OBJECTIVE： To observe clinical efficacy and safety of Kangfuxin liquid in the treatment of pediatric hand， foot and mouth disease. METHODS： 128 children with hand， foot and mouth disease were randomly divided into observation group and control group， with 64 cases in each group. Control group was given routine treatment as herpes and oral care， antibiotics for infective children reflected by hemogram elevation， fluid infusion and non-steroidal analgesic-antipyretic agent based on disease condition. Observation group was additionally given Kangfuxin liquid， 3 ml for below 3 year-old， tid and 5 ml for more than 3 year-old， tid. Clinical efficacy of 2 groups were observed as well as CRP， lactic acid， Ig， the level of myocardial enzyme before and after treatment； the time of symptoms and signs disappearance and ADR were compared between 2 groups after treatment. RESULTS： The total effective rate of observation group （89.06％） was significantly higher than that of control group （70.31％）， with statistical significance （P＜0.05）. There was no statistical significance in CRP， lactic acid， Ig and myocardial enzyme before treatment and IgM level after treatment between 2 groups， with statistical significance （P＞0.05）. CRP， lactic acid creatine kinase and lactate dehydrogenase level of 2 groups decreased significantly， while IgA and IgG levels increased significantly， and the observation group was higher than the control group， with statistical significance （P＜0.05）. Antipyretic time， hand foot skin rash subsided time and oral ulcer healing time of observation group were significantly shorter than those of control group， with statistical significance （P＜0.05）. No obvious ADR was found in 2 groups during treatment. CONCLUSIONS： Kangfuxin liquid is effective in the treatment of hand， foot and mouth disease in children， and can effectively improve CRP， Ig， lactic acid， and myocardial enzyme level with good safety.