Objective To observe the clinical effect and safety of Danshen injections, gamma globulin combined aspirin on the children with Kawasaki disease. Methods A total of 106 children with Kawasaki disease in our hospital were randomly divided into two groups. Fifty three patients in the control group received gamma globulin and aspirin therapy; and the other 53 patients in the observation group received Danshen injections on the basis of control group, 14 days as a course in both groups. The treatment effect rate, the release time of symptoms and the levels of ESR, CRP, TNF-α were observed. Results The total effect rate in the observe group was 92.5% (49/53), and the control group was 81.1% (43/53). There was significantly different between two groups (χ2=3.711, P=0.046). After the treatment, the levels of ESR (24.43 ± 0.46 mm/h vs. 30.03 ± 0.44 mm/h, t=3.971), CRP (3.01 ± 0.38 mg/L vs. 3.37 ± 0.36 mg/L, t=3.892); TNF-α (1.38 ± 0.70 pg/ml vs. 1.60 ± 0.53 pg/ml, t=3.632), PLT (0.22 ×109 ± 0.11×109 vs. 0.33 ×109 ± 0.12×109, t=3.167) in the obervation group were significantly lower than those in the control group; the levels of WBC (1.86 ×109 ± 0.18×109vs. 1.29×109 ± 0.20 ×109, t=3.211) in the observation group was significantly higher than that in the control group. The release time of fever (2.4 ± 0.8 d vs 3.3 ± 0.8 d, t=3.779), swelling of hand and foot (3.9 ± 1.5 d vs. 5.1 ± 1.7 d, t=4.007), necklymph nodes dissipate (4.0 ± 0.8 d vs. 5.1 ± 1.1 d, t=3.996), mucosal congestion (2.9 ± 0.7 d vs. 3.3 ± 1.1 d, t=4.264) in the observation group were significantly shorter than those in the control group (P<0.05). Conclusions The Danshen injections, gamma globulin combined with aspirin for the children with Kawasaki disease could reduce the release time of symptoms. Key words: Kawasaki's disease; Child; Dan Shen Zhu She Ye; Aspirin; Globulin; Clinical study