Weinstein James N, Lurie Jon D, Tosteson Tor D, Tosteson Anna N A, Blood Emily A, Abdu William A, Herkowitz Harry, Hilibrand Alan, Albert Todd, Fischgrund Jeffrey
Department of Orthopaedics, Dartmouth Medical School, Hanover, NH 03756, USA.
Spine (Phila Pa 1976). 2008 Dec 1;33(25):2789-800. doi: 10.1097/BRS.0b013e31818ed8f4.
Concurrent, prospective, randomized, and observational cohort study.
To assess the 4-year outcomes of surgery versus nonoperative care.
Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to nonoperative 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 nonoperative 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 months, 6 months, and annually thereafter.
Nonadherence to treatment assignment caused the intent-to-treat analyses to underestimate the treatment effects. In the 4-year combined as-treated analysis, those receiving surgery demonstrated significantly greater improvement in all the primary outcome measures (mean change surgery vs. nonoperative; treatment effect; 95% CI): BP (45.6 vs. 30.7; 15.0; 11.8 to 18.1), PF (44.6 vs. 29.7; 14.9;12.0 to 17.8) and ODI (-38.1 vs. -24.9; -13.2; -15.6 to -10.9). The percent working was similar between the surgery and nonoperative groups, 84.4% versus 78.4% respectively.
In a combined as-treated analysis at 4 years, patients who underwent surgery for a lumbar disc herniation achieved greater improvement than nonoperatively treated patients in all primary and secondary outcomes except work status.
同期、前瞻性、随机、观察性队列研究。
评估手术治疗与非手术治疗的4年疗效。
尽管随机试验已显示出短期手术治疗稍占优势，但手术治疗与非手术治疗的长期疗效仍存在争议。
符合影像学确诊的腰椎间盘突出症且满足SPORT纳入标准的手术候选患者，在美国11个州的13家脊柱诊所纳入前瞻性、随机（501名参与者）及观察性队列（743名参与者）。干预措施为标准开放式椎间盘切除术与常规非手术治疗。主要结局指标为基线至6周、3个月、6个月及此后每年评估的SF-36身体疼痛（BP）和身体功能（PF）量表以及改良Oswestry功能障碍指数（ODI - AAOS/Modems版本）的变化。
未遵循治疗分配导致意向性分析低估了治疗效果。在4年的综合实际治疗分析中，接受手术治疗的患者在所有主要结局指标上均有显著更大改善（平均变化手术组与非手术组；治疗效果；95%可信区间）：BP（45.6对30.7；15.0；11.8至18.1），PF（44.6对29.7；14.9；12.0至17.8）和ODI（-38.1对-24.9；-13.2；-15.6至-10.9）。手术组与非手术组的工作比例相似，分别为84.4%和78.4%。
在4年的综合实际治疗分析中，接受腰椎间盘突出症手术治疗的患者在除工作状态外的所有主要和次要结局方面比非手术治疗患者有更大改善。
