| BackgroundTourette’s syndrome (TS) is a neuropsychiatric disorder characterized by stereotypic, involuntary, purposeless and repetitive movements. The motor tics include headshakes, violent clonic tics consisting of thrusting head jerks and orofacial tics such as facial grimacing, eye blinking and throat clearing. It dosen’t occur regularity. The symptoms will aggravate after actuation, vanish after sleep, and decrease by divert attention.The diagnostic criteria of TS are1. The character of TS are motor tics and vocal tics, the two symptoms often occur not at the same time.2. Tics break out several times every day. It can last more than1year, and the period with no tics less than3months.3. The tics can cause conspicuouse restlessness, which can influence social intercourse, employment and some other social activities.4. It often occur before the age of18years.5. The symptoms are not cause by some drugs (such as stimulant), and morbus internus (such as Humtington’s chorea and viral encephalitis).As the inhibitor of DRD2, Haloperidol (Hal) is regarded as the effective medicine in treatment of TS. Although haloperidol is efficacious for the treatment of TS, a very high proportion of patients eventually discontinue the therapy because of the side effects. It’s side effects are concerned with the dosage. The commen side effects include lethargy, sedation, debilitation, dizziness and extrapyramidal symptoms (such as dysmyotonia, akathisia, thrill like Parkinson’s disease, et al). Tardive dyskinesia will occur after take this medicine for a long time. It will appear heteronomous stereotypy behaviors. Such side effects limited the usage of haloperidol. Ningdong granule (NDG), a TCM preparation, has been revealed to tranquilize and allay excitement in Tourette syndrome (TS). However, the present data were limited for lack of a double-blind and control trial, and the mechanism of NDG on TS children also remains obscure. This study therefore aimed to evaluate NDG’s short-term efficacy and safety in the treatment of TS children as an alternative medication.Objective1. To evaluate the efficiency of NDG and Haloperidol.2. To evaluate the differences in side effects of the three treatments, in order to identify more safe and reliable treatment options.Methods120children (6-18years) were equally divided into NDG group (n=30), Hal group (n=30), NDG+Hal (n=30) and control group(n=30) by a randomized computer-generated code. NDG group were assigned to receive NDG5mg/kg/day for8weeks. Patients in the haloperidol group were started at a dose of0.75mg/d and increased in1.5-3.0mg/day increments every2weeks to a maximum tolerated dose of4.5mg/d.;NDG+Hal group were assigned both of them. Control group was given placebo.As previously noted, the Yale Global Tic Severity Score (YGTSS), We rated the scores at the first clinic visit as the baseline scores and then every2weeks vocal for a total of8weeks of follow-up. Side effects were systematically recorded.Results1. Study populationOne hundred and twenty children were recruited to participate in this study. One patient in the control group and two patients in the NDG group missed the full course of treatment, so they were excluded from this analysis. The remaining subjects in the four groups were similar with regard to age, gender.2. Comparison of YGTSS tic scoresCompared with YGTSS total tic score, YGTSS motor tic score and YGTSS vocal tic score at baseline, the scores of NDG and Hal groups at end point reduced significantly (P<0.05). Compared with control group, the scores of NDG+Hal group reduced more significantly (P<0.01)3. Side effects controlThe incidence of sedation, extrapyramidal and QT prolongation reactions in Hal group and NDG+Hal group were lower than that in NDG and control group (P<0.05). The incidence of nausea and headache reactions in NDG+Hal group were lower than that in control group (P<0.05). The incidence of anxiety in NDG+Hal group were lower than that in NDG group (P<0.05).ConclusionBoth NDG and Hal could improve the syndrome of tics in TS, morewhile, NDG+Hal have better effect on TS. But the NDG have less side effects than Hal. BackgroundTourette’s syndrome (TS) is a neuropsychiatric disorder characterized by stereotypic, involuntary, purposeless and repetitive movements. The motor tics include headshakes, violent clonic tics consisting of thrusting head jerks and orofacial tics such as facial grimacing, eye blinking and throat clearing. It dosen’t occur regularity. The symptoms will aggravate after actuation, vanish after sleep, and decrease by divert attention.At present, the etiology and causes of the TS is not yet very clear, is generally believed that the pathogenesis of TS and genetic and neurological neurotransmitter system abnormalities, traumatic brain injury, infection, and the mother during pregnancy, life events and other biological, psychological and environmental factors can not be ignoredSome scholars believe that the disease has a significant familial aggregation, Leckman genetic factors, other risk and protective factors and the neurobiology of developmental factors interact to cause twitching, coercion and other tic-related symptoms of view. For TS pathophysiology and neurochemistry, that incidence with dopamine or5-hydroxytryptamine and y-aminobutyric acid neurotransmitter metabolic abnormalities. Or with the corresponding receptors, the vector function abnormalities or anomalies are closely related to expression in the striatum.Ningdong granule (NDG), a TCM preparation, has been revealed to tranquilize and allay excitement in Tourette syndrome (TS). However, the present data were limited for lack of a double-blind and control trial, and the mechanism of NDG on TS children also remains obscure. This study therefore aimed to evaluate NDG’s short-term efficacy and safety in the treatment of TS children as an alternative medication.ObjectiveTo evaluate the efficiency, safety, and possible mechanism of NDG.Observed side effects and toxicological effects of NDG and haloperidolMethods120children (6-18years) were equally divided into NDG group (n=30), Hal group(n=30), NDG+Hal(n=30) and control group (n=30) by a randomized computer-generated code. NDG group were assigned to receive NDG5mg/kg/day for8weeks. Patients in the haloperidol group were started at a dose of0.75mg/d and increased in1.5-3.0mg/day increments every2weeks to a maximum tolerated dose of4.5mg/d;NDG+Hal group were assigned both of them. Control group was given placebo. Mean while liver and renal tests were monitored as well.Results1. Study populationOne hundred and twenty children were recruited to participate in this study. four patient missed the full course of treatment, so they were excluded from this analysis. The remaining subjects in the four groups were similar with regard to age, gender.2. Contents of DA and HVA in sera by ELISAThe content of DA in sera was no significant different in the five groups (P>0.05). After treatment the HVA content in the NDG+Hal (66.25±12.88ng/ml)、NDG (67.07±16.01ng/ml)and Hal group (60.88±11.71ng/ml) were increased in different degree compared with the control group (47.13±7.58ng/ml)(P<0.05), The HVA content were more higher in the NDG+Hal group than in the NDG and Hal group (P<0.01, P<0.05).3. Contents of5-TH and5-HIAA in sera by ELISAThe content of5-TH and5-HIAA in sera were no significant differents in the four groups (P>0.05)4. Contents of GABA in sera by ELISA After treatment, the GABA content in the NDG+Hal (166.22±41.91pmol/ml)、 NDG(123.69±38.47pmol/ml)and Hal group(113.97±36.23pmol/ml) were increased in different degree compared with the control group (85.63±33.69pmol/ml)(P<0.05), The content of GABA were more higher in the NDG+Hal group than in the NDG and Hal group (P<0.01, P<0.05).5-Liver and kidney function testsThe content of ALT in sera were higher were more higher in the NDG+Hal group and Hal group than control group (P<0.05)ConclusionAfter NDG and Hal treatment, serum levels of HVA and GABA content were increased, it can be inferred that NDG and Hal therapeutic mechanism of TS may be an increase of DA metabolism, and excited the GABA system. |
PDF Full Text Request