木丹颗粒联合厄贝沙坦对早期糖尿病肾病血浆转化生长因子β1和同型半胱氨酸的影响：一项随机、开放、平行、对照研究

目的：探讨木丹颗粒联合厄贝沙坦对2型糖尿病早期肾病患者血浆转化生长因子β1（ TGF-β1）和同型半胱氨酸（ Hcy）的影响。方法采用前瞻性随机、开放、平行、对照的研究方法，将72例2型糖尿病早期肾病患者按随机数字表法分为厄贝沙坦组和木丹颗粒联合厄贝沙坦组（联合治疗组），观察2组基线及治疗48周后尿白蛋白排泄率（ UAER）、尿β2微球蛋白（β2-MG）、血浆转化生长因子β1及同型半胱氨酸等水平的变化。结果2组患者基线指标比较无统计学差异（ P﹥0.05）。治疗48周后，2组治疗前后差值比较显示，联合治疗组较厄贝沙坦组能更好地降低尿白蛋白排泄率、尿β2微球蛋白和血浆血浆转化生长因子β1水平（-37±12对-22±10）μg·min-1，（-0.40±0.17对-0.24±0.12）mg·L-1，（-31±15对-14±12）U·L-1，均P﹤0.01]。结论与厄贝沙坦单药治疗相比，木丹颗粒联合厄贝沙坦能更好地降低血浆转化生长因子β1水平，减少尿白蛋白排泄和尿β2微球蛋白，可能具有一定的肾脏保护功能。

Effects of Mudan Particles combined with irbesartan on the levels of serum transforming growth factor-β1 and homocysteine in patients with early diabetic nephropathy:A randomized,open,parallel,controlled study

Objective To investigate the effects of Mudan Particles combined with irbesartan on the levels of serum transforming growth factor-β1(TGF-β1)and homocysteine(Hcy)in patients with early diabetic nephropathy.Methods Application of prospectively randomized,open,parallel,controlled methods,a total of 72 patients with early diabetic ne-phropathy were selected,and were randomly divided into two groups for Mudan Particles combined with irbesartan (combined therapy)or irbesartan treatment,respectively.Changes in urinary albumin excretion rate(UAER),urine β2-mi-croglobulin(β2-MG),the levels of serum TGF-β1 and Hcy were measured and compared between two groups at both pre-and post-treatment of 48 weeks.Results There were no statistically significant difference in the baseline clinical character-istics of study participants between two treatment groups( P﹥0. 05 ). Comparison of therapy-related differences between groups showed that the combined therapy was better in reducing UAER,urineβ2-MG and serum TGF-β1 than the irbesar-tan group(-37±12 vs -22±10)μg·min-1,(-0.40±0.17 vs -0.24±0.12)mg·L-1,(-31±15 vs -14±12)U·L-1,re-spectively,all P﹤0.01].Conclusion Compared with irbesartan monotherapy,Mudan Particles combined with irbesartan treatment can better reduce serum TGF-β1 levels,decrease UAER and urine β2-MG,and may exert kidney protection effects in patients with early diabetic nephropathy.