目的 观察补阳还五汤合参芪地黄汤化裁治疗气阴两虚、络脉瘀阻证糖尿病肾病（diabetic kidney disease，DKD）Ⅲ-Ⅳ期患者临床疗效及对肾小管损伤的保护作用。方法 将132例符合纳入标准的DKD患者分为对照组和中药组，各66例。对照组给予西医基础治疗并联合恩格列净片，中药组在对照组基础上联合补阳还五汤合参芪地黄汤化裁方，两组患者连续用药12周。观察两组患者临床疗效，比较两组患者治疗前后中医证候积分、糖尿病生存质量特异性量表（diabetes specific quality of life scale，DSQL）评分、糖脂代谢指标、肾功能指标、肾小管损伤指标、炎症因子的表达及不良反应的发生率。结果 中药组的总有效率（87.93%）明显高于对照组（75.00%）（P<0.05）。治疗后，两组患者的中医证候积分、DSQL评分、糖脂代谢指标、肾小管损伤指标、炎症因子的表达显著降低，血白蛋白（albumin，ALB）明显升高（P<0.05），以中药组的中医证候积分、DSQL评分、肾小管损伤指标、炎症因子的表达降低更明显（P<0.05）。此外，与治疗前相比，治疗后对照组血尿素氮（urea nitrogen，BUN）、血肌酐（creatinine，Scr）无明显差异（P>0.05），而中药组BUN、Scr明显降低（P<0.05）；治疗后两组比较，BUN、Scr差异有统计学意义（P<0.05）。两组不良反应发生率差异无统计学意义（P>0.05）。结论 补阳还五汤合参芪地黄汤化裁治疗DKD的疗效确切，可有效地降低患者尿蛋白排泄，调节糖脂代谢紊乱，抑制炎症因子表达，改善肾脏损伤，延缓DKD进展，且安全性良好。

Objective To evaluate the clinical efficacy of Buyang Huanwu Decoction (补阳还五汤) combined with Shenqi Dihuang Decoction (参芪地黄汤) on Ⅲ-Ⅳ stage of diabetic kidney disease (DKD) with qi-yin deficiency syndrome of collateral blood stasis and its protective effect on renal tubular damage. Methods A total of 132 patients with DKD who met the inclusion criteria were randomly divided into the control group and Chinese medicine group, with 66 cases in each group. The control group was given basic treatment combined with empagliflozin tablets, and the Chinese medicine group was combined with Buyang Huanwu Decoction and Shenqi Dihuang Decoction on the basis of the control group. The patients in the two groups were treated continuously for 12 weeks. The clinical efficacy of the two groups of patients was compared, and the TCM syndrome scores, the diabetes specific quality of life scale (DSQL), glucose and lipid metabolism indexes, renal function indexes, renal tubular injury indexes, the expression of inflammatory factors and the incidence of adverse reactions were observed in the two groups before and after treatment. Results The total effective rate of the Chinese medicine group (87.93%) was significantly higher than that of the control group (75.00%) (P < 0.05). After treatment, the TCM symptom score, DSQL score, glucose and lipid metabolism indexes, renal tubular injury indexes and inflammatory factors in the two groups were significantly decreased, and serum albumin (ALB) was significantly increased (P < 0.05). While, the TCM syndrome scores, DSQL scores, renal tubular injury indexes, and inflammatory factors decreased more significantly in the Chinese medicine group (P < 0.05). In addition, there was no significant difference in urea nitrogen (BUN) and serum creatinine (Scr) in the control group compared with before treatment, but there were significant differences in BUN and Scr in the Chinese medicine group compared with before treatment (P < 0.05). Conclusion Buyang Huanwu Decoction combined with Shenqi Dihuang Decoction is effective in the treatment of DKD. It can effectively reduce urinary protein excretion, regulate glucose and lipid metabolism disorders, inhibit the expression of inflammatory factors, improve kidney damage, and delay the progression of DKD without increasing adverse drug reactions.

R285.64

河北省重点研发计划项目（223777150D）；河北省教育厅重点项目（ZD2021081）；河北省自然科学基金资助项目（H2022423342，H2022423320）；河北省中医药管理局科研计划项目（2023119，2023126）