Effects of Tangshenan Formula on Micro-Urinary Albumin, Microinflammation and Insulin Resistance in Patients with Early Diabetic Nephropathy
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摘要: 目的 观察糖肾安方对早期糖尿病肾病(DN)患者尿微量白蛋白(micro-UALB)、微炎症状态、胰岛素抵抗(IR)的影响。方法 86例早期DN气阴两虚兼血瘀证的患者, 按照随机数字表法分为对照组与观察组各43例。对照组进行常规治疗, 观察组在对照组的治疗基础上加服糖肾安方。12周后比较2组患者治疗前后的中医证候积分、尿蛋白指标[尿微量白蛋白(micro-UALB)、尿白蛋白/尿肌酐(UACR)]、血清炎症因子[白细胞介素6(IL-6)、C反应蛋白(CRP)、肿瘤坏死因子α(TNF-α)]、胰岛素抵抗指标[空腹胰岛素(FIN)、稳态模型评估IR指数(HOMA-IR)、空腹血糖(FBG)]及肾功能指标[血清肌酐(SCr)、血尿素(BUN)]的变化。结果 治疗后, 观察组中医证候积分、尿蛋白指标、炎症指标、IR指数均明显下降, 差异具有统计学意义(P < 0.05, P < 0.01)，观察组优于对照组(P < 0.05, P < 0.01)。结论 糖肾安方可有效改善早期DN患者症状、减少尿蛋白、抑制炎症因子及改善胰岛素抵抗。Abstract: OBJECTIVE To observe the effects of Tangshenan formula on micro-urinary albumin (micro-UALB), microinflammatory status and insulin resistance (IR) in patients with early diabetic nephropathy (DN).METHODS A total of 86 patients with early stage DN, identified as deficiency of both qi and yin combined with blood stasis syndrome, were divided into 43 patients in the control group and 43 patients in the observation group according to the random number table. The control group was treated conventionally, while the observation group was treated with Tangshenan formula on the basis of the treatment of the control group. After 12 weeks of treatment, we compared the changes in traditional Chinese medicine (TCM) syndrome score, urine protein indexes [urine micro-UALB, urine albumin/urinary albumin creatinine (UACR)], serum microinflammatory factors [interleukin 6 (IL-6), C-reactive protein (CRP), tumor necrosis factor α (TNF-α)], insulin resistance indexes [fasting insulin (FIN), homeostasis model assessment IR index (HOMA-IR)], fasting blood glucose (FBG), as well as renal function indexes [serum creatinine (SCr), blood urea nitrogen (BUN)].RESULTS After treatment, the TCM syndrome score, urine protein index, inflammation index and IR index in the observation group reduced significantly, and the differences were statistically significant (P < 0.05, P < 0.01); the results in the treatment group were better than those in the control group (P < 0.05, P < 0.01).CONCLUSION Tangshenan formula can effectively relieve the symptoms, reduce proteinuria, inhibit inflammatory factors and enhance insulin resistance in early DN patients.
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表 1 2组患者治疗前后中医证候积分比较(x±s, n=43)
组别 时间 总积分 尿浊 乏力 气短 咽干口燥 对照组 治疗前 20.81±5.18 2.02±1.06 2.86±0.68 2.47±0.85 2.42±0.70 治疗后 19.16±3.15 1.44±0.73* 2.58±0.63* 2.53±0.80 2.35±0.65 观察组 治疗前 20.58±4.68 2.33±0.84 2.77±0.61 2.37±0.79 2.33±0.68 治疗后 14.93±4.02**## 1.16±0.76* 2.37±0.66** 2.21±0.86 1.67±0.84**## 组别 时间 头晕 多梦 尿频尿多 手足心热 心悸 对照组 治疗前 2.23±0.92 2.35±0.81 2.33±0.94 2.63±0.82 1.51±0.83 治疗后 2.16±0.84 2.07±0.77 2.12±0.88 2.40±0.79* 1.51±0.77 观察组 治疗前 2.16±0.87 2.19±0.80 2.40±0.79 2.58±0.82 1.49±0.82 治疗后 1.81±0.88 1.4±0.82**## 1.72±0.70**# 1.74±0.85**## 1.17±0.83**## 注: 组内比较, *P < 0.05，**P < 0.01;组间比较, #P < 0.05, ##P < 0.01。 
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表 2 2组患者治疗前后尿蛋白指标比较(x±s, n=43)
组别 时间 micro-UALB/(mg·L-1) UACR/(mg·mmol-1) 对照组 治疗前 190.36±28.48 16.66±4.94 治疗后 181.26±27.34 16.48±4.22 观察组 治疗前 193.13±29.96 16.65±5.69 治疗后 134.76±31.67**## 10.09±3.59**## 注: 组内比较, **P < 0.01;组间比较, ##P < 0.01。
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表 3 2组患者治疗前后IR相关指标比较(x±s, n=43)
组别 时间 FBG/(mmol·L-1) FIN/(μU·mL-1) HOMA-IR 对照组 治疗前 6.69±0.73 15.92±7.16 57.32±13.57 治疗后 6.74±0.77 14.94±6.22 54.63±12.39 观察组 治疗前 6.75±0.82 15.18±5.84 57.53±12.72 治疗后 6.96±0.75 10.75±4.35**## 40.9±12.77**## 注: 组内比较, **P < 0.01;组间比较, ##P < 0.01。
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表 4 2组患者治疗前后炎症因子水平比较(x±s, n=43)
组别 时间 CRP/(mg·L-1) IL-6/(pg·mL-1) TNF-α/(pg·mL-1) 对照组 治疗前 7.13±1.94 6.64±2.01 4.26±1.10 治疗后 7.17±1.56 6.49±2.14 4.18±1.20 观察组 治疗前 7.36±1.47 6.88±2.17 4.21±1.05 治疗后 2.28±1.06**## 2.62±1.08**## 1.89±0.73**## 注: 组内比较, **P < 0.01;组间比较, ##P < 0.01。
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表 5 2组患者治疗前后肾功能比较(x±s, n=43)
组别 时间 BUN/(mmol·L-1) Scr/(μmol·L-1) 对照组 治疗前 5.39±0.90 67.36±7.49 治疗后 5.36±0.79 66.62±9.53 观察组 治疗前 5.66±0.62 67.12±8.13 治疗后 5.52±0.63 66.56±8.30
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