Abstract: Objective To compare the incidence of hematologic adverse drug reactions caused by domestic and imported docetaxel in the treatment of breast cancer and research its influencing factors. Methods This research was analyzed retrospectively. The hospitalized patients in our hospital, who suffered from breast cancer and received chemotherapy of domestic and imported docetaxel between Jan 1, 2015 and Dec 31, 2016 were screened out by adverse drug events' active moniroring and assessment system. The suspected cases were reviewed manually for further study. Results The incidence of hematologic ADRs related to domestic and imported docetaxel was 47.10% and 53.67% respectively. And there was no significant difference in incidence of hematologic ADRs caused by domestic and imported docetaxel (P =0.232).Their severe ADRs were both leukopenia and neutropenia. The incidence of leukopenia and neutropenia induced by domestic docetaxel was 4.52% and 3.23%, while the incidence of imported docetaxel was 2.26% and 2.26%, and no significant differences existed between them(P =0.252, P =0.840). Neither of them induced severe thrombocytopenia and anemia. BMI (OR:0.940, 95% CI:0.885-0.999, P =0.047) and lung metastasis (OR:2.005, 95% CI:1.022-3.933, P =0.043) were independent influencing factors of hematologic ADRs caused by docetaxel. Conclusion The incidence of hematologic ADRs caused by domestic and imported docetaxel was high and both should be closely monitored in the course of clinical use to prevent the occurrence of severe ADRs and treat timely. The safety study on key drugs and related ADRs can be accomplished efficiently by the system, and it's worth popularizing.

Key words: docetaxel, breast cancer, hypocytosis, adverse drug reaction, automatic surveillance