Objective To observe the clinical efficacy ofFufang Shenlu Granule for kidney-yang deficiency aplastic anemia (AA) and its effects on CD4+ T lymphocyte subsets, and explore its mechanism.Methods Forty AA patients were randomly divided into treatment group and control group, 20 cases in each group. The treatment group was treated withFufang Shenlu Granule combined with conventional western medicine therapy, while the control group was only treated with conventional western medicine therapy. The treatment lasted for 6 months, and follow-up visits lasted for at least one year. The clinical efficacy and T lymphocyte subsets ratio changes before and after treatment in the two groups were observed.Results The clinical efficacy of treatment group was better than that of control group (P<0.05). After treatment, the blood cell counts of the two groups were improved than those of before treatment (P<0.05,P<0.01). After treatment, the red blood cell count and hemoglobin of treatment group were higher than those of control group (P<0.05). Compared with the data before treatment in treatment group, the ratio of CD4+CD25+ cells in all CD4+ cells, and the ratio of CD4+CD25+FoxP3+ cells in all CD4+CD25+ cells increased (P<0.05); the ratio of Th1 and Th2 cells in all CD3+CD4+ decreased (P<0.05). The ratio of Th2 cells was lower than that before treatment in the control group (P<0.05).ConclusionFufang Shenlu Granule can enhance the treatment efficiency of AA with kidney-yang deficiency syndrome. The mechanism may be related to the decrease of Th1 cells, the increase of CD4+CD25+Tregs and their FoxP3 expression.