预防性使用牛磺罗定-尿激酶封管预防隧道式带袖套导管功能障碍：一项随机双盲试验。
Prevention of tunneled cuffed catheter dysfunction with prophylactic use of a taurolidine urokinase lock: A randomized double-blind trial.
机构信息
Department of Nephrology, Universitair Ziekenhuis Brussel, Vrije Universteit Brussel, Brussels, Belgium.
Department of Nephrology, Hôpitaux Iris-Sud, Brussels, Belgium.
出版信息
PLoS One. 2021 May 20;16(5):e0251793. doi: 10.1371/journal.pone.0251793. eCollection 2021.
BACKGROUND
The efficacy and cost-effectiveness of prophylactic thrombolytic locks in hemodialysis patients at high-risk of thrombotic dialysis catheter dysfunction is uncertain. We investigated this question in a double-blinded randomized controlled study.
METHODS
Prevalent hemodialysis patients from 8 Belgian hemodialysis units, with ≥2 separate episodes of thrombotic dysfunction of their tunneled cuffed catheter during the 6 months before inclusion, were randomized to either: taurolidine heparin locks thrice weekly (control arm) or the same locks twice a week combined with taurolidine urokinase locks once a week before the longest interval without HD (TaurolockU arm). The primary efficacy outcome was the incidence rate of catheter thrombotic dysfunction requiring thrombolytic locks to restore function.
RESULTS
68 hemodialysis patients (32 controls, 36 urokinase) were followed during 9875 catheter days between May 2015 and June 2017. Incidence rate of thrombotic catheter dysfunction was 4.8 in TaurolockU vs 12.1/1000 catheter days in control group (rate ratio 0.39; 95%CI 0.23-0.64). 15/36 (42%) catheters in the treatment group required at least one therapeutic urokinase lock vs 23/32 (72%) in the control group (P = 0.012). The two groups did not differ significantly in catheter-related bloodstream infection and combined cost of prophylactic and therapeutic catheter locks. The TaurolockU group had a numerically higher number of episodes of refractory thrombosis.
CONCLUSIONS
Prophylactic use of urokinase locks is highly effective in reducing the number of thrombotic catheter dysfunctions in catheters with a history of recurring dysfunction. Prophylactic use of urokinase locks did not reduce the overall costs associated with catheter locks and was associated with a numerically higher number of episodes of refractory thrombosis.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02036255.
背景
对于存在血栓性透析导管功能障碍高危风险的血液透析患者，预防性溶栓锁的疗效和成本效益尚不确定。我们在一项双盲随机对照研究中对此进行了研究。
方法
来自 8 家比利时血液透析单位的现有血液透析患者，在纳入前 6 个月内至少有 2 次隧道带袖套导管发生血栓性功能障碍，随机分为以下两组：每周三次使用牛磺胆酸钠肝素锁（对照组）或每周两次相同的锁，最长间隔不进行血液透析时每周一次使用牛磺胆酸钠尿激酶锁（TaurolockU 组）。主要疗效结局是需要溶栓锁恢复功能的导管血栓性功能障碍的发生率。
结果
2015 年 5 月至 2017 年 6 月期间，对 68 名血液透析患者（32 名对照组，36 名尿激酶组）进行了 9875 天导管的随访。TaurolockU 组的血栓性导管功能障碍发生率为 4.8/1000 导管天，对照组为 12.1/1000 导管天（发生率比为 0.39；95%CI 0.23-0.64）。治疗组 15/36（42%）导管需要至少一次治疗性尿激酶锁，而对照组 23/32（72%）需要（P=0.012）。两组在导管相关血流感染和预防性及治疗性导管锁的总费用方面无显著差异。TaurolockU 组的复发性血栓形成事件数量略多。
结论
在存在反复发作功能障碍的导管中，预防性使用尿激酶锁可有效减少血栓性导管功能障碍的发生次数。预防性使用尿激酶锁并不能降低与导管锁相关的总费用，且与复发性血栓形成事件数量略多有关。
试验注册
ClinicalTrials.gov 标识符：NCT02036255。
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