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Effect of zolpidem in chronic disorders of consciousness: a prospective open-label study.

机译:唑吡坦在慢性意识障碍中的作用:一项前瞻性开放标签研究。

摘要

Zolpidem has been reported as an "awakening drug" in some patients with disorders of consciousness (DOC). We here present the results of a prospective openlabel study in chronic DOC patients. Sixty patients (35±15 years; 18 females; mean time since insult ± SD: 4±5.5 years; 31 with traumatic etiology) with a diagnosis of vegetative state/unresponsive wakefulness syndrome (n=28) or minimally conscious state (n=32) were behaviorally assessed using the Coma Recovery Scale-Revised (CRS-R) before and one hour after administration of 10 mg of zolpidem. At the group level, the diagnosis did not change after intake of zolpidem (p=0.10) and CRS-R total scores decreased (p=0.01). Twelve patients (20%) showed improved behaviors and/or CRS-R total scores after zolpidem administration but in only one patient was the diagnosis after zolpidem intake found to show a significant improvement (functional object use), which suggested a change of diagnosis. However, in this patient, a double-blind placebo-controlled trial was performed in order to better specify the effects of zolpidem, but the patient, on this trial, failed to show any clinical improvements. The present open-label study therefore failed to show any clinically significant improvement (i.e., change of Effect of zolpidem in chronic disorders of consciousness: a prospective open-label study diagnosis) in any of the 60 studied chronic DOC patients.
机译:唑吡坦据报道在某些意识障碍(DOC)患者中是“唤醒药物”。我们在这里介绍了在慢性DOC患者中进行的前瞻性开放标签研究的结果。 60名患者被诊断为植物状态/无反应性清醒综合症(n = 28)或最低意识状态(n =在服用10 mg唑吡坦之前和之后一小时,使用昏迷恢复量表修订版(CRS-R)对行为进行了行为评估。在组一级,摄入唑吡坦后诊断无变化(p = 0.10),CRS-R总分降低(p = 0.01)。服用唑吡坦后有12名患者(20%)表现出改善的行为和/或CRS-R总评分,但只有1例患者在服用唑吡坦后发现诊断有明显改善(使用功能对象),这提示诊断改变。然而,在该患者中进行了一项双盲安慰剂对照试验,以更好地说明唑吡坦的作用,但该患者在该试验中未显示出任何临床改善。因此,本公开标签研究未能显示出在60例被研究的慢性DOC患者中有任何临床上的显着改善(即,唑吡坦对慢性意识障碍的作用改变:一项前瞻性公开标签研究诊断)。

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