Department of Medicine, School of Clinical Sciences, Monash University, Melbourne, Australia.
Department of Clinical Sciences, Lund University, Malmö, Sweden.
J Bone Miner Res. 2019 Jan;34(1):3-21. doi: 10.1002/jbmr.3653.
Vertebral augmentation is among the current standards of care to reduce pain in patients with vertebral fractures (VF), yet a lack of consensus regarding efficacy and safety of percutaneous vertebroplasty and kyphoplasty raises questions on what basis clinicians should choose one therapy over another. Given the lack of consensus in the field, the American Society for Bone and Mineral Research (ASBMR) leadership charged this Task Force to address key questions on the efficacy and safety of vertebral augmentation and other nonpharmacological approaches for the treatment of pain after VF. This report details the findings and recommendations of this Task Force. For patients with acutely painful VF, percutaneous vertebroplasty provides no demonstrable clinically significant benefit over placebo. Results did not differ according to duration of pain. There is also insufficient evidence to support kyphoplasty over nonsurgical management, percutaneous vertebroplasty, vertebral body stenting, or KIVA®. There is limited evidence to determine the risk of incident VF or serious adverse effects (AE) related to either percutaneous vertebroplasty or kyphoplasty. No recommendation can be made about harms, but they cannot be excluded. For patients with painful VF, it is unclear whether spinal bracing improves physical function, disability, or quality of life. Exercise may improve mobility and may reduce pain and fear of falling but does not reduce falls or fractures in individuals with VF. General and intervention-specific research recommendations stress the need to reduce study bias and address methodological flaws in study design and data collection. This includes the need for larger sample sizes, inclusion of a placebo control, more data on serious AE, and more research on nonpharmacologic interventions. Routine use of vertebral augmentation is not supported by current evidence. When it is offered, patients should be fully informed about the evidence. Anti-osteoporotic medications reduce the risk of subsequent vertebral fractures by 40-70%. © 2018 American Society for Bone and Mineral Research.
椎体强化术是目前治疗椎体骨折（VF）患者疼痛的标准方法之一，但经皮椎体成形术和椎体后凸成形术的疗效和安全性缺乏共识，这使得临床医生应该选择哪种治疗方法存在疑问。鉴于该领域缺乏共识，美国骨骼矿物质研究学会（ASBMR）领导层责成该工作组解决关于椎体强化术和其他非药物治疗方法治疗 VF 后疼痛的疗效和安全性的关键问题。本报告详细介绍了该工作组的调查结果和建议。对于急性疼痛性 VF 患者，经皮椎体成形术与安慰剂相比没有明显的临床获益。疼痛持续时间不同，结果也没有差异。也没有足够的证据支持经皮球囊扩张椎体后凸成形术优于非手术治疗、经皮椎体成形术、椎体支架置入术或 KIVA®。有限的证据可确定与经皮椎体成形术或经皮球囊扩张椎体后凸成形术相关的新发 VF 或严重不良事件（AE）的风险。无法对危害做出推荐，但也不能排除危害。对于疼痛性 VF 患者，脊柱支具是否能改善身体功能、残疾或生活质量尚不清楚。运动可能会改善活动能力，减轻疼痛和跌倒恐惧，但不能减少 VF 患者的跌倒或骨折。一般和干预特异性研究建议强调需要减少研究偏倚，并解决研究设计和数据收集方法上的缺陷。这包括需要更大的样本量、纳入安慰剂对照、更多关于严重 AE 的数据以及更多关于非药物干预的研究。常规使用椎体强化术目前没有得到证据支持。当提供这种治疗方法时，应让患者充分了解相关证据。抗骨质疏松药物可将后续椎体骨折的风险降低 40-70%。 © 2018 美国骨骼矿物质研究学会。
