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金刚烷胺对创伤性脑损伤结局的影响:一项双盲、随机、对照临床试验。

The effects of amantadine on traumatic brain injury outcome: a double-blind, randomized, controlled, clinical trial.

作者信息

Ghalaenovi Hossein, Fattahi Arash, Koohpayehzadeh Jalil, Khodadost Mahmoud, Fatahi Neda, Taheri Morteza, Azimi Alireza, Rohani Sadra, Rahatlou Hessam

机构信息

a Medical Doctor, Assistant Professor of Neurosurgery,Department of Neurosurgery , Iran University of Medical Sciences , Tehran , Iran.

b Community medicine , Iran University of Medical Sciences , Tehran , Iran.

出版信息

Brain Inj. 2018;32(8):1050-1055. doi: 10.1080/02699052.2018.1476733. Epub 2018 May 23.

Abstract

INTRODUCTION

Amantadine, as a dopamine receptor agonist, may stimulate and help the recovery of the nervous system after traumatic brain injury (TBI).

METHODS

We performed this study as a double-blind, randomized, controlled clinical trial with target population including all patients with TBI who scored nine or lower on the Glasgow Coma Scale (GCS), admitted to our hospital between January 2013 and April 2014. The protocol included administration of the drug (placebo or amantadine) for 6 weeks and patient evaluation using the GCS and FOUR score on the first, third and seventh days after the drug was started. After 6 months from starting study drug, the patients were evaluated on the Mini-Mental State Examination, Glasgow Outcome Study, Disability Rating Scale and Karnofsky Performance Scale.

RESULTS

We included 40 patients in the study. The mean age of the patients was 36.77 ± 18.21. As an only important finding, the amantadine group registered an important rise between the first and the seventh day of study drug (∆GCS7-GCS1) with p-value = 0.044.

CONCLUSION

Based on our findings during the first week and the 6 months (since starting drug) follow-ups, prescribing amantadine did not lead to reportable effects on the patients' level of consciousness, memory, disability, cognition, mortality and performance.

摘要

引言

金刚烷胺作为一种多巴胺受体激动剂,可能刺激并有助于创伤性脑损伤(TBI)后神经系统的恢复。

方法

我们开展了这项双盲、随机、对照临床试验,目标人群包括2013年1月至2014年4月期间入住我院、格拉斯哥昏迷量表(GCS)评分在9分及以下的所有TBI患者。方案包括给药(安慰剂或金刚烷胺)6周,并在开始用药后的第1天、第3天和第7天使用GCS和FOUR评分对患者进行评估。在开始研究药物6个月后,对患者进行简易精神状态检查、格拉斯哥预后评分、残疾评定量表和卡氏功能状态量表评估。

结果

我们纳入了40例患者进行研究。患者的平均年龄为36.77±18.21。作为唯一一项重要发现,金刚烷胺组在研究药物的第1天和第7天之间有显著上升(∆GCS7 - GCS1),p值 = 0.044。

结论

根据我们在第一周和6个月(自开始用药起)随访期间的研究结果,开具金刚烷胺对患者的意识水平、记忆、残疾、认知、死亡率和功能未产生可报告的影响。

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