A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures
A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures
复制标题
DOI：
10.1056/nejmoa0900429
复制
发表时间：
2009-08-06
影响因子：
158.5
通讯作者：
Murphy, Bridie
中科院分区：
文献类型：
--
作者：
Buchbinder, Rachelle;Osborne, Richard H.;Murphy, Bridie
脊椎成形术已成为一种常见的治疗疼痛的脊椎骨骨折，但有有限的证据支持其use. METHODS我们进行了一项多中心，随机，双盲，安慰剂对照试验中，参与者与一个或两个疼痛的脊椎骨骨折，是不到12个月的持续时间和未愈合，证实了磁共振成像，随机分配接受椎体成形术或假手术。根据治疗中心、性别和症状持续时间（≥ 6周）对参与者进行分层。在1周、1个月、3个月和6个月时评估结局。主要结果是3个月时的总体疼痛（0 - 10分，10分是最大的可想象的疼痛）。共有78名参与者参加了CRTTSA，71名（椎体成形术组38名中的35名和安慰剂组40名中的36名）完成了6个月的随访（91%）。椎体成形术在任何时间点的任何测量结果方面均无显著优势。在每次随访评估中，两个研究组的总体疼痛均显著减轻。3个月时，椎体成形术组和对照组疼痛评分的平均（+/- SD）降低分别为2.6 +/- 2.9和1.9 +/- 3.3（校正组间差异，0.6; 95%置信区间，-0.7至1.8）。两组在夜间和休息时疼痛、身体功能、生活质量和感知改善方面的改善相似。7个事件椎体骨折（3个在椎体成形术组和安慰剂组4）发生在6个月的随访periods.CONCLUSIONSWe相比，我们发现没有有益的影响椎体成形术与假手术的患者疼痛性椎体骨折，在1周或1，3，或6个月后治疗。（澳大利亚和新西兰临床试验注册编号：ACTRN 012605000079640）
BACKGROUNDVertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use.METHODSWe performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms (= 6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months.RESULTSA total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (+/- SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6 +/- 2.9 and 1.9 +/- 3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, -0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period.CONCLUSIONSWe found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment. (Australian New Zealand Clinical Trials Registry number, ACTRN012605000079640.)