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球囊扩张椎体后凸成形术与经皮椎体成形术治疗骨质疏松性椎体压缩性骨折的比较:系统评价和荟萃分析的证据分级。

Balloon kyphoplasty versus percutaneous vertebroplasty in treating osteoporotic vertebral compression fracture: grading the evidence through a systematic review and meta-analysis.

机构信息

Department of Orthopaedics, Tianjin Medical University General Hospital, 154 Anshan Street, Heping District, Tianjin, 300052, China.

出版信息

Eur Spine J. 2012 Sep;21(9):1844-59. doi: 10.1007/s00586-012-2441-6. Epub 2012 Jul 26.

Abstract

OBJECTIVE

To assess the safety and efficacy of balloon kyphoplasty (KP) compared with percutaneous vertebroplasty (VP) and provide recommendations for using these procedures to treat osteoporotic vertebral compression fractures (OVCF).

METHODS

A systematic search of all studies published through March 2012 was conducted using the MEDLINE, EMBASE, OVID, ScienceDirect and Cochrane CENTRAL databases. The randomized controlled trials (RCTs) and non-randomized controlled trials that compared KP to VP and provided data on safety and clinical effects were identified. Demographic characteristics, adverse events and clinical outcomes were manually extracted from all of the selected studies. The evidence quality levels and recommendations were assessed using the GRADE system.

RESULTS

Twelve studies encompassing 1,081 patients met the inclusion criteria. Subgroup meta-analyses were performed according to the study design. In the RCT subgroup, there were significant differences between the two procedures in short-term visual analog scale (VAS), long-term kyphosis angles, operative times and anterior vertebrae heights. In the cohort study subgroup, there were significant differences between the two procedures in short- and long-term VAS, short- and long-term Oswestry Disability Index (ODI), cement leakage rates, short- and long-term kyphosis angles, operative times and anterior vertebrae heights. However, there were no significant differences in long-term VAS or adjacent vertebral fracture rates in the RCT subgroup. There were no significant differences in short- or long-term VAS, short- or long-term ODI, cement leakage rates, adjacent vertebral fracture rates, short- or long-term kyphosis angles or anterior vertebrae heights in the CCT subgroup, and the adjacent vertebral fracture rates did not differ significantly in the cohort study subgroup. The overall GRADE system evidence quality was very low, which lowers our confidence in their recommendations.

CONCLUSIONS

KP and VP are both safe and effective surgical procedures for treating OVCF. KP may be superior to VP in patients with large kyphosis angles, vertebral fissures, fractures in the posterior edge of the vertebral body or significant height loss in the fractured vertebrae. Due to the poor quality of the evidence currently available, high-quality RCTs are required.

摘要

目的

评估球囊椎体后凸成形术(KP)与经皮椎体成形术(VP)的安全性和疗效,并为治疗骨质疏松性椎体压缩性骨折(OVCF)提供使用这些方法的建议。

方法

通过 MEDLINE、EMBASE、OVID、ScienceDirect 和 Cochrane CENTRAL 数据库,对截至 2012 年 3 月发表的所有研究进行了系统搜索。确定了比较 KP 与 VP 并提供安全性和临床效果数据的随机对照试验(RCT)和非随机对照试验。从所有入选研究中手动提取人口统计学特征、不良事件和临床结果。使用 GRADE 系统评估证据质量水平和推荐意见。

结果

纳入了 12 项研究,共 1081 例患者。根据研究设计进行了亚组荟萃分析。在 RCT 亚组中,两种方法在短期视觉模拟量表(VAS)、长期后凸角、手术时间和前部椎体高度方面存在显著差异。在队列研究亚组中,两种方法在短期和长期 VAS、短期和长期 Oswestry 功能障碍指数(ODI)、骨水泥渗漏率、短期和长期后凸角、手术时间和前部椎体高度方面存在显著差异。然而,在 RCT 亚组中,两种方法在长期 VAS 或相邻椎体骨折率方面没有显著差异。在 CCT 亚组中,两种方法在短期和长期 VAS、短期和长期 ODI、骨水泥渗漏率、相邻椎体骨折率、短期和长期后凸角或前部椎体高度方面没有显著差异,而在队列研究亚组中,相邻椎体骨折率没有显著差异。总体 GRADE 系统证据质量为极低,这降低了我们对其推荐意见的信心。

结论

KP 和 VP 都是治疗 OVCF 的安全有效的手术方法。在存在较大后凸角、椎体裂隙、椎体后缘骨折或骨折椎体高度明显丧失的患者中,KP 可能优于 VP。由于目前可用证据质量较差,需要进行高质量的 RCT。

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