新型国产临时血液透析导管的临床应用

Application of the new type and domestic made temporary hemodialysis catheter

目的观察新型国产临时血液透析导管治疗的有效性和安全性。方法选择2013年10月至2014年10月2家临床验证中心临时中心静脉置管血液透析的患者共140例，随机分为2组，验证组使用新型国产临时血液透析导管，对照组使用Arrow临时血液透析导管。对比2组导管的质量和操作性能，血流量和透析效果，及导管相关并发症的情况。结果共140例患者，平均年龄（61．06±16．02）岁，2组间基础资料比较无差异。验证组平均血流量（215．43±10．03）ml／min，导管留置时间为（30．49±15．65）天，spKt／V值为（1．23±0．04），URR（66．16±2．11）％，产品质量和操作性能得分率99．84％，与对照组相比均无差异（2组间比较血流量：t=-1．865，P=0．064；导管留置时间：t=-0．827，P=0．409：spKt／V：t=-1．601，P=0．112；URR：t=-1．791，P=0．075；产品质量和操作性能得分率：χ^2=-1．000，P=0．321）。验证组不良事件发生率为2．86％，对照组为1．43％，2组间比较无显著差异（χ^2=0．000，P=1．000），2组均无严重不良事件发生。结论新型国产临时血液透析导管的操作性、有效性和安全性良好，能为血液透析患者提供有效的、安全的临时血管通路。

Objective To evaluate the efficacy and safety of the new type and domestic made temporary hemodialysis catheter for hemodialysis patients. Methods A total of 140 patients in need of temporary central vein catheterization for hemodialysis from Oct. 2013 to Oct. 2014 in the two clinical centers were enrolled in this study. Patients were randomly divided into two groups. Half of the patients used the new type temporary hemodialysis catheter, and the rest of the patients used arrow temporary hemodialysis catheter for hemodialysis. The quality, manipulation, blood flow, dialysis adequacy and complications were compared between the two groups. Results The average age of the patients was 61.06±16.02 years. In test group, the average blood flow was 215.43±10.03 ml/min, indwelling duration was 30.49±15.65 days, spKt/Vwas 1.234-0.04, URR was 66.16±2.11%, and the scores of quality and ease of use were 99.84%, which had no differences from the control group （t=-1.865, P=0.064 for blood flow; t=-0.827, P=0.409 for indwelling duration; t=- 1. 601, P=-0.112 for spK t/V; t=- 1.79 1, P：0.075 for URR; and χ^2=- 1.000, P=0.321 for the scores of quality and ease of use）. The incidence of adverse event was 2.86% in test group and 1.43% in control group （χ^2=0.000, P： 1.000）. There was no treatment-related serious adverse effect in both groups. Conclusion This clinical study shows that the new type and domestic made temporary hemodialysis catheter is effective and safe for temporary blood access in hemodialysis patients.