2010年在某一机构中，用于脊柱融合的INFUSE“超说明书用药”的成本及使用频率。
Costs and frequency of "off-label" use of INFUSE for spinal fusions at one institution in 2010.
作者信息
Epstein Nancy E, Schwall Garry S
机构信息
Clinical Professor of Neurological Surgery, Department of Neurological Surgery, The Albert Einstein College of Medicine, Bronx, NY, 10461.
出版信息
Surg Neurol Int. 2011;2:115. doi: 10.4103/2152-7806.83929. Epub 2011 Aug 17.
BACKGROUND
INFUSE, bone morphogenetic protein-2 combined with bovine Type I collagen in the lumbar tapered fusion device (LT Cage), is used to promote anterior lumbar interbody fusion (ALIF). In spinal surgery, INFUSE is only Federal Drug Administration (FDA) approved for this "on-label" use. While the efficacy and possible complications due to INFUSE have been debated, we know less about the costs and frequency of "on-label" versus "off-label" use of INFUSE to perform spinal fusions.
METHODS
At one institution, we determined the costs (with overhead) and frequency of utilizing INFUSE "on-label" and "off-label" in performing spinal fusions during 2010.
RESULTS
During 2010, 177 spinal fusions utilized INFUSE. Ninety-six percent, or 170 of 177 spinal fusions, utilized INFUSE in an "off-label" capacity at a cost of $4,547,822. Only 4%, or seven of 177 cases, utilized INFUSE in an "on-label" capacity (ALIF); the total cost was $296,419.
CONCLUSIONS
In 2010, at one institution, 96% of the spinal fusions utilized INFUSE in an off-label capacity (cost $4,547,822), while only 4% were performed on-label (cost $296,4194).
背景
INFUSE（骨形态发生蛋白-2与牛I型胶原结合于腰椎锥形融合器（LT Cage）中）用于促进腰椎前路椎间融合术（ALIF）。在脊柱手术中，INFUSE仅获得美国食品药品监督管理局（FDA）批准用于这种“标签内”用途。虽然关于INFUSE的疗效及可能的并发症一直存在争议，但我们对INFUSE用于脊柱融合术的“标签内”与“标签外”使用成本及频率了解较少。
方法
在一家机构，我们确定了2010年脊柱融合术中使用INFUSE“标签内”和“标签外”的成本（含间接费用）及频率。
结果
2010年期间，177例脊柱融合术使用了INFUSE。177例脊柱融合术中的96%，即170例，以“标签外”方式使用INFUSE，成本为4,547,822美元。仅4%，即177例中的7例，以“标签内”方式（ALIF）使用INFUSE；总成本为296,419美元。
结论
2010年，在一家机构，96%的脊柱融合术以“标签外”方式使用INFUSE（成本为4,547,822美元），而仅4%为“标签内”手术（成本为296,419美元）。
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