| Objective:Tic disorders(TD)is a common chronic neuropsychiatric disorder in children.According to the clinical manifestations of TD children with spleen deficiency and phlegm accumulation syndrome,and the treatment principle of strengthen the spleen and dissipate phlegm,this study aims to explore the clinical effect of modified Liujunzi Decoction on TD of spleen deficiency and phlegm accumulation.Methods:A total of 76 children with tic disorder of spleen deficiency and phlegm accumulation who were treated in Weifang Hospital of Traditional Chinese Medicine from October 2021 to May 2022 were selected as the study subjects.According to the principle of random distribution,the study subjects were divided into control group and observation group by drawing lots.The control group(38 cases)was treated with Tiapride hydrochloride orally;38 cases in the observation group were treated with modified Liujunzi Decoction and Tiapride hydrochloride.Both groups were treated for 8weeks.The improvement of twitch symptoms in the two groups was evaluated by the score of Yale Global Tic Severityb Scale(YGTSS);With the principle basement of Guiding Principles for Clinical Research of New Chinese Medicines(Trial),the TCM symptom scoring table was developed,and the TCM syndrome score was compared to evaluate the improvement of TCM symptom evaluation;Combined with the reduction rate of YGTSS score and the improvement of TCM symptoms,the overall treatment effectiveness was calculated and the treatment effect was evaluated;The serum levels of interleukin-6(IL-6),5-hydroxytryptamine(5-HT),dopamine(DA)γ-aminobutyric acid(GABA)and other neurotransmitter levels;The levels of CD3~+,CD4~+,and CD8~+T lymphocyte subsets in fasting upper limb vein blood of the children before and after treatment were measured by flow cytometry,and the ratio of CD4~+/CD8~+was calculated;The level of vitamin A(Vit A)was detected by high performance liquid chromatography and vitamin D(Vit D)was detected by liquid chromatography-tandem mass spectrometry;During the treatment,the occurrence of adverse reactions in children was counted to evaluate the treatment safety.Results:1.The two groups could be compared in terms of gender,age and average course of disease.There was no statistically significant difference was exsited between the two groups(P>0.05).2.The motor tic scores,vocal tic scores,defect scores,and total YGTSS scores of the first two groups were comparable(P>0.05).After 8 weeks,scores decreased in both groups compared to before treatment(P<0.05).The motor tic score,vocal tic score,defect score,and YGTSS total score in the observation group after treatment were lower than those in the control group(P<0.05).3.The scores of primary symptoms,secondary symptoms and total scores of TCM symptoms before treatment were comparable between the two groups(P>0.05).After 8weeks,the scores of both the observation group and the control group were reduced compared with before treatment(P<0.05).Both treatment modalities improved the TCM symptoms of the children.The main symptom score,secondary symptom score and total score of TCM symptoms in the observation group were more reduced than those in the control group(P<0.05).The treatment effect of the observation group was more significant than that of the control group.4.The total effective rate of the observation group was 86.64%;The total effective rate of the control group was 81.58%,and the difference between the two groups was statistically significant(P<0.05).5.The serum levels of IL-6,5-HT,DA and GABA before treatment between the two groups were comparable(P>0.05).The levels of IL-6,5-HT and DA in both groups showed a downward trend compared with those before treatment in this group(P<0.05).The levels of IL-6,5-HT and DA in the observation group decreased significantly more significantly than those in the control group(P<0.05).The level of GABA after treatment in both groups showed an upward trend compared with before treatment.The GABA level in the observation group was higher than that in the control group(P<0.05).6.Before treatment,the levels of CD3~+,CD4~+,CD8~+,CD4~+/CD8~+between the two groups were comparable(P>0.05).The levels of CD3~+,CD4~+,CD4~+/CD8~+in both groups showed an upward trend compared with before treatment in this group(P<0.05).The CD3~+,CD4~+,CD4~+/CD8~+levels in the observation group increased significantly compared with the control group(P<0.05).CD8~+levels in both groups showed a downward trend compared with before treatment.The CD8~+level in the observation group was significantly higher than that in the control group(P<0.05).7.There was no significant difference between the levels of Vit A and Vit D before treatment between the two groups(P>0.05).The levels of Vit A and Vit D in both groups were higher than those in the treatment group after treatment,and the levels of Vit A and Vit D in the observation group were higher than those in the control group,and the difference was statistically significant(P<0.05).8.During the treatment,38 children in the control group with a total adverse reaction rate of 15.79%;Of the 38 children in the observation group with a total adverse reaction rate was 2.63%.The adverse reactions in the control group were more than those in the observation group,and the difference was not statistically significant(P>0.05).According to the classification and comparison of adverse events between the two groups,37 cases of Level 1 events and 1 case of Level 2 events in the control group and 32 cases of Level 1 events and 6 cases of Level 2 events in the observation group were statistically significant(P<0.05).Conclusion:Modified Liujunzi Decoction can effectively improve the tic symptoms of children with tic disorder due to spleen deficiency and phlegm accumulation.It has a better improvement on the level of neurotransmitter and immune function of children,which is worthy of clinical application. |
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