| Objective:In this study,the clinical efficacy and metabolic spectrum changes of 'tonifying kidney and strengthening brain acupuncture' combined with rehabilitation training in the treatment of cerebral palsy are observed by Gessel development diagnosis scale and amin o acid metabonomics test,and the corresponding differential metabolites are screened to e xplore the correlation between efficacy and metabolites.Methods:The study is conducted in two centers of Jiangsu Province Hospital of Chinese Medicine and Children's Hospital of Nanjing Medical University from April 2018 to De cember 2019.It is divided into two parts:clinical study and metabonomic study.According to the statistical requirements,take one side a=0.025,?=0.20,the average pass rate of t he treatment group and the control group is estimated to be 98%,and the non-inferiority threshold value 8 is 0.10,It is estimated that the number of cases in each group should be 24.Finally,10 cases in the treatment group and the control group are determined on account of the financial restrictions,and another 10 healthy children are recruited as the normal group.The treatment group and the control group follow the principle of rando m control and are grouped by random number table method.The treatment group uses't onifying kidney and strengthening brain acupuncture' combined with rehabilitation training,the control group receives routine rehabilitation training,and the normal group does not in tervene.The combination of treatment group and control group is called cerebral palsy gr oup.Before and 3 months after treatment,the cerebral palsy group is evaluated by GDS to calculate the corresponding DQ value and collect serum samples;in the normal group,ser um samples are collected once during the study period;all samples are collected and sen t to metabonomics test together.Results:The study finally include in the treament group(n=11),the control group(n=9),the normal group(n=10)and metabolomics samples(n=50).Results it is divided into two parts:clinical study and metabonomics study.1.Results of clinical study:In the cerebral palsy group,the DQ of each functional area in creases in varying degrees after treatment.The statistical analysis shows that the scores of adaptability,fine movement and personal social of GDS functional area and the average DQ scores in the treatment group significantly increase after treatment,and there is signifi cant difference(P<0.5).Although the score of gross motor movement and language improv es,there is no statistical significance(P>0.5).After treatment,the score of fine movement in the control group is significantly higher than before,but there is no significant difference in adaptability,gross motor movement,language,personal social and average DQ(P>0.05).2.Metabonomic results:(1)Before treatment,9 differential amino acids are screened betwee n the cerebral palsy group and the normal group,that is the serum glutamic acid,omithine,tyrosine,l-methionine and arginine in the cerebral palsy group,significantly down-regulated,Histidine,Citrulline,5-hydroxy-L-lysine and glutamine significantly up-regulate.(2)After treat ment:there are two differential amnio acids between the treatment group and the control group,citrulline and histidine.(3)In cerebral palsy group,there are more than 20 kinds of a mino acids before and after treatment,no differential amino acids.Conclusion:'tonifying kidney and strengthening brain acupuncture' and rehabilitation traini ng can play a therapeutic role in cerebral palsy by regulating the metabolism of amino a cids in the body;Citrulline and histidine may be biomarkers related to the short-term eff icacy of 'tonifying kidney and strengthening brain acupuncture'.Changes in amino acid metabolism may be more sensitive than clinical efficacy. |
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