中国血液净化

中国血液净化 ›› 2017, Vol. 16 ›› Issue (03): 148-153.doi: 10.3969/j.issn.1671-4091.2017.03.002

• 临床研究 • 上一篇    下一篇

杰瑞自动腹膜透析机用于维持性腹膜透析患者治疗的有效性与安全性研究：多中心、随机、二阶段交叉临床试验

赵慧萍1,李绍梅2,邢昌赢3,姜鸿4,赵占正5,刘映红6,芦丽霞1,谭会斌2,任海滨3,贾依娜西.阿扎提4,肖静5,符晓6,阎小妍7,王梅1   

  1. 100044 北京，1北京大学人民医院肾内科
    050000 石家庄，2河北医科大学第二医院肾内科
    210029 南京，3南京医科大学第一附属医院肾内科
    830001 乌鲁木齐，4新疆维吾尔自治区人民医院肾病科
    450052 郑州，5郑州大学第一附属医院肾内科
    410008 长沙，6中南大学湘雅二医院肾内科
    100191 北京，7北京大学临床研究所
  • 收稿日期:2017-01-12 修回日期:2017-01-28 出版日期:2017-03-12 发布日期:2017-03-12
  • 通讯作者: 王梅 wangmei1949@163.com E-mail:wangmei1949@163.com

The effectiveness and safety of Jerry automated peritoneal dialysis machine for maintenance peritoneal dialysis patients: a multicenter, randomized, and two phase crossover trial

  • Received:2017-01-12 Revised:2017-01-28 Online:2017-03-12 Published:2017-03-12

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摘要： 目的通过前瞻性、多中心、随机、对照研究，评价杰瑞腹膜透析机用于维持性腹膜透析患者治疗的有效性与安全性。方法研究对象来自全国6 家医院的腹膜透析中心，选择腹膜透析(以下简称腹膜透析)3 个月以上、病情稳定的慢性肾衰竭患者。试验组选用JARI-APD-1A 自动腹膜透析机，对照组选用Baxter HomeChoice 腹膜透析机。采用多中心、随机、开放、二阶段交叉阳性对照设计，两个阶段的周期均为1 日，主要有效性评价指标为单周期引流量的显示值与实测值之间的一致性以及单周期注入量的显示值与实测值之间的一致性，次要有效性评价指标为腹膜透析机设定温度的准确性以及毒素清除、电解质、酸碱紊乱的纠正效果，使用杰瑞腹膜透析机的研究结果均与Baxter HomeChoice 腹膜透析机的结果进行非劣效检验。安全性评价指标包括患者的临床症状、生命体征及机器故障发生情况等。结果①共84 名患者参加了本试验，其中男性47 人，女性37 人；平均年龄(45.33±11.34)岁，原发病以慢性肾小球肾炎为主，占50%，平均透析龄(37.70±27.67)月。②主要有效性评价指标：试验组与对照组单周期引流量的显示值与实测值之间的一致性，试验组97.62%、对照组98.81%达到了流量控制精度，通过非劣性检验显示，试验组不劣于对照组(Z=4.315,P＜0.001)；单周期注入量的显示值与实测值之间的一致性均达到了流量控制精度，通过非劣性检验显示，试验组不劣于对照组(Z=9.456,P＜0.001)。③次要有效性评价指标：试验组与对照组腹膜透析机实测温度均达到了精度要求，试验组不劣于对照组；另外，试验组与对照组相比，治疗前、后的血尿素、肌酐及电解质(钾、钠、氯、钙、磷、二氧化碳结合力)均无统计学差异。④安全性评价指标：患者使用两种腹膜透析机治疗过程中均无不适症状，无不良事件，治疗前后的生命体征未见显著性差异。试验组与对照组均无故障发生。结论通过多中心、随机、开放、二阶段交叉临床试验，杰瑞腹膜透析机达到了主要、次要有效性评价指标及安全性评价指标的标准，其有效性、安全性不劣于Baxter 腹膜透析机。

关键词: 腹膜透析, 自动化腹膜透析, 腹膜透析机, 有效性, 安全性

Abstract: Objective To evaluate the effectiveness and safety of Jerry automated peritoneal dialysis (APD) machine for maintenance peritoneal dialysis (PD) patients through a prospective, multicenter, randomized and controlled trial. Methods This study was carried out in 6 PD centers in China, and chronic renal failure patients treated with PD for more than 3 months were enrolled. Patients in the experimental group used JARI-APD-1AAPD machine, and those in the control group used Baxter HomeChoice APD machine. The calculated sample size should be 84 patients. A multicenter, randomized, two phase crossover, opened, and positive control trial was designed, and each phase lasted for one day. The primary effectiveness indices included consistency between displayed value and measured value of single cycle drainage volume and single cycle infusion volume. The secondary effectiveness indices included accuracy of temperature control, toxin removal, and correction of electrolyte and acid- base imbalance. Results from Jerry APD machine were compared to those from Baxter APD machine by non-inferiority test. The safety indices included clinical symptoms, vital signs, and occurrence of machine malfunction. SAS 9.4 software was used to analyze the results. Results ① A total of 84 patients (47 males and 37 females, average age 45.33±11.34 years old) were enrolled in this study. The predominant primary disease was chronic glomerulonephritis, accounting for 50% of the patients. The average dialysis duration was 37.70±27.67 months. ②As for primary effectiveness indices, the consistency between displayed value and measured value of single cycle drainage volume was 97.62% in experimental
group, accurately controlling the single cycle drainage volume and not inferior to that (98.81%) in control group (Z=4.315, P＜0.001); the consistency between displayed value and measured value of single infusion volume reached the accuracy of volume control in both groups and showed no difference between the two groups by non-inferiority test (Z=9.456, P＜0.001). ③As for secondary effectiveness indices, the measured temperature was consistent with the required accuracy in both groups, and experimental group was not inferior to control group in this index; the changes of blood urea, creatinine and electrolytes before and after the treatment also had no differences between the two groups. ④As for safety indices, the presence of uncomfortable symptoms, adverse events, and vital sign changes had no differences between the two groups. No machine malfunction was seen in both groups. Conclusions The multicenter randomized, opened, and two phase crossover clinical trial showed that the Jerry APD machine conformed to the standards of primary effectiveness indices, secondary effectiveness indices, and safety indices. Jerry APD machine is not inferior to Baxter APD machine in the effectiveness and safety indices.

Key words: Peritoneal dialysis, Automated peritoneal dialysis, Peritoneal dialysis machine, Effectiveness, Safety