Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne, Victoria.
Med J Aust. 2010 Mar 15;192(6):338-41. doi: 10.5694/j.1326-5377.2010.tb03534.x.
Our recent editorial in the Journal presents an accurate summary of our two randomised trials of vertebroplasty, which found no benefit of vertebroplasty over placebo. Participants in both trials are representative of patients seen in clinical practice and who would qualify for government-subsidised funding of vertebroplasty in Australia. Clinical experience and previous published literature are likely to have overestimated the treatment benefit of vertebroplasty for many reasons. This is why randomised placebo-controlled trials are required to determine the efficacy of treatment interventions, particularly when the condition being treated is self-limiting and the primary end point is improvement of symptoms. Based on the best evidence currently available, the routine use of vertebroplasty outside of the research setting for painful osteoporotic vertebral fractures appears unjustified.
我们最近在《期刊》上的社论准确总结了我们的两项随机椎体成形术试验，这两项试验均未发现椎体成形术优于安慰剂。两项试验的参与者均代表了在临床实践中看到的患者，并且符合澳大利亚政府补贴椎体成形术资金的条件。由于多种原因，临床经验和以前发表的文献可能高估了椎体成形术的治疗益处。这就是为什么需要进行随机安慰剂对照试验来确定治疗干预的疗效，特别是当治疗的疾病是自限性的，主要终点是症状改善时。根据目前可用的最佳证据，在研究环境之外常规使用椎体成形术治疗疼痛性骨质疏松性椎体骨折似乎是不合理的。
