was 87% (P < 0.001) and for untunneled catheters was 64% (P = 0.05). Fewer patients died from CRB in the TSC group (0 versus 5; P = 0.028). There were no differences in catheter flow problems and thrombosis (P = 0.75). No serious adverse events were encountered. Major bleeding episodes were significantly lower in the TSC group (P = 0.010). TSC 30% improves overall patency rates and reduces catheter-related infections and major bleeding episodes for both tunneled and untunneled hemodialysis catheters. Flow problems are not reduced.

摘要

透析间期血液透析导管封管溶液有助于减少导管相关并发症,尤其是感染。然而,由于导管尖端渗漏,它们可能会引起副作用。最近,枸橼酸钠(TSC)因其抗菌特性和局部抗凝作用而受到推崇。在一项多中心、双盲、随机对照试验中,将30%的TSC与5000 U/ml的普通肝素用于预防导管相关感染、血栓形成和出血并发症进行了比较。由于导管相关菌血症存在差异(P < 0.01),该研究提前终止。在363名符合条件的患者中,291名可被随机分组。该研究包括98根带隧道涤纶套导管和193根非隧道导管。纳入时患者和导管特征无显著差异。在肝素组,46%的导管因任何并发症而不得不拔除,而TSC组为28%(P = 0.005)。TSC组的导管相关菌血症(CRB)发生率为每1000导管日1.1次,肝素组为4.1次(P < 0.001)。对于带隧道涤纶套导管,CRB的风险降低了87%(P < 0.001),对于非隧道导管降低了64%(P = 0.05)。TSC组死于CRB的患者较少(0例对5例;P = 0.028)。导管流量问题和血栓形成方面无差异(P = 0.75)。未遇到严重不良事件。TSC组的严重出血事件显著较少(P = 0.010)。30%的TSC可提高整体通畅率,并减少带隧道和非隧道血液透析导管的导管相关感染和严重出血事件。流量问题未减少。

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