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硫必利联合可乐定对比硫必利、可乐定单药用于儿童抽动障碍有效性和安全性的队列研究
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| 篇名： | 硫必利联合可乐定对比硫必利、可乐定单药用于儿童抽动障碍有效性和安全性的队列研究 |
| TITLE： | Cohort Study on the Effectiveness and Safety of Tiapride Combined with Clonidine versus Tiapride and Clonidine Alone for Children with Tic Disorders |
| 摘要： | 目的：比较硫必利、可乐定、硫必利联合可乐定等3种用药方案用于儿童抽动障碍（TD）的疗效和安全性。方法：连续性收集2019年1－12月于四川大学华西第二医院门诊部就诊的312例TD患儿的资料，按用药方案的不同分为可乐定组、硫必利组、硫必利联合可乐定组，每组104例。硫必利组患儿给予盐酸硫必利片，初始剂量为每天50～100mg，根据耐受情况和临床经验逐步增加剂量至每天150～500mg。可乐定组患儿给予可乐定透皮贴片，初始剂量为每周1mg，维持剂量为每周1～2mg，每周1次。硫必利联合可乐定组患儿给予盐酸硫必利片（用法用量同硫必利组）+可乐定透皮贴片（用法用量同可乐定组）。3组患儿用药疗程均为3个月，疗程结束后每3个月随访1次（随访时间均以治疗24、36、48周表示）。观察3组患儿治疗前和治疗4、8、12、24、36、48周时的耶鲁综合抽动严重程度量表（YGTSS）评分，并记录各随访时间点的不良反应发生情况。结果：治疗前3组患儿的YGTSS评分比较，差异无统计学意义（P＞0.05）。治疗4、8、12、24、36、48周时，3组患儿的YGTSS评分均显著低于同组治疗前（P＜0.05）。治疗4、8、12周时，硫必利联合可乐定组患儿的YGTSS评分均显著低于硫必利组和可乐定组（P＜0.05），而硫必利组和可乐定组比较差异无统计学意义（P＞0.05）；治疗24周时，硫必利联合可乐定组患儿的YGTSS评分显著低于硫必利组（P＜0.05），而硫必利联合可乐定组与可乐定组、硫必利组与可乐定组比较差异均无统计学意义（P＞0.05）；治疗36、48周时，3组患儿的YGTSS评分比较差异无统计学意义（P＞0.05）。治疗12周时，经Bonferroni法校正P值后的结果显示，硫必利联合可乐定组患儿的YGTSS评分均显著低于硫必利组和可乐定组（P＜0.0167），而硫必利组和可乐定组比较差异无统计学意义（P＞0.0167）。3组患儿的不良反应总发生率比较，差异无统计学意义（P＞0.05）。结论：可乐定、硫必利、硫必利联合可乐定等3种用药方案均能显著改善TD患儿的抽动症状，且安全性较好。 |
| 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 . |
| 期刊： | 2021年第32卷第20期 |
| 作者： | 杨春松，张伶俐，俞丹，杨亚亚，吴小芳 |
| AUTHORS： | YANG Chunsong ，ZHANG Lingli，YU Dan，YANG Yaya，WU Xiaofang |
| 关键字： | 抽动障碍；儿童；可乐定；硫必利；有效性；安全性；队列研究 |
| KEYWORDS： | Tic disorder ；Children；Clonidine；Tiapride；Efficacy；Safety；Cohort study |
| 阅读数： | 2470 次 |
| 本月下载数： | 5 次 |
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