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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。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。
Objective To evaluate the efficacy and safety of Jerry Peritoneal Dialysis Machine in the treatment of maintenance peritoneal dialysis patients by prospective, multicentre, randomized, controlled study. Methods Subjects from the peritoneal dialysis centers of 6 hospitals in China were selected. Patients with chronic renal failure who were stable in peritoneal dialysis (hereinafter referred to as peritoneal dialysis) for more than 3 months were selected. The experimental group selected JARI-APD-1A automatic peritoneal dialysis machine, the control group selected Baxter Home Choice peritoneal dialysis machine. The multi-center, randomized, open, two-phase cross-positive control design, the two stages of the cycle are 1, the main effectiveness of the evaluation indicators for the single-cycle drainage volume between the measured value and the consistency between the measured and single-cycle injection Volume of the display value and the measured value of the consistency between the secondary effectiveness evaluation index for the peritoneal dialysis machine set the temperature accuracy and toxin removal, electrolyte, acid-base disorders correction, the use of Jerry Peritoneal Dialysis Machine Research The results were compared with the results of the Baxter Home Choice peritoneal dialysis machine for non-inferiority tests. Safety evaluation indicators include the patient’s clinical symptoms, vital signs and machine failure and so on. Results A total of 84 patients participated in this study, including 47 males and 37 females. The average age was 45.33 ± 11.34 years. The primary disease was chronic glomerulonephritis (50%), and the average age of dialysis (37.70 ± 27.67) months. The main effectiveness of the evaluation index: the test group and control group single-cycle drainage volume of the display and the measured value of the consistency between the experimental group 97.62% 98.81% of the control group reached the flow control accuracy by non-inferiority test showed that the test Group was not inferior to the control group (Z = 4.315, P <0.001). The agreement between the single cycle injection quantity and the measured value reached the flow control accuracy. The non-inferiority test showed that the test group was not inferior to the control group Group (Z = 9.456, P <0.001). 3 secondary efficacy evaluation index: the test group and control group peritoneal dialysis machine measured temperature reached the accuracy requirements, the test group is not inferior to the control group; In addition, the test group compared with the control group, before and after treatment, blood urea, Creatinine and electrolytes (potassium, sodium, chlorine, calcium, phosphorus, carbon dioxide binding) were not statistically different. 4 Safety Evaluation Index: Patients using two kinds of peritoneal dialysis machine in the treatment of no symptoms, no adverse events, no significant differences in vital signs before and after treatment. The experimental group and the control group have no trouble. Conclusions Jerry Peritoneal Dialysis Machine achieves the primary and secondary effectiveness evaluation criteria and safety evaluation criteria through multi-center, randomized, open and two-stage clinical trials. Its effectiveness and safety are not inferior to those of Baxter Peritoneal Dialysis machine.