Zhao Jing, Sun Wei, Chen Jihong, Sun Zhuxing, Chen Dai, Cao Chunhua, Yang Min, Ma Jipei, Wang Ling, Xing Changying, Chen Yan, Sheng Meixiao, Zhou Enchao, Xu Lingdong, Gao Kun, Liu Lihua, Liu Qiong, Yi Lan, He Weiming, Zhu Yuanyuan
Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
Department of Nephrology, Wuxi People's Hospital, Wuxi, Jiangsu, China.
Evid Based Complement Alternat Med. 2020 Oct 21;2020:4073901. doi: 10.1155/2020/4073901. eCollection 2020.
It is generally considered that traditional Chinese medicine (TCM) therapy postpones the progression of some chronic kidney diseases (CKDs). Chinese medicine herbs are widely applied in TCM therapy. We aimed to evaluate clinical efficacy and safety of Chinese herbal formula granules in patients with CKD stage 3 through a prospective randomized controlled study.
A total of 343 participants with CKD stage 3 were recruited from 9 hospitals in Jiangsu Province between April 2014 and October 2016. Participants were randomly assigned to a treatment or control group. Patients in the treatment group orally took Chinese herbal formula granules twice a day, while controls received placebo granules. The duration of intervention was 24 weeks. Primary outcomes were 24-hour proteinuria, serum creatinine, and eGFR, which were measured every 4 weeks.
There was no statistical difference in 24-hour proteinuria between the two groups (0.97 ± 1.14 g/d vs. 0.97 ± 1.25 g/d). Patients in the treatment group had significantly lower serum creatinine level (130.78 ± 32.55 mol/L versus 149.12 ± 41.27 mol/L) and significantly higher eGFR level (55.74 ± 50.82 ml/min/1.73·m versus 44.46 ± 12.60 ml/min/1.73·m) than those in the control group ( < 0.05). There was no significant difference between two groups in the incidence of adverse events.
The treatment adopting Chinese herbal formula granules for 24 weeks improved kidney function of patients with CKD stage 3.
一般认为，中医治疗可延缓某些慢性肾脏病（CKD）的进展。中药在中医治疗中广泛应用。我们旨在通过一项前瞻性随机对照研究，评估中药配方颗粒对3期CKD患者的临床疗效和安全性。
2014年4月至2016年10月期间，从江苏省9家医院招募了343例3期CKD参与者。参与者被随机分配到治疗组或对照组。治疗组患者每天口服两次中药配方颗粒，而对照组服用安慰剂颗粒。干预持续时间为24周。主要结局指标为24小时蛋白尿、血清肌酐和估算肾小球滤过率（eGFR），每4周测量一次。
两组24小时蛋白尿无统计学差异（0.97±1.14g/d对0.97±1.25g/d）。治疗组患者的血清肌酐水平显著低于对照组（130.78±32.55μmol/L对149.12±41.27μmol/L），eGFR水平显著高于对照组（55.74±5.082ml/min/1.73·m²对44.46±12.60ml/min/1.73·m²）（P<0.05）。两组不良事件发生率无显著差异。
采用中药配方颗粒治疗24周可改善3期CKD患者的肾功能。
