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比较地塞米松、甲泼尼龙和倍他米松在腰椎经椎间孔硬膜外类固醇注射中的疗效和安全性。

Comparing the Effectiveness and Safety of Dexamethasone, Methylprednisolone and Betamethasone in Lumbar Transforaminal Epidural Steroid Injections.

机构信息

Department of Physical Medicine and Rehabilitation, University of Miami/Jackson Memorial Hospital, Miami, FL.

University of Miami Miller School of Medicine, Miami, FL.

出版信息

Pain Physician. 2024 Jul;27(5):341-348.

Abstract

BACKGROUND

Particulate steroids are thought to exert their effects for long durations at injection sites. However, these types of steroids carry higher risks when used in epidural steroid injections. Catastrophic spinal cord complications, including sudden-onset paraplegia, have been reported due to intravascular particulate steroid preparations that cause embolisms and occlusion of blood vessels, resulting in spinal cord infarctions. Clinicians, therefore, recommend nonparticulate steroids to mitigate these adverse events. To our knowledge, this is the first retrospective study that addresses the effectiveness and safety of methylprednisolone, dexamethasone, and betamethasone when used in transforaminal epidural steroid injections (TFESIs) for the treatment of lumbar radiculopathy.

OBJECTIVES

The primary goal of this study was to compare the proportion of patients who received injections of particulate steroids and required zero repeat injections within 12 months of their initial injection to the proportion of patients who received injections of nonparticulate steroids and also required zero repeat injections, as well as to compare the number of patients in the particulate cohort who required one or more repeat injections within 12 months of their initial injection to the number of patients in the nonparticulate cohort who required the same. The secondary goal was to evaluate the proportion of patients ultimately requiring surgery.

STUDY DESIGN

This is a single-center, IRB-approved, retrospective study evaluating the safety and effectiveness of nonparticulate as compared to particulate steroid medications when used in TFESIs as minimally invasive treatments for chronic lumbar radiculopathy.

SETTING

This study captured data (n = 1717) over a 4-year time frame (01/15/2018 to 01/15/2022).

METHODS

The following data were collected from each patient's chart: age, gender, BMI, race, date of initial injection, number of repeat injections at the same lumbosacral level and on the same side within 12 months of the initial injection, and lumbar surgery date (if applicable). Inclusion criteria included: 1) having chronic low back pain of radicular etiology; 2) being at least 18 years old; 3) having experienced the failure of conservative therapy after 12 weeks (including physical therapy and/or medications); 4) having positive physical exam findings supporting nerve impingement (straight leg raise, slump test); and 5) showing lumbar MRI evidence of nerve impingement from disc herniation. Exclusion criteria included: 1) having received prior lumbar surgery at any level (L1-S1); 2) having been given prior TFESIs fewer than 6 months prior to initial injection; 3) having contracted a systemic infection at the proposed injection site; 4) undergoing active cancer treatment; and 5) having gotten any other spine injections.

RESULTS

A significantly greater proportion of patients in the nonparticulate steroid cohort received 0 repeat injections (87.5% vs 71.4%, P < 0.001). The particulate steroid cohort demonstrated a significantly greater proportion of patients who received repeat injections within 12 months after the initial injections (12.5% vs 29.6%, P < 0.001). There were no significant differences among patients requiring surgery between the 2 cohorts. Other outcome measures included the identification of risk factors significantly associated with repeat injections. There was a statistically significant weak positive correlation between age and repeat injections (Pearson corr = 0.102; P < 0.001) and a weak negative correlation between ethnicity/race and repeat injections (point-biserial corr = -0.093; P < 0.001).  No adverse events were reported.

LIMITATIONS

Not all clinicians included in this study used each of the 3 steroid types, and all clinicians used either particulate or nonparticulate steroids exclusively.

CONCLUSIONS

Our study demonstrates that the clinical outcomes associated with TFESIs of nonparticulate steroids are superior to those associated with TFESIs of particulate steroids when either variety of medication is used to treat lumbar radiculopathy. This is the first study to include a clinically useful predictive model using information on laterality, age, and steroid type.

摘要

背景

颗粒状类固醇被认为在注射部位能长时间发挥作用。然而,当这些类型的类固醇用于硬膜外类固醇注射时,风险更高。由于血管内颗粒状类固醇制剂引起的栓塞和血管闭塞,导致脊髓梗死,已经报道了灾难性的脊髓并发症,包括突发性截瘫。因此,临床医生建议使用非颗粒类固醇来减轻这些不良事件。据我们所知,这是第一项研究使用甲泼尼龙、地塞米松和倍他米松在经椎间孔硬膜外类固醇注射(TFESI)治疗腰椎神经根病的有效性和安全性的回顾性研究。

目的

本研究的主要目的是比较初次注射后 12 个月内接受颗粒状类固醇注射且无需重复注射的患者比例与接受非颗粒状类固醇注射且也无需重复注射的患者比例,以及比较初次注射后 12 个月内颗粒状组中需要一次或多次重复注射的患者比例与非颗粒状组中需要相同数量重复注射的患者比例。次要目的是评估最终需要手术的患者比例。

研究设计

这是一项单中心、IRB 批准的回顾性研究,评估非颗粒状与颗粒状类固醇药物在 TFESI 中作为慢性腰椎神经根病的微创治疗的安全性和有效性。

设置

本研究在 4 年的时间框架内(2018 年 1 月 15 日至 2022 年 1 月 15 日)收集数据(n=1717)。

方法

从每位患者的图表中收集以下数据:年龄、性别、BMI、种族、初次注射日期、初次注射后 12 个月内同一腰椎水平和同一侧的重复注射次数以及腰椎手术日期(如果适用)。纳入标准包括:1)患有神经根源性慢性下腰痛;2)年龄至少 18 岁;3)经历了 12 周的保守治疗失败(包括物理治疗和/或药物治疗);4)有支持神经压迫的体格检查阳性发现(直腿抬高、 slumped 试验);5)腰椎 MRI 显示有椎间盘突出引起的神经压迫。排除标准包括:1)在任何水平(L1-S1)接受过腰椎手术;2)在初次注射前 6 个月内接受过 TFESI;3)在拟注射部位感染了全身感染;4)正在接受癌症治疗;5)接受过其他脊柱注射。

结果

非颗粒状类固醇组接受 0 次重复注射的患者比例明显更高(87.5% vs 71.4%,P < 0.001)。颗粒状类固醇组在初次注射后 12 个月内接受重复注射的患者比例明显更高(12.5% vs 29.6%,P < 0.001)。两组患者中需要手术的患者没有显著差异。其他结果包括确定与重复注射显著相关的风险因素。年龄与重复注射之间存在统计学上显著的弱正相关(Pearson corr=0.102;P < 0.001),种族/民族与重复注射之间存在统计学上显著的弱负相关(点双列 corr=-0.093;P < 0.001)。没有报告不良事件。

局限性

并非所有参与本研究的临床医生都使用了这 3 种类固醇类型中的每一种,所有临床医生都单独使用颗粒状或非颗粒状类固醇。

结论

我们的研究表明,当使用任何一种药物治疗腰椎神经根病时,TFESI 中非颗粒状类固醇的临床结果优于 TFESI 中颗粒状类固醇的临床结果。这是第一项使用关于侧别、年龄和类固醇类型的信息的具有临床意义的预测模型的研究。

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