Abstract:

Objective　To investigate the effect of Jinkui Shenqi pills combined with chlorosartan potassium tablets on renal fibrosis indicators in elderly patients with diabetic nephropathy of the yin-yang deficiency type based on the transforming growth factor-β1 (TGF-β1) /Smads signal pathway. Methods　A total of 110 elderly patients with diabetic nephropathy of the yin-yang deficiency type treated at Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine from January 2023 to January 2024 were selected for the randomized controlled trial, and were divided into a control group and an observation group by the random number table method, with 55 cases in each group. There were 29 males and 26 females in the observation group; they were (68.59±5.48) years old; their disease course was (2.14±0.72) years. There were 32 males and 23 females in the control group; they were (69.25±5.74) years old; their disease course was (2.37±0.68) years. The control group took chlorosartan potassium tablets and conventional treatment; in addition, the observation group took Jinkui Shenqi pills. Both groups were treated continuously for 2 months. The scores of Chinese medicine symptoms, blood glucose levels [fasting blood glucose (FBG) and 2-hour postprandial blood glucose (2hPBG)], levels of renal function indicators [blood urea nitrogen (BUN), serum creatinine (SCr), and 24-hour urinary protein (24hUpro)], levels of renal fibrosis indicators [connective tissue growth factor (CTGF), procollagen type Ⅲ (PCⅢ), laminin (LN), and collagen type Ⅳ (CⅣ)], and protein and mRNA expressions of TGF-β1, Smad2, Smad3, and Smad7 were compared between the two groups before and after the treatment. The clinical efficacies and incidence rates of adverse reactions were compared between the two groups. t and χ² tests were used for the statistical analysis. Results　Before the treatment, there were no statistical differences in the score of traditional Chinese medicine symptoms, levels of FBG, 2hPBG, BUN, SCr, 24hUpro, LN, PCⅢ, CⅣ, and CTGF, and protein and mRNA expressions of TGF-β1, Smad2, Smad3, and Smad7 between the two groups (all P>0.05). After the treatment, the scores of traditional Chinese medicine symptoms, levels of FBG, 2hPBG, BUN, SCr, 24hUpro, LN, PCⅢ, CⅣ, and CTGF, and protein and mRNA expressions of TGF-β1, Smad2, and Smad3 were lower than those before the treatment in both groups, and those in the observation group were lower than those in the control group (all P<0.05). After the treatment, the protein and mRNA expressions of Smad7 were higher than those before the treatment in both groups, and those in the observation group were higher than those in the control group (all P<0.05). The total clinical effective rate of the observation group was higher than that of the control group [92.73% (51/55) vs. 72.73% (40/55); χ²=7.698; P<0.05]. There was no statistical difference in the total incidence rate of adverse reactions between the two groups (χ²=0.440; P>0.05). Conclusion　Jinkui Shenqi pills combined with chlorosartan potassium tablets in the treatment of elderly patients with diabetic nephropathy of the yin-yang deficiency type is effective, which may improve their clinical symptoms and renal function inhibiting the expression of the TGF-β1/Smads signal pathway, and reduce the degree of renal fibrosis.

Key words: Diabetic nephropathy,  , TGF-β1/Smads signal pathway,  , Jingui Shenqi , pills,  , Chlorosartan potassium tablets,  , Yin-yang deficiency type,  , Renal fibrosis

摘要：

目的　基于转化生长因子-β1（TGF-β1）/Smads信号通路探讨金匮肾气丸联合氯沙坦钾片对老年阴阳两虚型糖尿病肾病患者肾脏纤维化指标的影响。方法　选取2023年1月至2024年1月陕西中医药大学附属医院收治的110例老年阴阳两虚型糖尿病肾病患者进行随机对照试验。采用随机数字表法将其分为对照组和观察组，各55例。观察组男29例，女26例，年龄（68.59±5.48）岁，糖尿病肾病病程（2.14±0.72）年。对照组男32例，女23例，年龄（69.25±5.74）岁，糖尿病肾病病程（2.37±0.68）年。对照组在常规治疗基础上予氯沙坦钾片，观察组在对照组基础上予金匮肾气丸；两组均连续治疗2个月。比较两组治疗前后中医证候积分、血糖水平［空腹血糖（fasting blood glucose，FBG）、餐后2 h血糖（2-hour postprandial blood glucose，2hPBG）］、肾功能指标［尿素氮（blood urea nitrogen，BUN）、肌酐（serum creatinine，SCr）、24 h尿蛋白定量（24-hour urinary protein，24hUpro）］、肾纤维化指标［结缔组织生长因子（connective tissue growth factor，CTGF）、Ⅲ型前胶原（procollagen type Ⅲ，PCⅢ）、层黏蛋白（laminin，LN）、Ⅳ型胶原（collagen type Ⅳ，CⅣ）］水平及TGF-β1、Smad2、Smad3、Smad7蛋白及mRNA的表达。比较两组临床疗效及不良反应发生情况。采用t检验和χ²进行统计分析。结果　治疗前，两组中医证候积分、FBG、2hPBG、BUN、SCr、24hUpro、LN、PCⅢ、CⅣ、CTGF水平及TGF-β1、Smad2、Smad3、Smad7蛋白及mRNA的表达差异均无统计学意义（均P>0.05）。治疗后，两组中医证候积分、FBG、2hPBG、BUN、SCr、24hUpro、LN、PCⅢ、CⅣ、CTGF水平及TGF-β1、Smad2、Smad3蛋白及mRNA的表达均低于治疗前，且观察组均低于对照组（均P<0.05）。治疗后，两组Smad7蛋白及mRNA的表达均高于治疗前，且观察组均高于对照组（均P<0.05）。观察组临床总有效率高于对照组［92.73%（51/55）比72.73%（40/55）；χ²=7.698，P<0.05］。两组不良反应总发生率差异无统计学意义（χ²=0.440，P>0.05）。结论　金匮肾气丸联合氯沙坦钾片治疗老年阴阳两虚型糖尿病肾病患者的效果较好，其或是通过抑制TGF-β1/Smads信号通路的表达，进而改善患者临床症状及肾功能，减轻肾脏纤维化程度。

关键词: 糖尿病肾病, TGF-β1/Smads信号通路, 金匮肾气丸, 氯沙坦钾片, 阴阳两虚型, 肾脏纤维化