中国血液净化

›› 2011, Vol. 10 ›› Issue (7): 368-371.doi: 10.3969/j.issn.1671-4091.2011.07.00

• 临床研究 • 上一篇    下一篇

便携式连续性血液净化机的临床应用验证研究

何 萍 周春华 孟建中 赵 军 余永武 李洪艳 于 颖 张 彬 董 珍   

  1. 海军总医院肾内科, 济南军区总医院血液净化科, 解放军三○二医院血液净化科
  • 收稿日期:2010-10-14 修回日期:1900-01-01 出版日期:2011-07-12 发布日期:2011-07-12
  • 通讯作者: 周春华

Clinical trials of the mobile continuous blood purification machine

HE Ping, ZHOU Chun-hua, MENG Jian-zhong, ZHAO Jun, YU Yong-wu, LI Hong-yan, YU Ying, ZHANG Bin, DONG Zhen   

  1. 1Department of Nephrology, Navy General Hospital of PLA, Beijing 100048; 2Department of Blood Purification, Ji’nan Military District General Hospital of PLA, Ji’nan 250031; 3Department of Blood Purification, the 302 Hospital of PLA, Beijing 100039
  • Received:2010-10-14 Revised:1900-01-01 Online:2011-07-12 Published:2011-07-12

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摘要：

目的 观察便携式连续性血液净化机临床应用的有效性和安全性，为其临床应用提供评价依据。 方法 采用自身交叉试验，将便携式连续性血液净化机和百特Aquarius连续床旁血液净化机进行比较，比较两种机器在治疗过程中的精确性、有效性和安全性，并进行统计学分析。 结果 便携式连续性血液净化机的脱水精度和置换液流量控制精度分别为0.10%～0.59%和0.00%～1.48%，均已达到国家标准。和百特Aquarius连续床旁血液净化机比较差异无统计学意义(P＞0.05)。治疗中便携式连续性血液净化机的各项报警系统工作正常、准确、灵敏，合格率均为100%。患者在治疗过程中均未发生任何不良事件。患者经治疗后肾功能指标血肌酐和尿素氮的水平显著下降，酸中毒及电解质紊乱得到有效纠正，各项指标治疗前后的变化与百特Aquarius连续床旁血液净化机比较差异均无统计学意义(P＞0.05)。 结论 便携式连续性血液净化机临床使用有效、安全，机器性能稳定，值得推广应用。

关键词: 便携式连续性血液净化机, 安全性, 有效性, 临床试验

Abstract:

Objective The accuracy, effectiveness and safety of the mobile continuous blood purification machine were evaluated clinically in order to address the possibility of clinical applications. Methods The mobile continuous blood purification machine was compared with Baxter Aquarius continuous blood purification machine in their accuracy, effectiveness and safety. Auto-cross design was used in the study. Results The accuracies for dehydration and for replacement flow control of the mobile continuous blood purification machine varied from 0.1-0.59% and from 0.00-1.48%, respectively, consistent with the national standards and comparable to those of Baxter Aquarius continuous blood purification machine (P＞0.05). During the operation of the mobile continuous blood purification machine, the alarm systems worked accurately and sensitively without any mechanical accident, and the vital signs of the subjects were stable. After dialysis with the mobile continuous blood purification machine, patients’ blood creatinine and urea decreased significantly, acidosis and electrolyte imbalances improved greatly, demonstrating the achievements indifferent from Baxter Aquarius continuous blood purification machine (P＞0.05). Conclusions The mobile continuous blood purification machine is accurate, effective, safe and stable in clinical trials, and is worthwhile to be recommended for clinical applications.

Key words: Safety, Accuracy, Effectiveness Clinical trial