经椎间盘内糖皮质激素注射治疗伴活动性椎间盘病的慢性下腰痛患者：一项随机试验。

Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial.

机构信息

From Sorbonne Paris Cité, Université Paris Descartes, Hôpitaux Universitaires Paris Centre, Groupe Hospitalier Cochin, INSERM UMR 1124, UFR Biomédicale des Saints-Pères, Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, INSERM UMR 1153, Université Paris Diderot, Hôpitaux Universitaires Saint-Louis-Lariboisière-Fernand-Widal, Groupe Hospitalier Lariboisière, and Institut Fédératif de Recherche sur le Handicap, Paris, France, and Centre Hospitalier Régional Universitaire de Lille, Hôpital Roger Salengro, Lille, France.

出版信息

Ann Intern Med. 2017 Apr 18;166(8):547-556. doi: 10.7326/M16-1700. Epub 2017 Mar 21.

DOI:10.7326/M16-1700

PMID:28319997

Abstract

BACKGROUND

Active discopathy is associated with a specific phenotype of chronic low back pain (LBP). Local inflammation has a role in active discopathy-associated symptoms.

OBJECTIVE

To assess the efficacy of a single glucocorticoid intradiscal injection (GC IDI) in patients with chronic LBP with active discopathy.

DESIGN

Prospective, parallel-group, double-blind, randomized, controlled study. (ClinicalTrials.gov: NCT00804531).

SETTING

3 tertiary care centers in France.

PATIENTS

135 patients with chronic LBP with active discopathy on magnetic resonance imaging (MRI).

INTERVENTION

A single GC IDI (25 mg prednisolone acetate) during discography (n = 67) or discography alone (n = 68).

MEASUREMENTS

The primary outcome was the percentage of patients with LBP intensity less than 40 on an 11-point numerical rating scale (0 [no pain] to 100 [maximum pain] in 10-point increments) in the previous 48 hours at 1 month after the intervention. The main secondary outcomes were LBP intensity and persistent active discopathy on MRI at 12 months and spine-specific limitations in activities, health-related quality of life, anxiety and depression, employment status, and use of analgesics and nonsteroidal anti-inflammatory drugs at 1 and 12 months.

RESULTS

All randomly assigned patients were included in the primary efficacy analysis. At 1 month after the intervention, the percentage of responders (LBP intensity <40) was higher in the GC IDI group (36 of 65 [55.4%]) than the control group (21 of 63 [33.3%]) (absolute risk difference, 22.1 percentage points [95% CI, 5.5 to 38.7 percentage points]; P = 0.009). The groups did not differ in LBP intensity at 12 months and in most secondary outcomes at 1 and 12 months.

LIMITATION

Tertiary care setting.

CONCLUSION

In chronic LBP associated with active discopathy, a single GC IDI reduces LBP at 1 month but not at 12 months.

PRIMARY FUNDING SOURCE

French Ministry of Health.

摘要

背景

活动型椎间盘病与慢性下腰痛（LBP）的特定表型有关。局部炎症在活动型椎间盘病相关症状中起作用。

目的

评估单次糖皮质激素椎间盘内注射（GC IDI）在慢性 LBP 伴活动型椎间盘病患者中的疗效。

设计

前瞻性、平行组、双盲、随机、对照研究。（ClinicalTrials.gov：NCT00804531）。

地点

法国 3 个三级护理中心。

患者

135 例慢性 LBP 伴 MRI 显示活动型椎间盘病的患者。

干预

在椎间盘造影术期间进行单次 GC IDI（25 毫克醋酸泼尼松龙）（n = 67）或单独进行椎间盘造影术（n = 68）。

测量

主要结局是干预后 1 个月前 48 小时内，11 点数字评分量表（0 [无疼痛]至 100 [最大疼痛]，每 10 点递增）上 LBP 强度小于 40%的患者比例。主要次要结局是 12 个月时 MRI 上持续活动型椎间盘病和脊柱特异性活动受限、健康相关生活质量、焦虑和抑郁、就业状况以及 1 个月和 12 个月时使用镇痛药和非甾体抗炎药的情况。

结果

所有随机分配的患者均纳入主要疗效分析。干预后 1 个月，GC IDI 组（65 例中有 36 例[55.4%]）的应答者（LBP 强度<40）比例高于对照组（63 例中有 21 例[33.3%]）（绝对风险差异，22.1 个百分点[95%CI，5.5 至 38.7 个百分点]；P = 0.009）。两组在 12 个月时的 LBP 强度以及在 1 个月和 12 个月时的大多数次要结局均无差异。