Abstract

Background

VAPOUR found vertebroplasty (V) more effective than placebo (P) in patients with severe pain and fracture duration less than 6 weeks. Exploratory analysis suggested that benefits were concentrated in the subgroup of patients with fractures ≤ 3-week duration. This difference may account for the three negative blinded trials that included few patients within this fracture time frame.

Purpose

To assess the safety and efficacy of early vertebroplasty for acute painful vertebral osteoporotic fractures within 3 weeks of fracture onset in the VAPOUR study.

Methods

Spearman’s rank log coefficients were calculated to reassess the relationship of pain reduction from vertebroplasty and fracture duration in the VAPOUR trial. We more fully report baseline and outcome data in patients with fractures ≤ 3-week duration.

Results

There were 46V and 47P patients with fractures ≤ 3-week duration. Baseline characteristics were similar. In total, 86 patients (41V, 45P) completed the 14-day questionnaire. The proportion of patients with reduction in pain from severe (NRS ≥ 7/10 was an inclusion requirement) to mild (NRS < 4) at 14 days was 21 (51%) V-group and 9 (20%) in the P-group (between-group difference 31 percentage points, 95% CI 12–50; p = 0.002). Early vertebroplasty provided greater reductions in mean NRS pain and Roland–Morris Disability.

Conclusion

Analysis of this patient subgroup from the VAPOUR trial, in the context of other randomised trial evidence, suggests clinically significant benefits from early vertebroplasty if performed within 3 weeks of fracture.

Graphic abstract

These slides can be retrieved from Electronic Supplementary Material.

中文翻译：

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急性疼痛性椎骨骨质疏松性骨折在3周内进行早期椎体成形术：VAPOR试验的亚组分析和文献复习。

摘要

背景

VAPOR发现在严重疼痛且骨折持续时间少于6周的患者中，椎体成形术（V）比安慰剂（P）更有效。探索性分析表明，受益时间集中在骨折≤3周的患者亚组中。这种差异可能解释了三项阴性盲试验，其中包括在该骨折时间范围内的极少患者。

目的

在VAPOR研究中，评估骨折发生后3周内早期椎体成形术治疗急性疼痛性椎骨骨质疏松性骨折的安全性和有效性。

方法

计算Spearman的等级对数系数，以重新评估VAPOR试验中椎骨成形术减轻疼痛与骨折持续时间的关系。对于骨折时间≤3周的患者，我们将更全面地报告基线和结果数据。

结果

骨折持续时间≤3周的46V和47P患者。基线特征相似。总共有86位患者（41V，45P）完成了为期14天的问卷调查。在14天时，疼痛减轻程度从严重（NRS≥7/10为纳入要求）到轻度（NRS <4）的患者比例为V组为21（51％），P组为9（20％）组（组间差异31个百分点，95％CI 12–50；p  = 0.002）。早期椎体成形术可大大减轻平均NRS疼痛和Roland-Morris残疾。

结论

在其他随机试验证据的背景下，对VAPOR试验中该患者亚组的分析表明，如果在骨折后3周内进行早期椎体成形术，则具有临床上的显着益处。

图形摘要

可以从电子补充材料中检索这些幻灯片。