Summary: In order to objectively evaluate the efficacy of intravenous gammaglobulin (IVIG) in the prevention and treatment of coronary artery lesion (CAL) in Kawasaki disease (KD) and the related factors influencing the IVIG efficacy, 314 children with KD were reviewed retrospectively and comparatively and were divided into IVIG plus aspirin group and ASA group. The occurrence and restoration of CAL in these two groups as well as many laboratory and clinical indexes including average hospital stay (days), total fever duration, defervescence time, platelet count, erythrocyte sedimentation rate, C reactive protein etc. were observed. The incidence of CAL was 39.5 % in the children with KD. In the IVIG+ASA group, the incidence of CAL was 34.3 % and 56.0 % in ASA group respectively (P<0.001). The incidence of CAL was reduced in the group in which 2.0 g/kg or 1.0 g/kg IVIG was administered as compared with the group in which IVIG was administered at a dose ≤0.6 g/kg or ≥3.0 g/kg (P<0.05). CAL occurred less frequently when IVIG was administered at 3-10 days of the course than that when IVIG was administered ≤3 days or >10 days (P<0.05). About 13.4 % of the CAL treated with IVIG was not recovered at the 12 th month of the course, mostly in the groups in which only ASA was administered and IVIG treatment was started 10 days later. The hospital stay (days), defervescence time, total fever duration, platelet count, erythrocyte sedimentation rate and C reactive protein were significantly reduced in IVIG+ASA group as compared with those in the ASA group (P<0.05). IVIG treatment can remarkably shorten the course of patients with KD and decrease the incidence of CAL, but the efficacy of IVIG in the prevention and treatment of KD disease is not as expected by people, therefore, reevaluation of the practical efficacy of IVIG is required.