目的 探討渴絡(luò)欣膠囊聯(lián)合培哚普利治療早期糖尿病腎病的臨床療效。方法 選取2021年6月—2023年1月鄭州大學(xué)第五附屬醫(yī)院收治的168例早期糖尿病腎病患者，按隨機(jī)數(shù)字表法將患者分為對(duì)照組和治療組，每組各84例。對(duì)照組晨服培哚普利叔丁胺片，4 mg/d，1次/d。治療組在對(duì)照組基礎(chǔ)上口服渴絡(luò)欣膠囊，4粒/次，3次/d。兩組療程12周。比較兩組臨床療效，治療前后中醫(yī)癥狀積分、腎功能指標(biāo)[24 h尿蛋白定量（24 h UP）等]、相關(guān)量表[腎臟病生活質(zhì)量量表1.3（KDQOL-SF 1.3）、簡(jiǎn)式抑郁-焦慮-壓力量表（DASS-21）]評(píng)分及血清血管生成抑制蛋白1（VASH-1）、高遷移率族蛋白B1（HMGB1）、CXC趨化因子配體10（CXCL10）水平。結(jié)果 治療后，治療組總有效率是94.05%，顯著高于對(duì)照組的84.52%（P＜0.05）。治療后，兩組氣短乏力積分、咽干口渴積分、肢體麻木積分、肢體麻木積分、腰膝酸軟積分、畏寒肢冷積分均較治療前顯著降低（P＜0.05）；治療后，治療組中醫(yī)癥狀積分低于對(duì)照組（P＜0.05）。治療后，兩組血肌酐（Scr）、24 h UP、尿蛋白排泄率（UAER）低于同組治療前（P＜0.05）；治療后，治療組腎功能指標(biāo)改善優(yōu)于對(duì)照組（P＜0.05）。治療后，兩組KDQOL-SF 1.3評(píng)分均顯著增高，而DASS-21評(píng)分均顯著降低（P＜0.05）；治療后，治療組KDQOL-SF 1.3評(píng)分和DASS-21評(píng)分改善優(yōu)于對(duì)照組（P＜0.05）。治療后，兩組血清VASH-1、HMGB1、CXCL10水平均顯著降低（P＜0.05）；治療后，治療組血清VASH-1、HMGB1、CXCL10水平低于對(duì)照組（P＜0.05）。結(jié)論 渴絡(luò)欣膠囊聯(lián)合培哚普利治療早期糖尿病腎病具有良好的療效，能有效緩解機(jī)體炎癥反應(yīng)、控制腎組織纖維化，在患者癥狀和負(fù)面情緒減輕、腎功能和生活質(zhì)量改善方面獲得更佳效果，值得臨床推廣應(yīng)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

河南省醫(yī)學(xué)科技攻關(guān)項(xiàng)目（LHGJ20210493）