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  4. Recombinant human erythropoietin plus methylprednisolone versus methylprednisolone in treatment of acute spinal cord injury:protocol for a systematic review and meta-analysis

Recombinant human erythropoietin plus methylprednisolone versus methylprednisolone in treatment of acute spinal cord injury:protocol for a systematic review and meta-analysis

BMJ Open, 2022 · DOI: 10.1136/bmjopen-2021-056689 · Published: January 1, 2022

Spinal Cord InjuryNeurologyResearch Methodology & Design

Simple Explanation

This study is a protocol for a systematic review and meta-analysis that aims to evaluate the effectiveness of using recombinant human erythropoietin (rHuEPO) in combination with methylprednisolone (MP) for treating spinal cord injuries (SCI). The goal is to determine if this combination therapy improves neurological function in SCI patients compared to using MP alone. The researchers plan to search multiple databases for randomized controlled trials (RCTs) that study the effects of rHuEPO plus MP on SCI patients. They will analyze the data from these trials to assess neurological function, quality of life, neurophysiological state, and related factors. The outcomes of interest include the American Spinal Injury Association (ASIA) score, WHOQOL-100 instrument score, and neurophysiological state. The study will also look at adverse events, treatment compliance, and acceptability.

Study Duration
Not specified
Participants
Patients with SCI in randomised controlled trials (RCTs)
Evidence Level
Systematic review and meta-analysis protocol

Key Findings

  • 1
    The primary outcome will be the American Spinal Injury Association score at the time of follow-up.
  • 2
    The secondary outcomes will be the WHOQOL-100 instrument score, neurophysiological state and related factors.
  • 3
    This study will only include randomised controlled trials and will be the first systematic review and meta-analysis to investigate the effect of recombinant human erythropoietin combined with methylprednisolone on neurological outcome in patients with spinal cord injury.

Research Summary

This protocol outlines a systematic review and meta-analysis to evaluate the efficacy of recombinant human erythropoietin (rHuEPO) plus methylprednisolone (MP) compared to MP alone in improving neurological function in patients with spinal cord injury (SCI). The study will search eight research databases for relevant randomized controlled trials (RCTs) and assess the risk of bias in the included studies. Statistical analysis will be performed using Stata V.14.0. The results of this review may support the development of formal recommendations regarding rHuEPO therapy for SCI patients and help with future research design.

Practical Implications

Clinical Practice Guidance

The findings of this study may support the development of formal recommendations regarding rHuEPO therapy for SCI patients.

Future Research Direction

This review can guide clinical decision making and future development of targeted neurorehabilitation protocols.

Drug Development

The results of this systematic review and meta-analysis will help clinicians and drug developers conduct more rHuEPO clinical trials and identify the direction of drug development for SCI in the future.

Study Limitations

  • 1
    One limitation is that we will search electronic databases of literatures published in English and Chinese, which may result in some missing studies published in other languages.
  • 2
    The included studies may be highly heterogeneous in the doses used and the methods of neurological function assessment.
  • 3
    It is possible that although our analysis reveals a positive result, the quality of the included studies may be insufficient to support the development of formal recommendations.

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