中国组织工程研究

中国组织工程研究 ›› 2017, Vol. 21 ›› Issue (2): 322-328.doi: 10.3969/j.issn.2095-4344.2017.02.028

• 生物材料循证医学 evidence-based medicine of biomaterials • 上一篇    

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

穆小平，易伟林，韦建勋，欧裕福，李柱海
  

  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
  • 收稿日期:2016-10-28 出版日期:2017-01-18 发布日期:2017-02-27
  • 通讯作者: 韦建勋，硕士，主任医师，硕士生导师，广西壮族自治区人民医院骨科，广西壮族自治区南宁市 530021
  • 作者简介:穆小平，男，1991年生，汉族，广西壮族自治区人民医院骨科在读硕士，主要从事脊柱骨病及创伤外科研究。 穆小平、易伟林为并列第一作者。

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

Mu Xiao-ping, Yi Wei-lin, Wei Jian-xun, Ou Yu-fu, Li Zhu-hai
  

  1. Department of Orthopaedics, the People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning 530021, Guangxi Zhuang Autonomous Region, China
  • Received:2016-10-28 Online:2017-01-18 Published:2017-02-27
  • Contact: Wei Jian-xun, Master, Chief physician, Master’s supervisor, Department of Orthopaedics, the People’s Hospital of Guangxi Zhuang Autonomous Region，Nanning 530021, Guangxi Zhuang Autonomous Region, China
  • About author:Mu Xiao-ping, Studying for master’s degree, Department of Orthopaedics, the People’s Hospital of Guangxi Zhuang Autonomous Region，Nanning 530021, Guangxi Zhuang Autonomous Region, China Yi Wei-lin, Department of Orthopaedics, the People’s Hospital of Guangxi Zhuang Autonomous Region，Nanning 530021, Guangxi Zhuang Autonomous Region, China Mu Xiao-ping and Yi Wei-lin contributed equally to this work.

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4

摘要：

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文题释义：
椎体压缩性骨折：多发生于中老年人群，创伤是其发生的重要原因之一，是脊柱骨折中较为多见的损伤类型，主要累及椎体前柱，呈楔形变，稳定性较好。其临床表现为病变椎体后方疼痛、活动受限，老年骨质疏松性椎体压缩性骨折较少出现脊髓或神经根的损伤。
椎体成形系统：包括经皮椎体成形和经皮椎体后凸成形，是目前治疗老年骨质疏松性椎体压缩性骨折最常用的干预措施。术中通过向病椎内注入骨水泥，使椎体强度和刚度增大，较大程度上重建了脊柱稳定性，降低椎体进一步被压缩及后凸畸形产生的概率，具有缓解疼痛、早期下床活动及改善生活质量的优势。

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PubMed、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RevMan 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。

关键词: 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

Abstract:

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: PubMed, Embase, Cochrane Library, CNKI, CqVip and WanFang 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 RevMan 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.

Key words: Spinal Fractures, Fractures, Compression, Evidence-Based Medicine, Tissue Engineering

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