中文摘要：

目的研究棘突间动态稳定装置Coflex的疗效、手术适应证与并发症。方法回顾性分析2007年11月至2010年10月因退行性腰椎疾病接受Coflex内固定手术108例患者资料，男性68例，女性40例；年龄37～75岁，平均53．5岁。患者中行单纯髓核摘除后单节段Coflex内固定59例（髓核摘除Coflex同定组），椎管狭窄开窗减压后单节段Coflex内固定41例（椎管开窗Coflex固定组），减压后Coflex结合相邻椎间融合椎弓根螺钉内固定6例，减压后双节段Coflex固定2例。以疼痛视觉模拟量表（VAS）评分、Oswestry功能障碍指数（ODI）评价临床疗效，以腹侧椎间隙高度（HV）、背侧椎间隙高度（HD）、椎间孔高度（HIF）及腰椎活动度（ROM）评估影像学变化。采用单向方差分析进行统计分析。结果本组病例随访时间13～49个月，平均28．8个月。各组术后腰痛、腿痛VAS评分及ODI指数均明显改善维持至末次随访（F=6．16～25．92，P=0．00）。统计分析显示髓核摘除Coflex固定组、椎管开窗Coflex固定组术后3dHD、HIF均显著增加（F=7．37—11．68，P〈0．05），髓核摘除Coflex固定组术后1年HD、HIF下降但较术前差异仍有统计学意义（F=6．31和7．05，P=0．00）。髓核摘除Coflex固定组、椎管开窗Coflex固定组术前ROM分别为6．3°±1．8°、6．2°±1．7°，末次随访为3．1°±0．6°、3．0°±0．8°。发生器械相关并发症3例（2．8％），包括假体固定翼折断、假体松动及棘突骨折各1例，而非器械相关并发症5例（4．6％），其中术中硬膜撕裂1例，创口浅表感染1例，再手术3例，以上并发症经相应处理后恢复良好。结论Coflex辅助治疗退行性腰椎疾病疗效显著，在维持节段稳定性同时，能保留一定的运动度，但必须严格掌握手术适应证，防止并发症。

英文摘要：

Objective To study indications and complications of interspinous process device Coflex for degenerative disk diseases. Methods One hundred and eight patients with degenerative lumbar disc diseases were underwent procedures of surgical decompression and additional fixation of Coflex between November 2007 and October 2010. Sixty-eight patients were male and the other fourty were female, and their average age was 53.5 years （range from 37 to 75 years）. Fifty-nine patients were underwent surgery of excision of nucleus pulposus and Coflex fixation, 41 patients were underwent surgery of decompression by fenestration and Coflex fixation, 6 patients were underwent surgery of topping-off, and 2 patients were underwent surgery of Coflex fixation for two level. Preoperative and postoperative visual analogue scales （VAS） and Oswestry disability index （ODI） were recorded, as well as height of ventral intervertebral space （HV） , height of dorsal intervertebral space （ HD ） , height of intervertebral foramen （HIF） and segmental range of motion （ ROM ）. One-way ANOVA was used for statistical analysis. Surgical complications were also recorded. Results The average follow-up time was 28.8 months. All groups had apparent improvement of VAS and ODI, and maintained well to last follow-up （F = 6. 16-25.92, P = 0. 00 ）. Statistical analysis showed that HD and HIF increased significantly in group with excision of nucleus pulposus and Coflex fixation and group with decompression by fenestration and Coflex fixation （ F = 7.37-11.68, P 〈 0. 05 ）. Although both HD and HIF decreased one-year after surgery, they were still higher than those preoperatively （F =6. 31 and 7.05 ,P =0. 00）. Preoperative segmental ROM was respectively 6. 3° ± 1.8° and 6. 2°±1.7° in group with excision of nucleus pulposus and Coflex fixation and group with decompression by fenestration and Coflex fixation, and 3.1° ±0. 6° and 3.0°±0. 8° at last follow-up. Three cases were found with device-related complications a