经皮激光椎间盘减压术与传统显微椎间盘切除术治疗坐骨神经痛的随机对照试验

Percutaneous laser disc decompression versus conventional microdiscectomy in sciatica: a randomized controlled trial.

作者信息

Brouwer Patrick A, Brand Ronald, van den Akker-van Marle M Elske, Jacobs Wilco C H, Schenk Barry, van den Berg-Huijsmans Annette A, Koes Bart W, van Buchem M A, Arts Mark P, Peul Wilco C

机构信息

Department of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.

Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.

出版信息

Spine J. 2015 May 1;15(5):857-65. doi: 10.1016/j.spinee.2015.01.020. Epub 2015 Jan 20.

DOI:10.1016/j.spinee.2015.01.020

PMID:25614151

Abstract

BACKGROUND CONTEXT

Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed.

PURPOSE

In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery.

STUDY DESIGN/SETTING: This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval.

PATIENT SAMPLE

One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included.

OUTCOME MEASURES

The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient's report of perceived recovery.

METHODS

Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands.

RESULTS

The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (-0.1; [95% confidence interval (CI), -2.3 to 2.1]) and 52 weeks (-1.1; 95% CI, -3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42-0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year.

CONCLUSIONS

At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery.

摘要

背景

经皮激光椎间盘减压术（PLDD）是一种用于治疗腰椎间盘突出症的微创手术，自1991年起获得美国食品药品监督管理局批准。然而，尚未进行过比较PLDD与传统治疗方法的随机试验。

目的

在本试验中，我们评估了PLDD策略与传统手术相比的有效性。

研究设计/地点：这项采用非劣效性设计的随机前瞻性试验，是在荷兰的两所学术医院和六所教学医院中，按照意向性分析方案进行的，并获得了机构审查委员会的全面批准。

患者样本

纳入了115名符合条件的手术候选人，他们因椎间盘突出导致坐骨神经痛，突出小于椎管的三分之一。

结局指标

本试验的主要结局指标包括用于评估坐骨神经痛的罗兰-莫里斯功能障碍问卷、背部和腿部疼痛的视觉模拟评分以及患者对恢复情况的报告。

方法

患者被随机分配至PLDD组（n = 57）或传统手术组（n = 58）。由于干预措施的性质，无法进行盲法。本研究由荷兰医疗保险委员会资助。

结果

主要结局指标罗兰-莫里斯功能障碍问卷显示，与传统手术相比，PLDD在8周（-0.1；[95%置信区间（CI），-2.3至2.1]）和52周（-1.1；95%CI，-3.4至1.1）时具有非劣效性。然而，传统手术的恢复速度更快（风险比，0.64 [95%CI，0.42 - 0.97]）。传统手术组的再次手术数量明显更少（38%对16%）。总体而言，PLDD策略（必要时延迟手术）在1年时产生了非劣效的结果。