Abstract: Objective To observe the effect of all-trans retinoic acid (ATRA) combined with arsenious acid (ATO) on liver function damage in patients with acute promyelocytic leukemia (APL).Methods From January 2012 to April 2021, 92 newly diagnosed APL patients (50 males and 42 females), aged 40 (12, 77) years, were reviewed. Among them, 38 cases were induced by ATRA or ATO alone, and 54 cases were induced by the combination treatment. Mann-Whitney U-test was used for measurement data and chi-square test was used for counting data. Kaplan-Meier method was used for survival analysis, and log-rank test was used for difference comparison.Results The complete remission (CR) time of combined induction group and single induction group was 27 (20, 38) days and 35 (25, 50) days, and the difference was statistically significant (P<0.05). There were 36 cases (66.7%) and 14 cases (36.8%) of liver function damage in combined induction group and single induction group respectively, and the difference was statistically significant (P<0.05). There were 23 cases (42.6%) and 5 cases (13.1%) of grade Ⅲ/Ⅳ liver damage in combined induction group and single induction group, and the difference was statistically significant (P<0.05). 87 patients with hematological CR continued to complete consolidation therapy (> 2 cycles), among which 23 patients received ATRA combined with ATO consolidation chemotherapy over 1 cycle, and 3 patients (13.0%) had liver function damage. The incidence of liver damage in ATRA combined with ATO consolidation therapy was significantly lower than that in combined induction therapy (P<0.05). 52 patients who completed consolidation therapy continued to receive ATRA and ATO sequential maintenance therapy, of which 12 patients (23.1%) had liver function damage. The incidence of liver function damage in ATRA and ATO sequential maintenance therapy was significantly lower than that in combined induction therapy (P<0.05). Patients were followed up until April 2021. 70 patients received ATO chemotherapy after induction, consolidation and maintenance treatment, including 28 patients with grade Ⅲ/Ⅳ liver damage. The overall survival (OS) rates of patients with grade Ⅲ/Ⅳ liver damage and non-grade Ⅲ/Ⅳ liver damage were 92.8% (26/28) and 95.2% (40/42), with no significant difference (P>0.05). Event free survival (EFS) rates were 85.7% (24/28) and 90.5% (38/42), with no significant difference (P>0.05).Conclusion ATRA combined with ATO can effectively shorten the time of reaching CR in APL patients, while increases the risk of liver function damage. However, the liver damage of most patients is transient and reversible. Compared with induction period of ATRA combined with ATO, the proportion of liver damage was significantly lower in patients receiving consolidation and maintenance therapy. In addition, liver damage caused by ATO does not affect the prognosis of patients.

Key words: Acute promyelocytic leukemia, All-trans retinoic acid, Arsenious acid, Liver function damage