| Objective:To observe the clinical therapeutic effect and safety of Xifeng Ditan Decoction on children with Tic Disorder caused by wind-phlegm disturbance.Method:From January,2019 to October,2020,72 children in Jiangsu Province Hospital of Traditional Chinese Medicine and Wuxi Children’s Hospital,those who met the inclusion criteria were divided into test group and control group by random number table,both included 36 children.During the study,the test group was provided with Xifeng Ditan Decoction along with the basic treatment,while the control group was provided with Thipiride and the basic treatment.The evaluation of both the test group and the control group were made after 12-weeks treatment along with follow-up,which mainly included the overall efficacy of two groups.Results:(1)Completion analysis:Both the test group and the control group were designed to start with 36 cases in the beginning,while during the study,1 case of the test group and 4 cases of the control group both fell off,which represented that the final analysis actually included 35 cases of the test group and 32 cases of the control group.(2)Overall curative effect evaluation:The efficacy evaluation of both groups were made after the treatment,which showed that 6 cases were estimated as arrested and 21 cases were estimated as efficient,and the effective rate of the test group was 77.14%.While it showed that 6 cases were estimated as arrested and 18 cases were estimated as efficient of the control group,and the effective rate of it was 75%,which after analysis showed that both of them were effective.(3)Comparison of Yale Scale scores:The Yale score of the test group and the control group both decreased after the study,including the total score,the motor score and the vocal score(P>0.05),indicating that both of them can improve the symptoms of children with Tic Disorders.Also,after analysis,there were no statistical difference between the two groups about their improvement on the total score,the motor score and the vocal score(P>0.05),which means that they share a similar clinical effect.(4)Evaluation of TCM syndrome curative effect:Compared with the TCM syndrome scores of the test group and the control group before the study,both of them decreased after a 12-weeks follow-up(P<0.001),which means that both of them can significantly improve the TCM syndrome of those who were diagnosed of Wind-phlegm-disturbing Type.What’s more,a comparison were made between the two groups on their sub-symptom score and their total score(P<0.001),which indicates that the test group was superior to the control group in reducing TCM sub-symptom score and TCM syndrome total score.(5)No adverse reactions happened in the test group during the study,while 2 cases were observed as lethargy in the control group.After the children were instructed to drink more water and take more rest,their symptoms could be relieved by themselves.Conclusion:(1)Xifeng Ditan Decoction and Thipiride Hydrochloride Tablets can effectively improve the clinical symptoms of children with TIC disorder caused by wind-phlegm disturbance,and their overall efficacy is equivalent.(2)Xifeng Ditan Decoction is superior to Thiapride Hydrochloride Tablets in improving the overall curative effect of accompanying symptoms and syndromes of TCM,which is worthy of clinical application. |