To observe the clinical efficacy of Shengma Biejia Decoction in the treatment of acute myeloid leukemia and evaluate its effect on T lymphocyte subsets in patients.Methods：A total of 70 cases of acute myeloid leukemia in Yankuang Group Co.，Ltd.General Hospital from April 2012 to April 2015 were included in the study.The random number method was used to divide into a control group and an observation group，with 35 cases in each group.35 healthy people in the same period were used as healthy control group.Two groups of patients received routine treatment，including liver protection，antiemetic，nutritional support，etc.The control group was treated with DA，HA or EA regimen on the basis of routine treatment.On the basis of the control group，the observation group added Shengma Biejia Decoction，1 dose per day，and 200 mL decoction，and took 60 doses with warm decoction in the morning and evening.The changes of SF-36 quality of life scale，hematopoiesis recovery time，recurrence time and complications，interleukin 2(IL-2)，interleukin 4(IL-4)，interleukin 10(IL-10)and interferon(IFN-gamma)concentration in the 2 groups were observed before and after treatment.The changes of CD3+，CD4+ and CD8+ levels were observed.Results：1)the score of SF-36 quality of life was increased after treatment in the 2 groups than before treatment(P<0.05)，and the increase of the observation group was better than that of the control group(P<0.05). 2)the recovery time of marrow nucleated cells(ANC)>0.5×109/L and recovery time of platelet>20.0×109/L in the observation group were obviously shortened than that of the control group(P<0.05)，and the recurrence time was significantly longer than that in the control group(P<0.05).3)After treatment，the CD3+，CD4+ and CD4+/CD8+ of the 2 groups were all higher than those before the treatment，and CD8+ was lower than that before the treatment.Among them，the observation group was better than that of the control group(P<0.05).The difference between the 2 groups after the treatment and the healthy control group was still statistically significant(P<0.05).4)after treatment，the IL-2 and IFN-gamma in the 2 groups were all higher than before the treatment，IL-4 and IL-10 were lower than those before the treatment，and the improvement of the observation group was better than that of the control group(P<0.05).The difference between the 2 groups after the treatment and the healthy control group was still statistically significant(P<0.05).5)The main adverse reactions in the 2 groups were pharynx infection，urine blood，oral infection and gastrointestinal reaction.The incidence of adverse reactions in the observation group was lower than that of the control group(P<0.05).Conclusion：Shengma Biejia Decoction can effectively assist in the treatment of acute myeloid leukemia and reduce the incidence of ADR，and its mechanism may be related to the correction of the disorder of T cell subgroup in patients.