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脊髓损伤后的急性不良事件及其与长期神经和功能结局的关系:来自北美脊髓损伤临床试验网络的分析。

Acute Adverse Events After Spinal Cord Injury and Their Relationship to Long-term Neurologic and Functional Outcomes: Analysis From the North American Clinical Trials Network for Spinal Cord Injury.

机构信息

Division of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.

Division of Orthopaedic Surgery, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.

出版信息

Crit Care Med. 2019 Nov;47(11):e854-e862. doi: 10.1097/CCM.0000000000003937.

Abstract

OBJECTIVES

There are few contemporary, prospective multicenter series on the spectrum of acute adverse events and their relationship to long-term outcomes after traumatic spinal cord injury. The goal of this study is to assess the prevalence of adverse events after traumatic spinal cord injury and to evaluate the effects on long-term clinical outcome.

DESIGN

Multicenter prospective registry.

SETTING

Consortium of 11 university-affiliated medical centers in the North American Clinical Trials Network.

PATIENTS

Eight-hundred one spinal cord injury patients enrolled by participating centers.

INTERVENTIONS

Appropriate spinal cord injury treatment at individual centers.

MEASUREMENTS AND MAIN RESULTS

A total of 2,303 adverse events were recorded for 502 patients (63%). Penalized maximum logistic regression models were fitted to estimate the likelihood of neurologic recovery (ASIA Impairment Scale improvement ≥ 1 grade point) and functional outcomes in subjects who developed adverse events at 6 months postinjury. After accounting for potential confounders, the group that developed adverse events showed less neurologic recovery (odds ratio, 0.55; 95% CI, 0.32-0.96) and was more likely to require assisted breathing (odds ratio, 6.55; 95% CI, 1.17-36.67); dependent ambulation (odds ratio, 7.38; 95% CI, 4.35-13.06) and have impaired bladder (odds ratio, 9.63; 95% CI, 5.19-17.87) or bowel function (odds ratio, 7.86; 95% CI, 4.31-14.32) measured using the Spinal Cord Independence Measure subscores.

CONCLUSIONS

Results from this contemporary series demonstrate that acute adverse events are common and are associated with worsened long-term outcomes after traumatic spinal cord injury.

摘要

目的

目前仅有少数关于创伤性脊髓损伤后急性不良事件及其与长期结局关系的当代、前瞻性多中心系列研究。本研究的目的是评估创伤性脊髓损伤后不良事件的发生率,并评估其对长期临床结局的影响。

设计

多中心前瞻性登记研究。

地点

北美临床试验网络 11 家大学附属医院的联合体。

患者

由参与中心纳入的 801 名脊髓损伤患者。

干预措施

各中心采取适当的脊髓损伤治疗。

测量和主要结果

共记录了 502 例患者(63%)的 2303 例不良事件。对 6 个月时发生不良事件的患者,采用惩罚最大似然回归模型估计神经功能恢复(ASIA 损伤量表改善≥1 级)和功能结局的可能性。在考虑潜在混杂因素后,发生不良事件的组显示出较低的神经功能恢复(优势比,0.55;95%可信区间,0.32-0.96),更有可能需要辅助呼吸(优势比,6.55;95%可信区间,1.17-36.67);依赖步行(优势比,7.38;95%可信区间,4.35-13.06)和膀胱(优势比,9.63;95%可信区间,5.19-17.87)或肠道功能受损(优势比,7.86;95%可信区间,4.31-14.32),这些功能使用脊髓独立性测量子评分进行评估。

结论

本当代系列研究结果表明,急性不良事件很常见,与创伤性脊髓损伤后长期结局恶化相关。

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