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经椎间孔硬膜外类固醇注射:疗效和安全性的系统评价和荟萃分析。

Transforaminal Epidural Steroid Injections: A Systematic Review and Meta-Analysis of Efficacy and Safety.

机构信息

The Helm Center for Pain Management.

Precision Spine Care, Tyler, TX.

出版信息

Pain Physician. 2021 Jan;24(S1):S209-S232.

Abstract

BACKGROUND

Transforaminal epidural injections have been used since the late 1990s to treat lumbar radicular pain. They have been the subject of considerable attention, with varying conclusions from systematic reviews as to their efficacy. Transforaminal injections have been associated with rare but major complications. Further, the use of transforaminal injections has increased since the passage of the Affordable Care Act. Finally, with the SARS-CoV-2 pandemic, there has been heightened concern regarding the risk associated with steroid injections.

OBJECTIVES

To evaluate and update the effectiveness of transforaminal injections for 4 indications: radicular pain; from spinal stenosis; from failed back surgery syndrome; and for axial low back pain; and to evaluate the safety of the procedure.

STUDY DESIGN

A systematic review and meta-analysis of the efficacy of transforaminal injections.

METHODS

The available literature on transforaminal injections was reviewed and the quality assessed. The level of evidence was classified on a 5-point scale based on the quality of evidence developed by the US Preventive Services Task Force (USPSTF) and modified by the American Society of Interventional Pain Physicians (ASIPP). Data sources included relevant literature from 1966 to April 2020, and manual searches of the bibliographies of known primary and review articles. Pain relief and functional improvement were the primary outcome measures. A minimum of 6 months pain relief follow-up was required.

RESULTS

For this systematic review, 66 studies were identified. Eighteen randomized controlled trials met the inclusion criteria. No observational studies were included. Eleven randomized controlled trials dealt with various aspects of transforaminal injections for radicular pain owing to disc herniation. Based on these studies, there is Level 1 evidence supporting the use of transforaminal injections for radicular pain owing to disc herniation. A meta-analysis showed that at both 3 and 6 months, there was highly statistically significant improvement in both pain and function with both particulate and nonparticulate steroids. For radicular pain from central stenosis there is one moderate quality study, with Level IV evidence. For radicular pain caused by failed back surgery syndrome there is one moderate quality study, with Level IV evidence. For radicular pain from foraminal stenosis and for axial pain there is Level V evidence, opinion-based/consensus, supporting the use of transforaminal injections. Transforaminal injections are generally safe. However, they have been associated with major neurologic complications related to cord infarct. Causes other than intraluminal injection of particulates appear to be at play. The use of an infraneural approach and of blunt needles appear to offer the greatest patient safety. Because of concern over the role of particulate steroids, multiple other injectates have been evaluated, including nonparticulate steroids, tumor necrosis factor alpha (TNF-a) inhibitors, and local anesthetics without steroids. No injectate has been proven superior. If there is concern about immunosuppression because of risk of COVID-19 infection, either the lowest possible dose of steroid or no steroid should be used.

LIMITATIONS

The study was limited by the paucity of literature for some indications.

CONCLUSIONS

There is Level I evidence for the use of transforaminal injections for radicular pain from disc herniations.

摘要

背景

经椎间孔硬膜外注射自 20 世纪 90 年代末以来一直用于治疗腰椎神经根痛。它们一直受到相当多的关注,系统评价对其疗效的结论也各不相同。经椎间孔注射与罕见但严重的并发症有关。此外,自《平价医疗法案》通过以来,经椎间孔注射的使用有所增加。最后,随着 SARS-CoV-2 大流行,人们对与类固醇注射相关的风险更加关注。

目的

评估和更新经椎间孔注射治疗 4 种适应证的有效性:神经根痛;来自椎管狭窄症;来自失败的腰椎手术综合征;和轴向腰痛;并评估该手术的安全性。

研究设计

经椎间孔注射有效性的系统评价和荟萃分析。

方法

对经椎间孔注射的相关文献进行了回顾和质量评估。根据美国预防服务工作组(USPSTF)制定的、经美国介入性疼痛医师协会(ASIPP)修改的 5 级证据质量标准,对证据水平进行了分类。数据来源包括 1966 年至 2020 年 4 月的相关文献,以及已知原始和综述文章的参考文献手动搜索。疼痛缓解和功能改善是主要的观察指标。需要至少 6 个月的疼痛缓解随访。

结果

本系统评价共确定了 66 项研究。18 项随机对照试验符合纳入标准。没有包括观察性研究。11 项随机对照试验涉及经椎间孔注射治疗椎间盘突出症引起的神经根痛的各个方面。基于这些研究,有 1 级证据支持经椎间孔注射治疗椎间盘突出症引起的神经根痛。荟萃分析显示,在 3 个月和 6 个月时,无论是颗粒状还是非颗粒状类固醇,都有高度统计学意义的疼痛和功能改善。对于因中央狭窄引起的神经根痛,有一项中等质量的研究,证据水平为 IV 级。对于因失败的腰椎手术综合征引起的神经根痛,有一项中等质量的研究,证据水平为 IV 级。对于椎间孔狭窄引起的神经根痛和轴向疼痛,有 5 级证据,基于观点/共识,支持经椎间孔注射。经椎间孔注射一般是安全的。然而,它们与与脊髓梗死相关的主要神经并发症有关。除了腔内注射颗粒外,似乎还有其他原因。使用神经下途径和钝针似乎为患者提供了最大的安全性。由于担心颗粒状类固醇的作用,已经评估了多种其他注射剂,包括非颗粒状类固醇、肿瘤坏死因子-α(TNF-a)抑制剂和不含类固醇的局部麻醉剂。没有一种注射剂被证明是优越的。如果因 COVID-19 感染而担心免疫抑制,可以使用最低剂量的类固醇或不使用类固醇。

局限性

该研究受到一些适应证文献不足的限制。

结论

对于椎间盘突出症引起的神经根痛,有 1 级证据支持使用经椎间孔注射。

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