Weinstein James N, Lurie Jon D, Tosteson Tor D, Hanscom Brett, Tosteson Anna N A, Blood Emily A, Birkmeyer Nancy J O, Hilibrand Alan S, Herkowitz Harry, Cammisa Frank P, Albert Todd J, Emery Sanford E, Lenke Lawrence G, Abdu William A, Longley Michael, Errico Thomas J, Hu Serena S
Department of Orthopaedics, Dartmouth Medical School, Lebanon, NH, USA.
N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.
BACKGROUND: Management of degenerative spondylolisthesis with spinal stenosis is controversial. Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials. METHODS: Surgical candidates from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a randomized cohort or an observational cohort. Treatment was standard decompressive laminectomy (with or without fusion) or usual nonsurgical care. The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) bodily pain and physical function scores (100-point scales, with higher scores indicating less severe symptoms) and the modified Oswestry Disability Index (100-point scale, with lower scores indicating less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years. RESULTS: We enrolled 304 patients in the randomized cohort and 303 in the observational cohort. The baseline characteristics of the two cohorts were similar. The one-year crossover rates were high in the randomized cohort (approximately 40% in each direction) but moderate in the observational cohort (17% crossover to surgery and 3% crossover to nonsurgical care). The intention-to-treat analysis for the randomized cohort showed no statistically significant effects for the primary outcomes. The as-treated analysis for both cohorts combined showed a significant advantage for surgery at 3 months that increased at 1 year and diminished only slightly at 2 years. The treatment effects at 2 years were 18.1 for bodily pain (95% confidence interval [CI], 14.5 to 21.7), 18.3 for physical function (95% CI, 14.6 to 21.9), and -16.7 for the Oswestry Disability Index (95% CI, -19.5 to -13.9). There was little evidence of harm from either treatment. CONCLUSIONS: In nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically. (ClinicalTrials.gov number, NCT00000409 [ClinicalTrials.gov].).
背景：退行性腰椎滑脱伴椎管狭窄的治疗存在争议。手术被广泛应用，但与非手术治疗相比，其有效性尚未在对照试验中得到证实。 方法：来自美国11个州13个中心的手术候选者，若有至少12周的症状且影像学证实为退行性腰椎滑脱，则可选择参加随机队列或观察性队列研究。治疗方法为标准减压椎板切除术（伴或不伴融合术）或常规非手术治疗。主要结局指标为医学结局研究简明健康调查问卷（SF-36）中的身体疼痛和身体功能评分（100分制，分数越高表明症状越轻）以及改良Oswestry功能障碍指数（100分制，分数越低表明症状越轻），分别于6周、3个月、6个月、1年和2年时进行评估。 结果：我们在随机队列中纳入了304例患者，在观察性队列中纳入了303例患者。两个队列的基线特征相似。随机队列中的一年交叉率较高（每个方向约40%），但观察性队列中的交叉率适中（17%交叉至手术组，3%交叉至非手术治疗组）。随机队列的意向性分析显示主要结局无统计学显著效应。两个队列合并后的实际治疗分析显示，手术在3个月时有显著优势，1年时优势增加，2年时仅略有下降。2年时的治疗效果为身体疼痛18.1（95%置信区间[CI]，14.5至21.7），身体功能18.3（95%CI，14.6至21.9），Oswestry功能障碍指数为-16.7（95%CI，-19.5至-13.9）。几乎没有证据表明两种治疗有不良影响。 结论：在对潜在混杂基线因素进行仔细控制的非随机实际治疗比较中，退行性腰椎滑脱伴椎管狭窄患者接受手术治疗在2年期间的疼痛和功能改善明显大于非手术治疗患者。（临床试验注册号，NCT00000409[ClinicalTrials.gov]。）
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