J Bone Miner Res. 2014 Jun;29(6):1346-55. doi: 10.1002/jbmr.2157.
We previously reported the results of a randomized controlled trial that found no benefit of vertebroplasty over a sham procedure for acute osteoporotic vertebral fractures up to 6 months. We report here the 12-month and 24-month clinical outcomes of this trial. Eligible participants (n = 78) were randomly assigned to receive either vertebroplasty (n = 38) or a sham procedure (n = 40). Randomization was stratified by treatment center, sex, and symptom duration (<6 weeks or ≥6 weeks). Participants, investigators (except the treating radiologists), and outcome assessors were blinded to group assignments. Enrolment occurred between April 2004 and October 2008 with follow-up completed October 2010. The primary outcome was overall pain measured on a scale of 0 (no pain) to 10 (maximal imaginable pain). Secondary outcomes included pain at rest and at night, disability, quality of life, perceived recovery, and adverse events, including incident clinically apparent vertebral fractures. At 12 and 24 months, complete data were available for 67 (86%) and 57 (73%) participants, respectively. At 12 months participants in the active group improved by 2.4 ± 2.7 (mean ± SD) units in overall pain compared with 1.9 ± 2.8 units in the sham group, adjusted between-group mean difference (MD) 0.3 (95% confidence interval [CI], –0.9 to 1.5), whereas at 24 months participants in the active group had improved by 3.0 ± 3.1 units compared with 1.9 ± 3.0 units in the sham group, MD 1.1 (95% CI, –0.3 to 2.4). No significant between-group differences were observed for any of the secondary efficacy outcomes at 12 or 24 months. There were no between-group differences in incident clinical vertebral fractures up to 24 months (active: n = 14, sham: n = 13), although the study had inadequate power for this outcome. These results provide further evidence that the use of this treatment in routine care is unsupported.
我们之前报道了一项随机对照试验的结果，该试验发现对于急性骨质疏松性椎体骨折，椎体成形术与假手术相比在 6 个月内没有获益。我们在此报告该试验的 12 个月和 24 个月的临床结果。符合条件的参与者（n=78）被随机分配接受椎体成形术（n=38）或假手术（n=40）。随机分组按治疗中心、性别和症状持续时间（<6 周或≥6 周）分层。参与者、研究者（除治疗放射科医生外）和结局评估者对分组情况均不知情。入组时间为 2004 年 4 月至 2008 年 10 月，随访于 2010 年 10 月完成。主要结局指标是 0（无痛）到 10（最大想象疼痛）的整体疼痛评分。次要结局指标包括静息时和夜间疼痛、残疾、生活质量、感知恢复和不良事件，包括新发临床明显椎体骨折。在 12 个月和 24 个月时，分别有 67（86%）和 57（73%）名参与者完成了完整数据采集。在 12 个月时，活性组的参与者在整体疼痛方面改善了 2.4±2.7 个单位，而假手术组改善了 1.9±2.8 个单位，调整后的组间平均差异（MD）为 0.3（95%置信区间[CI]，-0.9 至 1.5），而在 24 个月时，活性组的参与者改善了 3.0±3.1 个单位，而假手术组改善了 1.9±3.0 个单位，MD 为 1.1（95%CI，-0.3 至 2.4）。在 12 个月和 24 个月时，在任何次要疗效指标上均未观察到组间差异。在 24 个月内，活性组和假手术组均未发生新发临床椎体骨折（活性组：n=14，假手术组：n=13），尽管该研究对该结局的效力不足。这些结果进一步表明，在常规治疗中使用这种治疗方法是没有依据的。
