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持续坐骨神经痛 4 至 12 个月的手术与保守治疗比较。

Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months.

机构信息

From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.

出版信息

N Engl J Med. 2020 Mar 19;382(12):1093-1102. doi: 10.1056/NEJMoa1912658.

Abstract

BACKGROUND

The treatment of chronic sciatica caused by herniation of a lumbar disk has not been well studied in comparison with acute disk herniation. Data are needed on whether diskectomy or a conservative approach is better for sciatica that has persisted for several months.

METHODS

In a single-center trial, we randomly assigned patients with sciatica that had lasted for 4 to 12 months and lumbar disk herniation at the L4-L5 or L5-S1 level in a 1:1 ratio to undergo microdiskectomy or to receive 6 months of standardized nonoperative care followed by surgery if needed. Surgery was performed by spine surgeons who used conventional microdiskectomy techniques. The primary outcome was the intensity of leg pain on a visual analogue scale (ranging from 0 to 10, with higher scores indicating more severe pain) at 6 months after enrollment. Secondary outcomes were the score on the Oswestry Disability Index, back and leg pain, and quality-of-life scores at 6 weeks, 3 months, 6 months, and 1 year.

RESULTS

From 2010 through 2016, a total of 790 patients were screened; of those patients, 128 were enrolled, with 64 in each group. Among the patients assigned to undergo surgery, the median time from randomization to surgery was 3.1 weeks; of the 64 patients in the nonsurgical group, 22 (34%) crossed over to undergo surgery at a median of 11 months after enrollment. At baseline, the mean score for leg-pain intensity was 7.7 in the surgical group and 8.0 in the nonsurgical group. The primary outcome of the leg-pain intensity score at 6 months was 2.8 in the surgical group and 5.2 in the nonsurgical group (adjusted mean difference, 2.4; 95% confidence interval, 1.4 to 3.4; P<0.001). Secondary outcomes including the score on the Owestry Disability Index and pain at 12 months were in the same direction as the primary outcome. Nine patients had adverse events associated with surgery, and one patient underwent repeat surgery for recurrent disk herniation.

CONCLUSIONS

In this single-center trial involving patients with sciatica lasting more than 4 months and caused by lumbar disk herniation, microdiskectomy was superior to nonsurgical care with respect to pain intensity at 6 months of follow-up. (Funded by Physicians' Services Incorporated Foundation; ClinicalTrials.gov number, NCT01335646.).

摘要

背景

与急性椎间盘突出症相比,对于已经持续数月的慢性坐骨神经痛的治疗,研究尚不充分。需要了解椎间盘切除术与保守治疗方法哪种更适合坐骨神经痛。

方法

在一项单中心试验中,我们按照 1:1 的比例将坐骨神经痛持续 4 至 12 个月且 L4-L5 或 L5-S1 水平存在腰椎间盘突出的患者随机分为接受微创手术或接受 6 个月的标准非手术治疗,如果需要则随后进行手术。手术由使用传统微创手术技术的脊柱外科医生进行。主要结局是在入组后 6 个月时腿部疼痛的视觉模拟量表(范围为 0 至 10,分数越高表示疼痛越严重)的强度。次要结局是 Oswestry 残疾指数、腰背腿痛和生活质量评分在 6 周、3 个月、6 个月和 1 年时的得分。

结果

2010 年至 2016 年期间,共有 790 名患者接受了筛查;其中 128 名患者入选,每组 64 名。在接受手术的患者中,从随机分组到手术的中位时间为 3.1 周;在非手术组的 64 名患者中,有 22 名(34%)在入组后 11 个月交叉进行手术。在基线时,手术组腿部疼痛强度的平均得分为 7.7,非手术组为 8.0。6 个月时腿部疼痛强度评分的主要结局为手术组 2.8,非手术组 5.2(调整平均差异,2.4;95%置信区间,1.4 至 3.4;P<0.001)。次要结局包括 Owestry 残疾指数评分和 12 个月时的疼痛均与主要结局一致。9 名患者发生与手术相关的不良事件,1 名患者因椎间盘再次突出而再次手术。

结论

在这项涉及坐骨神经痛持续 4 个月以上且由腰椎间盘突出引起的患者的单中心试验中,与非手术治疗相比,微创手术在 6 个月的随访时在疼痛强度方面更优。(由医师服务公司基金会资助;ClinicalTrials.gov 编号,NCT01335646。)

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