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等离子体椎间盘减压术治疗包裹型颈椎间盘突出症:一项随机对照试验。

Plasma disc decompression for contained cervical disc herniation: a randomized, controlled trial.

机构信息

Policlinico Casilino, U.O.C. Neurochirurgica, Via Casilina, 1049-00169 Rome, Italy.

出版信息

Eur Spine J. 2010 Mar;19(3):477-86. doi: 10.1007/s00586-009-1189-0. Epub 2009 Nov 10.

Abstract

Prospective case series studies have shown that plasma disc decompression (PDD) using the COBLATION SpineWand device (ArthroCare Corporation, Austin, TX) is effective for decompressing the disc nucleus in symptomatic contained cervical disc herniations. This prospective, randomized controlled clinical trial was conducted to evaluate the clinical outcomes of percutaneous PDD as compared to conservative care (CC) through 1 year. Patients (n = 115) had neck/arm pain >50 on the visual analog scale (VAS) pain scale and had failed at least 30 days of failed CC. Patients were randomly assigned to receive either PDD (n = 62) or CC (n = 58). Clinical outcome was determined by VAS pain score, neck disability index (NDI) score, and SF-36 health survey, collected at 6 weeks, 3 months, 6 months, and 1 year. The PDD group had significantly lower VAS pain scores at all follow-up time points (PDD vs. CC: 6 weeks, -46.87 +/- 2.71 vs. -15.26 +/- 1.97; 3 months, -53.16 +/- 2.74 vs. -30.45 +/- 2.59; 6 months, -56.22 +/- 2.63 vs. -40.26 +/- 2.56; 1 year, -65.73 +/- 2.24 vs. -36.45 +/- 2.86; GEE, P < 0.0001). PDD patients also had significant NDI score improvement over baseline when compared to CC patients at the 6 weeks (PDD vs. CC: -9.15 +/- 1.06 vs. -4.61 +/- 0.53, P < 0.0001) and 1 year (PDD vs. CC: -16.70 +/- 0.29 vs. -12.40 +/- 1.26, P = 0.005) follow-ups. PDD patients showed statistically significant improvement over baseline in SF-36 physical component summary scores when compared to CC patients at 6 weeks and 1 year (PDD vs. CC: 8.86 + 8.04 vs. 4.24 +/- 3.79, P = 0.0004; 17.64 +/- 10.37 vs. 10.50 +/- 10.6, P = 0.0003, respectively). In patients who had neck/arm pain due to a contained cervical disc herniation, PDD was associated with significantly better clinical outcomes than a CC regimen. At 1 year, CC patients appeared to suffer a "relapse, showing signs of decline in most measurements, whereas PDD patients showed continued stable improvement.

摘要

前瞻性病例系列研究表明,使用 COBLATION SpineWand 设备(ArthroCare 公司,奥斯汀,TX)进行等离子体椎间盘减压(PDD)对有症状的颈椎间盘突出症的椎间盘核减压是有效的。这项前瞻性、随机对照临床试验旨在评估经皮 PDD 与保守治疗(CC)相比在 1 年内的临床疗效。患者(n=115)的颈部/手臂疼痛评分>50(视觉模拟量表[VAS]疼痛评分),且至少有 30 天的 CC 治疗失败。患者被随机分配接受 PDD(n=62)或 CC(n=58)治疗。临床结果通过 VAS 疼痛评分、颈部残疾指数(NDI)评分和 SF-36 健康调查来确定,分别在 6 周、3 个月、6 个月和 1 年收集。PDD 组在所有随访时间点的 VAS 疼痛评分均显著降低(PDD 与 CC:6 周,-46.87+/-2.71 vs. -15.26+/-1.97;3 个月,-53.16+/-2.74 vs. -30.45+/-2.59;6 个月,-56.22+/-2.63 vs. -40.26+/-2.56;1 年,-65.73+/-2.24 vs. -36.45+/-2.86;广义估计方程,P<0.0001)。与 CC 组相比,PDD 组在 6 周(PDD 与 CC:-9.15+/-1.06 vs. -4.61+/-0.53,P<0.0001)和 1 年(PDD 与 CC:-16.70+/-0.29 vs. -12.40+/-1.26,P=0.005)随访时的 NDI 评分也有显著改善。与 CC 组相比,PDD 组在 6 周和 1 年时 SF-36 生理成分综合评分较基线有显著改善(PDD 与 CC:8.86+8.04 vs. 4.24+/-3.79,P=0.0004;17.64+/-10.37 vs. 10.50+/-10.6,P=0.0003)。在因颈椎间盘突出症而出现颈部/手臂疼痛的患者中,与 CC 治疗方案相比,PDD 与显著更好的临床结果相关。在 1 年时,CC 组似乎出现“复发”,在大多数测量指标上出现下降迹象,而 PDD 组则表现出持续稳定的改善。

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