Li Shen, Rao Xiang-Rong, Dai Xi-Wen, Pei Kun, Wang Lee, Huo Bao-Min, Wang Xiu-Juan, Kong Ling-Xin, Zhang Nan-Nan, Lian Feng-Mei
Nephrology Department of Guang'anmen Hospital, China Academy of Chinese Medical Sciences Nephrology Department of South Area of Guang'anmen Hospital, China Academy of Chinese Medical Sciences Nephrology Department of Beijing Fangshan Hospital of Traditional Chinese Medicine Drug Clinical Trial Institution of State Food and Drug Administration of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Medicine (Baltimore). 2017 Jul;96(28):e7448. doi: 10.1097/MD.0000000000007448.
The high worldwide prevalence of chronic kidney disease (CKD) is a critical health problem and the development of more effective therapies is urgently needed. We conducted a randomized, double-blinded, placebo-controlled clinical trial from October 2010 to December 2012 to assess whether Fu-Zheng-Qu-Zhuo oral liquid (FZQZ) has a beneficial effect in preventing CKD progression when added to standard integrated therapies.
Patients with CKD stage 3 to 4 from 3 hospitals in Beijing, China were enrolled. Patients were randomly assigned to the FZQZ or placebo groups and were treated with standard integrated therapy plus FZQZ or placebo (20 mL each time, 3 times/d) for 12 months. Patients received post-trial follow-up until October 2014. The primary outcome was the estimated glomerular filtration rate (eGFR)-Slope (mL/min per 1.73 m2 per month) during the in-trial time, which was calculated by the eGFR regression curve estimated from each serum creatinine measurement during the in-trial period. Secondary outcomes were changes in 24-h urine protein excretion (24-h UP) and albumin and hemoglobin levels from baseline during the in-trial period. Time to composite endpoint events (initiation of long-term dialysis, doubling of serum creatinine, or CKD-related death during the in-trial and post-trial phases) was assessed as a secondary outcome.
A total of 68 patients (43 in the FZQZ group and 25 in the placebo group) completed the in-trial and post-trial phases, with an average follow-up time of 31.6 ± 9.6months. The FZQZ group had amean eGFR-Slope of 0.25 ± 1.44 as compared with -0.72 ± 1.46 (mL/min per 1.73m2 per month) in the placebo group during the in-trial period (P = .003). The FZQZ group showed decreased 24-h UP, with a change from baseline of -0.08 (interquartile range [IQR], -0.33 to 0.01) versus 0.01 (IQR, -0.19 to 0.33) g/24h in the placebo group (P = .049). Decreased risk of composite endpoint events was observed only in the post-trial phase (hazard ratio = 0.42, 95% confidence interval: 0.16-1.11, P = .038). No significant differences in albumin and hemoglobin level changes were observed.
Adding FZQZ oral liquid to standard integrated therapies may aid in attenuating CKD progression.
慢性肾脏病（CKD）在全球范围内的高患病率是一个关键的健康问题，迫切需要开发更有效的治疗方法。我们于2010年10月至2012年12月进行了一项随机、双盲、安慰剂对照临床试验，以评估扶正祛浊口服液（FZQZ）在标准综合治疗基础上添加时对预防CKD进展是否具有有益作用。
招募了来自中国北京3家医院的3至4期CKD患者。患者被随机分配至FZQZ组或安慰剂组，并接受标准综合治疗加FZQZ或安慰剂（每次20毫升，每日3次）治疗12个月。患者接受试验后随访直至2014年10月。主要结局是试验期间估计肾小球滤过率（eGFR）斜率（毫升/分钟每1.73平方米每月），通过试验期间每次血清肌酐测量估计的eGFR回归曲线计算得出。次要结局是试验期间24小时尿蛋白排泄量（24-h UP）以及白蛋白和血红蛋白水平相对于基线的变化。将复合终点事件发生时间（试验期间和试验后阶段开始长期透析、血清肌酐翻倍或CKD相关死亡）作为次要结局进行评估。
共有68例患者（FZQZ组43例，安慰剂组25例）完成了试验期间和试验后阶段，平均随访时间为31.6±9.6个月。试验期间，FZQZ组的平均eGFR斜率为0.25±1.44，而安慰剂组为-0.72±1.46（毫升/分钟每1.73平方米每月）（P = 0.003）。FZQZ组24-h UP降低，相对于基线的变化为-0.08（四分位间距[IQR]，-0.33至0.01）克/24小时，而安慰剂组为0.01（IQR，-0.19至0.33）克/24小时（P = 0.049）。仅在试验后阶段观察到复合终点事件风险降低（风险比=0.42，95%置信区间：0.16 - 1.11，P = 0.038）。白蛋白和血红蛋白水平变化未观察到显著差异。
在标准综合治疗基础上添加FZQZ口服液可能有助于减缓CKD进展。
