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OBJECTIVE：To compa re the effectiveness and safety of three regimens of tiapride ，clonidine and tiapride combined with clonidine in the treatment of tic disorder （TD）in children. METHODS ：A sequential collection of 312 children with TD from the outpatient department of West China Second Hospital of Sichuan University were conducted during Jan.-Dec. 2019. They were divided into clonidine group ，tiapride group ，tiapride combined with clo nidine group ，with 104 cases in each group. Tiapride group was given Tiapride hydrochloride tablets with initial dose of 50-100 mg per day ，and the dose was gradually increased to 150-500 mg per day according to tolerance and clinical experience. Clonidine group was given Clonidine transdermal patches ，once a week ，with initial dose of 1 mg each week ，maintenance dose of 1-2 mg each week ，once a week. Tiapride combined with clonidine group was given Tiapride hydrochloride tablets （same usage and dosage as tiapride group ）+ Clonidine transdermal patches （same usage and dosage as clonidine group ）. The treatment course of 3 groups was 3 months. After the treatment ，they were followed up every 3 months（the following were expressed as 24，36 and 48 weeks after treatment ）. Yale global tie severity scale （YGTSS）scores of 3 groups were observed before treatment ，after 4，8，12，24，36，48 weeks of treatment，and the occurrence of ADR was recorded at different follow up time points. RESULTS ：Before treatment ，there was no statistical significance in YGTSS scores among 3 groups（P＞0.05）. After 4，8，12，24，36 and 48 weeks of treatment ，YGTSS scores of 3 groups were significantly lower than those before treatment （P＜0.05）. After 4，8 and 12 weeks of treatment ，YGTSS scores of tiapride combined with clonidine group were significantly lower than tiapride group and clonidine group （P＜0.05），while there was no statistical significance between tiapride group and clonidine group （P＞0.05）. At 24 weeks of treatment ，YGTSS score of children in tiopride combined with clonidine group was significantly lower than tiopride group （P＜0.05），but there were no significant differences between tiopride combined with clonidine group and tiopride group ，and between tiopride group and clonidine group （P＞0.05）. After 36 and 48 weeks of treatment ，there was no significant difference in YGTSS scores among 3 groups（P＞0.05）. After 12 weeks of treatment ，the results of P value corrected by Bonferroni method showed that YGTSS score of tiopride combined with clonidine group was significantly lower than those of tiopride group and clonidine group （P＜0.016 7）， while there was no statistical significance in the difference between tiopride group and clonidine group （P＞0.016 7）. There was no statistically significant difference in the total incidence of ADR among 3 groups（P＞0.05）. CONCLUSIONS ：Clonidine，tiapride and tiapride combined with clonidine can significantly improve the tic symptoms of TD children with good safety .
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Objective To evaluate the efficacy and safety of Choudongning (CDN) Capsule in children with Tourette’s syndrome of spleen deficiency and phlegm accumulation. Methods A stratified-block randomized, parallel-controlled, double-blind, double- dummy, multi-center trials were designed for clinical study. A total of 240 patients were enrolled and separated randomly into experimental group and positive control group in the rate of 1:1. Patients in the experimental group orally took CDN Capsule and simulated Tiapridal Tablets; The patients in positive control group took Tiapridal Tablets and simulated CDN Capsule. Treatment course lasted for 6 weeks. The clinical efficacy and integrals of YGTSS twitch, the factor scores of motor tics and vocal tics, YGTSS social function damage, traditional Chinese medicine syndrome efficacy were observed to evaluate its security. Results The total effective rate of YGTSS twitch clinical efficacy was 71.19% in the experimental group and 67.50% in the positive control group, respectively. The results of non-inferiority test indicated that the efficacy of experimental group was not worse than that in the positive control group. There was no significant difference between two groups in YGTSS twitch integrals, motor tics and vocal tics’ factor scores, YGTSS social function damage, and traditional Chinese medicine syndrome efficacy. Only two ADRs (1.67%) in the experimental group and six ADRs (5%) in the positive control group were observed during clinical trials. The incidence of ADRs in the experimental group was lower than that in the positive control group with no statistical difference. Conclusion CDN Capsule have similar efficacy on the treatment of Tourette’s syndrome of spleen deficiency and phlegm accumulation contrast to Tiapridal Tablets, with lower adverse reactions and better safety.
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Objective To observe curative effect of Ningdong granules on tourette syndrome (TS) concomitant with sleep disorder in children.Methods Eighty-three cases were diagnosed by diagnosis and statistics of mental-disorder (DSMIV) TS criterion and diagnostic standard of traditional Chinese medicine,and then were divided into 3 groups:tiapride hydrochloride group (n =25),Ningdong granules group (n =30) and tiapride hydrochloride plus Ningdong granules group (n =28).Yale global tic severity scale (YGTSS) and Athens insomnia scale (Athens) were used for rating the clinical efficacy before and after treatment.The enrolled children were treated for a period of three months.Results The therapeutic effective rate of TS in tiapride hydrochloride group,Ningdong granules group and tiapride hydrochloride plus Ningdong granules group was 92.0％,90.0％ and 96.4％,respectively.The therapeutic effective rate of sleep disorder was 84.0％,93.3％ and 96.4％,respectively.Mter treatment,YGTSS and Athens scores were significantly changed in all three groups (P ＜ 0.05).Athens score was significantly different between tiapride hydrochloride plus Ningdong granules group and tiapride hydrochloride group (P ＜ 0.05).The total number of adverse reactions was 16,1 and 8,with significant difference (P ＜ 0.01).Conclusion Curative effect of Ningdong granules is similar to that of tiapride hydrochloride on treating TS,but Ningdong granules is more effective than tiapride hydrochloride on treating sleep disorder with less adverse reactions.Combination therapy of Ningdong granules with tiapride hydrochloride is the better choice for treating TS with sleep disorder,and it can also reduce the incidence of adverse reactions of tiapride hydrochloride.
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Objective To evaluate the efficacy of itopride hydrochloride combined with alpha-lipoic acid in treatment of diabetic gastroparesis.Methods One hundred and ten patients with diabetic gastroparesis were randomly assigned to two groups.Sixty patients received α-lipoic acid plus itopride (α-lipoic acid 0.6 g intravenously for 14 d plus itopride 50 mg orally t.i.d), and 50 cases received oral itopride only.The clinical symptoms including postprandial abdominal fullness, belching, acid reflux, anorexia, nausea and vomiting were observed;the gastric emptying rate was tested, and plasma motilin and serum ganstrin levels were measured groups, before and after two weeks of treatment.Results The clinical symptom scores of combination therapy group (4.62 ± 3.46 vs.12.26-± 3.43) and control groups (5.43-± 3.65 vs.12.31-± 3.37) were improved after treatment.The overall effective rate of combination group was 91.6％ and that of itopride therapy group was 78.0％ (x2 =4.098, P ＜ 0.05).Gastric emptying rate of combination group [(76.9 ± 9.7) ％ vs.(37.3 ± 10.2) ％] was increased more markedly than that ofitopridegroup[(57.2-± 10.4)％ vs.(36.8-± 11.2)％] (t =10.221, P ＜0.05).Plasma motilin and serum ganstrin levels in combination group [(640.2 ± 64.4) ng/L vs.(554.0 ± 67.6) ng/L, (152.6 ± 20.3)ng/L vs.(96.8 ± 22.2)ng/L] were reduced more markedly than those in itopride group [(636.3 ±66.4)ng/L vs.(589.4 48.3)ng/L, (153.5-± 19.4) ng/L vs.(120.9 ± 19.7)ng/L] respectively (t =3.100, 5.959, all P ＜ 0.05).Conclusion For patients with diabetic gastroparesis, α-lipoic acid and itopride combination therapy can significantly improve symptoms and gastric emptying rate, decrease motlin and gastrin levels;and the efficacy of combination therapy is better than that of itopride monotherapy.
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Objective To investigate the efficacy and safety of Ningdong granule on Obsessive-compulsive disorder (OCD) associated with Tourette's syndrome (TS).Methods Thirty-six patients with OCD associated with TS were randomly divided into 2 groups.18 patients in the treatment group were treated with ND granule,and 18 patients in the control group were treated with fluoxetine,the initial dose of fluoxetine was 10 mg/d,and maximum dose was 60 mg/d.All of the participants with history of medication had to be medication-free for≥ 1 weeks prior to the study.The severity of tics and OCD were evaluated at baseline and at end point (8 w),with Yale Global Tic Severity Scale (YGTSS)and Yale-Brown Obsessive Compulsive Scale (Y-BOCS),the contents of 5-HT in serum were measured by ELISA.Side-effects were evaluated according to an adverse event chart produced by this study team.Results The effective rate of treating tics in treatment group was 88.89％ (16/18),and in control group was 77.78％ (14/18).The effective rate of treating OCD in treatment group was 83.33％ (15/18),and in control group was 88.89％ (16/18).The differences in the aspects between treatment group and control group were not significant (P＞0.05).Compared with YGTSS scores [the treatment group was (27.28 ± 8.10),the control group was (29.17 ± 7.53)] and Y-BOCS scores [the treatment group was (22.72 ± 6.75),the control group was (23.17 ± 6.12)] at baseline,the scores YGTSS scores [the treatment group was (12.72±5.20),the control group was (15.50±5.39)] and Y-BOCS scores [the treatment group was (1250± 4.38),the control group was (12.22±4.31)] of both two groups at end point reduced significantly (P＜0.01),but the difference between the two groups was not significant (P＞0.05).The contents of serum 5-HT in the two groups were significantly raised after treatment [the treatment group was (86.05±24.26 vs 66.00±19.63) ng/ml,P=0.01),the control group was (91.16±26.07 vs 67.52±21.18) ng/ml,P＜0.01].Only one subject reported adverse reactions in the treatment group,while 6 subjects experienced adverse reactions in the control group,but no difference was shown in comparison of the aspect between the treatment group and the control group (P＞0.05).Conclusion ND granule with tiapride could improve the syndrome of tics and OCD associated with TS.ND granule with tiapride and fluoxetine with tiapride showed similar efficacy and safety for OCD with TS.
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The human ether-a-go-go-related gene (hERG) channel is important for repolarization in human myocardium and is a common target for drugs that prolong the QT interval. We studied the effects of two antipsychotics, tiapride and sulpiride, on hERG channels expressed in Xenopus oocytes and also on delayed rectifier K+ currents in guinea pig cardiomyocytes. Neither the amplitude of the hERG outward currents measured at the end of the voltage pulse, nor the amplitude of hERG tail currents, showed any concentration-dependent changes with either tiapride or sulpiride (3~300 micrometer). However, our findings did show that tiapride increased the potential for half-maximal activation (V(1/2)) of HERG at 10~300 micrometer, whereas sulpiride increased the maximum conductance (G(max)) at 3, 10 and 100 micrometer. In guinea pig ventricular myocytes, bath applications of 100 and 500 micrometer tiapride at 36degrees C blocked rapidly activating delayed rectifier K+ current (I(Kr)) by 40.3% and 70.0%, respectively. Also, sulpiride at 100 and 500 micrometer blocked I(Kr) by 38.9% and 76.5%, respectively. However, neither tiapride nor sulpiride significantly affected the slowly activating delayed rectifier K+ current (I(Ks)) at the same concentrations. Our findings suggest that the concentrations of the antipsychotics required to evoke a 50% inhibition of IKr are well above the reported therapeutic plasma concentrations of free and total compound.
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Animals , Humans , Antipsychotic Agents , Baths , Guinea Pigs , Muscle Cells , Myocardium , Myocytes, Cardiac , Oocytes , Plasma , Sulpiride , Tiapride Hydrochloride , XenopusABSTRACT
Objective:Tiapride has been used effectively in the clinic for the treatment of dyskinesias and tic disorders including Tourette syndrome. The purpose of the retrospective study is to evaluate the effectiveness of tiapride with the horn of saiga tatarica in treatment of hemifacial spasm. Method:Twenty-eight patients with idio-pathic hemifacial spasm, who were previously treated with carbamazepine, or acupuncture, or botulinum toxin injection, but refused to continue the previous therapies, were treated with tiapride, at a dosage of 50 mg /time once to thrice per day, combined with the horn of saiga tatarica at a dosage of 0. 15 g to 0. 30 g/time once per day. The dosage of tiapride can been up to 100 mg/time once to thrice per day in some cases if necessary. The effectiveness of the therapy was evaluated from the time of three months after the beginning of the treatment. The main efficacy parameter was the degree of spasm reduction, that is, the classification of spasm before versus after the treatment. Result:The duration of following up is between 3 months and 12 months. Twenty-five cases out of 28 patients have demonstrated a significant reduction of spasm. Of which, eight cases were completely relieved, 12 cases marked relieved and 5 cases partially relieved. The effective rate is 89. 29%. Conclusion:Tiapride combined with the horn of saiga tatarica was effective and safe in reducing hemifacial spasm. However, further data from blinded trials and long-term following up are required before this treatment can be considered to be one of the main medical treatment options for hemifacial spasm.