Clinical Efficacy Of Kaixinningshen San Granules On Children’s Attention Deficit Hyperactivity Disorder From The Perspective Of General Practice

Objective: Pediatric attention deficit hyperactivity disorder is a very common pediatric disorder disorder,which is mainly manifested as three major manifestations of inattention,hyperactivity and impulsivity,and there are no specific diagnostic criteria.In this study,the clinical efficacy and safety of Kaixinningshen San Granules in children with attention deficit hyperactivity disorder were observed through a randomized controlled trial,which provided an effective clinical basis for the treatment of ADHD by traditional Chinese medicine.Methods: This study was carried out from April 2022 to January 2023,with adolescents and children aged 5-12 as the main research subjects,and the general practitioner of the general practitioner community conducted initial screening and management of the community children,and was confirmed and administered by the outpatient pediatrician of the Affiliated Hospital of Shandong University of Chinese Medicine,and a total of 68 children were included.Referring to the recommendations of the second edition of the Guidelines for the Prevention and Treatment of Attention Deficit Hyperactivity Disorder in China released in December 2015,the criteria of the Fifth Edition of the American Manual of Diagnosis and Statistics of Mental Disorders(DSM-IV.)were selected for the diagnosis of ADHD.Trials followed the randomised controlled principle and were divided into intervention and control groups.The control group was given psychological and behavioral therapy,and the intervention group was given oral Kaixinningshen San Granules on this basis.According to the standard standard process of new Chinese medicines,the children’s conditions were recorded before and after treatment with a 4-week intervention cycle,including the scores and adverse reactions of the attention deficit and hyperactivity disorder scale,the Conners hyperactivity index score scale and the TCM syndrome score scale,and the effective rates of the two groups were calculated according to the scale scores.The SPSS 26.0 statistical software was used to statistically analyze the data before and after the intervention.Result: A total of 65 children with ADHD were observed in clinical trials due to loss to follow-up and other reasons,including 33 cases in the intervention group and 32 cases in the control group.In terms of total response rate,the total effective rate of the intervention group was 78.79%;The total effective rate of the control group was 34.38%,and there was a significant difference in the effective rate between the intervention group and the control group(P<0.05).In the comparison of SNAP-IV scale scores,the SNAP-IV scores of the two groups after treatment compared with those before treatment were statistically significant(P<0.05),and after treatment,the SNPA-IV scores in the intervention group were significantly smaller than those in the control group,and the difference was statistically significant(P<0.05).In the comparison of Conners scale scores,there was a significant difference between the two groups after treatment compared with the Conners scale score before treatment(P<0.05),and after treatment,the Conners scale score in the intervention group was significantly smaller than that in the control group(P<0.05).In the intra-group comparison of TCM syndrome points,main symptom points and secondary symptom points,the scores of the two groups after treatment were reduced to a certain extent compared with those before treatment,and the difference was statistically significant(P<0.05).In the comparison between groups after treatment,the total score of TCM symptoms,main symptom score and secondary symptom score of the intervention group were lower than those of the control group,especially in the intervention group in improving secondary symptoms,and the difference was statistically significant(P<0.05).No adverse reactions were recorded in the two groups during the medication.Conclusion: Through the observation of the clinical efficacy of children with attention deficit hyperactivity disorder,it is found that the combination of Kaixinningshen San Granules combined with psychological and behavioral therapy has a certain efficacy on children with ADHD,and has a relatively stable safety,and this study also provides clinical evidence for the treatment of ADHD in children with traditional Chinese medicine.