Clinical efficacy of compound Huangdai tablets combined with all-trans retinoic acid in the treatment of acute promyelocytic leukemia / 中国基层医药

ABSTRACT

Objective:To investigate the clinical efficacy of compound Huangdai tablets combined with all-trans retinoic acid in the treatment of acute promyelocytic leukemia. Methods:A total of 120 patients with acute promyelocytic leukemia who received treatment in the First People's Hospital of Huzhou, China between February 2013 and February 2015 were included in this study. They were randomly assigned to receive either all-trans retinoic acid, mercaptopurine and methotrexate in combination (control group, n = 60) or all-trans retinoic acid combined with compound Huangdai tablets (study group, n = 60). The time to hemoglobin rebounding, the time to platelet count rebounding, and the time to first complete remission were recorded. The recurrence and death of patients during 5 years of follow up were recorded. Adverse drug reactions during the treatment period were recorded. Results:The time to hemoglobin rebounding, the time to platelet count rebounding, and the time to first complete remission in the study group were (19.56 ± 2.61) days, (20.42 ± 2.73) days, (1.74 ± 0.45) months, respectively, which were significantly shorter than those in the control group [(28.42 ± 3.85) days, (30.63 ± 4.02) days, (3.31 ± 0.69) months, t = 10.328, 9.746, 8.521, P < 0.001]. The 1-year and 5-year recurrence rate in the study group were 11.37% and 21.67% respectively, which were significantly lower than those in the control group [28.33%, 41.67%, χ2 = 5.208, 5.546, P = 0.022, 0.019]. 5-year mortality rate in the study group was significantly lower than that in the control group [8.33% vs. 25.00%, χ2 = 6.000, P = 0.014]. There was no significant difference in adverse drug reaction between study and control group [28.33% vs. 26.67%, χ2 = 0.042, P = 0.838]. Conclusion:Compound Huangdai tablets combined with all-trans retinoic acid can effectively shorten the remission time of acute promyelocytic leukemia, reduces the disease recurrence rate and mortality rate, and is highly safe.