腰椎管狭窄症的手术治疗与非手术治疗？一项随机对照试验。

Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial.

作者信息

Malmivaara Antti, Slätis Pär, Heliövaara Markku, Sainio Päivi, Kinnunen Heikki, Kankare Jyrki, Dalin-Hirvonen Nina, Seitsalo Seppo, Herno Arto, Kortekangas Pirkko, Niinimäki Timo, Rönty Hannu, Tallroth Kaj, Turunen Veli, Knekt Paul, Härkänen Tommi, Hurri Heikki

机构信息

Finnish Office for Health Technology Assessment, National Research and Development Center, FinOHTA/Stakes, Helsinki, Finland.

出版信息

Spine (Phila Pa 1976). 2007 Jan 1;32(1):1-8. doi: 10.1097/01.brs.0000251014.81875.6d.

DOI:10.1097/01.brs.0000251014.81875.6d

PMID:17202885

Abstract

STUDY DESIGN

A randomized controlled trial.

OBJECTIVES

To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis.

SUMMARY OF BACKGROUND DATA

No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis.

METHODS

Four university hospitals agreed on the classification of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles, nonoperative treatment options, and follow-up protocols. A total of 94 patients were randomized into a surgical or nonoperative treatment group: 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (scale, 0-100). Data on the intensity of leg and back pain (scales, 0-10), as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6, 12, and 24 months.

RESULTS

Both treatment groups showed improvement during follow-up. At 1 year, the mean difference in favor of surgery was 11.3 in disability (95% confidence interval [CI], 4.3-18.4), 1.7 in leg pain (95% CI, 0.4-3.0), and 2.3(95% CI, 1.1-3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI, 0.8-14.9) 1.5 in leg pain (95% CI, 0.3-2.8), and 2.1 in back pain (95% CI, 1.0-3.3). Walking ability, either reported or measured, did not differ between the two treatment groups.

CONCLUSIONS

Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these differences persist.

摘要

研究设计

一项随机对照试验。

目的

评估减压手术与非手术措施相比在治疗腰椎管狭窄症患者中的有效性。

背景数据总结

此前尚无随机试验评估手术与保守治疗相比对椎管狭窄症的有效性。

方法

四家大学医院就疾病分类、纳入和排除标准、影像学检查常规、手术原则、非手术治疗方案以及随访方案达成一致。共有94例患者被随机分为手术治疗组或非手术治疗组，分别为50例和44例。手术包括对10例患者的狭窄节段进行潜行减压椎板切除术，并辅以经椎弓根融合术。主要结局基于使用Oswestry功能障碍指数（范围0 - 100）评估功能障碍。在随机分组时以及在6个月、12个月和24个月的随访检查时收集腿部和背部疼痛强度数据（范围0 - 10），以及自我报告和测量的步行能力数据。

结果

两个治疗组在随访期间均有改善。1年时，手术组在功能障碍方面的平均优势差异为11.3（95%置信区间[CI]，4.3 - 18.4），腿部疼痛方面为1.7（95%CI，0.4 - 3.0），背部疼痛方面为2.3（95%CI，1.1 - 3.6）。在2年随访时，平均差异略小：功能障碍方面为7.8（95%CI，0.8 - 14.9），腿部疼痛方面为1.5（95%CI，0.3 - 2.8），背部疼痛方面为2.1（95%CI，1.0 - 3.3）。两个治疗组在报告的或测量的步行能力方面没有差异。