融合与单纯减压治疗退变性腰椎滑脱伴椎管狭窄：基于基准试验的目标试验模拟
Fusion versus decompression alone for lumbar degenerative spondylolisthesis and spinal stenosis: a target trial emulation with index trial benchmarking.
机构信息
Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.
EBPI-UWZH Musculoskeletal Epidemiology Research Group, University of Zurich and Balgrist University Hospital, Zurich, Switzerland.
出版信息
Eur Spine J. 2024 Nov;33(11):4281-4291. doi: 10.1007/s00586-024-08495-0. Epub 2024 Sep 21.
PURPOSE
The value of adding fusion to decompression surgery for lumbar degenerative spondylolisthesis and spinal canal stenosis remains debated. Therefore, the comparative effectiveness and selected healthcare resource utilization of patients undergoing decompression with or without fusion surgery at 3 years follow-up was assessed.
METHODS
Using observational data from the Lumbar Stenosis Outcome Study and a target trial emulation with index trial benchmarking approach, our study assessed the comparative effectiveness of the two main surgical interventions for lumbar degenerative spondylolisthesis-fusion and decompression alone in patients with lumbar degenerative spondylolisthesis and spinal canal stenosis. The primary outcome-measure was change in health-related quality of life (EuroQol Health Related Quality of Life 5-Dimension 3-Level questionnaire [EQ-5D-3L]); secondary outcome measures were change in back/leg pain intensity (Numeric Rating Scale), change in satisfaction (Spinal Stenosis Measure satisfaction subscale), physical therapy and oral analgesic use (healthcare utilization).
RESULTS
153 patients underwent decompression alone and 62 had decompression plus fusion. After inverse probability weighting, 137 patients were included in the decompression alone group (mean age, 73.9 [7.5] years; 77 female [56%]) and 36 in the decompression plus fusion group (mean age, 70.1 [6.7] years; 18 female [50%]). Our findings were compatible with no standardized mean differences in EQ-5D-3L summary index change score at 3 years (EQ-5D-3L German: 0.07 [95% confidence interval (CI), - 0.25 to 0.39]; EQ-5D-3L French: 0.18 [95% CI, - 0.14 to 0.50]). No between-group differences in change in back/leg pain intensity or satisfaction were found. Decompression plus fusion was associated with greater physical therapy utilization at 3 years follow-up.
CONCLUSION
Decompression alone should be considered the primary option for patients with lumbar degenerative spondylolisthesis and spinal stenosis.
目的
对于腰椎退变性滑脱伴椎管狭窄症患者，减压手术联合融合术的价值仍存在争议。因此，本研究旨在评估术后 3 年随访时接受减压手术联合融合术与单纯减压手术患者的治疗效果和特定医疗资源利用情况。
方法
本研究使用腰椎狭窄症研究的观察性数据和以目标试验为模拟、以基准试验为指标的试验仿真方法，评估了两种主要手术干预措施（融合与单纯减压）治疗腰椎退变性滑脱伴椎管狭窄症患者的疗效。主要结局指标为健康相关生活质量的变化（EuroQol 健康相关生活质量 5 维 3 级问卷[EQ-5D-3L]）；次要结局指标为腰背疼痛强度的变化（数字评分量表）、满意度的变化（腰椎管狭窄症测量满意度子量表）、物理治疗和口服镇痛药物的使用（医疗资源利用情况）。
结果
153 例患者接受单纯减压手术，62 例患者接受减压联合融合手术。经过逆概率加权后，137 例患者纳入单纯减压组（平均年龄 73.9 [7.5]岁，77 例女性[56%]），36 例患者纳入减压联合融合组（平均年龄 70.1 [6.7]岁，18 例女性[50%]）。我们的发现与 3 年时 EQ-5D-3L 综合指数变化评分无标准化均数差值一致（EQ-5D-3L 德国评分：0.07 [95%置信区间（CI）：-0.25 至 0.39]；EQ-5D-3L 法国评分：0.18 [95%CI：-0.14 至 0.50]）。两组间腰背疼痛强度或满意度的变化均无差异。与单纯减压组相比，减压联合融合组在术后 3 年时更倾向于接受物理治疗。
结论
对于腰椎退变性滑脱伴椎管狭窄症患者，单纯减压手术应作为首选治疗方案。
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