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医疗保险人群中硬膜外皮质类固醇注射相关严重脊柱不良事件的风险。

Risk of serious spinal adverse events associated with epidural corticosteroid injections in the Medicare population.

机构信息

Division of Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USA

Department of Perioperative Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.

出版信息

Reg Anesth Pain Med. 2021 Mar;46(3):203-209. doi: 10.1136/rapm-2020-101778. Epub 2020 Dec 4.

Abstract

BACKGROUND

Epidural corticosteroid injections (ESIs) are widely performed and have an unquantified risk of serious spinal adverse events (SSAEs). We sought to determine the rate of SSAEs following ESI and to compare the rates by spinal level, injection approach and corticosteroid formulation.

METHODS

We included patients enrolled in Medicare parts A and B who had an ESI between 1 January 2009 and 30 September 2015. We identified potential cases as patients with spine-related diagnoses within 3 days after the first eligible ESI. Event categorization as probable, possible or non-case was based on review of medical records. The rates of probable and possible cases were expressed per 1 000 000 patients overall, and by spinal level, injection approach and corticosteroid formulation. A score test was used to compare these rates.

RESULTS

We identified 1 355 957 eligible ESIs during the study period. Of the 110 potential cases, 43 were selected for medical record review and 11 were categorized as probable, yielding a rate of 8.1 per 1 000 000 patients (95% CI 4.5 to 14.5). Risk of SSAEs was statistically higher with cervical/thoracic injections (29.4, 95% CI 12.5 to 68.8) compared with lumbar/sacral injections (5.1, 95% CI 2.3 to 11.0) (p value 0.001). Event rates for lumbar/sacral non-transforaminal injections was 8.8 (95% CI 4.0 to 19.1). Event rates for particulate (7.5, 95% CI 3.9 to 14.2) and non-particulate formulations (13.1, 95% CI 3.6 to 47.9) appeared similar (p value 0.47).

CONCLUSION

Between 2009 and 2015, rates of SSAEs following ESI in the Medicare population were low. Patients receiving cervical/thoracic ESIs were at higher risk of SSAE than those receiving lumbar/sacral ESIs. Event rates were similar for each corticosteroid formulation.

摘要

背景

硬膜外皮质类固醇注射(ESI)被广泛应用,但存在无法量化的严重脊柱不良事件(SSAE)风险。我们旨在确定 ESI 后 SSAE 的发生率,并比较不同脊柱水平、注射途径和皮质类固醇制剂的发生率。

方法

我们纳入了 2009 年 1 月 1 日至 2015 年 9 月 30 日期间接受 Medicare 部分 A 和 B 保险的患者,这些患者接受了 ESI。我们将首次接受 ESI 后 3 天内有脊柱相关诊断的患者视为潜在病例。根据病历回顾,将事件分类为可能、很可能或非病例。总体上,以每 100 万患者为单位,以及根据脊柱水平、注射途径和皮质类固醇制剂,分别表示可能和很可能病例的发生率。使用评分检验比较这些发生率。

结果

在研究期间,我们共确定了 1355957 例符合条件的 ESI。在 110 例潜在病例中,有 43 例进行了病历回顾,其中 11 例被归类为可能病例,发生率为每 100 万患者 8.1 例(95%CI:4.5 至 14.5)。与腰椎/骶骨注射(5.1,95%CI:2.3 至 11.0)相比,颈椎/胸椎注射(29.4,95%CI:12.5 至 68.8)的 SSAE 风险更高(p 值<0.001)。腰椎/骶骨非经椎间孔注射的事件发生率为 8.8(95%CI:4.0 至 19.1)。颗粒制剂(7.5,95%CI:3.9 至 14.2)和非颗粒制剂(13.1,95%CI:3.6 至 47.9)的事件发生率似乎相似(p 值=0.47)。

结论

2009 年至 2015 年期间,医疗保险人群中 ESI 后 SSAE 的发生率较低。接受颈椎/胸椎 ESI 的患者发生 SSAE 的风险高于接受腰椎/骶骨 ESI 的患者。每种皮质类固醇制剂的事件发生率相似。

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