ABSTRACT
Objective:To evaluate the clinical efficacy of Jianpi-Huazhuo Decoction in the treatment of complication patients with phlegm-dampness in type 2 diabetes mellitus (T2DM) and Diabetic nephropathies (DN). Methods:A total of 72 patients with with phlegm dampness T2DM and DN in Huaibei Traditional Chinese Medicine Hospital of Anhui Province from June 2018 to June 2020 were randomly divided into two groups with 36 in each group. The control group were treated with oral metformin sustained-release tablets on the basis of diabetes propaganda. The observation group was treated with Jianpi-Huazhuo Decoction on the basis of the control group. Both groups were treated for 4 weeks. The blood glucose (plasma, enzyme method), HbA1c (whole blood, high performance liquid chromatography) and fasting insulin (serum, chemiluminescence method) were measured, and homeostasis model assessment of insulin resistance (HOMA-IR) was calculated. Plasma BUN, SCR and urinary albumin excretion rate (UAER) were measured by automatic biochemical analyzer. The plasma laminin (LN), procollagen Ⅲ (PC Ⅲ) and collagen type Ⅳ (Ⅳ-c) were detected by ELISA. The adverse events during treatment were observed and the clinical efficacy was evaluated. Results:The total effective rate was 86.1% (31/36) in the observation group and 58.3% (21/36) in the control group ( χ2 =6.923, P=0.009). After treatment, the levels of FBG, 2 hPG, HbA1c, FINS and HOMA-IR in the observation group were significanlty lower than those in the control group ( t values were 4.242, 2.751, 3.565, 3.613 and 4.512, respectively, all Ps<0.05). After treatment, the plasma levels of LN, PC Ⅲ and Ⅳ-c were significanlty lower than those in the control group ( t values were 3.612, 1.864 and 2.046, respectively, all Ps<0.05). After treatment, the levels of serum creatinine and urinary albumin excretion rate in the control group were significanlty lower than those in the control group ( t values were 5.864 and 3.286, respectively, all Ps<0.05). Conclusion:The Jianpi-Huazhuo Decoction can reduce the blood glucose level and renal fibrosis related factors in patients with phlegm dampness T2DM complicated with DN, improve the clinical symptoms and improve the clinical curative effect.