To observe the clinical effects of compound oleum lithospermi combined with loratadine in the treatment of mild and moderate atopic dermatitis(AD).Methods:The effect of different therapy was evaluated through a randomized，open，parallel-group trial.The observation group was treated with oleum lithospermi combined with loratadine，and the control group was given pimecrolimus combined with loratadine.The TCM syndrome types，skin lesion area and the level of erythema，papule，skin peeling，leakage or scabby，scales，hypertrophy and moss of patients were observed and recorded，and the effective rate and the incidence of adverse reactions were calculated.The clinical efficacy of drugs was comprehensively evaluated.Results:The therapeutic effect of compound oleum lithospermi combined with loratadine was close to pimecrolimus combined with loratadine on relieving AD skin lesions area，itching，skin peeling and hypertrophy(P>005)，but it had limited effects on improving erythema and skin peeling.The overall efficiency was 758%，which was less than 933% of pimecrolimus group.But compound oleum lithospermi group had slow action with stable efficacy.The incidence of adverse reactions was 256% and recurrence rate was 606%.The pimecrolimus group had quick action，and had a 1579% of incidence of adverse reactions and 667% of recurrence rate.It is easy to have adverse reactions in the application of pimecrolimus for patients with skin damage of heart-fire hyperactivity and spleen deficiency.Conclusion:Compound oleum lithospermi combined with loratadine can reduce skin lesion of mild and moderate level，and has significant security advantage on patients with TCM syndrome types of heart-fire hyperactivity and spleen deficiency.