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OBJECTIVE:To explore the relationship between the efficacy of realgar for the treatment of myelo-dysplastic syndromes with multilineage dysplasia(MDS-MLD) and arsenic concentration in the pe-ripheral blood of patients.METHODS:In this prospective study,a total of 50 MDS-MLD patients were treated with traditional Chinese drugs containing realgar for 3 months in Xiyuan Hospital from March 2018 to January 2019.Routine blood examination as well as liver and kid-ney function were monitored before and after treat-ment.The concentration of arsenic in the peripher-al blood was measured using an atomic fluores-cence spectrometer after treatment.The correla-tion between clinical effect and arsenic concentra-tion was analyzed by Spearman\'s method.RESULTS:The treatment response rate was 54％.Two patients (4％) achieved complete remission,50％ (25 of 50) showed hematologic improvement,and 23 patients had stable disease (23％).No dis-ease progression was observed.Arsenic concentra-tion in the peripheral blood ranged from 14.60 to 85.96 μg/L.Clinical efficacy was positively correlat-ed with arsenic concentration (P ＜ 0.05).The inci-dence of mild adverse reactions was 16％.CONCLUSION:A relatively high concentration of arsenic in the peripheral blood may improve the clinical efficacy of realgar in MDS-MLD patients.