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创伤性胸段 ASIA A 检查和临床试验的可能性。

Traumatic thoracic ASIA A examinations and potential for clinical trials.

机构信息

Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia, PA 19107, USA.

出版信息

Spine (Phila Pa 1976). 2009 Nov 1;34(23):2525-9. doi: 10.1097/BRS.0b013e3181bd1402.

DOI:10.1097/BRS.0b013e3181bd1402
PMID:19927102
Abstract

STUDY DESIGN

Retrospective review of prospective database.

OBJECTIVE

To define the variability of neurologic examination and recovery after nonpenetrating complete thoracic spinal cord injuries (American Spinal Injury Association [ASIA] A).

SUMMARY OF BACKGROUND DATA

Neurologic examinations after spinal cord injury (SCI) can be difficult and inconsistent. Unlike cervical SCI patients, alterations in thoracic (below T1) complete SCI (ASIA A-based on the ASIA Impairment Scale [AIS]) patients' examinations are based only on sensory testing, thus changes in the neurologic level (NL) are determined only by sensory changes.

METHODS

A retrospective review of the placebo control patients in a multicenter prospective database used for the pharmacologic trial of Sygen. Patients were included if they had a complete thoracic SCI on initial evaluation, with completed ASIA examinations at follow-up weeks 4, 8, 16, 26, and 52. Specifically, pin prick (PP) and light touch (LT) were assessed and the absolute change was calculated as the number of spinal levels at a given observation time.

RESULTS

Three thousand one hundred sixty-five patients were initially screened for the Sygen clinical trial, of which 51 were the control placebo patients used in this analysis. Alterations from the baseline examination (PP and LT) were fairly consistent and the median change/recovery in neurologic examination was 1 spinal level. Across all observations postbaseline, the average change for PP was 1.48 +/- 0.13 (mean +/- SE), and for LT, 1.40 +/- 0.13. There were equal proportions of directional changes (none, improved, lost).

CONCLUSION

Changes in a thoracic complete (ASIA A) SCI patients ASIA examination as measured through sensory methods (PP/LT) are fairly uncommon. The overall examination had only 1- to 2-level variability across patients, indicating minimal change in the sensory examination over the follow-up period. Stability in the ASIA examination as measured through sensory methods has thus been demonstrated over time, making it an excellent tool to monitor changes in neurologic function.

摘要

研究设计

前瞻性数据库的回顾性研究。

目的

定义非穿透性完全胸段脊髓损伤(美国脊髓损伤协会 [ASIA] A 级)后的神经检查和恢复的可变性。

背景资料概要

脊髓损伤(SCI)后的神经检查可能很困难且不一致。与颈段 SCI 患者不同,胸段(T1 以下)完全 SCI(基于 ASIA 损伤量表 [AIS] 的 ASIA A 级)患者的检查仅基于感觉测试,因此神经水平(NL)的变化仅通过感觉变化来确定。

方法

对多中心前瞻性数据库中药物试验的安慰剂对照患者进行回顾性审查。如果患者在初始评估时有完全的胸段 SCI,并在随访的第 4、8、16、26 和 52 周完成 ASIA 检查,则将其纳入研究。具体来说,评估针刺觉(PP)和轻触觉(LT),并计算特定观察时间的脊髓水平绝对变化。

结果

3165 名患者最初接受了 Sygen 临床试验的筛选,其中 51 名是用于本分析的安慰剂对照患者。基线检查(PP 和 LT)的变化相当一致,神经检查的中位数变化/恢复为 1 个脊髓水平。在所有基线后观察中,PP 的平均变化为 1.48 +/- 0.13(平均值 +/- SE),LT 为 1.40 +/- 0.13。有相同比例的方向变化(无变化、改善、丧失)。

结论

通过感觉方法(PP/LT)测量的胸段完全性(ASIA A)SCI 患者 ASIA 检查的变化相当少见。在患者之间,整体检查的变化仅为 1-2 个水平,表明在随访期间感觉检查的变化很小。通过感觉方法测量的 ASIA 检查的稳定性随着时间的推移得到了证明,使其成为监测神经功能变化的极好工具。

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