Efficacy and Safety of Niaoduqing Particles for Delaying Moderate-to-severe Renal Dysfunction: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study

被引：12

作者：

Zheng Ying ^{[1
]}

Cai GuangYan ^{[1
]}

He LiQun ^{[2
]}

Lin HongLi ^{[3
]}

Cheng XiaoHong ^{[4
]}

Wang NianSong ^{[5
]}

Jian GuiHua ^{[5
]}

Liu XuSheng ^{[6
]}

Liu YuNing ^{[7
]}

Ni ZhaoHui ^{[8
]}

Fang JingAi ^{[9
]}

Ding HanLu ^{[10
]}

Guo Wang ^{[11
]}

He YaNi ^{[12
]}

Wang LiHua ^{[13
]}

Wang YaPing ^{[14
]}

Yang HongTao ^{[15
]}

Ye ZhiMing ^{[16
]}

Yu RenHuan ^{[17
]}

Zhao LiJuan ^{[18
]}

Zhou WenHua ^{[19
]}

Li WenGe ^{[20
]}

Mao HuiJuan ^{[21
]}

Zhan YongLi ^{[22
]}

Hu Zhao ^{[23
]}

Yao Chen ^{[24
]}

Wei RiBao ^{[1
]}

Chen XiangMei

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 (DAV), National Clinical Research Center for Kidney Diseases, Beijing, China

[2] Department of Nephrology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China

[3] Department of Nephrology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China

[4] Department of Nephrology, Shaanxi Traditional Chinese Medicine Hospital, Xi’an, Shaanxi, China

[5] Department of Nephrology and Rheumatology, Affiliated Sixth People’s Hospital, Shanghai Jiao Tong University, Shanghai, China

[6] Department of Nephrology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, China

[7] Department of Nephrology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China

[8] Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University, Shanghai, China

[9] Department of Nephrology, First Affiliated Hospital of Shanxi Medical University, Taiyuan, Shanxi, China

[10] Department of Nephrology, University of Electronic Science and Technology, Sichuan Academy of Sciences and Sichuan Provincial People’s Hospital, Chengdu, Sichuan, China

[11] Department of Nephrology, Beijing Friendship Hospital, Capital Medical University, Beijing, China

[12] Department of Nephrology, Daping Hospital, Third Military Medical University, Chongqing, China

[13] Department of Nephrology, Second Affiliated Hospital of Shanxi Medical University, Taiyuan, Shanxi, China

[14] Department of Nephrology, Army General Hospital, Beijing, China

[15] Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China

[16] Department of Nephrology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China

[17] Department of Nephrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China

[18] Department of Nephrology, Xijing Hospital, The Fourth Military Medical University, Xi’an, Shaanxi, China

[19] Department of Nephrology, Second Hospital of Jilin University, Changchun, Jilin, China

[20] Department of Nephrology, China-Japan Friendship Hospital, Beijing, China

[21] Department of Nephrology, Jiangsu Province Hospital, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

[22] Department of Nephrology, Guang’anmen Hospital of China Academy of Traditional Chinese Medical Sciences, Beijing, China

[23] Department of Nephrology, Qilu Hospital of Shandong University, Jinan, Shandong, China

[24] Peking University Clinical Research Institute, Peking University, Beijing, China

来源：

中华医学杂志英文版 | 2017年 / 130卷 / 20期

关键词：

Chronic Kidney Disease; Moderate-to-severe Renal Dysfunction; Niaoduqing Particles; Randomized Controlled Trial; Traditional Chinese Medicine;

D O I：

暂无

中图分类号：

R692 [肾疾病];

学科分类号：

1002 ; 100210 ;

摘要：

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’st-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) μmol/L 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 (?5.7–0.8) 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.Trial Registration: Chinese Clinical Trial Register, ChiCTR-TRC-12002448; http://www.chictr.org.cn/showproj.aspx?proj=7102.

引用

页码：2402 / 2409

页数：8

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