OBJECTIVE: To observe the efficacy and safety of Zhenqi fuzheng granule combined with dasatinib in the treatment of BCR/ABL positive leukemia. METHODS: 40 patients with BCR-ABL positive chronic myeloid leukemia or PH-positive acute lymphoblastic leukemia were randomly divided into control group (20 cases) and observation group(20 cases). Control group received Dasatinib tablet, CML patients in chronic period received 100 mg, once a day, orally, morning or evening; CML patients in acceleration period and blastic period received 140 mg, once a day, orally, morning or evening, swallow whole, no cut or crushed. Observation group additionally received 15 g of Zhenqi fuzheng granule, twice a day. The treatment course for both groups was 24 months. Hematologic response, cytogenetic response and molecular biological response in 2 groups were observed, fatality rate, mean follow-up time and the incidence of adverse reactions were followed-up. RESULTS: CCR in observation group was significantly higher than control group, mean follow-up time was longer than control group, CCR median time was significantly shorter than control group, the incidence of adverse reactions and fatality rate were significantly lower than control group, the differences were statistically significant (P<0.05). There were no significant differences in the cytogenetic response and molecular biological response in 2 groups (P>0.05). CONCLUSIONS: Zhenqi fuzheng granule combined with dasatinib is superior to dasatinib alone in proving hematologic response and safety in the treatment of BCR-ABL positive leukemia, and similar in cytogenetic response and molecular biological response.