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[关于退行性腰椎疼痛的手术器械辅助治疗及疼痛缓解的争议。科学证据结果]

[Controversies about instrumented surgery and pain relief in degenerative lumbar spine pain. Results of scientific evidence].

作者信息

Robaina-Padrón F J

机构信息

Unidad del Dolor Crónico y Neurocirugía Funcional, Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria.

出版信息

Neurocirugia (Astur). 2007 Oct;18(5):406-13.

Abstract

Investigation and development of new techniques for intrumented surgery of the spine is not free of conflicts of interest. The influence of financial forces in the development of new technologies an its immediately application to spine surgery, shows the relationship between the published results and the industry support. Even authors who have defend eagerly fusion techniques, it have been demonstrated that them are very much involved in the revision of new articles to be published and in the approval process of new spinal technologies. When we analyze the published results of spine surgery, we must bear in mind what have been call in the "American Stock and Exchange" as "the bubble of spine surgery". The scientific literature doesn't show clear evidence in the cost-benefit studies of most instrumented surgical interventions of the spine compare with the conservative treatments. It has not been yet demonstrated that fusion surgery and disc replacement are better options than the conservative treatment. It's necessary to point out that at present "there are relationships between the industry and back pain, and there is also an industry of the back pain". Nonetheless, the "market of the spine surgery" is growing up because patients are demanding solutions for their back problems. The tide of scientific evidence seams to go against the spinal fusions in the degenerative disc disease, discogenic pain and inespecific back pain. After decades of advances in this field, the results of spinal fusions are mediocre. New epidemiological studies show that "spinal fusion must be accepted as a non proved or experimental method for the treatment of back pain". The surgical literature on spinal fusion published in the last 20 years following the Cochrane's method establish that: 1- this is at least incomplete, not reliable and careless; 2- the instrumentation seems to slightly increase the fusion rate; 3- the instrumentation doesn't improve the clinical results in general, lacking studies in subgroups of patients. We still are needing randomized studies to compare the surgical results with the natural history of the disease, the placebo effect, or the conservative treatment. The European Guidelines for lumbar chronic pain management show a "strong evidence" indicating that complex and demanding spine surgery where different instrumentation is used, is not more effective than a simple, safer and cheaper posterolateral fusion without instrumentation. Recently, the literature published in this field is sending a message to use "minimally invasive techniques", abandon transpedicular fusions and clearly indicating that we must apply the knowledge accumulated at least along the last 20 years based on the scientific evidence. In conclusion, based in recent information, we must recommend the "abandon of the instrumented pathway" in a great number of present indications for degenerative spine surgery, and look for new strategies in the field of rehabilitation and conservative treatments correctly apply, using before the decompressive and instrumented surgery all the interventional and minimally invasive techniques that are presently offer in the field of modem lumbar chronic pain treatment.

摘要

脊柱手术新技术的研发并非没有利益冲突。经济力量对新技术发展及其在脊柱手术中的直接应用产生影响,这体现了已发表研究结果与行业支持之间的关系。即使是那些热切捍卫融合技术的作者,也已证明他们在待发表新文章的修订以及新脊柱技术的审批过程中深度参与。当我们分析脊柱手术的已发表结果时,必须牢记在“美国证券交易所”被称为“脊柱手术泡沫”的情况。科学文献并未在大多数脊柱器械手术干预与保守治疗的成本效益研究中显示出明确证据。尚未证明融合手术和椎间盘置换比保守治疗是更好的选择。必须指出,目前“行业与背痛之间存在关联,而且还存在一个背痛产业”。尽管如此,“脊柱手术市场”正在增长,因为患者对背部问题的解决方案有需求。科学证据的潮流似乎不利于退行性椎间盘疾病、椎间盘源性疼痛和非特异性背痛中的脊柱融合术。在该领域经过数十年发展后,脊柱融合术的结果平平。新的流行病学研究表明,“脊柱融合术必须被视为一种未经证实或试验性的背痛治疗方法”。按照Cochrane方法在过去20年发表的关于脊柱融合术的外科文献表明:1 - 这至少是不完整、不可靠且粗心的;2 - 器械似乎能略微提高融合率;3 - 器械总体上并未改善临床结果,缺乏针对患者亚组的研究。我们仍需要随机研究来将手术结果与疾病的自然病程、安慰剂效应或保守治疗进行比较。欧洲腰椎慢性疼痛管理指南显示“有力证据”表明,使用不同器械的复杂且要求高的脊柱手术并不比简单、更安全且更便宜的非器械辅助后外侧融合术更有效。最近,该领域发表的文献传递出一个信息,即采用“微创技术”,摒弃经椎弓根融合术,并明确表明我们必须运用至少过去20年积累的基于科学证据的知识。总之,基于近期信息,我们必须建议在目前大量退行性脊柱手术适应症中“摒弃器械辅助手术路径”,并在康复和保守治疗领域寻找新策略,正确应用,在减压和器械辅助手术之前先采用现代腰椎慢性疼痛治疗领域目前提供的所有介入性和微创技术。

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