| Objective To compare the efficacy and safety of nilotinib and imatinib in the early treatment (three months) of chronic myelogenous leukemia (CML). Methods A total of 129 cases of chronic myelogenous leukemia patients admitted to our hospital from Jan 2007 to Dec 2017 were selected and randomized into two groups according to the ratio of 1:7, among whom 18 patients were treated with nilotinib 300~400mg twice a day, and 111 patients with imatinib 300~400mg once daily. Bone marrow morphology and BCR-ABLIS were assessed after three months of medication, and the efficacy (the proportion of BCR-ABLIS ≤ 10%, BCR-ABLIS ≤ 0.0032%) and safety(the occurrence of leukopenia, thrombocytopenia, anemia, prolongation of Q-T interval, and liver dysfunction, skeletal muscle pain, edema, rash, gastrointestinal symptoms and other adverse reactions) were compared. Results The percentage of patients with BCR-ABLIS ≤ 10% and BCR-ABLIS ≤ 0.0032% in nilotinib group was both higher than that in imatinib group (94.44% vs 69.37%; 55.55% vs 27.92%) after three months of medication, and the differences were statistically significant. There were two cases in nilotinib group (11.11%). There was no significant difference in the incidence of adverse reactions between the two groups (P>0.05). Conclusion The early molecular response rate of nilotinib is higher than imatinib in the treatment of CML, and the depth of remission is better than imatinib. No difference exists in the occurrence rate of adverse reactions. |
