芪黄固肾通络方治疗脾肾气虚、湿浊血瘀型非透析慢性肾脏病矿物质及骨代谢异常的临床研究

Clinical Study on Qihuang Gushen Tongluo Prescription for Chronic Kidney Disease-Mineral and Bone Disorder in Non-Dialysis Patients with Spleen-Kidney Qi Deficiency， Dampness Turbidity and Blood Stasis

    摘要
  • 摘要:
    目的 观察芪黄固肾通络方治疗脾肾气虚、湿浊血瘀型非透析慢性肾脏病矿物质及骨代谢异常（CKD-MBD）的临床疗效及对患者血清成纤维细胞生长因子23（FGF-23）的影响。
    方法 将68例脾肾气虚、湿浊血瘀型非透析CKD-MBD患者随机分为对照组、观察组各34例，对照组予西医基础治疗，观察组在对照组治疗基础上加服芪黄固肾通络方，4周为1个疗程，2组均治疗2个疗程。治疗前后比较2组患者肾功能血尿素氮（BUN）、血肌酐（Scr）、估算肾小球滤过率（eGFR）、钙磷代谢血钙（Ca）、磷（P）、全段甲状旁腺激素（iPTH）、FGF-23水平及中医证候积分的变化。记录治疗期间不良反应发生情况。
    结果 治疗8周，2组BUN、P、iPTH、FGF-23水平及中医证候总积分均明显下降、Ca水平显著升高（P<0.05），观察组Scr亦显著下降、eGFR显著上升（P<0.05），观察组优于对照组（P<0.05）；观察组CKD-MBD疗效、中医证候疗效总有效率分别为88.2%、73.5%，对照组分别为67.6%、52.9%，观察组优于对照组（P<0.05）。治疗前后2组安全性指标未见明显异常，治疗期间未见过敏等严重不良反应。
    结论 芪黄固肾通络方可显著改善脾肾气虚、湿浊血瘀型非透析CKD-MBD患者的临床症状，且安全性良好，可能与下调FGF-23的表达水平有关。

     

    Abstract:
    OBJECTIVE To observe the clinical efficacy of Qihuang Gushen Tongluo Prescription in treating non-dialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD) characterized by spleen-kidney qi deficiency, dampness turbidity and blood stasis, and to investigate its effect on serum fibroblast growth factor 23 (FGF-23).
    METHODS Sixty-eight non-dialysis CKD-MBD patients with spleen-kidney qi deficiency, dampness turbidity and blood stasis were randomly divided into a control group and an observation group (n=34 each). The control group received basic Western medical treatment, while the observation group received Qihuang Gushen Tongluo Prescription in addition to the basic treatment. One treatment course lasted 4 weeks, and both groups underwent two courses of treatment. Changes in renal function blood urea nitrogen (BUN), serum creatinine (Scr), estimated glomerular filtration rate (eGFR), calcium-phosphorus metabolism serum calcium (Ca), phosphorus (P), intact parathyroid hormone (iPTH), FGF-23 levels, and TCM syndrome scores were compared before and after treatment; adverse reactions were also recorded.
    RESULTS After 8 weeks of treatment, levels of BUN, P, iPTH, and FGF-23, as well as total TCM syndrome scores, decreased significantly, while Ca levels increased significantly in both groups (P<0.05). In the observation group, Scr decreased significantly and eGFR increased significantly (P<0.05), with the observation group outperforming the control group (P<0.05). The total effective rates for CKD-MBD and TCM syndrome were 88.2% and 73.5% in the observation group, and 67.6% and 52.9% in the control group, respectively; the observation group showed superior results compared to the control group (P<0.05). No significant abnormalities in safety indicators were observed in either group before or after treatment, and no allergic reactions or serious adverse events occurred during the treatment period.
    CONCLUSION Qihuang Gushen Tongluo Prescription can significantly improve clinical symptoms in non-dialysis CKD-MBD patients presenting with spleen-kidney qi deficiency, dampness turbidity and blood stasis; it demonstrates a favorable safety profile, and its mechanism may be associated with the downregulation of FGF-23 expression levels.

     

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