目的 探究益肾化湿颗粒联合复方α-酮酸治疗非透析慢性肾脏病的临床疗效。方法 选取2021年7月—2024年7月香港中文大学（深圳）第二附属医院86例非透析慢性肾脏病患者，根据使用药物方案差异将患者分为对照组和治疗组，每组各43例。对照组口服复方α-酮酸片，5片/次，3次/d，进餐时用药。治疗组在对照组治疗基础上口服益肾化湿颗粒，1袋/次，3次/d，温水冲服。两组均连续治疗4个月。观察两组的临床疗效和临床症状消失时间，比较两组肾功能指标、肠道菌群、运动耐力和疲乏相关指标的变化情况。结果 治疗后，治疗组总有效率是86.05%，显著高于对照组的67.44%（P＜0.05）。治疗过程中，治疗组水肿消退时间、多尿消失时间、血尿消失时间及腰痛消失时间均显著短于对照组（P＜0.05）。治疗后，两组血肌酐（Scr）、尿酸（UA）、血尿素氮（BUN）、24 h尿蛋白定量（24 h Upro）均较同组治疗前显著降低（P＜0.05）；且治疗后，治疗组肾功能指标低于对照组（P＜0.05）。治疗后，两组大肠杆菌均较治疗前显著降低，而粪肠球菌、双歧杆菌、乳酸杆菌显著升高（P＜0.05）；且治疗后，治疗组肠道菌群改善优于对照组（P＜0.05）。治疗后，两组无氧阈（AT）、峰值摄氧量（VO_2peak）、峰值氧脉搏（VO₂/HR_peak）均显著高于治疗前，而运动耐力指标、慢性病治疗功能评估-疲劳量表（FACIT-F）评分低于治疗前，且治疗组运动耐力指标、FACIT-F评分改善优于对照组（P＜0.05）。结论 益肾化湿颗粒联合复方α-酮酸治疗能增加非透析慢性肾脏病患者获益，缓解临床症状，改善肾功能和运动耐力，纠正肠道菌群失衡，减轻疲乏，安全性较高。

Objective To investigate the therapeutic effect of Yishen Huashi Granules combined with compound α-ketoacid in treatment of non-dialysis chronic kidney disease. Methods A total of 86 patients with non-dialysis chronic kidney disease in the Second Affiliated Hospital of the Chinese University of Hong Kong (Shenzhen) from July 2021 to July 2024 were selected and divided into control group and treatment group according to the difference in drug use regimen, with 43 cases in each group. Patients in control group were po administered with Compound α-Ketoacid Tablets, 5 tablets/time, three times daily. Patients in treatment group were po administered with Yishen Huashi Granules with warm water on the basis of the control group, 1 bag/time, three times daily. Both groups were treated continuously for 4 months. The clinical efficacy and duration of clinical symptoms were observed, and the changes of renal function indexes, intestinal flora, exercise endurance and fatigue related indexes were compared between two groups. Results After treatment, the total effective rate of the treatment group was 86.05%, significantly higher than that of the control group (67.44%) (P < 0.05). In the course of treatment, the disappearance time of edema, polyuria, hematuria, and low back pain in treatment group were significantly shorter than those in control group (P < 0.05). After treatment, serum creatinine (Scr), uric acid (UA), blood urea nitrogen (BUN) and 24 h urinary protein quantity (24 h Upro) in two groups were significantly decreased compared with before treatment (P < 0.05). After treatment, the renal function indexes of treatment group was lower than those of control group (P < 0.05). After treatment, Escherichia coli in both groups was significantly lower than that before treatment, but Enterococcus faecalis, Bifidobacterium and Lactobacillus were significantly increased (P < 0.05). After treatment, the improvement of intestinal flora in treatment group was better than that in control group (P < 0.05). After treatment, anaerobic threshold (AT), peak oxygen uptake (VO₂peak) and peak oxygen pulse (VO₂/HRpeak) in both groups were significantly higher than those before treatment, but exercise endurance indexes and FACIT-F score were lower than those before treatment. The improvement of exercise endurance indexes and FACIT-F score in treatment group were better than those in control group (P < 0.05). Conclusion Yishen Huashi Granules combined with compound α-ketoacid can increase the benefit of non-dialysis chronic kidney disease patients, and can alleviate clinical symptoms, improve renal function and exercise endurance, correct intestinal flora imbalance, reduce fatigue with high safety.

R983

香港中文大学（深圳）院校联合基金重点项目（HUUF-ZD-202301）