Balloon Kyphoplasty for the Treatment of Acute Vertebral Compression Fractures: 2-Year Results From a Randomized Trial
Balloon Kyphoplasty for the Treatment of Acute Vertebral Compression Fractures: 2-Year Results From a Randomized Trial
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DOI：
10.1002/jbmr.364
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发表时间：
2011-07-01
影响因子：
6.2
通讯作者：
Wardlaw, Douglas
中科院分区：
文献类型：
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作者：
Boonen, Steven;Van Meirhaeghe, Jan;Wardlaw, Douglas
脊椎骨折通常是痛苦的，并导致生活质量下降和残疾。我们比较了球囊后凸成形术和非手术治疗急性疼痛骨折患者24个月的疗效和安全性。有1到3个椎体骨折的成年人在疼痛开始后3个月内随机接受后凸成形术(n=149)或非手术治疗(n=151)。在24个月内对生活质量、功能、残疾和疼痛进行评估。与非手术治疗相比，在24个月的随访期内，后凸成形术与短式36(SF-36)物理成分概要(PCS)评分的平均改善相关[总体治疗效果3.24分，95%可信区间(CI)1.47-5.01，p=.0004]；6个月时差异仍有统计学意义(3.39分，95%可信区间1.13~5.64，p=.003)，12个月时差异无统计学意义(1.70分，95%CI-0.59~3.98，p=.15)，24个月时差异无统计学意义(1.68分，95%CI-0.63~3.99，p=.15)。在24个月后凸成形术中观察到背痛有较大的改善(总体治疗效果-1.49分，95%CI-1.88至-1.10，P
Vertebral fractures are often painful and lead to reduced quality of life and disability. We compared the efficacy and safety of balloon kyphoplasty to nonsurgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n = 149) or nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24-month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47-5.01, p = .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64, p = .003) but not at 12 months (1.70 points, 95% CI -0.59 to 3.98, p = .15) or 24 months (1.68 points, 95% CI -0.63 to 3.99, p = .15). Greater improvement in back pain was observed over 24 months for kyphoplasty (overall treatment effect -1.49 points, 95% CI -1.88 to -1.10, p