目的 探讨金匮肾气丸联合复方α-酮酸治疗慢性肾功能衰竭维持性血液透析的临床疗效。方法 纳入2023年4月—2025年7月河北北方学院附属第一医院收治的120例慢性肾功能衰竭维持性血液透析患者，使用随机数字表法将其平均分为对照组和治疗组，每组各60例。对照组口服复方α-酮酸片，4片/次，3次/d。在对照组基础上，治疗组口服金匮肾气丸，1袋/次，2次/d。两组患者疗程12周。比较两组临床疗效，治疗前后肾功能指标[血肌酐（Scr）、尿素氮（BUN）、内生肌酐清除率（Ccr）、β2-微球蛋白（β2-MG）]、临床症状积分、心理痛苦筛查量表（DSS）和肾脏病生活质量简明量表1.3版（KDQOL-SFTM1.3）评分及血清成纤维细胞生长因子-23（FGF-23）、可溶性Klotho蛋白（sKlotho）、中性粒细胞明胶酶相关脂质运载蛋白（NGAL）、白细胞介素-17（IL-17）、超敏C反应蛋白（hs-CRP）水平。结果 治疗后，治疗组总有效率为93.33%，较对照组的80.00%明显升高（P＜0.05）。治疗后，两组Scr、BUN、β2-MG降低（P＜0.05），Ccr增高（P＜0.05）；治疗组肾功能优于对照组（P＜0.05）。治疗后，两组临床症状积分、DSS评分减少（P＜0.05），KDQOL-SFTM1.3评分增加（P＜0.05）；治疗组上述评分优于对照组（P＜0.05）。治疗后，两组血清FGF23、NGAL、IL-17、hs-CRP水平降低（P＜0.05），sKlotho水平上升（P＜0.05）；治疗组血清学指标均优于对照组（P＜0.05）。结论 金匮肾气丸联合复方α-酮酸治疗慢性肾功能衰竭维持性血液透析，能在调控矿物质代谢、抑制肾小管损伤及微炎症状态方面获得有利作用，进一步改善肾功能和临床症状，提高生活质量并减轻心理痛苦。

Objective To explore the clinical efficacy of Jinkui Shenqi Pills combined with compound α-ketoacid in treatment of maintenance hemodialysis for chronic renal failure. Methods A total of 120 patients with chronic renal failure undergoing maintenance hemodialysis admitted to the First Affiliated Hospital of Hebei North University between April 2023 and July 2025 were enrolled. The patients were equally divided into a control group and a treatment group using the random number table method, with 60 cases in each group. Patients in the control group were po administered with Compound α-ketoacid Tablets, 4 tablets per time, three times daily. On the basis of the control regimen, patients in the treatment group were po administered with Jinkui Shenqi Pills, 1 sachet per time, twice daily. The treatment course for both groups lasted 12 weeks. The clinical efficacy, renal function indicators such as serum creatinine (Scr), blood urea nitrogen (BUN), endogenous creatinine clearance rate (Ccr), β2-microglobulin (β2-MG), clinical symptom scores, psychological distress screening scale (DSS), and kidney disease quality of life simplified scale 1.3 (KDQOL-SFTM1.3) scores, as well as serum fibroblast growth factor-23 (FGF-23), soluble Klotho protein (sKlotho), neutrophil gelatinase associated lipocalin (NGAL), interleukin-17 (IL-17), and high-sensitivity C-reactive protein (hs CRP) levels were compared between the two groups before and after treatment. Results After treatment, the total effective rate of the treatment group was 93.33%, which was significantly higher than 80.00% of the control group (P < 0.05). After treatment, Scr, BUN, and β2-MG in both groups decreased (P < 0.05), while Ccr increased (P < 0.05); The renal function of the treatment group was superior to that of the control group(P < 0.05). After treatment, the clinical symptom scores and DSS scores of both groups decreased (P < 0.05), while the KDQOL-SFTM1.3 score increased (P < 0.05); The above scores in the treatment group were better than those in the control group (P < 0.05). After treatment, the levels of serum FGF23, NGAL, IL-17, and hs CRP in both groups decreased (P < 0.05), while the level of sKlotho increased (P < 0.05); All serological indicators in the treatment group were significantly better than those in the control group (P < 0.05). Conclusion For patients with chronic renal failure on maintenance hemodialysis, combination therapy with Jinkui Shenqi Pills and compound α-ketoacid exerts favorable effects on regulating mineral metabolism, alleviating renal tubular injury and suppressing microinflammatory status. It can further improve renal function and clinical symptoms, elevate quality of life, and relieve psychological distress.

R983

河北省医学科学研究课题计划项目（20241691）