高黏度与普通黏度骨水泥椎体成形系统修复骨质疏松性椎体压缩性骨折的荟萃分析  

High viscosity versus common viscosity bone cement systems in the treatment of osteoporotic vertebral compressive fractures: a Meta-analysis

作　　者：穆小平[1] 易伟林 韦建勋[1] 欧裕福[1] 李柱海 

机构地区：[1]广西壮族自治区人民医院骨科,广西壮族自治区南宁市530021

出　　处：《中国组织工程研究》2017年第2期322-328,共7页Chinese Journal of Tissue Engineering Research

摘　　要：背景:椎体成形系统修复骨质疏松性椎体压缩性骨折的疗效已得到肯定,但骨水泥渗漏导致的相关并发症仍时有发生。根据渗漏因素分析所产生的高黏度骨水泥安全性和有效性高,但缺乏大样本、高强度的证据研究。目的:系统评价高黏度与普通黏度骨水泥椎体成形系统修复椎体压缩性骨折的安全性和有效性。方法:计算机检索Pub Med、Embase、Cochrane Library、中国知网、维普及万方数据库等,检索时间均为各数据库自建库以来至2016年1月,收集关于高黏度骨水泥与普通黏度对比修复椎体压缩性骨折的随机或临床对照研究。由2名研究员根据Cochrane系统评价的方法独立对纳入研究的文献质量进行评价并提取数据,采用Rev Man 5.2软件进行数据分析。结果与结论:1纳入4个随机对照试验,6个临床对照试验;2Meta分析结果显示,与普通骨水泥相比,高黏度骨水泥在注射剂量[MD=0.17,95%CI(-0.04,0.38)]、目测类比评分[随机对照试验:MD=-0.30,95%CI(-0.72,0.11);临床对照试验:MD=-0.05,95%CI(-0.43,0.32)]以及术后椎体再骨折[OR=1.77,95%CI(0.24,12.86)]方面,差异均无显著性意义;但高黏度骨水泥组术后Oswestry功能障碍指数降低更明显[MD=-2.99,95%CI(-5.85,-0.13)],Cobb角恢复更佳[MD=-3.19,95%CI(-5.27,-1.10)],骨水泥渗漏率更低[OR=0.35,95%CI(0.24,0.51)],差异有显著性意义;3与普通黏度骨水泥相比,高黏度骨水泥椎体成形在恢复脊柱功能、生理结构以及减少渗漏方面更具优势。鉴于研究样本量小、异质性高,结论仍需大样本、高质量的随机对照试验予以论证。BACKGROUND： Vertebroplasty system has been proved to be effective for osteoporotic vertebral compressive fracture（OVCF）; however, bone cement leakage-related complications occur frequently. Thereafter, high-viscosity bone cement system with high safety and efficacy is developed, but there is still a lack of large-scale and high quality research. OBJECTIVE： To systematically review the efficacy and safety of high viscosity versus common bone cement systems for OVCF.METHODS： Pub Med, Embase, Cochrane Library, CNKI, Cq Vip and Wan Fang databases were searched to collect the literatures about randomized controlled trials（RCTs） or clinical controlled trials（CCTs） of high viscosity versus common bone cement systems for OVCF published before January 2016. The quality assessment of included literatures and data extraction were performed by two researchers independently according to the Cochrane system. Data analysis was conducted using Rev Man 5. 2 software. RESULTS AND CONCLUSION： Four RCTs and six CCTs were enrolled. The results of Meta-analysis indicate that there were no significant differences in the volume of bone cement [MD=0.17, 95% CI（-0.04, 0.38）], visual analogue scale scores [RCT： MD=-0.30, 95%CI（-0.72, 0.11）; CCT： MD=-0.05, 95%CI（-0.43, 0.32）] and incidence of second fractures [OR=1.77, 95%CI（0.24, 12.86）] between two bone cements. However, patients undergoing high viscosity bone cement system have significantly lower Oswestry disability index scores [MD=-2.99, 95%CI（-5.85,-0.13）], greater recovery of Cobb angle [MD=-3.19, 95%CI（-5.27,-1.10）] and lower incidence of cement leakage [OR=0.35, 95%CI（0.24, 0.51）]. High viscosity bone cement system in the treatment of OVCF shows good results at recovery of spinal structure and function and reducing leakage. Due to the limited quantity of included literature sand high heterogeneity, more large scale and high quality RCTs are still needed for further verification.

关 键 词：脊柱骨折 骨折 压缩性 循证医学 组织工程 生物材料 骨生物材料 高黏度骨水泥 椎体压缩性骨折 椎体成形 疗效 骨质疏松 荟萃分析 

分 类 号：R318[医药卫生—生物医学工程]