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可乐定透皮贴剂治疗抽动障碍儿童的疗效和耐受性:一项前瞻性、开放性、单组、自身对照研究。

The Efficacy and Tolerability of the Clonidine Transdermal Patch in the Treatment for Children with Tic Disorders: A Prospective, Open, Single-Group, Self-Controlled Study.

作者信息

Song Pan-Pan, Jiang Li, Li Xiu-Juan, Hong Si-Qi, Li Shuang-Zi, Hu Yue

机构信息

Department of Neurology, Children's Hospital Affiliated to Chongqing University of Medical Sciences, Chongqing, China; Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, China; Key Laboratory of Pediatrics in Chongqing, CSTC2009CA5002, Chongqing, China; Chongqing International Science and Technology Cooperation Center for Child Development and Disorders, Chongqing, China.

出版信息

Front Neurol. 2017 Feb 23;8:32. doi: 10.3389/fneur.2017.00032. eCollection 2017.

DOI:10.3389/fneur.2017.00032
PMID:28280480
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5322220/
Abstract

BACKGROUND

To evaluate the efficacy and tolerability of a clonidine transdermal patch in the treatment of children with tic disorders (TD) and to establish a predictive model for patients.

METHODS

Forty-one patients who met the inclusion criteria entered into 12 weeks of prospective, open, single-group, self-controlled treatment with a clonidine transdermal patch. The Yale Global Tic Severity Scale (YGTSS) was employed before therapy (baseline) and at 4, 8, and 12 weeks after therapy.

RESULTS

(1) The total effect rates of treatment with a clonidine transdermal patch were 29.27, 53.66, and 63.41% at 4, 8, and 12 weeks, respectively. Compared with the baseline, the differences were significant at three different observation periods. (2) Compared to the level of 25% reduction, there were significant decreases in the score-reducing rate of motor tic and total tic severities at 12 weeks. (3) If the disease course was ≤24 months and the motor tic score was <16 at the baseline, there was an effective rate of 100% for treatment with the clonidine transdermal patch. If the disease course was ≤24 months and the motor tic score was >16, there was an effective rate of 57.1%. If the disease course was >24 months and the clinical classification was chronic TD, there was an effective rate of 62.5%. If the disease course was >24 months and the clinical classification was Tourette's syndrome, 90% of the patients were invalid. (4) The main adverse events were rash, slight dizziness, and headache.

CONCLUSION

(1) When patients were pretreated with a D2-dopamine receptor antagonist that was ineffective or not tolerated well, switching to a clonidine transdermal patch treatment was effective and safe. (2) A clonidine transdermal patch could be a first-line medication for mild and moderate TD cases that are characterized by motor tics.

摘要

背景

评估可乐定透皮贴剂治疗抽动障碍(TD)患儿的疗效和耐受性,并建立患者预测模型。

方法

41例符合纳入标准的患者接受为期12周的可乐定透皮贴剂前瞻性、开放性、单组、自身对照治疗。在治疗前(基线)以及治疗后4周、8周和12周采用耶鲁综合抽动严重程度量表(YGTSS)进行评估。

结果

(1)可乐定透皮贴剂治疗的总有效率在4周、8周和12周分别为29.27%、53.66%和63.41%。与基线相比,在三个不同观察期差异均有统计学意义。(2)与降低25%的水平相比,12周时运动性抽动和总抽动严重程度的评分降低率有显著下降。(3)若病程≤24个月且基线时运动性抽动评分<16分,可乐定透皮贴剂治疗有效率为100%。若病程≤24个月且运动性抽动评分>16分,有效率为57.1%。若病程>24个月且临床分类为慢性TD,有效率为62.5%。若病程>24个月且临床分类为 Tourette 综合征,90%的患者治疗无效。(4)主要不良事件为皮疹、轻度头晕和头痛。

结论

(1)当患者使用D2 - 多巴胺受体拮抗剂预处理无效或耐受性差时,改用可乐定透皮贴剂治疗有效且安全。(2)可乐定透皮贴剂可作为以运动性抽动为特征的轻中度TD病例的一线用药。

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Perceptions of treatment for tics among young people with Tourette syndrome and their parents: a mixed methods study.抽动秽语综合征青少年及其父母对抽动治疗的看法:一项混合方法研究。
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Clonidine in Tourette syndrome and sensorimotor gating.可乐定在抽动秽语综合征与感觉运动门控中的作用
透皮给药系统的设计特点、质量源于设计方法、特性、治疗应用及临床考量——综述
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