Beckworth William J, Ghanbari Gilad M, Lamas-Basulto Eduardo, Taylor Benjamin
AdventHealth, USA. 50 Hospital Drive, Hendersonville, NC, 28792, USA.
Department of Physical Medicine and Rehabilitation, Emory University, Atlanta, GA, USA.
Interv Pain Med. 2024 Jun 5;3(2):100420. doi: 10.1016/j.inpm.2024.100420. eCollection 2024 Jun.
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.
The objective of this study was to evaluate the safety of cervical TFESIs with non-particulate steroids.
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.
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.
This study supports the safety of cervical TFESIs with non-particulate steroids as recommended by consensus opinions from medical societies.
2014年,美国食品药品监督管理局(FDA)发布了一项药物安全警告,指出硬膜外腔使用类固醇可能导致罕见但严重的神经不良事件。FDA确认了131例神经不良事件病例,大多数并发症与颈椎经椎间孔硬膜外注射(TFESI)有关。这些并发症发生在非颗粒类固醇标准使用之前。许多人仍然认为颈椎TFESI不安全。
本研究的目的是评估使用非颗粒类固醇进行颈椎TFESI的安全性。
通过回顾与执行医生相关的CPT代码64479,对2004年至[具体年份]在一所学术机构进行的所有颈椎TFESI进行了回顾,当时非颗粒类固醇的使用更为普遍。向所有治疗医生和科室主任询问了灾难性并发症(中风、脊髓损伤、死亡或其他)情况。对连续200例颈椎TFESI进行了二次分析,观察护士在恢复过程、次日电话随访和门诊随访记录中记录的即时和延迟副作用。
2004年至[具体年份],CPT代码64479使用了6967次,其中颈椎TFESI 6241例,胸椎TFESI 726例。未发生灾难性并发症。在连续200例颈椎TFESI的亚组分析中,7例患者(3.5%,95%可信区间1.0 - 6.0)疼痛短暂加重,18例(9%,95%可信区间5.0 - 13.0)疼痛无变化,171例(85.5%,95%可信区间80.6 - 90.4)疼痛减轻。所有参与者的平均疼痛评分下降了3.7(95% 3.0 - 4.4)分。75.5%(95%可信区间69.5 - 81.5)的患者疼痛评分下降2分,62.5%(95%可信区间59.1 - 65.9)的患者疼痛评分下降3分。7例疼痛短暂加重的患者中有5例在数字评分量表上疼痛增加3分。报告了以下各1例:失眠、血糖>500、伴有疼痛的短暂拇指麻木和高血压。报告了2例头痛病例。
本研究支持医学协会共识意见所推荐的使用非颗粒类固醇进行颈椎TFESI的安全性。