Objective To observe the Compound Xiancao granule's clinical effect in the treatment of early diabetic nephropathy, and to evaluate its effectiveness and safety. Methods A total of 60 hospitalized patients with I-III diabetic nephropathy and deficiency of both spleen and kidney, blocking of dampness-heat in TCM syndrome differentiation were selected from Ruikang Hospital Afillicated to Guangxi University of Chinese Medicine and were randomly assigned into a control group with 30 cases and a treatment group with 30 cases. The control group was treated with western therapy by routinely reduced blood sugar, controlled blood pressure, moderated exercise and other basic treatment. Correspondingly, the treatment group was treated with same method, but additionally with use of 27 g of the Compound Xiancao granule for three times per day. The treatment courses of both groups lasted for 3 months, and the clinical sign of patients before and after the treatment and indexes of urine (ACR, Cyst C, UAER,Uβ2-MG), blood glucose (FPG、2hPG and HbAlc), Hcy, cTnT were observed to compare the curative effects of two methods respectively. Results The overall clinical efficacy on two groups had significant difference ( < 0.05). The total effective rate of control group was 55.17% and the the total effective rate of treatment group was 85.71%( <0.05). A more significant decrease in syndrome score of TCM in treatment group was noticed while both groups' syndrome score of TCM showed a decline ( <0.05). ACR, UAER, Uβ2-MG, UCyst C, Hcy and cTnT in both groups were decreased after treatment ( < 0.05), but the decline of those indexes in treatment group was comparatively more significant ( < 0.05). FPG, 2hPG and HbA1C showed a reduction after treatment in both groups, but no obvious difference was observed in the comparison of above indexes between two groups ( >0.05). Conclusions The Compound Xiancao granule is considered valid in reducing DN patients' syndrome score of TCM, improving renal function and decreasing the excretion of urinary protein. Its clinical efficiency is not completely relying on the deduction of blood glucose.%目的：通过观察复方仙草颗粒治疗早期糖尿病肾病临床疗效，评价该药的有效性及安全性，并探讨其作用机制。方法选取在广西中医药大学附属瑞康医院就诊的60例早期糖尿病肾病的患者（属于糖尿病肾病III期且中医辨证属脾肾亏虚，湿热瘀血），随机分为治疗组和对照组各30例，对照组采用西医常规治疗（降糖、适量运动、控制血压等），治疗组在对照组治疗的基础上加服复方仙草颗粒，两组共同疗程为12周。监测两组患者治疗前后尿液相关指标（ACR、UCyst C、UAER、Uβ2- MG）、血糖（FPG、2hPG、HbAlc）、血清同型半胱氨酸（Hcy）及心肌肌钙蛋白T（cTnT），同时观察患者治疗前后的临床体征及症状改善状况，比较两组治疗后的效果。结果治疗后两组患者取得较好的疗效，治疗组85.71%优于对照组55.17%（<0.05）。两组中医症候积分经过治疗后均有所下降（<0.05），但治疗组较对照组下降更为明显（<0.05）。两组治疗后ACR、UAER、Uβ2- MG及UCyst C均有所下降（<0.05），但治疗组较对照组下降更为明显（<0.05）。两组治疗后Hcy、cTnT均有所下降（<0.05），但治疗组较对照组下降更为明显（<0.05）。两组FPG、2hPG及HbAlc治疗后均有下降（<0.05），但两组FPG、2hPG及HbAlc治疗后比较差异无统计学意义（>0.05）。结论复方仙草颗粒可改善早期糖尿病肾病患者的中医证候积分，改善肾功能，减少尿白蛋白排泄，取得较好的临床疗效且并不依赖于血糖的控制。
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