| Objective:To evaluate the clinical effect on the treatment of children with tic disorders of heart-fire and liver-fire type by Pinggan Qingxin Mixture.Methods:70 children with TD of heart-fire and liver-fire type were randomly divided into two groups: treatment group(n = 34)and control group(n = 36).The treatment group was treated with Pinggan Qingxin Mixture and the control group with tiapride hydrochloride for 4 weeks.Statistical analysis of general data,before treatment,2weeks after treatment,4 weeks after treatment according to the clinical symptoms of children,The therapeutic effect was evaluated by Yale Comprehensive tic severity scale(YGTSS)and TCM Syndrome scale of Children’s tic Disorder,and the adverse reactions were observed in the two groups.Results:1.Comparison of clinical efficacy : 72 cases met the inclusion criteria,2 cases fell out,70 cases were included,34 cases in the treatment group and 36 cases in the control group.The effective rate of clinical effect in the treatment group was 85.29%and that in the control group was 77.78%.The difference is not statistically significant(P > 0.05).2.Comparison of the scores of YGTSS scale:the total score of YGTSS scale,the score of motor tic symptom,the score of vocal tic symptom and the defect score of the two groups were significantly improved before and after treatment(P<0.05).Compared with each other in total score of YGTSS scale,score of motor tic symptom and defect score,the improvement degree of treatment group was better than that of control group(P<0.05),but there was no significant difference in the score of vocal tic symptom(P>0.05).3.Comparison of the curative effect of TCM syndrome: the total effective rate of TCM syndrome in the treatment group was 94.12% and that in the control group was 83.33%,the difference was statistically significant(P<0.05).4.Comparison of the scores of main symptoms and secondary symptoms in TCM: the improvement degree of motor and vocal twitching in the treatment group was comparable to that in the control group(P>0.05).The improvement degree of the secondary symptom,restless,upset,irritable,grumpy,sore in tongue,red in the eyes,red in the pharynx,short red urine and great constipation,was better than that of control group(P<0.05),which indicated that the treatment group could obviously improve the clinical symptoms of TCM syndrome of children with TD of heart-fire and liver-fire type.5.Comparison of curative effects of disease grading:The effective rate of mild disease was 100% in the treatment group,66.67% in the control group,91.67% in the moderate disease group,86.36% in the control group,and both groups in the severe disease group was 100%.There was no significant difference between mild and severe condition(P>0.05),but there was significant difference in moderate disease(P<0.05).It was suggested that the treatment group was superior to the control group in the curative effect of moderate TD of heart-fire and liver-fire type.6.Safety evaluation: clinical trials for all children,the treatment group and control group before and after treatment,respectively,for the blood routine,urine routine,liver function(ALT,AST),kidney(BUN,Cr)check,are no exception.No adverse events occurred during the whole trial,and the vital signs and physical examination of safety were normal.Conclusion:1.Pinggan Qingxin Mixture can improve the clinical tic symptoms of children with TD of heart-fire and liver-fire type.2.Pinggan Qingxin Mixture in the improvement with TD of heart-fire and liver-fire type,the effect of scores of The total scores of YGTSS,motor tics and defect significantly.3.Pinggan Qingxin Mixture can significantly improve the clinical symptoms of TCM syndromes in children with TD of heart-fire and liver-fire type.4.Pinggan Qingxin Mixture is an effective drug for treating moderate TD of heart-fire and liver-fire type.5.Pinggan Qingxin Mixture is effective and safe in the treatment of TD. |
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