首页> 中文期刊>中华骨科杂志 >后路减压融合术对比单纯减压治疗短节段腰椎管狭窄症无优势:基于随机对照试验的meta分析

后路减压融合术对比单纯减压治疗短节段腰椎管狭窄症无优势:基于随机对照试验的meta分析

摘要

Objective A meta-analysis is to be performed to compare the entire efficacy on decompression (D) alone and decompression with fusion (F) for patients with 1-2 level lumbar stenosis (LSS) regardless of degenerative spandylolisthesis (DS) based on published RCTs.Methods The databases include Pubmed,Embase,Cochrane Library and Web of Science from January 1970 to March 2018 with a certain search strategy and inclusion criteria.Two reviewers assessed eligible trials,evaluated articles quality and extracted information independently and the information included basic characteristics of demographic information,primary and secondary measures,then data synthesis and meta-analysis was progressed as well as subgroup analysis by DS and follow-up time (36 months).Continuous variables were reported as weighted mean difference (WMD) and dichotomous variables were reported as odds ratios (ORs).Finally the strength of evidence and grade of recommendation was evaluated by the grades of recommendation,assessment,development and evaluation (GRADE) system for the overall outcome.Results A total of 9 RCTs with a low to moderate risk of bias met inclusion criteria with a total of 857 patients (367 were in D group and 490 were in F group) in 1-2 level operation and the average age,sex ratio and preoperative visual analogue scale (VAS) were of no significance.In primary measures,there were no statistical difference in VAS changes on back and leg pain between D and F group [MD=-0.03,95% CI (--0.38,0.76),Z=0.08,P=0.94;MD=0.1 1,95%CI (-1.08,1.30),Z=0.18,P=0.86,respectively];Patients' satisfaction was of no difference between the two groups (OR=0.74,P=0.48),together with the change of Oswestry disability index (ODI,P=0.29) and European quality of life-5 dimensions (EQ-SD,P=0.41).As to the secondary measures,there were no difference in the rate of complication (OR=0.75,P=0.50) and reoperation (OR=1.93,P=0.11) while a statistical significance of longer operation duration (P=0.000),more blood loss (P=0.004),longer hospital stays (P=0.000) but amazing lower rate of ASD (OR=2.35,P=0.02) in F group.The subgroup analysis on whether combined with DS showed that basically all of the compared measures were in consistency with the whole meta-analysis;As to the follow-up,there was a higher reoperation rate in middle-to-long term (> 36months) in D group while the other measures were in line with the overall meta-analysis and adjacent segment degeneration/disease (ASD) was the most seasons of reoperation yet no matter the follow-up time.According to the GRADE system,the grade of this meta-analysis is of "High" quality.Conclusion F group has no better clinical results than D alone in short-segment LSS,regardless of DS,and even further,no significant change with shot-term or middle-to-long term follow-up.F approach has a longer duration of operation,more hospital stays and more blood loss,even perhaps a lager cost.According to the GRADE,the grade of this meta-analysis is of "High" quality,the grade strength of recommendation was "Strong".%目的 基于已发表的随机对照试验(randomized controlled trials,RCTs),对单纯减压与减压加融合术治疗短节段腰椎管狭窄症无论合并退变性滑脱(degenerative spondylolisthesis,DS)的整体疗效进行meta分析.方法 检索数据库包括Pubmed、Embase、Cochrane Library及Web of Science,设定检索时间为1970年1月至2018年3月,根据纳入标准和排除标准选取相关文章,两名成员独立筛选符合条件的文献、进行文献质量评价并提取数据信息.数据信息包括人口统计学和手术信息、主要结果和次要结果,后进行数据合成和meta分析;并根据有无合并退变性滑脱及随访时间(36个月)进行亚组分析.连续变量由加权平均差异(weighted mean difference,WMD)表示,双变量由比值比(odds ratios,ORs)表示.最终结果通过the grades of recommendation,assessment,development and evaluation (GRADE)系统提供论证强度和证据等级.结果 经筛选纳入9篇低度到中度偏倚风险的RCTs,共857例研究对象,其中单纯减压组367例,融合组490例,手术节段均为1~2节段,两组平均年龄、性别比和术前视觉模拟评分法(visual analogue scale,VAS)评分均无统计学差异.腰背痛和下肢痛VAS改变值在两组间无统计学差异(MD=-0.03,P=0.94;MD=0.11,P=0.86);两组间Oswestry功能障碍指数(Oswestry disability index,ODI),欧洲五维健康量表(european quality of life-5 dimensions,EQ-5D)及患者满意度方面均无统计学差异(分别为P=0.29,P=0.41和P=0.48).并发症发生率及二次手术率在两组无统计学差异(分别为OR=0.75,P=0.50和0R=1.93,P=0.11),融合组较单纯减压组手术时间长、出血量多、住院周期长(分别为P<0.001,P=0.004和P<0.001)但邻近节段退变(adjacent segment degeneration,ASD)发生率低(0R=2.35,P=0.02).亚组分析对合并退变性滑脱的两组进行分析结果与整体结果大致相同,随访时间上对于术后中长期随访(> 36个月)发现单纯减压组再手术率高于融合组(P=0.03),而其他结果与整体结果一致,而且不论短期还是中长期,两组再手术率最主要的原因均为ASD.根据GRADE系统,文章结果的论证等级为“高”.结论 融合组相对于单纯减压组在治疗短节段腰椎管狭窄症整体疗效中并无优势,无论有无退变性滑脱;无论术后短期还是中长期随访两组疗效均相当.GRADE系统指出文章论证等级为“高”,结论的推荐强度为“强”.

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