A randomized trial of vertebroplasty for osteoporotic spinal fractures.
A randomized trial of vertebroplasty for osteoporotic spinal fractures.
复制标题
DOI：
10.1056/nejmoa0900563
复制
发表时间：
2009-08-06
期刊：
影响因子：
--
通讯作者：
Jarvik JG
中科院分区：
文献类型：
--
作者：
Kallmes DF;Comstock BA;Heagerty PJ;Turner JA;Wilson DJ;Diamond TH;Edwards R;Gray LA;Stout L;Owen S;Hollingworth W;Ghdoke B;Annesley-Williams DJ;Ralston SH;Jarvik JG
椎体成形术通常用于治疗疼痛、骨质疏松性椎体压缩性骨折。在这项多中心试验中，我们随机分配1-3例疼痛的骨质疏松性椎体压缩性骨折患者进行椎体成形术或不使用骨水泥的模拟椎体成形术。主要结果是修改后的Roland-Morris残疾问卷（RDQ）评分（范围0-23）和患者在一个月前24小时的平均疼痛强度评分（0-10数值评分量表）。患者在一个月后被允许穿越。所有患者接受了指定的干预措施（68例椎体成形术和63例模拟椎体成形术）。两组患者的基线特征相似。1个月时，椎体成形术组和对照组在RDQ（治疗差异：0.7;95% CI: - 1.3, 2.8; P = 0.49）或疼痛评分（治疗差异：0.7;95% CI: - 0.3, 1.7; P = 0.19）上均无显著差异。两组患者在干预后均表现出残疾和疼痛的立即改善。尽管两组在一个月的次要结果上没有显著差异，但椎体成形术组有更高的临床意义的疼痛改善率（比基线减少30%）（64%对48%，P = 0.06）。3个月时，对照组的交叉率更高（43%对12%，P<0.001）。每组均有1例严重不良事件。骨质疏松性压缩性骨折疼痛和疼痛相关残疾的改善在椎体成形术患者和无骨水泥模拟椎体成形术患者中相似。
Vertebroplasty is used commonly to treat painful, osteoporotic vertebral compression fractures. In this multi-center trial, we randomly assigned patients with 1-3 painful, osteoporotic vertebral compression fractures to vertebroplasty or to a simulated vertebroplasty without cement. The primary outcomes were modified Roland-Morris Disability Questionnaire (RDQ) scores (range, 0–23) and patient ratings of average pain intensity in the preceding 24 hours (0–10 numerical rating scale) at one month. Patients were allowed to cross over after one month. All patients received their assigned interventions (68 vertebroplasty and 63 simulated vertebroplasty). The baseline characteristics were similar in the two groups. At one month, the vertebroplasty and control groups did not differ significantly on either the RDQ (treatment difference: 0.7; 95% CI: −1.3, 2.8; P = 0.49) or the pain rating (treatment difference: 0.7; 95% CI: −0.3, 1.7; P = 0.19). Both groups showed immediate improvement in disability and pain after the intervention. Although the groups did not differ significantly on any secondary outcome at one month, there was a trend toward a higher rate of clinically meaningful improvement in pain (30% decrease from baseline) in the vertebroplasty group (64% versus 48%, P = 0.06). At three months, there was a higher crossover rate in the control group (43% versus 12%, P<0.001)). There was one serious adverse event in each group. Improvement in osteoporotic compression fracture pain and pain-related disability was similar in patients treated with vertebroplasty and patients treated with simulated vertebroplasty without cement.