Department of Spine Surgery, The First Affiliated Hospital of Harbin Medical University, No. 23 Youzheng Road, Harbin, 150001, Heilongjiang, People's Republic of China.
Department of Orthopedics, Chinese PLA General Hospital, Beijing, 100853, People's Republic of China.
Osteoporos Int. 2019 Dec;30(12):2369-2380. doi: 10.1007/s00198-019-05101-8. Epub 2019 Aug 3.
Osteoporotic vertebral compression fractures (OVCFs) are common in the elderly population and are often treated using percutaneous vertebroplasty (PVP). However, the effectiveness of PVP reported by various randomized controlled trials (RCTs) is inconclusive. This study aimed to analyze, from published literature, the efficacy and safety of PVP for OVCFs.
A search was conducted in Medline, EMBASE, and Cochrane Libraries since their respective inception on January 1, 2019, for RCTs of OVCFs treated with PVP compared with non-operative treatment. The primary outcomes were pain relief at 1 to 2 weeks, 1 to 3 months, and 6 to 12 months. The secondary outcome was the rate of occurrence of new vertebral fractures. Meta-analysis was performed using a random effect model.
A total of 13 RCTs comprising 1624 patients were included. For the blinded studies, statistical differences were found between PVP and the sham injection group for the 3 primary outcomes in the subgroup of the Vertebroplasty for Acute Painful Osteoporotic fractURes (VAPOUR) trial. Although pain scores were similar between the PVP group and the sham injection group for the VAPOUR trial at each period, the effect size of PVP increased over time. For the open-label studies, PVP significantly reduced pain at all time points. The risk of new vertebral fractures was similar between the PVP groups and control groups.
Application of PVP was effective and safe only in patients with acute OVCFs having persistent and severe pain. No benefits were recorded, among patients with older fractures or those bearing non-severe symptoms.
骨质疏松性椎体压缩性骨折（OVCFs）在老年人群中很常见，通常采用经皮椎体成形术（PVP）治疗。然而，各种随机对照试验（RCTs）报告的 PVP 的疗效并不明确。本研究旨在从已发表的文献中分析 PVP 治疗 OVCFs 的疗效和安全性。
从 Medline、EMBASE 和 Cochrane Libraries 中进行检索，检索时间均从 2019 年 1 月 1 日开始，纳入比较 PVP 与非手术治疗 OVCFs 的 RCTs。主要结局为治疗后 1 至 2 周、1 至 3 个月和 6 至 12 个月时的疼痛缓解程度。次要结局为新发椎体骨折的发生率。采用随机效应模型进行荟萃分析。
共纳入 13 项 RCTs，包含 1624 名患者。对于盲法研究，在 Vertebroplasty for Acute Painful Osteoporotic fractURes（VAPOUR）试验的亚组中，PVP 与假注射组在 3 个主要结局上存在统计学差异。尽管在 VAPOUR 试验的每个时间段，PVP 组和假注射组的疼痛评分相似，但 PVP 的效应大小随时间增加而增加。对于开放标签研究，PVP 在所有时间点均显著减轻疼痛。PVP 组和对照组的新发椎体骨折风险相似。
仅在患有持续性和严重疼痛的急性 OVCFs 患者中应用 PVP 是有效且安全的。对于陈旧性骨折或症状不严重的患者，未记录到获益。
