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用于治疗犬特发性头部震颤综合征的伊美替尼:一项随机、双盲、安慰剂对照研究。

Imepitoin for treatment of idiopathic head tremor syndrome in dogs: A randomized, blinded, placebo-controlled study.

机构信息

Centre for Clinical Veterinary Medicine, LMU Munich, Munich, Germany.

Institute of Pharmacology, Toxicology, and Pharmacy, LMU Munich, Munich, Germany.

出版信息

J Vet Intern Med. 2020 Nov;34(6):2571-2581. doi: 10.1111/jvim.15955. Epub 2020 Nov 7.

Abstract

BACKGROUND

Idiopathic head tremor syndrome is a paroxysmal movement disorder of unknown etiology. Spontaneous remission may occur, but owners may request treatment in severely affected dogs with continued episodes. Controlled studies of the disease are not available.

HYPOTHESIS/OBJECTIVES: A drug with gamma amino butyric acid-ergic and anxiolytic effects will decrease head tremor episodes.

ANIMALS

Twenty-four dogs with severe nonremitting head tremor and presumptive clinical diagnosis of idiopathic head tremor syndrome.

METHODS

Prospective, blinded, placebo-controlled clinical trial to compare imepitoin with placebo in dogs with frequent episodes of idiopathic head tremor. Evaluation of efficacy used the quotient T2/T1 that represented prolongation of the head tremor-free period compared to a 3-month baseline. A dog was considered a responder if tremors subsided or if the head tremor-free period was 3× longer than the longest period during baseline (T2/T1 ≥ 3). Sample size calculations considered a large effect of imepitoin on T2/T1 (Cohen's d = 0.8).

RESULTS

There were no responders in the placebo group (0/12). In the imepitoin group, the responder rate was 17% (2/12; P = .18) with T2/T1 3.8 and 4.0. Mean T2/T1 was 1.0 ± 1.4 in the imepitoin and 0.4 ± 0.4 in the placebo group (P = .37).

CONCLUSION AND CLINICAL IMPORTANCE

Imepitoin did not result in a significant overall benefit. Future studies should focus on treatment of subgroups with a common pathophysiology and similar comorbidities.

摘要

背景

特发性头部震颤综合征是一种病因不明的阵发性运动障碍。可能会自发缓解,但在持续发作的严重受影响的犬中,主人可能会要求治疗。目前尚无关于该疾病的对照研究。

假设/目的:具有γ-氨基丁酸能和抗焦虑作用的药物将减少头部震颤发作。

动物

24 只患有严重且无法缓解的头部震颤且疑似特发性头部震颤综合征的犬。

方法

对 24 只患有频繁特发性头部震颤且疑似特发性头部震颤综合征的犬进行前瞻性、双盲、安慰剂对照临床试验,比较伊美托因与安慰剂的疗效。使用 T2/T1 比值评估疗效,该比值代表与 3 个月基线相比,头部震颤无发作期的延长。如果震颤减轻或头部震颤无发作期是基线最长时间的 3 倍(T2/T1≥3),则认为犬为应答者。样本量计算考虑了伊美托因对 T2/T1 的大效应(Cohen's d = 0.8)。

结果

安慰剂组无应答者(0/12)。伊美托因组的应答率为 17%(2/12;P =.18),T2/T1 为 3.8 和 4.0。伊美托因组和安慰剂组的平均 T2/T1 分别为 1.0±1.4 和 0.4±0.4(P =.37)。

结论和临床意义

伊美托因并没有显著的整体获益。未来的研究应集中在具有共同病理生理学和相似合并症的亚组的治疗上。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e58d/7694850/f69be08219de/JVIM-34-2571-g001.jpg

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