观察肾衰方（由姜半夏、陈皮、茯苓、白术、竹茹、巴戟天、积雪草、大黄等中药组成）对脾肾气虚、浊瘀内 蕴证慢性肾脏病（CKD）3-4期患者的治疗作用。【方法】 将70例脾肾气虚、浊瘀内蕴证CKD 3-4期患者随机分为治疗组和对照 组，每组各35例。对照组给予CKD常规西医一体化治疗，治疗组在对照组的基础上给予中药汤剂肾衰方治疗，疗程为8周。 观察2组患者治疗前后中医证候积分、肾功能指标[血肌酐（Scr）、血清尿素氮（BUN）、血清胱抑素（CysC）、血尿酸（UA）和估 算肾小球滤过率（eGFR）]及超敏 C 反应蛋白（hs-CRP）水平的变化情况，并评价 2 组患者的中医证候疗效及安全性。 【结果】（1）脱落情况方面，治疗组脱落 5 例，对照组脱落 3 例，最终共纳入 62 例患者，其中治疗组 30 例，对照组 32 例。 （2）中医证候疗效方面，治疗8周后，治疗组的总有效率为86.67%（26/30），对照组为59.38%（19/32），组间比较，治疗组的 中医证候疗效明显优于对照组（P＜0.01）。（3）中医证候积分方面，治疗后，2 组患者的中医证候积分均较治疗前明显下降 （P＜0.01），且治疗组的下降作用明显优于对照组（P＜0.01）。（4）肾功能指标方面，治疗后，2 组患者的 Scr、BUN、CysC、 UA水平均较治疗前下降（P＜0.05），eGFR水平均较治疗前升高（P＜0.05），且治疗组对Scr、BUN、CysC、UA水平的下降作 用及对 eGFR水平的升高作用均明显优于对照组（P＜0.05）。（5）炎症因子方面，治疗后，2组患者的血清 hs-CRP水平均较治 疗前改善（P＜0.05），且治疗组的改善作用明显优于对照组（P＜0.05）。（6）安全性方面，治疗期间，2组患者的安全性指标如 血常规、粪便常规+潜血、肝功能、电解质、心电图等方面均未见明显改变。【结论】 肾衰方在治疗脾肾气虚、浊瘀内蕴证 CKD 3-4期患者方面疗效确切，能一定程度改善患者临床症状，有效降低Scr、BUN、CysC、UA水平，提高eGFR水平，改 善肾功能，并能降低血清hs-CRP水平，减轻患者的微炎症状态，延缓疾病的进展。

To observe the therapeutic effect of Shenshuai Formula （composed of Pinelliae Rhizoma Praeparatum Cum Zingibere et Alumine， Citri Reticulatae Pericarpium， Poria， Atractylodis Macrocephalae Rhizoma，Bambusae Caulis in Taenia，Morindae Officinalis Radix，Centellae Herba，Rhei Radix et Rhizoma， etc.） on patients with chronic kidney disease （CKD） at stage 3-4 of spleen-kidney qi deficiency with internal accumulation of turbid-phlegm and stasis type. Methods Seventy patients with CKD at stage 3-4 of spleen-kidney qi deficiency with internal accumulation of turbid-phlegm and stasis type were randomly divided into a treatment group and a control group，with 35 patients in each group. The control group was given the conventional western medicine integrated treatment for CKD， and the treatment group was given the Chinese herbal decoction of Shenshuai Formula on the basis of treatment for the control group. The course of treatment for the two groups covered 8 weeks. The changes of traditional Chinese medicine （TCM） syndrome scores，renal function indicators of serum creatinine （Scr），blood urea nitrogen （BUN），serum cystatin C （CysC），blood uric acid （UA） and estimated glomerular filtration rate （eGFR），and the level of hypersensitive C-reactive protein （hs-CRP） in the two groups before and after the treatment were observed. Moreover，the TCM syndrome efficacy and clinical safety in the two groups were evaluated. Results （1） During the trial，5 cases in the treatment group and 3 cases in the control group fell off，and eventually a total of 62 patients were included in the trial，including 30 cases in the treatment group and 32 cases in the control group.（2） After 8 weeks of treatment，the total effective rate for TCM syndrome efficacy of the treatment group was 86.67%（26/30），and that of the control group was 59.38%（19/32）. The intergroup comparison showed that the TCM syndrome efficacy in the treatment group was significantly superior to that in the control group （P＜0.01）.（3） After treatment，the scores of TCM syndromes in the two groups were significantly decreased when compared with those before treatment （P＜0.01），and the decrease in the treatment group was more obvious than that in the control group （P＜0.01）.（4） After treatment， the renal function indicator levels of Scr，BUN，CysC and UA in the two groups were decreased when compared with those before treatment （P＜0.05），and the level of eGFR was increased when compared with that before treatment （P＜0.05）. The intergroup comparison showed that the decrease in the levels of Scr，BUN，CysC and UA and the increase in the level of eGFR in the treatment group were superior to those in the control group （P＜0.05）.（5）After treatment， the inflammatory factor level of serum hs-CRP in the two groups was improved when compared with that before treatment （P＜0.05），and the improvement in the treatment group was superior to that in the control group （P＜ 0.05）.（6） During the treatment period，no significant changes in the safety indicators such as blood routine test， stool routine test and occult blood test，liver function，electrolyte，and electrocardiogram were presented in the two groups. Conclusion Shenshuai Formula exerts certain effect in the treatment of patients with CKD at stage 3-4 of spleen-kidney qi deficiency with internal accumulation of turbid-phlegm and stasis type. It can relieve the clinical symptoms of the patients to certain extent，effectively decrease the levels of Scr，BUN，CysC and UA， increase the eGFR，improve renal function，lower the level of serum hs-CRP，reduce the micro-inflammatory state of patients，and delay the progress of the disease.

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