Data from: High-dose methylprednisolone for acute traumatic spinal cord injury: A meta-analysis

Objective Due to the continuing debates on the utility of high-dose
methylprednisolone (MP) early after acute spinal cord injury (ASCI), we
aim to evaluate the therapeutic and adverse effects of high-dose MP
according to NASCIS-2 dosing protocol in comparison to no steroids on
patients with ASCI, by performing a meta-analysis on the basis of the
current available clinical trials. Methods We searched PubMed and Cochrane
Library (to May 22 2018) for studies comparing neurological recoveries,
adverse events and in-hospital costs between ASCI patients who underwent
high-dose MP treatment or not. Data were synthesized with corresponding
statistical models according to the degree of heterogeneity. Results We
enrolled 16 studies (1863 participants) including 3 RCTs and 13
observational studies. Pooled results indicated that MP was not associated
with an increase in motor score improvement (RCTs: p = 0.84; Observational
studies: p = 0.44) and incidence of recovery by at least one grade on the
ASIA Impairment Scale (AIS) or Frankel (p=0.53). Meanwhile, MP did not
lead to better sensory recovery (p=0.07). However, MP was associated with
a significant higher incidence of gastrointestinal hemorrhage (p=0.04) and
respiratory tract infection (p=0.01). The difference in the overall
in-hospital costs between MP and control groups was not statistically
significant (p=0.78). Conclusions Based on the current evidence, high-dose
MP treatment, in comparison to controls, does not contribute to better
neurological recoveries but may increase the risk of adverse events in
patients with ASCI. Therefore, we recommend against routine use of
high-dose MP early after ASCI.

研究目的 鉴于当前针对急性脊髓损伤（acute spinal cord injury, ASCI）早期应用大剂量甲泼尼龙（high-dose methylprednisolone, MP）的疗效仍存在诸多争议，本研究旨在基于现有已发表的临床研究开展Meta分析，对比遵循NASCIS-2给药方案的大剂量MP治疗与不使用类固醇激素方案对急性脊髓损伤患者的治疗效果及不良反应。

研究方法 我们检索了PubMed及Cochrane图书馆（截至2018年5月22日），筛选对比接受大剂量MP治疗与未接受该治疗的急性脊髓损伤患者的神经功能恢复情况、不良事件发生率及住院总费用的相关研究。根据研究间异质性程度，采用对应统计模型对提取的数据进行合并分析。

研究结果 本研究共纳入16项相关研究，共计1863名受试者，其中包含3项随机对照试验（randomized controlled trial, RCT）与13项观察性研究。合并分析结果显示：MP治疗与运动功能评分改善幅度的提升无显著相关性（随机对照试验：p=0.84；观察性研究：p=0.44），亦未显著提升患者达到ASIA损伤分级（ASIA Impairment Scale, AIS）或Frankel分级至少提升1级的恢复比例（p=0.53）。同时，MP治疗未带来更优的感觉功能恢复效果（p=0.07）。但值得注意的是，MP治疗与胃肠道出血（p=0.04）及呼吸道感染（p=0.01）的发生率显著升高相关。两组患者的总体住院费用差异无统计学意义（p=0.78）。

研究结论 基于现有临床证据，相较于对照组，急性脊髓损伤患者早期应用大剂量MP治疗并不能带来更理想的神经功能恢复，反而可能增加不良事件的发生风险。因此，我们不推荐急性脊髓损伤患者早期常规使用大剂量甲泼尼龙。