Spine：全间盘置换治疗腰痛短期效果与融合手术相当

研究设计：系统性文献回顾。

目的：比较全椎间盘置换与融合手术或其他治疗方式治疗腰椎退变性间盘疾病所致慢性腰痛的临床效果。

背景资料概述：目前，全椎间盘置换在腰椎退变性间盘疾病治疗中的应用逐渐增多，但相比运动节段融合手术或保守治疗方法其疗效如何，尚不明确。

方法：通过PubMedCentral，MEDLINE，EMBASE，BIOSIS，ClinicalTrials.gov以及FDA临床试验注册系统等数据库，全面检索全椎间盘置换与其他治疗方式治疗腰椎退变性间盘疾病的随机对照试验文献。采用Cochrane回审查小组标准评价偏奇风险，依据GRADE法对证据质量进行分级。由两位评价者独立筛选研究文献、评价偏奇风险和提取数据资料。结果及置信区间上限与预定的临床相关性差异进行比较。

结果：共有7项随访时间为24个月的随机对照试验纳入本研究。由于赞助和缺乏盲法设计导致这些研究存在偏奇风险。1项研究比较间盘置换与康复治疗发现，手术治疗具有显著优势，但未达设定阈值。6项研究比较间盘置换与融合手术发现，患者采用间盘置换后其平均视觉模拟腰背疼痛评分改善程度高于5.2 mm（2项研究；95%置信区间：0.2–10.3），为低质量证据；术后24个月，间盘置换组的Oswestry功能障碍指数评分高于融合手术组4.3分以上（5项研究；95%置信区间：1.85–6.68），为低质量证据。置信区间上限在预定的临床相关性差异以下。

结论：尽管（间盘置换与其他治疗方法的）疗效存在统计学意义，但临床改善的差异并没有超过普遍接受的临床差异界限。邻近节段疾病和/或小关节退变的预防没有获得准确的评估。因此认为，（间盘置换手术）术后几年可能会出现相关危害和并发症，脊柱外科学界应采取谨慎的态度大规模地应用这一技术。尽管事实上全间盘置换似乎能有效治疗所选患者的腰痛，但其短期效果几乎和融合手术相当。

Total Disc Replacement for Chronic Discogenic Low Back Pain: A Cochrane Review

Study Design

Systematic literature review.

Objective

To assess the effect of total disc replacement for chronic low back pain due to lumbar degenerative disc disease compared with fusion or other treatment options.

Summary of Background Data. There is an increasing use in disc replacement devices for degenerative disc disease, but their effectiveness compared with other interventions such as fusion of the motion segment or conservative treatment remains unclear.

Methods

A comprehensive search in PubMedCentral, MEDLINE, EMBASE, BIOSIS, ClinicalTrials.gov, and FDA trials register was conducted. Randomized controlled trials comparing total disc replacement with any other intervention for degenerative disc disease were included. Risk of bias was assessed using the criteria of the Cochrane Back Review Group. Quality of evidence was graded according to the GRADE approach. Two review authors independently selected studies, assessed risk of bias, and extracted data. Results and upper bounds of confidence intervals were compared with predefined clinically relevant differences.

Results

We included 7 randomized controlled trials with a follow-up of 24 months. There is risk of bias in the included studies due to sponsoring and absence of any kind of blinding. One study compared disc replacement with rehabilitation and found a significant advantage in favor of surgery, which, however, did not reach the predefined threshold. Six studies compared disc replacement with fusion and found that the mean improvement in visual analogue scale score of back pain was 5.2 mm higher (2 studies; 95% confidence interval 0.2–10.3) with a low quality of evidence. The improvement of Oswestry disability index score at 24 months in the disc replacement group was 4.3 points more than in the fusion group (5 studies; 95% confidence interval 1.85–6.68) with a low quality of evidence. Both upper bounds of the confidence intervals were below the predefined clinically relevant difference.

Conclusion

Although statistically significant, the differences in clinical improvement were not beyond generally accepted boundaries for clinical relevance. Prevention of adjacent level disease and/or facet joint degeneration was not properly assessed. Therefore, because we think that harm and complications may occur after some years, the spine surgery community should be prudent to adopt this technology on a large scale, despite the fact that total disc replacement seems to be effective in treating low back pain in selected patients, and in the short term is at least equivalent to fusion surgery.