Zhongyu Liu1, Yang Yang1, Lei He1, Mao Pang1, Chunxiao Luo1, Bin Liu1, Limin Rong2. 1. 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. 2. 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. ronglm3@163.com.
Abstract
OBJECTIVE: 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. METHODS: 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. RESULTS: 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: p = 0.84; observational studies: p = 0.44) and incidence of recovery by at least one grade on the American Spinal Injury Association Impairment Scale or Frankel (p = 0.53). Meanwhile, MP did not lead to better sensory recovery (p = 0.07). However, MP was associated with a significantly 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 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.
OBJECTIVE: 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. METHODS: 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. RESULTS: 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: p = 0.84; observational studies: p = 0.44) and incidence of recovery by at least one grade on the American Spinal Injury Association Impairment Scale or Frankel (p = 0.53). Meanwhile, MP did not lead to better sensory recovery (p = 0.07). However, MP was associated with a significantly 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 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.
Authors: Dezhi Lu; Yang Yang; Pingping Zhang; Zhenjiang Ma; Wentao Li; Yan Song; Haiyang Feng; Wenqiang Yu; Fuchao Ren; Tao Li; Hong Zeng; Jinwu Wang Journal: Tissue Eng Regen Med Date: 2022-06-29 Impact factor: 4.169
Authors: Dana M Otzel; Hui Jean Kok; Zachary A Graham; Elisabeth R Barton; Joshua F Yarrow Journal: Curr Opin Pharmacol Date: 2021-08-28 Impact factor: 4.768
Authors: Ihtisham Sultan; Nayan Lamba; Aaron Liew; Phoung Doung; Ishaan Tewarie; James J Amamoo; Laxmi Gannu; Shreya Chawla; Joanne Doucette; Christian D Cerecedo-Lopez; Stefania Papatheodorou; Ian Tafel; Linda S Aglio; Timothy R Smith; Hasan Zaidi; Rania A Mekary Journal: Heliyon Date: 2020-02-19