Liu Shi-Yi, Huang Po, Zhang Ning
Department of Nephropathy Diseases, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing 100102, China.
Beijing Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.
Ann Transl Med. 2019 Mar;7(6):114. doi: 10.21037/atm.2018.12.29.
To evaluate the efficacy and safety of a traditional Chinese medicine (TCM), Fu-Zheng-Qu-Zhuo, on retarding the progress of stage 3-4 chronic kidney disease (CKD).
We searched the relevant randomized controlled trials (RCTs) from the Medline, Cochrane Library, Embase, SinoMed, Wanfang, CNKI, and Weipu (VIP) databases from their inception to June 2018. Conference proceedings, and reference lists of relevant articles and two reviewers, independently identified the relevant studies. RevMan software was used for statistical analysis. The fixed-effect model was applied if there was either no or low heterogeneity, and pooled odds ratios (ORs) were estimated using the Mantel-Haenszel method. Publication bias was assessed if there were more than ten studies in one outcome. All hypotheses were tested at the alpha =0.05 level.
Ten studies with 1,308 participants were included, and eight studies were included in the meta-analysis. Compared with the control group, the occurrence of composite endpoint events (defined as the initiation of dialysis, CKD-related death, or the doubling of serum creatinine) was significantly reduced in the treatment group [risk ratio (RR) =0.56, 95% CI: 0.33-0.94, P=0.029, I=0.0%]. In addition, it did not increase the risk of hyperkalemia (RR =1.43, 95% CI: 0.85-2.42, P=0.180, I=0.0%).
In conclusion, the Fu-Zheng-Qu-Zhuo method combined with integrated therapy decreased the occurrence of composite endpoint events and retarded the progress of stage 3-4 CKD. In addition, there was no increase in the risk of hyperkalemia. We recommend the use of the Fu-Zheng-Qu-Zhuo method combined with integrated therapy for stage 3-4 CKD.
评估中药扶正祛浊延缓3 - 4期慢性肾脏病（CKD）进展的疗效和安全性。
检索Medline、Cochrane图书馆、Embase、中国生物医学文献数据库、万方数据库、中国知网和维普数据库中从建库至2018年6月的相关随机对照试验（RCT）。会议论文集以及相关文章的参考文献列表，由两位审稿人独立识别相关研究。使用RevMan软件进行统计分析。若无异质性或异质性较低，则应用固定效应模型，采用Mantel - Haenszel法估计合并比值比（OR）。若某一结局的研究超过十项，则评估发表偏倚。所有假设检验的显著性水平为α = 0.05。
纳入10项研究，共1308名参与者，其中8项研究纳入荟萃分析。与对照组相比，治疗组复合终点事件（定义为开始透析、CKD相关死亡或血清肌酐翻倍）的发生率显著降低[风险比（RR）= 0.56，95%置信区间（CI）：0.33 - 0.94，P = 0.029，I² = 0.0%]。此外，其未增加高钾血症风险（RR = 1.43，95% CI：0.85 - 2.42，P = 0.180，I² = 0.0%）。
综上所述，扶正祛浊法联合综合治疗可降低复合终点事件的发生率，延缓3 - 4期CKD的进展。此外，未增加高钾血症风险。我们推荐对3 - 4期CKD使用扶正祛浊法联合综合治疗。
