Safety,Effectiveness,and Manipulability of Peritoneal Dialysis Machines Made in China:A Randomized,Crossover, Multicenter Clinical Study

作     者：Xue-Ying Cao Ya-Ni He Jian-Hui Zhou Shi-Ren Sun Li-Ning Miao Wen Chen Jing-Ai Fang Ming Wang Nian-Song Wang Hong-Li Lin Jian Liu Zhao-Hui Ni Wen-Hu Liu Yu Na Jiu-Yang Zhao Zhi-Yong Guo Hong-Guang Zheng Wei Shi Geng-Ru Jiang Guang-Yan Cai Xiang-Mei Chen 

作者机构：Department of NephrologyChinese People's Liberation Army General HospitalChinese People's Liberation Army Institute of NephrologyState Key Laboratory of Kidney Diseases (2011DAVO0088)National Clinical Research Center for Kidney DiseasesBeiiing 100853China Department of NephrologyThe First Affiliated Hospital of Xinjiang Medical UniversityUrumqiXinjiang 830054China Department of NephrologyRenji HospitalShanghai Jiao Tong UniversityShanghai 200127China Department of NephrologyBeijing Friendship HospitalCapital Medical UniversityBeijing 100050China Department of NephrologyThe 306^th Hospital of People's Liberation ArmyBeijing 100101China Department of NephrologyThe Second Affiliated Hospital of Dalian Medical UniversityDalian Medical UniversityDalianLiaoning 116023China Department of NephrologyChanghai HospitalThe Second Military Medical UniversityShanghai 200433China Department of NephrologyPeople's Liberation Army General Hospital of Shenyang Military RegionShenyangLiaoning 110016China Department of NephrologyGuangdong General HospitalGuangdong Academy of Medical SciencesGuangzhouGuangdong 510080China Department of NephrologyXinhua HospitalShanghai Jiao Tong University School of MedicineShanghai 200092China Department of NephrologyDaping HospitalArmy Military Medical UniversityChongqing 400042China Department of NephrologyXijing HospitalThe Fourth Military Medical UniversityXi'anShaanxi 710032China Department of NephrologySecond Hospital of Jilin UniversityChangchunJilin 130041China Department of NephrologyHainan Provincial Agricultural Reclamation General HospitalHaikouHainan 570311China Department of NephrologyFirst Affiliated Hospital of Shanxi Medical UniversityTaiyuanShanxi 030001China Department of NephrologyHangzhou First People's HospitalHangzhouZhejiang 310006China Department of Nephrology and RheumatologyAffiliated Sixth People's HospitalShanghai Jiao Tong UniversityShanghai 200233China Department of NephrologyFirst Affiliated Hospital of Dalian Medical UniversityDalianLiaoning 116011China 

出 版 物：《Chinese Medical Journal》 (中华医学杂志（英文版）)

年 卷 期：2018年第131卷第23期

页      面：2785-2791页

核心收录：

学科分类：10[医学] 

基　　金：National Key Technology Research and Development Program, (2015BAI12B06) National Science & Technology Pilar Program, (2011BAI10B08) Chinese Medical Association, CMA, (15020050593) Chinese Medical Association, CMA National Basic Research Program of China (973 Program), (2016YFC1103004) National Basic Research Program of China (973 Program) 

主　　题：Automated Peritoneal Dialysis Effectiveness Peritoneal Dialysis Peritoneal Dialysis Machine Safety 

摘      要：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%