方法:系统评价和荟萃分析。
背景:棘突间装置(IPD)被用作选定的腰椎管狭窄(LSS)患者的治疗方法。然而,IPD的使用仍存在争议,认为与传统减压相比,IPD的再手术率明显更高.因此,meta分析的目的是评估IPD治疗与传统治疗相比的有效性和安全性.
方法:检索PubMed的数据库,Embase和Cochrane,中国国家知识基础设施,截至2024年1月的重庆贵宾数据库和万方数据库。通过使用特定的合格标准来确定相关研究,并基于主要和次要终点提取和分析数据。
结果:共纳入13项研究(5项RCT和8项回顾性研究)。末次随访Oswestey残疾指数(ODI)评分差异无统计学意义(MD=-3.81,95%CI:-8.91-1.28,P=.14)。末次随访时视觉模拟量表(VAS)背痛评分差异有统计学意义(MD=-1.59,95%CI:-3.09--0.09,P=.04),但末次随访中腿部疼痛无显著差异(MD=-2.35,95%CI:-6.15-1.45,P=.23)。更重要的是,操作时间,出血损失,总并发症和再手术率无明显差异。然而,与传统减压相比,IPD具有更高的设备问题(比值比[OR]=9.00,95%CI:2.39-33.91,P=.001)和更小的硬脑膜撕裂(OR=0.32,95%CI:0.15-0.67,P=.002)。
结论:尽管与传统减压术相比,IPD的腰痛评分较低,硬脑膜撕裂也较低,目前的证据表明,与单独减压治疗相比,患者报告的IPD结局没有优势.然而,这些发现需要多中心进一步验证,双盲和大样本随机对照试验。
METHODS: Systematic
review and meta-analysis.
BACKGROUND: Interspinous process devices (IPD) were used as a treatment in selected patients with lumbar spinal stenosis (LSS). However, the use of IPD was still debated that it had significantly higher reoperation rates compared to traditional decompression. Therefore, the purpose of the meta-analysis was to evaluate the effectiveness and safety of IPD treatment in comparison to traditional treatment.
METHODS: The databases were searched of PubMed, Embase and the Cochrane, Chinese National Knowledge Infrastructure, Chongqing VIP Database and Wan Fang Database up to January 2024. Relevant studies were identified by using specific eligibility criteria and data was extracted and analyzed based on primary and secondary endpoints.
RESULTS: A total of 13 studies were included (5 RCTs and 8 retrospective studies). There was no significant difference of Oswestey Disability Index (ODI) score in the last follow-up (MD = -3.81, 95% CI: -8.91-1.28, P = .14). There was significant difference of Visual Analog Scale (VAS) back pain scoring in the last follow-up (MD = -1.59, 95% CI: -3.09--0.09, P = .04), but there existed no significant difference of leg pain in the last follow-up (MD = -2.35, 95% CI: -6.15-1.45, P = .23). What\'s more, operation time, bleeding loss, total complications and reoperation rate had no significant difference. However, IPD had higher device problems (odds ratio [OR] = 9.00, 95% CI: 2.39-33.91, P = .001) and lesser dural tears (OR = 0.32, 95% CI: 0.15-0.67, P = .002) compared to traditional decompression.
CONCLUSIONS: Although IPD had lower back pain score and lower dural tears compared with traditional decompression, current evidence indicated no superiority for patient-reported outcomes for IPD compared with alone decompression treatment. However, these findings needed to be verified in further by multicenter, double-blind and large sample RCTs.