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体外冲击波疗法治疗脊髓损伤,是否应提前进入临床试验?一项基于动物研究的系统评价和荟萃分析。

Extracorporeal shockwave therapy in spinal cord injury, early to advance to clinical trials? A systematic review and meta-analysis on animal studies.

机构信息

Physiology Research Center, 440827Iran University of Medical Sciences, Tehran, Iran.

出版信息

Neuroradiol J. 2021 Dec;34(6):552-561. doi: 10.1177/19714009211026899. Epub 2021 Jul 5.

Abstract

BACKGROUND

As there is no consensus over the efficacy of extracorporeal shockwave therapy in the management of spinal cord injury complications, the current meta-analysis aims to investigate preclinical evidence on the matter.

METHODS

The search strategy was developed based on keywords related to 'spinal cord injury' and 'extracorporeal shockwave therapy'. A primary search was conducted in Medline, Embase, Scopus and Web of Science until the end of 2020. Studies which administered extracorporeal shockwave therapy on spinal cord injury animal models and evaluated motor function and/or histological findings were included. The standardised mean difference with a 95% confidence interval (CI) were calculated.

RESULTS

Seven articles were included. Locomotion was significantly improved in the extracorporeal shockwave therapy treated group (standardised mean difference 1.68, 95% CI 1.05-2.31, =0.032). It seems that the efficacy of extracorporeal shockwave therapy with an energy flux density of 0.1 mJ/mm is higher than 0.04 mJ/mm (=0.044). Shockwave therapy was found to increase axonal sprouting (standardised mean difference 1.31, 95% CI 0.65, 1.96), vascular endothelial growth factor tissue levels (standardised mean difference 1.36, 95% CI 0.54, 2.18) and cell survival (standardised mean difference 2.49, 95% CI 0.93, 4.04). It also significantly prevents axonal degeneration (standardised mean difference 2.25, 95% CI 1.47, 3.02).

CONCLUSION

Extracorporeal shockwave therapy significantly improves locomotor recovery in spinal cord injury animal models through neural tissue regeneration. Nonetheless, in spite of the promising results and clinical application of extracorporeal shockwave therapy in various conditions, current evidence implies that designing clinical trials on extracorporeal shockwave therapy in the management of spinal cord injury may not be soon. Hence, further preclinical studies with the effort to reach the safest and the most efficient treatment protocol are needed.

摘要

背景

由于体外冲击波疗法在治疗脊髓损伤并发症方面的疗效尚无共识,本次荟萃分析旨在对此进行临床前证据调查。

方法

根据“脊髓损伤”和“体外冲击波疗法”相关关键词制定检索策略。在 Medline、Embase、Scopus 和 Web of Science 进行初步检索,检索时间截至 2020 年底。纳入对脊髓损伤动物模型进行体外冲击波治疗并评估运动功能和/或组织学发现的研究。计算标准化均数差值及其 95%置信区间(CI)。

结果

纳入 7 篇文献。与对照组相比,接受体外冲击波治疗的动物模型的运动功能明显改善(标准化均数差值 1.68,95%CI 1.05-2.31,=0.032)。似乎 0.1 mJ/mm 的能量通量密度的体外冲击波疗法的疗效高于 0.04 mJ/mm(=0.044)。研究发现冲击波疗法可增加轴突发芽(标准化均数差值 1.31,95%CI 0.65,1.96)、血管内皮生长因子组织水平(标准化均数差值 1.36,95%CI 0.54,2.18)和细胞存活(标准化均数差值 2.49,95%CI 0.93,4.04)。它还能显著预防轴突变性(标准化均数差值 2.25,95%CI 1.47,3.02)。

结论

体外冲击波疗法通过神经组织再生显著改善脊髓损伤动物模型的运动功能恢复。尽管体外冲击波疗法在各种情况下的临床应用和有前景的结果,但目前的证据表明,在管理脊髓损伤方面设计体外冲击波疗法的临床试验可能不会很快进行。因此,需要进一步进行临床前研究,努力制定最安全、最有效的治疗方案。

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Stem Cells Therapy for Spinal Cord Injury.脊髓损伤的干细胞治疗。
Int J Mol Sci. 2018 Mar 30;19(4):1039. doi: 10.3390/ijms19041039.

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