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继续保守治疗与交叉至射频椎体成形术:治疗椎体骨折的比较效果研究。

Continuing conservative care versus crossover to radiofrequency kyphoplasty: a comparative effectiveness study on the treatment of vertebral body fractures.

机构信息

Klinik und Poliklinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn, Sigmund-Freund-Str. 25, 53105 Bonn, Germany.

出版信息

Eur Spine J. 2012 May;21(5):930-6. doi: 10.1007/s00586-012-2148-8. Epub 2012 Jan 11.

DOI:10.1007/s00586-012-2148-8
PMID:22234722
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3337894/
Abstract

BACKGROUND

There is controversy about how to treat vertebral fractures. Conservative care is the default approach. Radiofrequency kyphoplasty uses ultrahigh viscosity cement to restore spinal posture and stabilize the fracture. The aims of this study were to compare radiofrequency kyphoplasty to conservative care and assess the usual algorithm of starting all patients on conservative care for 6 weeks before offering surgery.

METHODS

Elderly patients with painful osteoporotic vertebral compression fractures were all treated with 6 weeks of conservative care (analgesics, bracing, and physiotherapy). They were then offered the choice of continuing conservative care or crossing over to radiofrequency kyphoplasty, at 6 and 12 weeks. Clinical success was defined as: (1) VAS pain improvement ≥2, (2) final VAS pain ≤5, (3) no functional worsening on ODI.

RESULTS

After the initial 6 weeks of conservative care, only 1 of 65 patients met the criteria for clinical success, and median VAS improvement was 0. After 12 weeks of conservative care, only 5 of 38 patients met the criteria for clinical success, and median VAS improvement was 1. At the 6-week follow-up after radiofrequency kyphoplasty, 31 of 33 surgery patients met the criteria for clinical success, and median VAS improvement was 5.

CONCLUSION

For the vast majority of patients with a VAS ≥5, conservative care did not provide meaningful clinical improvement. In contrast, nearly all patients who underwent radiofrequency kyphoplasty had rapid substantial improvement. Surgery was clearly much more effective than conservative care and should be offered to patients much sooner.

摘要

背景

对于椎体骨折的治疗存在争议。保守治疗是默认的方法。射频椎体成形术使用超高粘度的水泥来恢复脊柱姿势并稳定骨折。本研究的目的是比较射频椎体成形术与保守治疗,并评估对所有患者最初采用 6 周保守治疗,然后再提供手术的常规方案。

方法

所有患有疼痛性骨质疏松性椎体压缩性骨折的老年患者均接受 6 周的保守治疗(镇痛药、支具和物理疗法)。然后,在第 6 周和第 12 周,他们可以选择继续保守治疗或交叉接受射频椎体成形术。临床成功定义为:(1)VAS 疼痛改善≥2;(2)最终 VAS 疼痛≤5;(3)ODI 无功能恶化。

结果

在最初的 6 周保守治疗后,只有 65 名患者中的 1 名符合临床成功标准,VAS 中位数改善为 0。在 12 周的保守治疗后,只有 38 名患者中的 5 名符合临床成功标准,VAS 中位数改善为 1。在射频椎体成形术后 6 周的随访中,33 名手术患者中有 31 名符合临床成功标准,VAS 中位数改善为 5。

结论

对于 VAS≥5 的绝大多数患者,保守治疗并未提供有意义的临床改善。相比之下,几乎所有接受射频椎体成形术的患者都迅速显著改善。手术明显比保守治疗更有效,应该更早地提供给患者。

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本文引用的文献

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Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial.椎体成形术与保守治疗急性骨质疏松性椎体压缩骨折(Vertos II):一项开放标签随机试验。
Lancet. 2010 Sep 25;376(9746):1085-92. doi: 10.1016/S0140-6736(10)60954-3. Epub 2010 Aug 9.
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[DFine radiofrequency kyphoplasty (RFK)--kyphoplasty with ultrahigh viscosity cement].[精细射频椎体后凸成形术(RFK)——使用超高粘度骨水泥的椎体后凸成形术]
Rofo. 2010 Sep;182(9):803-5. doi: 10.1055/s-0029-1245385. Epub 2010 Apr 27.
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Invited editorial presents an accurate summary of the results of two randomised placebo-controlled trials of vertebroplasty.特邀社论准确总结了两项随机安慰剂对照椎体成形术试验的结果。
Med J Aust. 2010 Mar 15;192(6):338-41. doi: 10.5694/j.1326-5377.2010.tb03534.x.
4
Vertebroplasty for painful acute osteoporotic vertebral fractures: recent Medical Journal of Australia editorial is not relevant to the patient group that we treat with vertebroplasty.椎体成形术治疗疼痛性急性骨质疏松性椎体骨折:近期《澳大利亚医学杂志》社论与我们治疗椎体成形术患者的群体无关。
Med J Aust. 2010 Mar 15;192(6):334-7. doi: 10.5694/j.1326-5377.2010.tb03533.x.
5
Vertebroplasty, evidence and professional protest.
Med J Aust. 2010 Mar 15;192(6):301-2. doi: 10.5694/j.1326-5377.2010.tb03526.x.
6
Vertebroplasty appears no better than placebo for painful osteoporotic spinal fractures, and has potential to cause harm.椎体成形术对于疼痛性骨质疏松性脊柱骨折似乎并不比安慰剂效果更好,且有可能造成伤害。
Med J Aust. 2009 Nov 2;191(9):476-7. doi: 10.5694/j.1326-5377.2010.tb03467.x.
7
Response to "randomized vertebroplasty trials: bad news or sham news?".对“随机椎体成形术试验:坏消息还是假消息?”的回应
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8
Randomized vertebroplasty trials: bad news or sham news?随机椎体成形术试验:坏消息还是虚假消息?
AJNR Am J Neuroradiol. 2009 Nov;30(10):1808-9. doi: 10.3174/ajnr.A1875. Epub 2009 Oct 8.
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Vertebroplasty: about sense and nonsense of uncontrolled "controlled randomized prospective trials".椎体成形术:关于无对照“对照随机前瞻性试验”的是与非
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On guidelines for comparative effectiveness research using nonrandomized studies in secondary data sources.关于利用二次数据源中的非随机研究进行比较效果研究的指南。
Value Health. 2009 Nov-Dec;12(8):1041. doi: 10.1111/j.1524-4733.2009.00607.x. Epub 2009 Sep 10.