目的 探讨渴络欣胶囊联合培哚普利治疗早期糖尿病肾病的临床疗效。方法 选取2021年6月—2023年1月郑州大学第五附属医院收治的168例早期糖尿病肾病患者，按随机数字表法将患者分为对照组和治疗组，每组各84例。对照组晨服培哚普利叔丁胺片，4 mg/d，1次/d。治疗组在对照组基础上口服渴络欣胶囊，4粒/次，3次/d。两组疗程12周。比较两组临床疗效，治疗前后中医症状积分、肾功能指标[24 h尿蛋白定量（24 h UP）等]、相关量表[肾脏病生活质量量表1.3（KDQOL-SF 1.3）、简式抑郁-焦虑-压力量表（DASS-21）]评分及血清血管生成抑制蛋白1（VASH-1）、高迁移率族蛋白B1（HMGB1）、CXC趋化因子配体10（CXCL10）水平。结果 治疗后，治疗组总有效率是94.05%，显著高于对照组的84.52%（P＜0.05）。治疗后，两组气短乏力积分、咽干口渴积分、肢体麻木积分、肢体麻木积分、腰膝酸软积分、畏寒肢冷积分均较治疗前显著降低（P＜0.05）；治疗后，治疗组中医症状积分低于对照组（P＜0.05）。治疗后，两组血肌酐（Scr）、24 h UP、尿蛋白排泄率（UAER）低于同组治疗前（P＜0.05）；治疗后，治疗组肾功能指标改善优于对照组（P＜0.05）。治疗后，两组KDQOL-SF 1.3评分均显著增高，而DASS-21评分均显著降低（P＜0.05）；治疗后，治疗组KDQOL-SF 1.3评分和DASS-21评分改善优于对照组（P＜0.05）。治疗后，两组血清VASH-1、HMGB1、CXCL10水平均显著降低（P＜0.05）；治疗后，治疗组血清VASH-1、HMGB1、CXCL10水平低于对照组（P＜0.05）。结论 渴络欣胶囊联合培哚普利治疗早期糖尿病肾病具有良好的疗效，能有效缓解机体炎症反应、控制肾组织纤维化，在患者症状和负面情绪减轻、肾功能和生活质量改善方面获得更佳效果，值得临床推广应用。

Objective To explore the clinical efficacy of Keluoxin Capsules combined with perindopril in treatment of early diabetes nephropathy. Methods A total of 168 patients with early diabetic nephropathy admitted to the Fifth Affiliated Hospital of Zhengzhou University from June 2021 to January 2023 were selected and divided into control group and treatment group according to random number table method, with 84 patients in each group. Patients in the control group were po administered with Perindopril tert-Butylamine Tablets in the morning, 4 mg/d, once daily. Patients in the treatment group were po administered with Keluoxin Capsules on the basis of the control group, 4 grains/time, three times daily. Both groups were treated for 12 weeks. The clinical efficacy of two groups was observed, and traditional Chinese medicine symptom scores, renal function indicators
[24 hour urinary protein quantification (24-hour UP)], related scales
[Kidney Disease Quality of Life Scale 1.3 (KDQOL-SF 1.3), Simplified Depression Anxiety Stress Scale (DASS-21)] scores before and after treatment, as well as serum levels of angiogenic inhibitory protein-1 (VASH-1), high mobility group protein B1 (HMGB1), and CXC chemokine ligand 10 (CXCL10) in two groups were compared. Results After treatment, the total effective rate of the treatment group was 94.05%, which was significantly higher than that of the control group (84.52%, P < 0.05). After treatment, the scores of shortness of breath and fatigue, dry throat and thirst, limb numbness, limb numbness, waist and knee tenderness and cold limb fear were significantly decreased in both groups compared with before treatment (P < 0.05). After treatment, the TCM symptom score of the treatment group was lower than that of the control group (P < 0.05). After treatment, Scr, 24 h UP and UAER in 2 groups were lower than before treatment (P < 0.05). After treatment, the improvement of renal function index in treatment group was better than that in control group (P < 0.05). After treatment, KDQOL-SF 1.3 score was significantly increased in both groups, while DASS-21 score was significantly decreased (P < 0.05). After treatment, KDQOL-SF 1.3 and DASS-21 scores in the treatment group were better than those in the control group (P < 0.05). After treatment, the serum levels of VASH-1, HMGB1 and CXCL10 in 2 groups were significantly decreased (P < 0.05). After treatment, serum levels of VASH-1, HMGB1 and CXCL10 in the treatment group were lower than those in the control group (P < 0.05). Conclusion Keluoxin Capsules combined with perindopril has good curative effect in treatment of early diabetes nephropathy, and can effectively relieve inflammation, control renal fibrosis, reduce symptoms and negative emotions, improve renal function and quality of life in patients, which is worthy of clinical application.

R977

河南省医学科技攻关项目（LHGJ20210493）