颈椎人工椎间盘置换与椎间盘切除融合术后邻近节段退变比较研究的Meta分析

Adjacent segment degeneration and disease after cervical total disc replacement vs anterior cervical discectomy and fusion: a Meta-analysis of randomized controlled trials

中文关键词:  颈椎人工间盘置换术  颈前路椎间盘切除融合术  邻近节段退变  邻近节段病  Meta分析

英文关键词:Cervical total disc replacement  Anterior cervical discectomy and fusion  Adjacent segment degeneration  Adjacent segment disease  Meta-analysis

中文摘要:

  【摘要】 目的：通过Meta分析系统评价颈椎人工间盘置换术（cervical total disc replacement，TDR）与颈前路椎间盘切除融合术（anterior cervical discectomy and fusion，ACDF）对邻近节段退变（adjacent segment degeneration，ASDeg）、邻近节段病（adjacent segment disease，ASDis）发生的影响。方法：根据Cochrane系统评价指南，通过PubMed、Medline、EMBASE、Cochrane图书馆、中国生物医学文献数据库（CBM）和万方数据库（Wanfang Database）检索2002年1月~2016年6月之间关于TDR和ACDF术后出现ASDeg、ASDis的随机对照试验（randomized controlled trials, RCTs），由两名研究人员独立筛选文章。纳入文献的方法学质量和偏倚风险通过Cochrane系统评价指南进行评价，提取数据包括ASDeg、ASDis以及再手术率的相关信息，研究结果以ASDeg和ASDis的发生作为直接结果，以邻近节段再手术率作为间接结果评估邻近节段病变的发生，并根据随访时间和研究地点分层进行亚组分析，最终对整篇Meta分析通过证据质量分级和推荐强度系统（the grades of recommendation，assessment，development and evaluation，GRADE）进行质量评估。结果：共纳入了11篇RCTs，包括2632名研究对象。对于整体的ASD（包括直接和间接结果），TDR的发生率明显低于ACDF（OR=0.6；95% CI[0.38，0.73]；P<0.00001），差异有统计学意义。ASDeg和再手术率方面，TDR相对于ACDF具有明显优势（分别为OR=0.58，95％ CI[0.46，0.72]，P<0.00001和OR=0.52，95% CI[0.30，0.87]，P=0.01）。以随访时间5年为分界点，不论随访＜5年还是≥5年，在ASDeg发生率上，TDR的优势都比ACDF显著（分别为OR=0.63，P=0.001；OR=0.49，P=0.0002），并且这种优势可能随时间延长有扩大趋势。以研究地点分层，不论在美国（7篇RCTs）还是中国（4篇RCTs），TDR在邻近节段退变（ASDeg）发生率上均有优势（P<0.0001，P=0.03）。根据GRADE评分，该Meta分析的质量级别为中等质量。结论：与ACDF相比，TDR在降低ASDeg和再手术率方面具有优势。

英文摘要:

  【Abstract】 Objectives: To analyze whether cervical total disc replacement(TDR) superior to anterior cervical discectomy and fusion(ACDF) in decreasing the incidence of adjacent segment degeneration(ASDeg) and adjacent segment disease(ASDis) by Meta-analysis. Methods: The PubMed, Medline, EMBASE, Cochrane Library, CBM and Wanfang databases were searched up for randomized controlled trials (RCTs) form January 2002 to June 2016, which reported ASDeg, ASDis and reoperation on adjacent segments after TDR and ACDF. The RCTs were evaluated by two investigators independently. A meta-analysis was performed according to the guidelines of Cochrane Collaboration. The tool of Cochrane Collaboration for assessing methodological quality and risk of bias was applied to separate included studies. Data extraction mainly contained the incidence of ASDeg and ASDis which were regarded as direct outcomes, the incidence of reoperation on adjacent segments which was regarded as indirect outcome to reflect adjacent segment degeneration or disease. Follow-up time and trial sites were stratified practically in clinic to perform subgroup-analysis. Eventually the quality of the whole meta-analysis was evaluated by using the grades of recommendation, assessment, development and evaluation(GRADE). Results: Eleven studies with 2,632 patients were included in the meta-analysis. The outcomes showed that the overall rate of adjacent segment degeneration/disease(ASD) in TDR group was statistically lower than that in ACDF group(OR=0.6; 95% CI[0.38, 0.73]; P<0.00001). More specifically, both the incidence of ASDeg and reoperation rate were significantly lower in patients by TDR than in those by ACDF(OR=0.58, 95％CI[0.46, 0.72], P<0.00001; OR=0.52, 95% CI[0.30, 0.87], P=0.01, respectively). Subgroup analysis according to the follow-up time: the rate of ASDeg was lower in patients by TDR than in those by ACDF no matter it was longer than 5 years or not (OR=0.63, P=0.001; OR=0.49, P=0.0002, respectively), and TDR tended to increase the superiority across time. The rate of ASDeg was also statistically different between patients who underwent TDR and patients who underwent ACDF both in the US and China(P<0.0001, P=0.03, respectively). According to GRADE, the overall quality of this Meta-analysis was moderate-quality. Conclusions: TDR significantly decreases the rate of ASDeg and reoperation compared with ACDF, and the superiority may become more apparent over time.