| Objective:1.To observe the clinical effect of JingNing Formula Granule on children with Attention Deficit Hyperactivity Disorder.2.To research the possible mechanism of action of JingNing Formula Granule in treating children with ADHD,by detecting the content of the neurotransmitter serotonin,including dopamine(DA),norepinephrine(NE)and 5-serotonin content(5-HT),then explore and testify whether the effect of the JingNing Formula Granule is achieved by the change of the content of nerve monoamine neurotransmitters or not.3.To intervene in spontaneously hypertensive rats taken the traditional Chinese medicine-JingNing Granule and compare the effect with those taken the western medicine-Atomoxetine,then test the content of DA,NE and 5-HT in serum of SHR model rats,finally make a summative evaluation.Methods:The clinical experiment:according to diagnostic criteria of the Traditional Chinese Medica and Western medicine,there were totally 34 children with Attention Deficit Hyperactivity Disorder were selected from the pediatric department of Dong zhi men Hospital affiliated to Beijing University of Chinese Medicine from June 2015 to January 2017.The child’s legal guardian signed the informed consent,then established the children as object of the research.These children took the JingNing Formula Granule for 12 weeks,collected the children’s serum at the begin and end of the treatment.And the serum neurotransmitters and the content of the DA,NE and 5-HT were measured by the high performance liquid chromatography.The animal experiment:50 SHR male rats were chosen and divided them randomly into five groups with ten rats in each group:the model group,the control group of Atomoxetine Hydrochloride,the low dose group of JingNing,the middle dose group of JingNing and the high dose group of JingNing.At the same time,10 Wistar rats were regarded as the normal control group.After six weeks’s intragastric administration respectively,with the method of drawing blood from the abdominal aorta,the contents of DA,NE and 5-HT in serum were measured by the high performance liquid chromatography.Results:the clinical experiment result:after 12 weeks of treatment with JingNing Formula Granule,the total score of Traditional Chinese Medical syndrome was increased,and there was different in statistics(P<0.05);The main symptoms of traditional Chinese medicine(hyperactivity,lacking of concentration,low efficiency of study)were statistically significant after treatment(P<0.01);The minor symptoms of Traditional Chinese Medical were statistically after treatment including less sleep,dreaminess,feverish sensation over the palm and sole,dry mouth,lusterless face,spontaneous sweating and night sweats(P<0.05);There was an difference between the diet,tongue and pulse manifestation after treatment(P<0.05);Stool was not statistically meaning after treatment(P>0.05);The hyperactivity index was improved,there were an different in Statistics(P<0.05).The scoring,wrong numberand and leakage cancellation number of strokes in the cancellation experiment had statistical obvious difference(P<0.01);In this research,32 cases were collected,however the serum was collected 14 cases at the begin and end of the treatment.After the treatment,the content of children’s serum DA was increased clearly,which had statistical meaning(P<0.05).The content of children’s NE serum had a downtrend,but with no statistical meaning(P>0.05).The content of serum 5-HT showed an upward trend,with no statistical meaning(P>0.05).In the disease efficacy evaluation,there were 6 cases markedly effective,markedly effective rate is 18.6%.20 cases effective,effective rate is 62.5%,6 cases invalid,invalid rate is 18.6%,so 26 cases are total effective,and the total efficiency is 81.2%.In the Traditional Chinese Medical Qi and Yin deficiency syndrome efficacy evaluation,there were 5 cases markedly effective,markedly effective rate is 15.6%,22 cases effective,effective rate is 68.8%,5 cases invalid,invalid rate is 15.6%,so 27 cases are total effective,and the total efficiency is 84.4%.In animal experiments:2.1 The statistics of the serum dopamine content is as follows:The content of the model group is lower than that of the normal control group(P=0.000).The content of high dose group of JingNing is higher than that of the model group(P=0.047).The content of the middle dose group of JingNing is higher than that pf the model group(P=0.009).The content of the middle dose group of JingNing is higher than that of the Atomoxetine Hydrochloride group(P=0.016).The content of the middle dose group of JingNing is higher than that of the the low group(P=0.026).All the data has statistical meaning.2.2 The statistics of the Serum 5-serotonin content is as follows:the content of the model group is lower than that of the normal control group(P=0.000).The content of the high dose group of JingNing is higher than that of the model group(P=0.018).The content of the middle dose group of JingNing is higher than that of the model group(P=0.003).The content of the high dose group of JingNing is higher than that of the Atomoxetine Hydrochloride group(P=0.025).The content of the middle dose group of JingNing is higher than that of the Atomoxetine Hydrochloride group(P=0.004).The content of the middle dose group of JingNing is higher than that of the low group(P=0.026).All the data has statistical meaning.2.3 The comparison of the serum norepinephrine content has no statistical meaning(P=0.118),but according to the average and standard deviation,the content of the model group is higher than that of the normal group,the content of the high,middle and low dose of JingNing group and the Atomoxetine Hydrochloride group are higher than that of the normal group,which are lower than that of the model group,and the content of the Atomoxetine Hydrochloride group is lower than that of the three JingNing groups.Conclusion:1.JingNing Formula Granule can improve the clinical symptoms of attention deficit hyperactivity disorde with a type of deficiency of both QI and YIN.2.JingNing Formula Granule can increase the content of dopamine in serum of children.3.The high and middle dose of JingNing can rise the content of DA in serum of SHR rats.4.The high and middle dose of JingNing can rise the content of 5-HT in serum of SHR rats and higher than Atomoxetine Hydrochloride. |
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