Stanford University School of Medicine, 450 Broadway St, Redwood City, CA 94063, USA.
Spine J. 2011 Jun;11(6):511-6. doi: 10.1016/j.spinee.2011.02.013. Epub 2011 May 25.
The commercially available growth factor recombinant bone morphogenic protein-2 (rhBMP-2) used in spinal fusion has been associated with numerous adverse reactions, including inflammatory reactions in soft tissue, heterotopic bone formation, radiculitis, osteolysis, and cage or graft subsidence. The original Food and Drug Administration Summary of anterior lumbar interbody fusion (ALIF) reported 12 retrograde ejaculation (RE) events (8%) in the rhBMP-2 groups compared with (1.4%) in the control group. It had been debated whether this finding was related to rhBMP-2 use.
To compare the incidence of RE after ALIF in patients with and without rhBMP-2 use.
Retrospective analysis of prospectively gathered outcomes data on consecutive subjects having ALIF with and without rhBMP-2 use.
Male patients with lumbar spondylosis or spondylolisthesis having ALIF of the lowest one or two lumbar levels with and without rhBMP-2.
Report of RE as a new finding after ALIF.
From the comprehensive outcome database at a high-volume university practice, male subjects having ALIF for one- (L5/S1) or two-level (L4/L5, L5/S1) lumbar fusion were identified. Retrograde ejaculation events were recorded and comparative incidence compared.
The two groups were comparable for age and additional procedures performed. There were 69 L5/S1 ALIFs performed with rhBMP-2 and 174 ALIFs performed without rhBMP-2 during the study period. Of those, 24 and 64 were two-level ALIFs performed with and without rhBMP-2, respectively. There were five RE events (7.2%) reported in the rhBMP-2 group and 1 (0.6%) in the control group. Comparing single-level L5/S1 ALIF, there was a 6.7% and 0% rate of RE in the rhBMP-2 versus control groups, respectively. At 1 year after surgery, three of six affected subjects reported resolution of the RE.
This study confirms previous reports of a higher rate of RE in ALIF procedures using rhBMP-2. This may be an important consideration in subjects concerned with sterility after surgery.
商业上可获得的生长因子重组骨形态发生蛋白-2（rhBMP-2）用于脊柱融合已与许多不良反应相关，包括软组织炎症、异位骨形成、神经根炎、骨溶解和笼或移植物下沉。最初的食品和药物管理局（FDA）报告称，在前路腰椎椎间融合术（ALIF）中，rhBMP-2 组有 12 例逆行射精（RE）事件（8%），而对照组有 1.4%。有人争论说，这一发现是否与 rhBMP-2 的使用有关。
比较有和无 rhBMP-2 应用的 ALIF 后 RE 的发生率。
对前瞻性收集的连续接受 ALIF 治疗的患者进行回顾性分析，这些患者有无 rhBMP-2 应用。
患有腰椎管狭窄症或腰椎滑脱症的男性患者，接受最低一个或两个腰椎水平的 ALIF 治疗，有和无 rhBMP-2。
报告 ALIF 后新出现的 RE。
从高容量大学实践的综合结果数据库中，确定了进行单侧（L5/S1）或双侧（L4/L5、L5/S1）腰椎融合术的男性患者。记录逆行射精事件，并比较发生率。
两组在年龄和进行的其他手术方面具有可比性。在研究期间，共进行了 69 例 L5/S1 ALIF 联合 rhBMP-2 治疗和 174 例无 rhBMP-2 治疗。其中，24 例和 64 例为双侧 L4/L5、L5/S1 ALIF 联合和不联合 rhBMP-2 治疗。rhBMP-2 组有 5 例（7.2%）报告发生逆行射精，对照组有 1 例（0.6%）。比较单节段 L5/S1 ALIF，rhBMP-2 组和对照组的逆行射精发生率分别为 6.7%和 0%。术后 1 年，6 例受影响患者中有 3 例报告逆行射精缓解。
本研究证实了先前报告的 rhBMP-2 用于 ALIF 手术时逆行射精发生率较高的情况。对于术后关心无菌性的患者来说，这可能是一个重要的考虑因素。
