Cohort Study on the Effectiveness and Safety of Tiapride Combined with Clonidine versus Tiapride and Clonidine Alone for Children with Tic Disorders / 中国药房

ABSTRACT

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 .