早期头部抬高运动与标准护理治疗严重获得性脑损伤患者：系统评价与荟萃分析和试验序贯分析。
Early head-up mobilisation versus standard care for patients with severe acquired brain injury: A systematic review with meta-analysis and Trial Sequential Analysis.
机构信息
Department of Neurorehabilitation, Traumatic Brain Injury, Rigshospitalet, Copenhagen University Hospital, Hvidovre, Denmark.
Department of Clinical Medicine, Faculty of Healthcare Sciences, University of Copenhagen, Copenhagen, Denmark.
出版信息
PLoS One. 2020 Aug 13;15(8):e0237136. doi: 10.1371/journal.pone.0237136. eCollection 2020.
BACKGROUND
There is increasing focus on earlier rehabilitation in patients with traumatic or hypoxic brain injury or stroke. This systematic review evaluates the benefits and harms of early head-up mobilisation versus standard care in patients with severe acquired brain injury.
METHODS
We searched Medline, CENTRAL, EMBASE, four other databases and 13 selected clinical trial registries until April 2020. Eligible randomised clinical trials compared early head-up mobilisation versus standard care in patients with severe acquired brain injury and were analysed conducting random- and fixed-effects meta-analyses and Trial Sequential Analysis (TSA). Certainty of evidence was assessed by GRADE.
MAIN RESULTS
We identified four randomised clinical trials (total n = 385 patients) with severe acquired brain injury (stroke 86% and traumatic brain injury 13%). Two trials were at low risk and two at high risk of bias. We found no evidence of a difference between early mobilisation vs. standard care on mortality or poor functional outcome at end of the intervention (relative risk (RR) 1.19, 95% CI 0.93 to 1.53; I2 0%; very low certainty) or at maximal follow-up (RR 1.03, 95% CI 0.89 to 1.21; I2 0%; very low certainty). We found evidence against an effect on quality of life at maximal follow-up. The proportion of patients with at least one serious adverse event did not differ at end of intervention or at maximal follow-up. For most comparisons, TSA suggested that further trials are needed.
CONCLUSIONS
We found no evidence of a difference between early mobilisation versus standard care for patients with severe acquired brain injury. Early mobilisation appeared not to exert a major impact on quality of life. This systematic review highlights the insufficient evidence in patients with severe brain injury, and no firm conclusions can be drawn from these data.
TRIAL REGISTRATION
Protocol uploaded to PROSPERO: April 2018 (revised October 2018, CRD42018088790).
背景
人们越来越关注创伤性或缺氧性脑损伤或中风患者的早期康复。本系统评价评估了严重获得性脑损伤患者中早期头高位移动与标准护理相比的益处和危害。
方法
我们检索了 Medline、CENTRAL、EMBASE、其他四个数据库和 13 个选定的临床试验注册处，直到 2020 年 4 月。合格的随机临床试验比较了严重获得性脑损伤患者的早期头高位移动与标准护理，并通过随机和固定效应荟萃分析以及试验序贯分析（TSA）进行分析。通过 GRADE 评估证据确定性。
主要结果
我们确定了四项随机临床试验（共 385 名严重获得性脑损伤患者[86%为中风，13%为创伤性脑损伤]）。两项试验的偏倚风险较低，两项试验的偏倚风险较高。我们没有发现早期移动与标准护理在干预结束时（相对风险（RR）1.19，95%CI 0.93 至 1.53；I2 0%；极低确定性）或最大随访时（RR 1.03，95%CI 0.89 至 1.21；I2 0%；极低确定性）死亡率或不良功能结局之间存在差异的证据。我们有证据表明，在最大随访时，生活质量没有受到影响。干预结束时和最大随访时至少有一次严重不良事件的患者比例没有差异。对于大多数比较，TSA 表明需要进一步的试验。
结论
我们没有发现严重获得性脑损伤患者中早期移动与标准护理之间的差异。早期移动似乎对生活质量没有产生重大影响。本系统评价强调了严重脑损伤患者证据不足，不能从这些数据中得出确凿的结论。
试验注册
方案于 2018 年 4 月上传至 PROSPERO（2018 年 10 月修订，CRD42018088790）。
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