| Autor: |
Ying Zheng, Guang-Yan Cai, Li-Qun He, Hong-Li Lin, Xiao-Hong Cheng, Nian-Song Wang, Gui-Hua Jian, Xu-Sheng Liu, Yu-Ning Liu, Zhao-Hui Ni, Jing-Ai Fang, Han-Lu Ding, Wang Guo, Ya-Ni He, Li-Hua Wang, Ya-Ping Wang, Hong-Tao Yang, Zhi-Ming Ye, Ren-Huan Yu, Li-Juan Zhao, Wen-Hua Zhou, Wen-Ge Li, Hui-Juan Mao, Yong-Li Zhan, Zhao Hu, Chen Yao, Ri-Bao Wei, Xiang-Mei Chen |
| Jazyk: |
angličtina |
| Rok vydání: |
2017 |
| Předmět: |
|
| Zdroj: |
Chinese Medical Journal, Vol 130, Iss 20, Pp 2402-2409 (2017) |
| Druh dokumentu: |
article |
| ISSN: |
0366-6999 |
| DOI: |
10.4103/0366-6999.216407 |
| Popis: |
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) 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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
|
