From the Department of Spine Surgery, Institute of Drug Clinical Trial for Orthopedic Diseases, The Third Affiliated Hospital of Sun Yat-sen University; Guangdong Provincial Center for Engineering and Technology Research of Minimally Invasive Spine Surgery; and Guangdong Provincial Center for Quality Control of Minimally Invasive Spine Surgery, Guangzhou, China.
Neurology. 2019 Aug 27;93(9):e841-e850. doi: 10.1212/WNL.0000000000007998. Epub 2019 Jul 29.
Due to the continuing debates on the utility of high-dose methylprednisolone (MP) early after acute spinal cord injury (ASCI), we aimed to evaluate the therapeutic and adverse effects of high-dose MP according to the second National Acute Spinal Cord Injury Study (NASCIS-2) dosing protocol in comparison to no steroids in patients with ASCI by performing a meta-analysis on the basis of the current available clinical trials.
We searched PubMed and Cochrane Library (to May 22, 2018) for studies comparing neurologic 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.
We enrolled 16 studies (1,863 participants) including 3 randomized controlled trials (RCTs) and 13 observational studies. Pooled results indicated that MP was not associated with an increase in motor score improvement (RCTs: = 0.84; observational studies: = 0.44) and incidence of recovery by at least one grade on the American Spinal Injury Association Impairment Scale or Frankel ( = 0.53). Meanwhile, MP did not lead to better sensory recovery ( = 0.07). However, MP was associated with a significantly higher incidence of gastrointestinal hemorrhage ( = 0.04) and respiratory tract infection ( = 0.01). The difference in the overall in-hospital costs between MP and control groups was not statistically significant ( = 0.78).
Based on the current evidence, high-dose MP treatment, in comparison to controls, does not contribute to better neurologic 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.
由于人们对急性脊髓损伤（ASCI）后早期使用大剂量甲基强的松龙（MP）的效果仍存在争议，我们旨在通过对现有临床试验进行荟萃分析，按照第二国家急性脊髓损伤研究（NASCIS-2）的给药方案，评估高剂量 MP 与不使用类固醇治疗 ASCI 患者的治疗效果和不良反应。
我们检索了 PubMed 和 Cochrane Library（截至 2018 年 5 月 22 日），以比较接受高剂量 MP 治疗和未接受治疗的 ASCI 患者的神经功能恢复、不良反应和住院费用。根据异质性程度，采用相应的统计模型对数据进行综合分析。
我们纳入了 16 项研究（1863 名参与者），包括 3 项随机对照试验（RCT）和 13 项观察性研究。汇总结果表明，MP 治疗与运动评分改善增加无关（RCT： = 0.84；观察性研究： = 0.44），也与美国脊髓损伤协会损伤量表或 Frankel 分级至少提高 1 级的恢复发生率无关（ = 0.53）。同时，MP 也不能改善感觉恢复（ = 0.07）。然而，MP 与胃肠道出血（ = 0.04）和呼吸道感染（ = 0.01）发生率显著增加有关。MP 组与对照组的总住院费用差异无统计学意义（ = 0.78）。
基于现有证据，与对照组相比，大剂量 MP 治疗并不能改善神经功能恢复，但可能会增加 ASCI 患者发生不良反应的风险。因此，我们不建议常规在 ASCI 后早期使用大剂量 MP。
