Efficacy and safety of Zicuiyin decoction on diabetic kidney disease: A multicenter, randomized controlled trial
Efficacy and safety of Zicuiyin decoction on diabetic kidney disease: A multicenter, randomized controlled trial
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紫翠饮汤治疗糖尿病肾病的疗效和安全性：多中心、随机对照试验
DOI：
10.1016/j.phymed.2022.154079
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发表时间：
2022-04-09
期刊：
影响因子：
7.9
通讯作者：
Yuan, Xin-hui
中科院分区：
文献类型：
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作者：
Liu, Jia;Gao, Li-dong;Yuan, Xin-hui
工作背景：自清代张锡春先生创制紫翠饮，在我国治疗糖尿病及其并发症已有两个多世纪的历史。黄葵胶囊是一种治疗糖尿病肾病的中成药。为了确定ZCY在治疗DKD方面是否非劣效于HKC，进行了一项多中心、平行对照、开放标签、随机临床试验。方法：本临床试验于2018年1月至2019年12月在天津三个中心招募了88例DKD患者。在常规治疗的基础上，随机分为HKC组（2.5g，TID）和ZCY组（生药量75 g，150 ml，BID），疗程8周。主要结局是估计肾小球滤过率（eGFR）的变化。次要结局包括血清肌酐（SCr）、尿白蛋白排泄率、24 h尿蛋白、尿白蛋白/肌酐比值、糖化血红蛋白A1 c、症状评分和微生物群组成的变化。结果：HKC组和ZCY组的eGFR变化分别为-7.08 ± 24.65和2.57 ± 18.49 ml/min/1.73 m2（p < 0.05）。估计平均值之间差异的95%置信下限为1.93 ml/min/1.73 m2，确立了ZCY的优效性。与HKC比较，ZCY能显著降低SCr和症状评分（p < 0.05）。两组其他指标比较差异无统计学意义（p > 0.05）。ZCY改善肠道微生物群生态失调，包括增加普雷沃氏菌科和乳酸杆菌科，减少肠杆菌科，梭菌科和微球菌科。任何组均未报告严重不良事件。结论：中药滋肾饮具有较好的改善和保护肾功能的作用。这将是治疗DKD的另一种选择，特别是那些eGFR下降和肠道微生物群失调的人。试验注册：中国临床试验注册中心：ChiCTR-OON-17012076。2017年7月21日注册
Backgroud: Zicuiyin (ZCY) decoction created by Xichun Zhang in the Qing dynasty has been used on diabetes mellitus and complications for more than two centuries in China. Huangkui capsule (HKC) is a listed Chinese patent medicine to treat diabetic kidney disease (DKD). To determine whether ZCY is non-inferior to HKC in the treatment of DKD, a multicenter, parallel-control, open-label, randomized clinical trial was conducted. Methods: In this clinical trial, 88 DKD patients were recruited at three centers in Tianjin from January 2018 to December 2019. They were randomized to receive HKC (2.5 g, TID) or ZCY (crude drug amount 75 g, 150 ml, BID) for eight weeks based on routine treatment. The primary outcome was the change of estimated glomerular filtration rate (eGFR). The secondary outcomes included change of serum creatinine (SCr), urinary albumin excretion rate, 24 h urinary protein, urinary albumin-creatinine ratio, glycosylated hemoglobin A1c, symptom scores, and microbiota compositions profiles. Results: The change of eGFR in HKC and ZCY groups were -7.08 +/- 24.65 and 2.57 +/- 18.49 ml/min/1.73 m2, respectively (p < 0.05). The 95% lower confidence limit for the difference between the estimated means was 1.93 ml/min/1.73 m2, establishing the superiority of ZCY. Compared to HKC, ZCY could significantly decrease SCr and symptom scores (p < 0.05). There were no significant differences in other outcomes between the two groups (p > 0.05). ZCY ameliorated gut microbiota dysbiosis, including increased Prevotellaceae and Lactobacillaceae and decreased Enterobacteriales, Clostridiaceae and Micrococcaceae. No severe adverse events were reported in any group. Conclusions: ZCY had better efficacy in improving and protecting kidney function. It would be an alternative option to treat DKD, especially those who decline eGFR and gut microbiota dysbiosis. Trial registration: Chinese Clinical Trial Registry: ChiCTR-OON-17012076. Registered July 21, 2017