Background: Automated peritoneal dialysis (APD) can cater to individual needs, provide treatment while asleep, take into account the adequacy of dialysis, and improve the quality of life. Currently, independent research and development of APD machines made in China are more conducive to patients. A randomized, multicenter, crossover study was conducted by comparing an APD machine made in China with an imported machine. The safety, effectiveness, and manipulability of the two machines were compared.
Methods: Two hundred and sixty patients who underwent peritoneal dialysis (PD) on a regular basis in 18 centers between August 2015 and February 2016 were included. The inclusion criteria include age ≥18 years and PD ≥30 days. The exclusion criteria were as follows: hemodialysis; exit site or tunnel infection; and peritonitis ≤30 days. The patients were randomly divided into Group A, who were first treated with a FM machine made in China, then changed to an imported machine; and Group B, who were treated using the reverse sequence. APD treatment was performed with 10 L/10 h and 5 cycles of exchange. After 72 h, the daily peritoneal Kt/V, the accuracy of the injection rate, accuracy of the injection temperature, safety, and manipulability of the machine were assessed. Noninferiority test was conducted between the two groups.
Results: The daily peritoneal Kt/V in the APD machine made in China and the imported APD machine were 0.17 (0.14, 0.25) and 0.16 (0.13, 0.23), respectively. There was no significant difference between the groups (Z = 0.15, P = 0.703). The lower limit of the daily Kt/V difference between the two groups was 0.0069, which was greater than the noninferiority value of -0.07 in this study. The accuracy of the injection rate and injection temperature was 89.7% and 91.5%, respectively, in the domestic APD machine, which were both slightly better than the accuracy rates of 84.0% and 86.8% in the imported APD machine (89.7% vs. 84.0%, P = 0.2466; 91.5% vs. 86.8%, P = 0.0954). Therefore, the APD machine made in China was not inferior to the imported APD machine. The fuselage of the imported APD machine was space-saving, while the APD machine made in China was superior with respect to body mobility, man-machine dialog operation, alarm control, and patient information recognition.
Conclusions: The FM machine made in China was not inferior to the imported APD machine. In addition, the FM machine made in China had better operability.
Trial registration: Clinicaltrials.gov, NCT02525497; https://clinicaltrials.gov/ct2/results?cond=&term=NCT02525497&cntry=& state=&city=&dist=.
迈达FM自动化腹膜透析机随机、多中心、交叉对照研究 摘要 背景: 通过随机、多中心交叉对照研究，评价迈达FM腹膜透析机用于维持性腹膜透析患者治疗的安全性、有效性和可操作性。 方法: 研究对象来自全国18家医院接受腹膜透析（PD）治疗的患者（年龄≥18岁，PD≥30天；排除联合血液透析、出口或隧道感染、腹膜炎后30天内的患者）。试验组选用迈达FM腹膜透析机治疗，对照组选用Homechoice腹膜透析机治疗。采用随机、多中心交叉对照设计，各进行1个周期的治疗。主要评价指标为每日腹膜Kt/V，次要评价指标为注入准确率、注入温度准确率以及毒素电解质变化情况。采用问卷评分法比较两组的安全性和可操作性。将两组研究结果进行非劣效检验。 结果: （1）共260例维持性腹膜透析患者参加本研究，男性158例，女性102例；平均年龄（49.33±15.26）岁；（2）主要有效性评价指标：试验组和对照组的每日腹膜Kt/V分别为0.17（0.14,0.25）和0.16（0.13,0.23）。P值为0.7029，大于0.05，差异无统计学意义；且试验组与对照组每日Kt/V差值的95%CI下限为0.0069，大于本研究的非劣效界值-0.07。；（3）次要有效性评价指标：试验组和对照组注入准确率（89.7%和84.0%）和注入温度准确率（91.5%和86.8%）无显著差异；（4）安全性及可操作性：两组治疗过程中患者生命体征平稳，耐受性良好；对照组机身较节省空间，试验组的机身移动性、人机对话操作、报警控制和患者信息识别较好。 结论: 通过多中心随机交叉对照研究，迈达FM腹膜透析机可操作性良好，有效性、安全性达标，不劣于Homechoice腹膜透析机。.
Keywords: Automated Peritoneal Dialysis; Effectiveness; Peritoneal Dialysis; Peritoneal Dialysis Machine; Safety.