颈椎经椎间孔硬膜外类固醇注射的安全性

William J. Beckworth , Gilad M. Ghanbari , Eduardo Lamas-Basulto , Benjamin Taylor
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引用次数: 0

摘要

背景2014年,美国食品和药物管理局(FDA)发布了一项药物安全警告,称硬膜外腔注射类固醇可能导致罕见但严重的神经系统不良事件。FDA 发现了 131 例神经系统不良事件,其中大多数并发症与颈椎经椎间孔硬膜外注射 (TFESI) 有关。这些并发症发生在标准使用非颗粒类固醇之前。本研究的目的是评估使用非颗粒类固醇进行颈椎经椎硬膜外注射的安全性。方法在非颗粒类固醇开始普遍使用后,对一家学术机构 2004 年至 2021 年的所有颈椎经椎硬膜外注射进行了回顾,回顾的方法是查看与实施医师相关的 CPT 代码 64479。对所有主治医生和科室主任进行了有关灾难性并发症(中风、脊髓损伤、死亡或其他)的询问。我们还对 200 例连续的颈椎 TFESI 进行了二次分析,观察恢复期护士记录的即时和延迟副作用、术后第二天的电话和门诊随访记录。结果从 2004 年到 2021 年,CPT 编码 64479 共使用了 6967 次,其中颈椎 TFESI 6241 次,胸椎 TFESI 726 次。没有发生灾难性并发症。在对 200 例连续颈椎 TFESI 进行的子集分析中,7 例患者(3.5%,95 % CI 1.0-6.0)的疼痛短暂加剧,18 例患者(9%,95 % CI 5.0-13.0)的疼痛无变化,171 例患者(85.5%,95 % CI 80.6-90.4)的疼痛有所减轻。所有参与者的平均疼痛评分下降了 3.7(95 % CI 3.0-4.4)分。75.5%(95 % CI 69.5-81.5)的患者疼痛评分下降了 2 分,62.5%(95 % CI 59.1-65.9)的患者疼痛评分下降了 3 分。在 7 名出现一过性疼痛加剧的患者中,有 5 名患者的数字评分增加了≥3 分。据报告,失眠、血糖 500、一过性拇指麻木伴疼痛和高血压患者各占 1 例。结论这项研究支持医学会共识建议的使用非颗粒类固醇的颈椎 TFESIs 的安全性。
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Safety of cervical transforaminal epidural steroid injections

Background

In 2014 the FDA issued a drug safety warning that steroids in the epidural space may result in rare but serious neurological adverse events. The FDA identified 131 cases of neurological adverse events and most complications were related to cervical transforaminal epidural injections (TFESIs). These complications occurred before the standard use of non-particulate steroids. Many still consider cervical TFSEIs to be unsafe.

Objectives

The objective of this study was to evaluate the safety of cervical TFESIs with non-particulate steroids.

Methods

A review was done of all cervical TFESIs from 2004 to 2021 at an academic institution when non-particulate steroids became more commonly used by reviewing CPT code 64479 linked to the performing physician. All treating physicians and department directors were queried about catastrophic complications (stroke, spinal cord injury, death or other). A secondary analysis was done on 200 consecutive cervical TFESIs looking at immediate and delayed side-effects documented by the nurse in recovery, day-after phone calls and clinic follow-up notes.

Results

From 2004 to 2021 the CPT code 64479 was used 6967 times, with 6241 cervical TFESIs and 726 thoracic TFESIs. No catastrophic complications occurred. In the subset analysis of 200 consecutive cervical TFESIs, 7 patients (3.5 %, 95 % CI 1.0–6.0) had a transient increase in pain, 18 (9 %, 95 % CI 5.0–13.0) had no change in pain and 171 (85.5 %, 95 % CI 80.6–90.4) had a decrease in pain. The average pain score among all participants dropped 3.7 (95 % 3.0–4.4) points. A 2-point drop was seen in 75.5 % (95 % CI 69.5–81.5) and a 3-point drop was seen in 62.5 % (95 % CI 59.1–65.9). Five of the seven patients with transient increased pain had an increase of 3 points on numerical rating scale. There was one of each of the following reported: insomnia, glucose >500, transient thumb numbness with pain, and hypertension. Two cases of headaches were reported.

Conclusion

This study supports the safety of cervical TFESIs with non-particulate steroids as recommended by consensus opinions from medical societies.

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