Abstract:Objective To investigate the influences of Jiangtangjing granule on the curative effect of early diabetic nephropathy (DN) and on urinary microalbumin (UMA). Methods Forty-two patients with confirmed DN from August 2016 to September 2017 were selected and randomly divided into control group and observation group (n=21, each). The routine western medicine such as hypoglycemia and hypotension was given in control group, and the Jiangtangjing granule[self-made preparations of Nantong Hospital of Traditional Chinese Medicine, approval number:Z04001366, containing Huangqi (Astragalus propinquus), Huangjing (Polygonatumsibiricum), Yiyi (Coixlacryma-jobi seed), Gegen (Pueraria lobata root), Shanyao (Dioscoreapolystachya), Shanzha (Crataeguscuneata), Shuizhi (Hirudomedicinalis) and Baijiezi (Sinapis alba seed)] was added in observation group based on the routine treatment. All patients took medicine 3 times a day, 10 g each time with warm water for 8 weeks in both two groups. The change in the levels of UMA, urinary beta-2-microglobulin (β₂-MG), blood urea nitrogen (BUN) and serum creatinine (SCr) were observed before and after treatment; the difference of curative effect was evaluated based on the improvement of clinical symptoms and signs; the incidence of adverse drug reactions (ADR) was observed to evaluate their safety in two groups. Results The total effective rate was 85. 71% in observation group and 66. 67% in control group, but there was no statistical difference (P>0.05). Before treatment, there was no significant difference in Traditional Chinese Medicine (TCM) syndrome scores between two groups (P>0.05). After 2-, 4-and 8-week of treatment, TCM symptom scores decreased significantly compared with those before treatment in both two groups, and they were significantly lower in observation group than those in control group ( all P<0.05). Before treatment, there were no significant differences in residual renal function (RRF) and urine volume between two groups (P>0.05). After treatment, RRF and urine volume were significantly lower than those before treatment in two groups and decreased significantly in observation group compared with control group (P<0.05) ; UMA, β₂-MG, BUN and other indicators were significantly lower than those before treatment in both two groups, and UMA and β₂-MG in observation group were significantly lower than those in control group (all P<0.05). No obvious adverse drug reactions occurred during the treatment in both two groups without statistical difference in the incidence of drug related adverse reactions between two groups (P>0.05). Conclusion Jiangtangjing granule can significantly improve the clinical efficacy of early DN patients and reduce the levels of UMA, β₂-MG and BUN. The safety of medication-use process is good.