纳米羟基磷灰石与聚醚醚酮椎间融合器的比较△

Nano hydroxyapatite versus polyetheretherketone cage for intervertebral fusion: a meta-analysis

摘要:

［目的］ 系统评价纳米羟基磷灰石 （nano-hydroxyapatite, NHP） 与聚醚醚酮 （polyetheretherketone, PEEK） 两种不同材料融合器在脊柱融合术中应用效果。［方法］ 计算机检索 2021 年 10 月以前收录入中国知网、万方、维普、EMBASE、 PubMed、The Cochrane library 中国生物医学 （CBM） 数据库的文献，搜集有关 NHP 与 PEEK 融合器在脊柱融合术中效果对比的临床研究，采用 Stata/SE 12.0 软件对结局指标进行荟萃分析。［结果］共纳入 6 个研究，共包含 654 例患者，其中 NHP 组 365 例，PEEK 组 289 例。荟萃分析结果显示：与 PEEK 组相比，NHP 组在椎间隙高度 （WMD=-0.02，95%CI：-0.21~0.17，P= 0.843)、融合率（RR=1.002，95%CI：0.96~1.05，P=0.911）、塌陷率（RR=0.824，95%CI：0.47~1.44，P=0.494）、术后功能障碍指数 （WMD=0.13，95%CI：-0.77~1.03，P=0.779）、术后视觉模拟评分 （visual analogue scale, VAS）（WMD=0.11，95%CI：- 0.40~0.62，P=0.675）、融合节段曲度（WMD=-0.13，95%CI：-0.63~0.36，P=0.598）、手术时间（WMD=-2.26，95%CI：-7.17~ 2.64，P=0.366）和术中出血量（WMD=1.08，95%CI：-9.66~11.83，P=0.844）方面能达到相似的临床效果，并且差异均无统计学意义。［结论］ 与 PEEK 组相比，NHP 组具有相似的安全性及临床效果，是一种可代替 PEEK 融合器且较为理想的椎间支撑植骨材料。

Abstract:

[Objective] To systematically compare the clinical outcomes of nano- hydroxyapatite (NHP) versus polyetheretherketone (PEEK) cages used in spinal interbody fusion. [Methods] The clinical studies on the comparison of spinal fusion efficacy with NHP versus PEEK cages were collected from CNKI, Wanfang, VIP, EMBASE, PubMed and The Cochrane Library CBM databases before October 2021. Meta- analysis of outcome indicators was conducted using Stata/SE 12.0 software. [Results] A total of 6 studies were included into the study, involving 654 patients, including 365 patients in the NHP group and 289 patients in the PEEK group. As result of the meta-analysis, there were no significant differences between the two groups in terms of intervertebral height (WMD=- 0.02, 95% CI:-0.21~0.17, P= 0.843) , fusion rate (RR=1.002, 95%CI: 0.96~1.05, P=0.911) , collapse rate (RR=0.824, 95%CI: 0.47~1.44, P=0.494) , postoperative ODI (WMD=0.13, 95%CI: -0.77~1.03, P=0.779) , postoperative VAS score (WMD=0.11, 95%CI: -0.40~0.62, P=0.675) , fusion level curvature (WMD=-0.13, 95%CI：-0.63~0.3, P=0.598) , operative time (WMD=-2.26, 95%CI: -7.17~2.64, P=0.366) , and intraoperative blood loss (WMD=1.08, 95%CI: -9.66~11.83, P=0.844) . [Conclusion] The NHP cage proves similar safety and clinical outcomes with the PEEK cage, and the former is an ideal intervertebral fusion device to replace the latter.