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硫必利与安慰剂对比:亨廷顿舞蹈症治疗的双盲对照研究

Tiapride versus placebo: a double-blind comparative study in the management of Huntington's chorea.

作者信息

Deroover J, Baro F, Bourguignon R P, Smets P

出版信息

Curr Med Res Opin. 1984;9(5):329-38. doi: 10.1185/03007998409109601.

Abstract

A double-blind, placebo-controlled, crossover trial was carried out in 29 patients with Huntington's chorea to evaluate the effectiveness and tolerance of high doses of tiapride in the management of neurological symptoms. Patients were allocated at random into 3 groups to receive 3 g tiapride daily for two periods of 3 weeks either preceded, interrupted or followed by a 3-week period on placebo. Patients were assessed on entry and at the end of each treatment period using a battery of tests designed to measure choreatic movements, motor skills, recognition and reaction times, and mental state. Twenty-three patients completed the trial; only 2 of the 6 drop-outs withdrew because of drug-related side-effects (sedation and extrapyramidal signs). The results showed that tiapride treatment significantly improved choreatic movements and motor skills and these findings were supported by the objective psychometric measurements. Overall evaluation of effectiveness by the physician and patients indicated the significant superiority of tiapride over placebo. Treatment was generally well tolerated and although there were significantly more reports of sedation and extrapyramidal signs whilst patients were receiving tiapride, these effects were rated as mild in most cases and did not interfere with treatment.

摘要

对29例亨廷顿舞蹈症患者进行了一项双盲、安慰剂对照的交叉试验,以评估高剂量硫必利治疗神经症状的有效性和耐受性。患者被随机分为3组,在两个为期3周的疗程中,每天接受3克硫必利治疗,在这两个疗程之前、中间或之后有一个为期3周的安慰剂治疗期。在试验开始时以及每个治疗期结束时,使用一系列旨在测量舞蹈样动作、运动技能、认知和反应时间以及精神状态的测试对患者进行评估。23例患者完成了试验;6例退出者中只有2例因药物相关副作用(镇静和锥体外系症状)而退出。结果表明,硫必利治疗显著改善了舞蹈样动作和运动技能,这些发现得到了客观心理测量的支持。医生和患者对疗效的总体评估表明,硫必利明显优于安慰剂。治疗一般耐受性良好,虽然在患者接受硫必利治疗时有更多关于镇静和锥体外系症状的报告,但在大多数情况下,这些影响被评为轻度,并不影响治疗。

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