Objective: To investigate the effects of berberine on urine albumin/creatine ratio (UACR) and serum cystatin C (Cys C) in patients with type 2 diabetes mellitus (T2DM). Methods: A total of 114 T2DM inpatients or outpatients, including 46 males and 68 females aged (55±14) years between January 2015 and January 2016 were randomly divided into two groups: the control group (n=57) only with hypoglycemic agents, and the intervention group (n=57) with berberine (0.4 g, 3 times a day) on the basis of treatment from the control group. Both groups were treated and followed up for six months. All the clinical and biochemical parameters were routinely evaluated before and after treatment. And the safety of berberine was assessed. Results: After the treatment, the improvement of glycosylated hemoglobin (HbA1c), blood urea nitrogen (BUN), systolic pressure (SP), high sensitive C-reactive protein (hs-CRP), rythrocyte sedimentation rate (ESR), estimated glomerular filtration rate (eGFR) in the intervention group were significantly better than those in the control group (all P<0.05), as well as the UACR[47(26, 120) mg/g vs 103(42, 267) mg/g, P<0.001]and serum Cys C[(0.83±0.30) mg/L vs (0.98±0.25) mg/L, P=0.031]. However, there was no statistically significant difference of UACR and Cys C between before and after treatment in the control group (all P>0.05). Compared to the control group, the patients in the intervention group had lesser UACR[47(26, 120) mg/g vs 68(28, 158) mg/g, P=0.039], and lower serum Cys C[(0.83±0.30) mg/L vs (0.96±0.30)mg/L, P=0.041]. Berberine had no obvious adverse effects. Multiple linear regression analysis revealed that the berberine administration was independently associated with the reduction of UACR (β=-0.051, P=0.041) and Cys C (β=-0.068, P=0.033) in T2DM patients. Conclusion: Berberine improves diabetic kidney disease by reducing UACR and serum Cys C in T2DM patients, and it was safe.
目的： 探讨黄连素(小檗碱)对2型糖尿病患者血清胱抑素C(Cys C)及尿微量白蛋白/肌酐比值(UACR)的影响。 方法： 选择2015年1月至2016年1月在上海市第六人民医院金山分院内分泌科门诊或住院的114例既往2型糖尿病患者，其中男46例，女68例，年龄(55±14)岁，采用随机数字表法将患者随机分为干预组(57例)及对照组(57例)，对照组降糖治疗方案为单用或联合应用降糖药物，干预组在对照组治疗基础上联合黄连素片口服(黄连素0.4 g/次，3次/d)治疗，两组连续治疗6个月，比较两组治疗前后UACR、血清Cys C及肝肾功能、血脂等生化指标的变化并评估黄连素的安全性。 结果： 治疗6个月后，干预组与对照组相比，糖化血红蛋白(HbA1c)、血尿素氮、收缩压、超敏C反应蛋白(hs－CRP)、红细胞沉降率(ESR)低，估算肾小球滤过率(eGFR)高，差异均有统计学意义(均P<0.05)。干预组UACR较治疗前降低[47(26，120) mg/g比103(42，267)mg/g，P<0.001]，且低于同期对照组[68(28，158)mg/g](P＝0.039)；干预组血清Cys C水平较治疗前下降[(0.83±0.30)mg/L比(0.98±0.25)mg/L，P＝0.031)]，且低于同期对照组[(0.96±0.30)mg/L](P＝0.041)。对照组治疗后UACR、Cys C水平与治疗前比较差异均无统计学意义(均P>0.05)，干预组未见严重不良反应。多重线性回归分析结果显示，应用黄连素是UACR(β＝－0.051，P＝0.041)、Cys C(β＝－0.068，P＝0.033)下降的独立影响因素。 结论： 黄连素可改善2型糖尿病患者UACR及Cys C水平，且安全、有效。.
Keywords: Berberine; Cystatin C; Diabetes mellitus, type 2; Urine albumin/creatine ratio.