Objective：To observe the clinical effect and drug safety of Xiaoer Hulu San combined with ketotifen fumarate tablets for asthmatic bronchitis in children with syndrome of phlegm-dampness accumulation in lung.MethodsSelected 70 cases of children with asthmatic bronchitis with syndrome of phlegm-dampness accumulation in lung，and divided them into the treatment group and the control group according to random number table，35 cases in each group.The treatment group was given Xiaoer Hulu San combined with ketotifen fumarate tablets for treatment，while the control group was only given ketotifen fumarate tablets for treatment.Compared the clinical effect between the two groups，recorded the remission time of asthma， cough， and wheezing rale of children， and observed the drug safety.ResultsThe curative effect in the treatment group was better than that in the control group，the difference being significant(Z=-2.317，P=0.021).The obvious effective rate was 80.00%in the treatment group and 54.29%in the control group，the difference being significant(P＜0.05).The remission time of asthma，cough，and wheezing rale in the treatment group was shorter than that in the control group，differences being significant(P＜0.05).There was no adverse reaction being found in both groups.The detection results of hepatic and renal function of both groups before and after treatment were normal.ConclusionThe therapy of Xiaoer Hulu San combined with ketotifen fumarate tabletsfor asthmaticbronchitisin children with syndrome of phlegm-dampness accumulation in lung has exact clinical effect and high drug safety.