L-oxiracetam 和 oxiracetam 对轻度至中度脑外伤患者记忆力和认知障碍的影响：随机对照试验研究方案

IF 2.2 Q3 GERIATRICS & GERONTOLOGY Aging Medicine Pub Date : 2024-06-14 DOI:10.1002/agm2.12335

Tao Liu, Mingqi Liu, Meng Nie, Zhihao Zhao, Xuanhui Liu, Yu Qian, Yunhu Yu, Zhuang Sha, Chenrui Wu, Jiangyuan Yuan, Weiwei Jiang, Chuanxiang Lv, Liang Mi, Yu Tian, Jianning Zhang, Rongcai Jiang

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引用次数: 0

摘要

创伤性脑损伤（TBI）患者通常会出现记忆和认知障碍，而奥拉西坦类药物被认为可能会对这些症状产生积极影响。本研究采用多中心、随机、双盲、平行组、3 期临床试验设计，在中国 51 家医院的 74 个中心进行。共有 590 名符合标准的创伤性脑损伤患者将按 2:2:1 的比例随机分配到三组：L-奥西西坦组、奥西西坦组和安慰剂组。治疗期为 14 天，随访期为 90 天。主要结果指标是治疗后 90 天 Loewenstein 职业治疗认知评估分数的变化。次要结果包括其他认知评估、神经功能、日常生活活动和安全评估的变化。目前还没有有力的证据表明，L-奥西西坦和奥拉西坦能增强轻度至中度创伤性脑损伤患者的记忆力和认知功能。这项研究有可能回答这一关键的临床问题。Chinadrugtrials.org.cn，标识符为CTR20192539；ClinicalTrials.gov，标识符为NCT04205565。

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Effect of L-oxiracetam and oxiracetam on memory and cognitive impairment in mild-to-moderate traumatic brain injury patients: Study protocol for a randomized controlled trial

Objectives

Patients with traumatic brain injury (TBI) often suffer memory and cognitive impairments, and oxiracetam-like drugs are considered to have a positive impact on these symptoms potentially. However, the efficacy and safety of L-oxiracetam and oxiracetam in TBI patients have not been sufficiently investigated.

Methods

The study adopts a multicenter, randomized, double-blind, parallel-group, phase 3 clinical trial design in 74 centers across 51 hospitals in China. A total of 590 TBI patients meeting criteria will be randomly allocated into three groups in a 2:2:1 ratio: L-oxiracetam group, oxiracetam group, and placebo group. The treatment period is 14 days, with a follow-up period of 90 days. The primary outcome measure is the change in the Loewenstein Occupational Therapy Cognitive Assessment score at 90 days after treatment. Secondary outcomes include changes in other cognitive assessments, neurological function, activities of daily living, and safety assessments.

Discussion

There is no robust evidence to suggest that L-oxiracetam and oxiracetam can enhance memory and cognitive function in patients with mild to moderate TBI. This study has the potential to answer this crucial clinical question.