颈椎人工椎间盘置换术治疗单节段颈椎病疗效和安全性的系统评价

Effectiveness and Safety of Cervical Total Disc Replacement for Single Symptomatic Single-Level Cervical Degenerative Disc Disease:A Systematic Review

目的系统评价颈椎人工椎间盘置换术(TDR)与颈前路减压植骨融合术(ACDF)治疗单节段颈椎病的疗效和安全性。方法计算机检索MEDLINE(2000.1～2009.5)、EMbase(2000.1～2009.5)、OVID(2000.1～2009.5)、Cochrane图书馆对照试验注册库(2009年第1期)、中国生物医学文献数据库(2000.1～2009.5)、CNKI(2000.1～2009.5),手工检索《中华外科杂志》等6种相关杂志,纳入TDR和ACDF比较治疗单节段颈椎病的随机对照试验(RCT)。由2名评价者按纳入排除标准选择试验,评价质量并交叉核对后,采用RevMan 5.0软件进行Meta分析。结果共纳入6篇RCT,包括1?340例患者。Meta分析结果显示:TDR与ACDF两组术后颈痛评分[MD=–0.90,95%CI(–1.18,–0.62)]、术后上肢痛评分[MD=–0.70,95%CI(–0.86,–0.54)]、术后神经功能满意率[RR=1.06,95%CI(1.02,1.11),P=0.003]、再次手术发生率[RR=0.30,95%CI(0.17,0.53),P<0.000?1]和总体治愈率[RR=1.13,95%CI(1.06,1.22),P=0.000?6]的差异有统计学意义;而两组术后颈部功能障碍指数评分[WMD=1.53,95%CI(–0.55,3.61),P=0.15]、术后影像学满意率[RR=0.96,95%CI(0.92,1.01),P=0.11]和术后并发症发生率[RR=0.79,95%CI(0.49,1.28),P=0.34]差异无统计学意义。结论 TDR能缓解颈及上肢痛、改善神经功能、降低再次手术率,提高单节段颈椎病的总体治愈率,但在颈部功能改善、术后影像学评估及并发症发生等方面,TDR和ACDF疗效相似。

Objective To evaluate differences of clinical effects between cervical total disc replacement（TDR）and anterior cervical discectomy and fusion（ACDF）for single symptomatic single-level cervical degenerative disc disease.Methods Randomized controlled trials（RCTs）from the Cochrane Library Central Register of Controlled Trials（Issue 1,2009）,MEDLINE（2000 to May 2009）,EMbase（2000 to May 2009）,Ovid（2000 to May 2009）,CBM（2000 to May 2009）and CNKI（2000 to May 2009）were electronically searched.Additionally,six relevant journals were handsearched to identify RCTs about comparison of TDR and ACDF in the treatment of single-level cervical degenerative disc disease.All RCTs demonstrating these issues were included.RevMan 5.0 software was used for meta-analyses.Results Six RCTs involving 1 340 patients were included.The results of meta-analyses indicated that there were significant differences between the two groups in neurological success（RR=1.06,95%CI 1.02 to 1.11,P=0.003）,secondary surgical procedures（RR=0.30,95%CI 0.17 to 0.53,P0.0001）and overall success（RR=1.13,95%CI 1.06 to 1.22,P=0.0006）.However,there were no significant differences in Neck Disability Index（NDI）scores（WMD=1.53,95%CI –0.55 to 3.61,P=0.15）,neck pain scores（WMD= –2.87,95%CI 7.75 to 1.81,P=0.23）,arm pain scores（WMD= –0.7,95%CI –0.86 to –0.54,P=0.48）,radiography success（RR=0.96,95%CI 0.92 to 1.01,P=0.11）,and postoperative complications（RR=0.79,95%CI 0.49 to 1.28,P=0.34）between the two groups.Conclusion The evidence indicates that compared with ACDF,TDR could improve neurological status,reduce secondary surgical procedures and promote overall success for single-level cervical degenerative disc disease,but there are no significant differences in postoperative NDI,neck and arm pain scores,radiography success,and complications.