【目的】 探讨益肾养阴固精方（左归丸化裁）在2型糖尿病肾病气阴两虚证治疗中的应用价值，观察其对炎症反应、胰岛 β 细胞功能及肾功能的影响。【方法】 将 2020 年 5 月至 2023 年 7 月在陕西中医药大学附属医院就诊的 162 例 2 型糖尿病肾病 气阴两虚证患者按随机数字表法随机分为观察组和对照组，每组各 81例。对照组给予降压、护肾等西医常规治疗，观察组 在对照组的基础上联合益肾养阴固精方治疗，疗程为 12周。观察 2组患者治疗前后中医证候总积分、胰岛素敏感指数、胰 岛素分泌指数、24 h 尿蛋白定量（24hUTP）及血清糖化血红蛋白（HbA1c）、空腹胰岛素（FINS）、空腹血糖（FBG）、血肌酐 （SCr）、尿素氮（BUN）、转化生长因子β1（TGF-β1）、NLRP3炎症小体、白细胞介素6（IL-6）、超氧化物歧化酶（SOD）、1-磷酸 鞘氨醇（S1P）水平的变化情况，并比较 2组患者的临床疗效。【结果】（1）治疗12周后，观察组的总有效率为93.83%（76/81）， 对照组为 83.95%（68/81），组间比较，观察组的疗效明显优于对照组（χ2 = 9.163，P < 0.05）。（2）治疗后，2 组患者的胰岛素 敏感指数、胰岛素分泌指数均较治疗前升高（P < 0.05），中医证候总积分均较治疗前降低（P < 0.05），且观察组对胰岛素敏感 指数、胰岛素分泌指数的升高幅度及对中医证候总积分的降低幅度均明显优于对照组（P < 0.05）。（3）治疗后，2组患者的血 清 HbA1c、FINS、FBG、SCr、BUN 及 24hUTP 水平均较治疗前降低（P < 0.05），且观察组对血清 HbA1c、FINS、FBG、SCr、 BUN及24hUTP水平的降低幅度均明显优于对照组（P < 0.05）。（4）治疗后，2组患者的血清TGF-β1、IL-6、NLRP3炎症小体 水平均较治疗前降低（P < 0.05），血清 S1P、SOD 水平均较治疗前升高（P < 0.05），且观察组对血清 TGF-β1、IL-6、NLRP3 炎症小体水平的降低幅度及对血清S1P、SOD水平的升高幅度均明显优于对照组（P < 0.05）。【结论】 对于2型糖尿病肾病气阴 两虚证患者而言，联合益肾养阴固精方治疗有助于减轻炎症反应，改善胰岛β细胞功能，调节血糖水平，改善肾功能，提高 临床疗效。

Objective To explore the efficacy of Yishen Yangyin Gujing Prescription [derived from Zuogui Wan （Bolus for Replenishing Kidney-Yin）］ for the treatment of diabetic nephropathy in type 2 diabetes mellitus （T2DM）with qi and yin deficiency syndrome，and to observe its effects on inflammatory responses，pancreatic β- cell function and renal function. Methods A total of 162 T2DM patients with diabetic nephropathy of qi and yin deficiency syndrome who admitted to the Affiliated Hospital of Shaanxi University of Chinese Medicine from May 2020 to July 2023 were randomly divided into an observation group and a control group according to the random number table method，with 81 cases in each group. The control group was given conventional western medicine treatment for lowering blood pressure and renal protection，while the observation group was treated with Yishen Yangyin Gujing Prescription on the basis of treatment for the control group. The course of treatment for the two groups covered 12 weeks. Before and after the treatment， the changes in the outcomes of the two groups were observed，and the outcomes included the total scores of traditional Chinese medicine（TCM）syndrome，insulin sensitivity index，insulin secretion index，24-h urine total protein quantification（24hUTP），and serum levels of glycosylated hemoglobin（HbA1c）， fasting insulin（FINS）， fasting blood glucose（FBG）， serum creatinine （SCr）， blood urea nitrogen （BUN）， transforming growth factor β1 （TGF - β1）， NLRP3 inflammasome， interleukin 6（IL-6），superoxide dismutase（SOD）and sphingosine-1-phosphate（S1P）. After treatment，the clinical efficacy of the two groups of patients was compared. Results（1）After 12-week treatment， the total effective rate of the observation group was 93.83%（76/81），and that of the control group was 83.95%（68/81）. The intergroup comparison showed that the efficacy of the observation group was significantly superior to that of the control group（χ2 = 9.163，P < 0.05）.（2）After treatment，the insulin sensitivity index and insulin secretion index in the two groups of patients were increased（P < 0.05）and the total scores of TCM syndromes were decreased（P < 0.05） when compared with those before treatment， and the increase of insulin sensitivity index and insulin secretion index as well as the decrease of the total scores of TCM syndrome in the observation group was significantly superior to that in the control group（P < 0.05）.（3）After treatment，the serum levels of HbA1c， FINS，FBG，SCr，BUN and 24hUTP in the two groups of patients were decreased when compared with those before treatment（P < 0.05），and the decrease of the above indicators in the observation group was significantly superior to that in the control group（P < 0.05）.（4）After treatment，the serum TGF-β1，IL-6，and NLRP3 inflammasome levels in the two groups of patients were decreased（P < 0.05）and the serum S1P and SOD levels were increased（P < 0.05）when compared with those before treatment，and the decrease of serum TGF-β1，IL- 6，and NLRP3 inflammasome levels as well as the increase of serum S1P and SOD levels in the observation group was significantly superior to that in the control group（P < 0.05）. Conclusion For T2DM patients with diabetic nephropathy of qi and yin deficiency syndrome，the combined use of western medicine and Yishen Yangyin Gujing Prescription treatment is helpful to alleviate inflammatory response，improve the function of pancreatic β- cells， regulate the blood glucose level，improve renal function，and enhance the clinical efficacy.

R259.872

陕西省重点研发计划项目（编号：2020SF-336）