单位：[1]Department of Nephrology, State Key Laboratory of Kidney Disease, Chinese People’s Liberation Army General Hospital, Beijing 100853, China[2]Renal Division, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China[3]Division of Nephrology, Kidney Institute of People’s Liberation Army, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China[4]Department of Nephrology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510080, China院本部内科肾内科中山大学附属第一医院[5]Department of Nephropathy, Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, China[6]Department of Nephropathy, the Second Hospital of Jilin University, Changchun, Jilin 130041, China[7]Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu 210002, China[8]Department of Nephrology, Shanghai First People’s Hospital Affiliated to Jiao Tong University, Shanghai 200080, China[9]Department of Nephrology, Jinan General Hospital of People’s Liberation Army, Jinan, Shandong 250031, China[10]Department of Nephrology, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China大连医科大学附属第一医院[11]Department of Nephrology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia 750004, China[12]Kidney Disease Center, the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang 310003, China浙江大学医学院附属第一医院[13]Department of Nephrology, 455th Hospital of People’s Liberation Army, Shanghai 200052, China[14]Department of Nephrology, Daping Hospital, the Third Military Medical University, Chongqing 400042, China[15]Department of Nephrology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, Fujian 350025, China[16]Department of Nephrology, the Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116027, China[17]Division of Nephrology, Zhongshan Hospital, Shanghai Medical College, Fudan University, Shanghai 200032, China[18]Department of Nephrology, Third Hospital, Hebei Medical University, Shijiazhuang, Hebei 050051, China[19]Department of Nephrology, Second Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China[20]Department of Nephrology, the First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150001, China[21]Department of Nephrology, Affiliated Beijing Friendship Hospital, Faculty of Kidney Diseases, Capital Medical University, Beijing 100050, China临床科室肾脏内科肾脏内科首都医科大学附属北京友谊医院[22]Department of Nephrology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, Jiangsu 210029, China江苏省人民医院[23]Department of Nephrology, Provincial Hospital Affiliated to Shandong University, Jinan, Shangdong 250021, China[24]Department of Nephrology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
Background A multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis (PD) solutions. Some researchers believe that 6 L/d is enough for adequate dialysis, but there is no multi-center prospective study on Chinese population to confirm this. In this study, we evaluated the efficacy and safety of domestic PD solution (Changfu) and its difference between 6 L and 8 L dosage. Methods Adult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages, i.e., 6 L dose with Changfu dialysis solution, 6 L dose with Baxter dialysis solution, 8 L dose with Changfu dialysis solution, and 8 L dose with Baxter dialysis solution. After 48 weeks, the changes of primary and secondary efficacy indices were compared between different types and different dosages. We also analyzed the changes of safety indices. Results Changes of Kt/V from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of creatinine clearance rate (Ccr). Normalized protein catabolic rate (nPCR) from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of net ultrafiltration volume (nUF) and estimated glomerular filtration rate (eGFR). Changes of nPCR from baseline to 48 weeks between 6 L and 8 L showed no statistical differences; so did those of nUF and eGFR. The decline of Kt/V from baseline to 48 weeks in 6 L group was more than that in 8 L group. Change of Ccr was similar. During the 48-week period, the mean Kt/V was above 1.7/w, and mean Ccr was above 50 L.1.73 m(-2).w(-1). More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization, and the statistical differences disappeared after that. Conclusions The domestic PD solution (Changfu) was proven to be as effective as Baxter dialysis solution. During 48-week period, a dosage of 6 L/d was enough for these patients to reach adequate PD. Clinical study promotes technological optimization, further helps to improve the safety indices of the medical products.
基金：
National Science & Technology Pillar Program in the Twelfth Five-year Plan Period [2011BAI10B00]; Special Fund for Health Research in the Public Interest of the Ministry of Health [201002010]
第一作者单位：[1]Department of Nephrology, State Key Laboratory of Kidney Disease, Chinese People’s Liberation Army General Hospital, Beijing 100853, China
通讯作者：
通讯机构：[1]Department of Nephrology, State Key Laboratory of Kidney Disease, Chinese People’s Liberation Army General Hospital, Beijing 100853, China[*1]Department of Nephrology, State Key Laboratory of Kidney Disease, Chinese People’s Liberation Army General Hospital, Beijing 100853, China
推荐引用方式(GB/T 7714)：
Zhou Jian-hui,Ni Zhao-hui,Mei Chang-lin,et al.Efficacy and safety of Changfu peritoneal dialysis solution: a multi-center prospective randomized controlled trial[J].CHINESE MEDICAL JOURNAL.2013,126(22):4204-4209.doi:10.3760/cma.j.issn.0366-6999.20131722.
APA：
Zhou Jian-hui,Ni Zhao-hui,Mei Chang-lin,Yu Xue-qing,Liu Fu-you...&Chen Xiang-mei.(2013).Efficacy and safety of Changfu peritoneal dialysis solution: a multi-center prospective randomized controlled trial.CHINESE MEDICAL JOURNAL,126,(22)
MLA：
Zhou Jian-hui,et al."Efficacy and safety of Changfu peritoneal dialysis solution: a multi-center prospective randomized controlled trial".CHINESE MEDICAL JOURNAL 126..22(2013):4204-4209
