St George and Sutherland Clinical School UNSW, St George Hospital, Sydney, NSW, Australia.
Interventional Radiology, St George Private Hospital, Sydney, NSW, Australia.
Eur Spine J. 2020 Jul;29(7):1606-1613. doi: 10.1007/s00586-020-06362-2. Epub 2020 Mar 13.
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.
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.
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.
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.
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. These slides can be retrieved from Electronic Supplementary Material.
VAPOUR 研究发现，与安慰剂（P）相比，骨水泥成形术（V）对疼痛剧烈且骨折时间少于 6 周的患者更有效。探索性分析表明，该获益主要集中在骨折时间小于 3 周的亚组患者中。这一差异可能是因为纳入该骨折时间框架内患者较少的三项盲法阴性试验所致。
在 VAPOUR 研究中，评估骨折后 3 周内发生的急性疼痛性骨质疏松性椎体骨折行早期椎体成形术的安全性和有效性。
计算 Spearman 秩相关系数，以重新评估 VAPOUR 试验中椎体成形术缓解疼痛与骨折时间的关系。我们更全面地报告了骨折时间小于等于 3 周的患者的基线和结局数据。
共有 46 例 V 组和 47 例 P 组患者骨折时间小于等于 3 周。基线特征相似。共有 86 例患者（41 例 V 组，45 例 P 组）完成了 14 天的问卷调查。在 14 天时有 21 例（51%）V 组患者和 9 例（20%）P 组患者疼痛从重度（NRS≥7/10 是纳入标准）缓解至轻度（NRS<4），两组间差异为 31 个百分点，95%可信区间为 12-50；p=0.002）。早期椎体成形术能更显著减轻平均 NRS 疼痛和 Roland-Morris 残疾评分。
对 VAPOUR 试验中该患者亚组的分析，结合其他随机试验证据，提示如果在骨折后 3 周内进行，早期椎体成形术可带来有临床意义的获益。这些幻灯片可从电子补充材料中获取。
