Coflex棘突间动态稳定系统治疗腰椎间盘退行性疾病10年随访情况分析  

Analysis of Coflex Interspinous Dynamic Stabilization System for Treatment of Lumbar Degenerative Disc Disease:Minimal 10 Years Follow-up

作　　者：顾宏林 郑晓青 梁昌详 曾时兴 詹世强 昌耘冰 GU Hong-lin;ZHENG Xiao-qing;LIANG Chang-xiang;ZENG Shi-xing;ZHAN Shi-qiang;CHANG Yun-bing(Spine Department,Guangdong Provincial People's Hospital,Guangdong Academy of Medical Sciences,Guangzhou 510080,China)

机构地区：[1]广东省人民医院,广东省医学科学院脊柱外科,广东广州510080

出　　处：《中山大学学报（医学科学版）》2021年第6期913-922,共10页Journal of Sun Yat-Sen University:Medical Sciences

基　　金：广州市科技计划项目(202102020095)。

摘　　要：【目的】本研究通过对腰椎间盘退行性疾病患者进行回顾性观察,分析其使用Coflex棘突间动态稳定系统治疗的长期疗效、并发症发生率、再手术率及装置存留率,并探讨影响装置存留及再手术率的相关危险因素。【方法】2008年5月至2011年6月,109例在广东省人民医院诊断为腰椎退行性疾病患者,行后路减压或椎间盘切除+Coflex固定手术治疗,通过至少10年的随访,收集患者术前、术后疼痛视觉模拟评分、日本骨科学会评分及Os⁃westry残障指数等临床指标,并统计不同诊断患者手术并发症、再手术及装置长期存留情况。【结果】109例患者平均随访时间133.37±11.68,中位数130(123~142)个月。其中男性74例,女性35例,平均年龄45.55±11.83(21-79),中位数45(38~52)岁;术前诊断腰椎间盘突出症28例,腰椎管狭窄症16例,腰椎管狭窄合并腰椎间盘突出61例,腰椎滑脱症4例。术后末次随访临床指标均优于术前(P<0.05)。总体并发症发生率为12.8%(14/109),再手术率为9.2%(10/109),5年及10年的装置存留率为95.4%(104/109)。与其它诊断患者相比,腰椎间盘突出症患者并发症发生率(21.4%,6/28)及再手术率(14.3%,4/28)最高,5年及10年的装置存留率最低,为92.9%(26/28),而将Coflex置于邻近节段作为Topping-off的腰椎滑脱症患者无并发症及再手术情况,装置存留率为100%。【结论】腰椎后路减压或椎间盘切除后联合Coflex内固定应用于腰椎间盘退行性疾病,长期临床疗效良好,装置存留率高。并发症、再手术及装置移除风险可能与适应症选择有关。Coflex应慎用于腰椎间盘突出症,而以两节段内轻中度椎管狭窄及Top⁃ping-off作为适应症,则有较高安全性。【Objective】The aim of the present retrospective study was to access the long-term efficacy,complication rate,reoperation rate and survival rate of Coflex interspinous process dynamic stabilization system in the treatment of lumbar degenerative disc disease,and investigate the influencing factors of implant survivorship and reoperation.【Methods】Totally 109 patients with lumbar disc degenerative disease who underwent posterior decompression or discectomy+Coflex fixation in Guangdong Provincial People's Hospital from May 2008 to June 2011 followed up for minimal 10 years were selected.Preoperative and postoperative Japanese Orthopedic Association(JOA)score,Oswestry Disability Index(ODI),visual analogue scale(VAS)score were collected.And complications,reoperation,and device survival rate of patients with different diagnoses were evaluated.【Results】Of the 109 patients,74 cases were male and 35 cases were female,average 45.55±11.83,M(P_(25)~P_(75))[45(38~52)]years.28 cases were lumbar disc herniation,16 cases were diagnosed as lumbar stenosis,61 cases were lumbar stenosis combined with lumbar disc herniation,and 4 cases were spondylolisthesis.The mean follow-up time was 133.37±11.68(120-157),M(P_(25)~P_(75))[130(123~142)]months.VAS,JOA and ODI scores at last follow-up had significantly improved compared to pre-operation(P<0.05).Overall complication rate was 12.8%(14/109),the reoperation rate was 9.2%(10/109)and the 5-year and 10-year survival rates were 95.4%(104/109).Compared with patients of other diagnoses,patients with lumbar disc herniation had the highest rate of complication(21.4%,6/28)and reoperation rate(14.3%,4/28),and the lowest 5-year and 10-year survival rates(92.9%,26/28).Patients with spondylolisthesis who had Coflex placed at the adjacent segment as Topping-off had no complications or reoperation,and the survival rate was 100%.【Conclusions】Coflex implantation can achieve satisfactory long-term survival rate and clinical outcomes in the treatment of lumbar disc degenerative diseases.The

关 键 词：棘突间动态稳定系统 COFLEX 腰椎间盘退行性疾病 存留率 再手术 

分 类 号：R681.55[医药卫生—骨科学]