Radboud University Nijmegen Medical Centre, Department of Neurosurgery, Nijmegen, Netherlands.
Neurosurgery. 2010 Jun;66(6):1153-60; discussion 1160. doi: 10.1227/01.NEU.0000369189.09182.5F.
OBJECTIVE: A meta-analysis was performed to evaluate whether a beneficial clinical effect of cervical disk prostheses over conventional cervical diskectomy with fusion exists. METHODS: A literature search was completed ending February 4, 2009, that included the abstract books of recent major spine congresses. All studies reported the results of single-level cervical disease without myelopathy. The Visual Analog Score (VAS) of the arm, VAS of the neck, Neck Disability Index, Physical Composite Scores of the Short Form 36, and Mental Composite Score of the Short Form 36, as well as adverse events, were evaluated. RESULTS: Nine records were found, totaling 1533 patients. Of these, 1165 were evaluable at the last follow-up at 12 or 24 months. As an effect measure, a pooled odds ratio (OR) was calculated at 12 and 24 months. At 12 months, the VAS arm reached statistical significance (OR = 0.698; 95% confidence interval [CI], 0.571-0.853), as did the VAS neck (OR = 0.690; 95% CI, 0.562-0.847), and the Physical Composite Scores (OR = 1.362; 95% CI, 1.103-1.682) and the Mental Composite Score (OR = 1.270; 95% CI, 1.029-1.569) of the Short Form 36, favoring arthroplasty. The Neck Disability Index at 24 months also reached statistical difference (OR = 0.794; 95% CI, 0.641-0.984). All other measurements did not reveal any statistical difference. The number of complications, including secondary surgeries for adjacent segment disease, did not differ. CONCLUSION: A clinical benefit for the cervical disk prosthesis is not proven. Because none of the studies were blinded, bias of the patient or researcher is a probable explanation for the differences found. Therefore, these costly devices should not be used in daily clinical practice.
目的:通过荟萃分析来评估颈椎间盘假体与传统颈椎间盘切除术加融合术相比是否具有更好的临床效果。
方法:文献检索截至 2009 年 2 月 4 日,包括最近主要脊柱大会的摘要集。所有研究均报告了无脊髓病的单节段颈椎疾病的结果。评估的指标包括手臂视觉模拟评分(VAS)、颈部 VAS、颈部残疾指数、简明 36 健康调查量表的身体综合评分和精神综合评分,以及不良事件。
结果:共找到 9 条记录,总计 1533 例患者。其中,1165 例患者在 12 或 24 个月的最后随访时可评估。作为效应量,计算了 12 个月和 24 个月时的合并优势比(OR)。在 12 个月时,手臂 VAS 达到统计学意义(OR=0.698;95%置信区间[CI],0.571-0.853),颈部 VAS(OR=0.690;95%CI,0.562-0.847),以及简明 36 健康调查量表的身体综合评分(OR=1.362;95%CI,1.103-1.682)和精神综合评分(OR=1.270;95%CI,1.029-1.569)也具有统计学意义,有利于关节成形术。24 个月时的颈部残疾指数也达到了统计学差异(OR=0.794;95%CI,0.641-0.984)。其他所有测量指标均未显示出任何统计学差异。包括相邻节段疾病的二次手术在内的并发症数量没有差异。
结论:颈椎间盘假体的临床获益未得到证实。由于没有一项研究是盲法的,因此患者或研究者的偏倚可能是造成差异的原因。因此,这些昂贵的器械不应该在日常临床实践中使用。
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