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Percutaneous vertebroplasty versus non-operative treatment for osteoporotic vertebral compression fractures: a meta-analysis of randomized controlled trials.
Osteoporosis International ( IF 4.2 ) Pub Date : 2019-08-03 , DOI: 10.1007/s00198-019-05101-8
S Lou 1 , X Shi 1 , X Zhang 1 , H Lyu 2 , Z Li 2 , Y Wang 1
Affiliation  

PURPOSE 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.

中文翻译:

经皮椎体成形术与非手术治疗骨质疏松性椎体压缩性骨折:随机对照试验的荟萃分析。

目的 骨质疏松性椎体压缩性骨折 (OVCF) 在老年人群中很常见,通常使用经皮椎体成形术 (PVP) 进行治疗。然而,各种随机对照试验(RCT)报告的 PVP 的有效性尚无定论。本研究旨在从已发表的文献中分析 PVP 对 OVCFs 的疗效和安全性。方法 自 2019 年 1 月 1 日各自成立以来,在 Medline、EMBASE 和 Cochrane 图书馆中进行了搜索,以比较接受 PVP 治疗的 OVCF 与非手术治疗的 RCT。主要结局是 1 至 2 周、1 至 3 个月和 6 至 12 个月时的疼痛缓解。次要结果是新椎体骨折的发生率。使用随机效应模型进行荟萃分析。结果 共纳入 13 项 RCT,包括 1624 名患者。对于盲法研究,在椎体成形术治疗急性疼痛性骨质疏松性骨折 (VAPOUR) 试验的亚组中,PVP 和假注射组之间的 3 项主要结果存在统计学差异。尽管 PVP 组和假注射组在每个时期的 VAPOR 试验中的疼痛评分相似,但 PVP 的影响大小随着时间的推移而增加。对于开放标签研究,PVP 在所有时间点都显着减轻了疼痛。PVP 组和对照组之间新发椎体骨折的风险相似。结论 PVP 的应用仅在具有持续性和剧烈疼痛的急性 OVCF 患者中是有效和安全的。在骨折较旧或症状不严重的患者中,没有记录到任何益处。在椎体成形术治疗急性疼痛性骨质疏松性骨折 (VAPOUR) 试验的亚组中,PVP 和假注射组之间的 3 项主要结果存在统计学差异。尽管 PVP 组和假注射组在每个时期的 VAPOR 试验中的疼痛评分相似,但 PVP 的影响大小随着时间的推移而增加。对于开放标签研究,PVP 在所有时间点都显着减轻了疼痛。PVP 组和对照组之间新发椎体骨折的风险相似。结论 PVP 的应用仅在具有持续性和剧烈疼痛的急性 OVCF 患者中是有效和安全的。在骨折较旧或症状不严重的患者中,没有记录到任何益处。在椎体成形术治疗急性疼痛性骨质疏松性骨折 (VAPOUR) 试验的亚组中,PVP 和假注射组之间的 3 项主要结果存在统计学差异。尽管 PVP 组和假注射组在每个时期的 VAPOR 试验中的疼痛评分相似,但 PVP 的影响大小随着时间的推移而增加。对于开放标签研究,PVP 在所有时间点都显着减轻了疼痛。PVP 组和对照组之间新发椎体骨折的风险相似。结论 PVP 的应用仅在具有持续性和剧烈疼痛的急性 OVCF 患者中是有效和安全的。在骨折较旧或症状不严重的患者中,没有记录到任何益处。
更新日期:2019-08-03
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