Hsu Ken Y, Zucherman James F, Hartjen Charles A, Mehalic Thomas F, Implicito Dante A, Martin Michael J, Johnson Donald R, Skidmore Grant A, Vessa Paul P, Dwyer James W, Cauthen Joseph C, Ozuna Richard M
Department of Orthopaedics, St. Mary's Medical Center, St. Mary's Spine Center, San Francisco, California 94117, USA.
J Neurosurg Spine. 2006 Dec;5(6):500-7. doi: 10.3171/spi.2006.5.6.500.
This study was conducted to compare the quality of life (QOL) in patients with neurogenic intermittent claudication (NIC) secondary to lumbar spinal stenosis (LSS). Using the 36-Item Short Form (SF-36) questionnaire, the authors compared the results obtained in patients treated with the X STOP Interspinous Process Decompression (IPD) System with those obtained in patients who underwent nonoperative therapies.
Patients with LSS were enrolled in a prospective 2-year multicenter study and randomized either to the X STOP or nonoperative group. The SF-36 survey was used to assess the QOL before treatment and at 6 weeks, 6 months, 1 year, and 2 years posttreatment. An analysis of variance was used to compare individual pre- and posttreatment mean SF-36 domain scores between the two groups and within each treatment group. At all posttreatment time points, the authors observed the following: (1) mean domain scores in X STOP-treated patients were significantly greater than those in patients treated nonoperatively, with the exception of the mean General Health (GH), Role Emotional, and Mental Component Summary scores at 2 years; and (2) mean posttreatment domain scores documented in X STOP-treated patients were significantly greater than mean pretreatment scores, with the exception of mean GH scores at 6, 12, and 24 months.
The results of this study demonstrate that the X STOP device is significantly more effective than nonoperative therapy in improving the QOL in patients with LSS. The results are comparable with those reported in other studies involving traditional decompressive techniques for LSS and suggest that the X STOP implant can provide an effective treatment compared with nonoperative and conventional surgical therapies.
本研究旨在比较腰椎管狭窄症（LSS）继发神经源性间歇性跛行（NIC）患者的生活质量（QOL）。作者使用36项简明健康状况调查量表（SF-36）问卷，比较了接受X STOP棘突间减压（IPD）系统治疗的患者与接受非手术治疗的患者的结果。
LSS患者被纳入一项为期2年的前瞻性多中心研究，并随机分为X STOP组或非手术组。SF-36调查用于评估治疗前以及治疗后6周、6个月、1年和2年的生活质量。采用方差分析比较两组之间以及各治疗组内治疗前后SF-36各领域平均得分。在所有治疗后的时间点，作者观察到以下情况：（1）除2年时的一般健康（GH）、角色情感和心理成分总得分外，接受X STOP治疗的患者各领域平均得分显著高于非手术治疗的患者；（2）接受X STOP治疗的患者治疗后各领域平均得分显著高于治疗前得分，但6个月、12个月和24个月时的平均GH得分除外。
本研究结果表明，X STOP装置在改善LSS患者生活质量方面比非手术治疗显著更有效。这些结果与其他涉及LSS传统减压技术的研究报告结果相当，表明与非手术和传统手术治疗相比，X STOP植入物可提供一种有效的治疗方法。
