Coflex治疗腰椎退行性疾患的临床疗效分析

Clinical observation of Coflex interspious instrumentation in the surgical treatment of lumbar degenerative disease

[目的]比较腰椎后路椎间融合术与Coflex动态固定术后临床疗效的变化和对相邻节段活动度的影响。[方法]2007年6月～2009年6月期间收治腰椎退行性疾病（L4、5）患者42例,随机分为常规减压＋Coflex固定组（21例）和传统后路椎间融合内固定组（21例）。所有患者术前、术后随访均应用Oswestry功能障碍指数、VAS评分,并行过伸过屈动力位X线检查,测量并比较两组间L3、4、L4、5、L5S1及L2～S1的活动度（ROM）变化情况。[结果]所有患者获得12～40个月（平均24个月）的随访。术后随访VAS评分及ODI均得到明显改善,与术前相比均有显著性差异（P〈0.001）,但两组间无明显差异（P〉0.05）。融合组术后L4、5及L2～S1节段的ROM均较术前明显下降（P〈0.05）,而相邻节段L3、4、L5S1的ROM无显著变化（P〉0.05）。Coflex组术后L3、4及L2～S1节段的ROM明显提高（P〈0.05）,L4、5及L5S1节段的ROM无明显变化（P〉0.05）。[结论]Coflex固定系统治疗单节段腰椎退变性疾病取得了满意的中短期临床疗效,但没有充分证据证明动态固定技术可以取代传统的融合技术,手术适应证的合理选择十分重要。

[Objective]To treat degenerative lumbar spinal disorders by Coflex interspinous instrumentation and fusion fixation,and evaluate the clinical effect and influence on the adjacent segments. [Methods]Forty-two consecutive patients with one level（L4、5） lumbar degenerative disease treated in our study between June 2007 and June 2009 were included in.They were randomly and evently assigned into an experimental group of decompression and interspinous instrumentation with the Coflex system（n=21） and a control group of traditional interbody fusion（n=21）.A score of VAS and the Oswestry Disability Index were used to assess clinical outcome preoperatively and postoperatively.All patients experienced flexion/extension radiographs before surgery and at the latest follow-up.ROM was assessed at the index level（L4、5）,the cranial/caudal adjacent levels（L3、4/L5S1）,and at the lumbar spine from L2 to S1.[Results]All cases were followed up for 24 months averagely.The postoperative VAS and ODI showed a significant postoperative reduction of disability during the whole period of follow-up.There was a signifcant reduction of the global ROM of the lumbar spine（L2S1） and the segmental ROM at the index level（L4、5） in the fusion group,whereas adjacent level ROM did not change signifcantly.In the Coflex group,there was a signifcant improvement of the global ROM of the lumbar spine（L2S1） and the segmental ROM at the index level（L3、4）.No signifcant changes of L4、5 and L5S1 were noted.[Conclusion]This study shows that monosegmental posterior interspinous stabilization with the Coflex system demonstrates excellent outcome for improvement in back pain,neurogenic claudication and patient satisfaction in short and mid-term follow-up duration.At present,there is no overwhelming evidence to suggest that the system performs better than traditional fusion as far as the long-term results are concerned.The selection of suitable surgical candidates and determination of valid indications for operative treatment are very important.