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被引量：9

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

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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 Home Choice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 Home Choice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 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-1A APD machine, and those in the control group used Baxter Home Choice 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.（2）As 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-inferi