Cancer Risk from Bone Morphogenetic Protein Exposure in Spinal Arthrodesis
Cancer Risk from Bone Morphogenetic Protein Exposure in Spinal Arthrodesis
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DOI：
10.2106/jbjs.m.01190
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发表时间：
2014-09-03
影响因子：
5.3
通讯作者：
Anderson, Paul A.
中科院分区：
文献类型：
--
作者：
Kelly, Mick P.;Savage, Jason W.;Anderson, Paul A.
背景资料：美国食品和药物管理局报告称，在一项随机对照试验中，与对照组相比，接受脊柱关节固定术并暴露于高剂量重组人骨形态发生蛋白-2（rhBMP-2）的患者的癌症发病率更高。本研究的目的是确定脊柱骨形态发生蛋白融合术后癌症的风险。方法：我们回顾性分析了2005年至2010年接受脊柱关节融合术的467，916名医疗保险患者的癌症发病率。排除了先前诊断为癌症的患者。BMP组的平均随访时间为2.85年，对照组为2.94年。主要的结果衡量标准是脊柱关节融合术后有或没有暴露于BMP.Results的发展新的恶性病变的相对风险：BMP暴露后发展为癌症的相对风险为0.938（95%置信区间[95%CI]：0.913至0.964），这是显着的。在BMP组中，5.9%的患者发展为浸润性癌症，而对照组为6.5%。BMP暴露后发生癌症的相对风险在男性中为0.98（95%CI：0.94至1.02），在女性中为0.93（95%CI：0.90至0.97）。对照组表现出较高的发病率，每一种类型的癌症，除了胰腺cancer.Conclusions：最近的临床使用BMP是没有相关的检测到的癌症的风险增加，平均2.9年的时间窗口。
Background: The U.S. Food and Drug Administration reported a higher incidence of cancer in patients who had spinal arthrodesis and were exposed to a high dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) compared with the control group in a randomized controlled trial. The purpose of this study was to determine the risk of cancer after spinal arthrodesis with BMP.Methods: We retrospectively analyzed the incidence of cancer in 467,916 Medicare patients undergoing spinal arthrodesis from 2005 to 2010. Patients with a preexisting diagnosis of cancer were excluded. The average follow-up duration was 2.85 years for the BMP group and 2.94 years for the control group. The main outcome measure was the relative risk of developing new malignant lesions after spinal arthrodesis with or without exposure to BMP.Results: The relative risk of developing cancer after BMP exposure was 0.938 (95% confidence interval [95% CI]: 0.913 to 0.964), which was significant. In the BMP group, 5.9% of the patients developed an invasive cancer compared with 6.5% of the patients in the control group. The relative risk of developing cancer after BMP exposure was 0.98 in males (95% CI: 0.94 to 1.02) and 0.93 (95% CI: 0.90 to 0.97) in females. The control group showed a higher incidence of each type of cancer except pancreatic cancer.Conclusions: Recent clinical use of BMP was not associated with a detectable increase in the risk of cancer within a mean 2.9-year time window.