Coflex^(TM)在腰腿痛治疗中的初步观察

Coflex interspinous dynamic internal fixation for the treatment of low back pain

目的初步探讨Coflex^(TM)治疗腰腿痛的临床疗效。方法 2007年12月至2009年6月,采用Coflex^(TM)治疗腰椎管狭窄症和椎间盘突出症患者22例,男12例,女10例;年龄39～60岁,平均43岁。椎管狭窄症14例,椎间盘突出症8例。手术方式分为3种:单节段Coflex18例、连续双节段Coflex 2例、单节段PLIF+Coflex 2例。所有患者手术前后均进行Oswestry功能障碍指数评分(ODI)和疼痛视觉评分(VAS)。影像学观察指标包括X线中立位椎间隙中点、后缘高度,动力位手术节段椎体间活动度。结果所有患者均获得随访,随访时间3～9个月,平均5.4个月。ODI分值术前平均66.2±9.1,术后降至15.3±7.5(P<0.05);VAS平均分值由术前的5.6±0.6下降到术后1.8±0.4(P<0.05)。术后未出现感染、脑脊液漏、植入物脱落等相关并发症。X线检查见手术节段椎间活动度下降(P<0.05),椎管狭窄病例椎间隙高度有所恢复(P<0.05),椎间盘突出病例椎间隙略有塌陷(P=0.053)。结论 Coflex^(TM)作为近来应用于临床的一种新技术,对于椎间盘突出症、椎管狭窄症的近期疗效满意,可恢复椎管狭窄病例的椎间隙高度,保持一定椎间活动度,短期相关并发症较少。但由于临床应用时间短、病例数量少,其适应证的选择以及长期疗效尚需进一步探索。

Objective To assess the clinical outcomes of Coflex interspinous dynamic internal fixation for low back pain.Methods From December 2007 to June 2009,22 patients with intervertebral disc herniated（8 cases） and lumbar spinal stenosis（14 cases） were treated with Coflex interspinous dynamic internal fixation,including 12 males and 10 females with an average age of 43 years（range,39 to 60 years）.Of the 22 patients,simple Coflex fixation was used in 18,couple Coflex fixation in 2,Coflex compound PLIF in 2.The ODI scores and VAS were assessed before and after operation. The radiological measurement included ventral and dorsal intervertebral space height,segmental intervertebral angles of the instrumented levels on flexion extension radiographs.Results All the patients were followed up for 3 to 9 months.There were significant differences in the ODI scores and the VAS by paired t test（P〈0.05）.There were no complications associated with the Coflex device.The height of dorso intervertebral disc was increased obviously in the patients with lumbar spinal stenosis,while the height was decreased in the intervertebral disc herniated;the range of motion in instrumented levels was decreased on flexion extension radiographs,but remained 7 degrees.Conclusion The clinical outcomes are satisfactory to treat intervertebral disc herniate and lumbar spinal stenosis symptoms by using Coflex^（？） device. It is available in increasing the intervertebral space,remaining range of motion in instrumented segment and preventing the adjacent segment degeneration.Therefore,due to the short time of application and a small number of cases,the indications and complications of the COFLEX^（TM） need further exploration.