Efficacy and Safety of Niaoduqing Particles for Delaying Moderate-to-severe Renal Dysfunction: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study
单位：[1]Department of Nephrology, Chinese People’s Liberation Army General Hospital, Chinese People’s Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China[2]Department of Nephrology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China[3]Department of Nephrology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China大连医科大学附属第一医院[4]Department of Nephrology, Shaanxi Traditional Chinese Medicine Hospital, Xi’an, Shaanxi 710003, China[5]Department of Nephrology and Rheumatology, Affiliated Sixth People’s Hospital, Shanghai Jiao Tong University, Shanghai 200233, China[6]Department of Nephrology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong 510120, China广东省中医院[7]Department of Nephrology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing 100700, China[8]Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University, Shanghai 200127, China[9]Department of Nephrology, First Affiliated Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China[10]Department of Nephrology, University of Electronic Science and Technology, Sichuan Academy of Sciences and Sichuan Provincial People’s Hospital, Chengdu, Sichuan 610072, China四川省人民医院[11]Department of Nephrology, Beijing Friendship Hospital, 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[12]Department of Nephrology, Daping Hospital, Third Military Medical University, Chongqing 400042, China[13]Department of Nephrology, Second Affiliated Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China[14]Department of Nephrology, Army General Hospital, Beijing 100700, China[15]Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300192, China[16]Department of Nephrology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong 510030, China广东省人民医院[17]Department of Nephrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China[18]Department of Nephrology, Xijing Hospital, The Fourth Military Medical University, Xi’an, Shaanxi 710032, China[19]Department of Nephrology, Second Hospital of Jilin University, Changchun, Jilin 130041, China[20]Department of Nephrology, China‑Japan Friendship Hospital, Beijing 100029, China[21]Department of Nephrology, Jiangsu Province Hospital, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China江苏省人民医院[22]Department of Nephrology, Guang’anmen Hospital of China Academy of Traditional Chinese Medical Sciences, Beijing 100053, China[23]Department of Nephrology, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China[24]Peking University Clinical Research Institute, Peking University, Beijing 100191, China
Background: Chronic kidney disease (CKD) with moderate-to-severe renal dysfunction usually exhibits an irreversible course, and available treatments for delaying the progression to end-stage renal disease are limited. This study aimed to assess the efficacy and safety of the traditional Chinese medicine, Niaoduqing particles, for delaying renal dysfunction in patients with stage 3b-4 CKD. Methods: The present study was a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial. From May 2013 to December 2013, 300 CKD patients with an estimated glomerular filtration rate (eGFR) between 20 and 45 ml.min(-1) 1.73 m(-2), aged 18-70 years were recruited from 22 hospitals in 11 Chinese provinces. Patients were randomized in a 1:1 ratio to either a test group, which was administered Niaoduqing particles 5 g thrice daily and 10 g before bedtime for 24 weeks, or a control group, which was administered a placebo using the same methods. The primary endpoints were changes in baseline serum creatinine (Scr) and eGFR after completion of treatment. The primary endpoints were analyzed using Student's t-test or Wilcoxon's rank-sum test. The present study reported results based on an intention-to-treat (ITT) analysis. Results: A total of 292 participants underwent the ITT analysis. At 24 weeks, the median (interquartile range) change in Scr was 1.1 (-13.0-24.1) and 11.7 (-2.6-42.9) junold, for the test and control groups, respectively (Z = 2.642, P = 0.008), and the median change in eGFR was 0.2 (-4.3-2.7) and 2.2 (-5.74.8) ml.min(-1) 1.73 m(-2) respectively (Z = 2.408, P = 0.016). There were no significant differences in adverse events between the groups. Conclusions: Niaoduqing particles safely and effectively delayed CKD progression in patients with stage 3b-4 CKD. This traditional Chinese medicine may be a promising alternative medication for patients with moderate-to-severe renal dysfunction.
基金：
National Key Technology RD ProgramNational Key Technology R&D Program [2013BAI09B05, 2015BAI12B06]; Key Program of the National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81330019]; General Program of the National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [811270794]; Beijing Science and Technology Project [D131100004713003, D171100002817002]
第一作者单位：[1]Department of Nephrology, Chinese People’s Liberation Army General Hospital, Chinese People’s Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China
通讯作者：
通讯机构：[1]Department of Nephrology, Chinese People’s Liberation Army General Hospital, Chinese People’s Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China[*1]Department of Nephrology, Chinese People’s Liberation Army General Hospital, Chinese People’s Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China
推荐引用方式(GB/T 7714)：
Ying Zheng,Guang‑Yan Cai,Li‑Qun He,et al.Efficacy and Safety of Niaoduqing Particles for Delaying Moderate-to-severe Renal Dysfunction: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study[J].CHINESE MEDICAL JOURNAL.2017,130(20):2402-+.doi:10.4103/0366-6999.216407.
APA：
Ying Zheng,Guang‑Yan Cai,Li‑Qun He,Hong‑Li Lin,Xiao‑Hong Cheng...&Xiang‑Mei Chen.(2017).Efficacy and Safety of Niaoduqing Particles for Delaying Moderate-to-severe Renal Dysfunction: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study.CHINESE MEDICAL JOURNAL,130,(20)
MLA：
Ying Zheng,et al."Efficacy and Safety of Niaoduqing Particles for Delaying Moderate-to-severe Renal Dysfunction: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study".CHINESE MEDICAL JOURNAL 130..20(2017):2402-+
