钽合金微孔内置物和自体骨植骨在颈前路椎间融合术中应用效果与安全性的Meta分析

Porous tantalum metal implant versus bone autograft in cervical spine fusion: a Meta-analysis of effect and safety

中文关键词:  颈椎病  钽合金  微孔金属  自体骨植骨  椎间融合术  Meta分析

英文关键词:Cervical spondylopathy  Porous metal implant  Tantalum metal  Bone autograft  Spinal fusion  Meta-analysis

中文摘要:

  【摘要】 目的：系统评价钽合金微孔内置物和自体骨植骨在颈前路椎间盘切除减压融合术（ACDF）中应用的效果及安全性。方法：计算机检索PubMed、Medline、Ｅmbase、Ovid、Cochrane Library、SinoMed等数据库，纳入关于颈前路椎间盘切除减压钽合金微孔内置物植骨或自体骨植骨融合治疗颈椎病的随机对照研究，应用Review Manager软件进行数据分析。选取平均手术时间、手术失血量、住院时间、疼痛视觉模拟评分（visual analogue scale，VAS）、并发症发生率、融合率和满意率等指标进行合并比较。结果：共有5篇随机对照研究符合纳入标准，其中2篇为多中心研究，3篇为单中心研究；5篇文献对于随机序列产生均有充分描述，1篇文献对分配隐藏有充分描述，1篇文献对评价者的盲性有充分描述，3篇文献明确报道失访人数为0，4篇文献内容阐述详尽，信息偏倚较小。共有254例患者，钽合金微孔内置物植骨组142例，自体髂骨植骨融合组112例。钽合金微孔内置物融合组的平均手术时间[MD=-28.85，95%CI（-47.09，-10.60），P=0.002]、末次随访时VAS评分[MD=-0.31，95%CI（-0.43，-0.19），P<0.0001]和满意率[OR=2.20，95%CI（1.06，4.55），P=0.035]都显著性优于自体骨植骨融合组；而平均手术出血量[MD=-73.61，95%CI（-217.72，70.51），P=0.32]、住院天数[MD=-0.51，95%CI（-1.08，0.06），P=0.08]、融合率[OR=0.63，95%CI（0.15，2.70），P=0.53]和术后并发症率[OR=0.25，95%CI（0.04，1.58），P=0.14]的差异无统计学意义。结论：颈前路椎间盘切除减压钽合金微孔内置物植骨与自体骨植骨治疗颈椎病均可取得良好的疗效，钽合金微孔内置物植骨融合在手术时间、VAS评分和满意率上优于自体骨植骨融合。

英文摘要:

  【Abstract】 Objectives: To systematically compare porous tantalum metal implant and bone autograft in anterior cervical discectomy and fusion(ACDF) in cervical spondylopathy. Methods: 6 databases were searched for relevant randomized controlled trials(RCTs) that compared porous metal implants and bone autografts in cervical interbody fusion. Risks of bias in the RCTs were assessed by using the Cochrane Risk of Bias. Review Manager was used to analyze the data of operation time, blood loss, hospital stay, visual analogue scale (VAS), complication rate, fusion rate and satisfaction. Results: Five RCTs(n=254 patients) were identified according to our inclusion criteria. Two of the 5 studies were multiple-centers and the other 3 were mono-centers. The 5 RCTs described adequate methods of random sequence generation, but allocation concealment and blinding were described in one trial. 3 studies were as low risk of incomplete outcome data and 4 studies were as low risk of selective reporting. For the RCTs, there were significant differences in operation time[MD=-28.85, 95% CI(-47.09, -10.60), P=0.002], VAS[MD=-0.31, 95% CI(-0.43, -0.19), P<0.0001], and satisfaction[OR=2.20, 95% CI(1.06, 4.55), P=0.0035]. However, no significant difference was detected in blood loss [MD=-73.61, 95% CI(-217.72, 70.51), P=0.32], hospital stay[MD=-0.51, 95% CI(-1.08, 0.06), P=0.08], fusion rate[OR=0.63, 95% CI(0.15, 2.70), P=0.53] or complication rate[OR=0.25, 95% CI(0.04, 1.58), P=0.14]. Conclusions: Porous tantalum metal implant is as effective and safe as the bone autograft in cervical interbody fusion. However, the porous tantalum metal implants can decrease operation time and VAS and improve clinical satisfaction significantly.