Surgical versus nonoperative treatment for lumbar disc herniation: eight-year results for the spine patient outcomes research trial.
Surgical versus nonoperative treatment for lumbar disc herniation: eight-year results for the spine patient outcomes research trial.
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DOI：
10.1097/brs.0000000000000088
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发表时间：
2014-01-01
期刊：
影响因子：
3
通讯作者：
Weinstein JN
中科院分区：
文献类型：
--
作者：
Lurie JD;Tosteson TD;Tosteson AN;Zhao W;Morgan TS;Abdu WA;Herkowitz H;Weinstein JN
同期前瞻性随机和观察性队列研究。评估手术与非手术治疗的8年结局。虽然随机试验表明，手术治疗的短期差异较小，但手术与非手术治疗的长期结局仍存在争议。在美国11个州的13家脊柱诊所，将符合SPORT资格标准的经影像学证实的腰椎间盘突出症手术候选人纳入前瞻性随机（501例受试者）和观察性队列（743例受试者）。干预措施是标准开放式椎间盘切除术与常规非手术治疗。主要结局指标为SF-36躯体疼痛（BP）和身体功能（PF）量表和改良的奥斯韦斯特里残疾指数（ODI - AAOS/Modems版本）较基线的变化，在6周、3个月和6个月时进行评估，此后每年进行评估。在随机化队列的意向治疗分析中，对于除工作状态外的所有主要和次要结局，均观察到手术的优势;然而，由于广泛不依从治疗分配（49%的患者被分配接受手术的非手术治疗，而60%的患者被分配接受手术），这些观察到的影响相对较小，并且对于主要结局（BP、PF、ODI）无统计学显著性。重要的是，在长期随访的意向治疗分析中，次要结局的总体比较明显高于手术（坐骨神经痛困扰[p > 0.005]，症状满意度[p > 0.013]和自我评价改善[p > 0.013]）。一项实际治疗分析显示，主要结局指标的手术治疗效果具有临床意义（手术与非手术的平均变化;治疗效果; 95% CI）：BP（45.3对34.4; 10.9; 7.7至14）; PF（42.2对31.5; 10.6; 7.7至13.5）和ODI（−36.2对−24.8; −11.2; −13.6至−9.1）。精心挑选的腰椎间盘突出症手术患者比非手术治疗患者获得了更大的改善;从4年到8年，两组（手术和非手术）的结局几乎没有退化。
Concurrent prospective randomized and observational cohort studies. To assess the 8-year outcomes of surgery vs. non-operative care. Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to non-operative treatment remain controversial. Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual non-operative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI - AAOS/Modems version) assessed at 6 weeks, 3 and 6 months, and annually thereafter. Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive non-adherence to treatment assignment (49% patients assigned to non-operative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (BP, PF, ODI). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [p > 0.005], satisfaction with symptoms [p > 0.013], and self-rated improvement [p > 0.013]) in long-term follow-up. An as-treated analysis showed clinically meaningful surgical treatment effects for primary outcome measures (mean change Surgery vs. Non-operative; treatment effect; 95% CI): BP (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5) and ODI (−36.2 vs. −24.8; −11.2; −13.6 to −9.1). Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than non-operatively treated patients; there was little to no degradation of outcomes in either group (operative and non-operative) from 4 to 8 years.