OBJECTIVE: To assess the available evidence related to dose-dependent effectiveness (i.e., bone fusion) and morbidity of osteobiologics used in anterior cervical discectomy and fusion (ACDF).
METHODS: Studies with more than 9 adult patients with degenerated/herniated cervical discs operated for one-to four-levels ACDF reporting used osteobiologics doses, fusion rates at six months or later, and related comorbidities were included. PubMed, EMBASE, ClinicalTrials, and Cochrane were searched through September 2021. Data extracted in spread sheet and risk of bias assessed using MINORS and Rob-2.
RESULTS: Sixteen studies were selected and sub-grouped into BMP and non-BMP osteobiologics. For the 10 BMP studies, doses varied from 0.26 to 2.1 mg in 649 patients with fusion rates of 95.3 to 100% at 12 months. For other osteobiologics, each of six studies reported one type of osteobiologic in certain dose/concentration/volume in a total of 580 patients with fusion rates of 6.8 to 96.9% at 12 months. Risk of bias was low in three of the 13 non-randomized (18.75%) and in all the three randomized studies (100%).
CONCLUSIONS: Taking into account the inconsistent reporting within available literature, for BMP usage in ACDF, doses lower than 0.7 mg per level can achieve equal successful fusion rates as higher doses, and there is no complication-free dose proved yet. It seems that the lower the dose the lower the incidence of serious complications. As for non-BMP osteobiologics the studies are very limited for each osteobiologic and thus conclusions must be drawn individually and with caution.
目的:评估与剂量依赖性有效性相关的现有证据(即,骨融合)和颈椎前路椎间盘切除术和融合术(ACDF)中使用的骨生物学的发病率。
方法:对9名以上接受一至四级ACDF手术的颈椎间盘退变/突出的成年患者的研究报告使用了骨生物学剂量,六个月或更晚的融合率,并包括相关的合并症。PubMed,EMBASE,临床试验,和Cochrane在2021年9月被搜索。使用MINORS和Rob-2评估传播表中提取的数据和偏倚风险。
结果:选择了16项研究,并将其分为BMP和非BMP骨生物制剂。对于10项BMP研究,649例患者的剂量为0.26~2.1mg,12个月时融合率为95.3~100%.对于其他骨生物制剂,6项研究中的每一项均报道了总共580例患者在一定剂量/浓度/体积下的一种骨生物学类型,12个月时的融合率为6.8~96.9%.在13项非随机研究(18.75%)和所有3项随机研究(100%)中,偏倚风险较低。
结论:考虑到现有文献中的不一致报告,对于ACDF中的BMP用法,每个水平低于0.7mg的剂量可以达到与高剂量相同的成功融合率,目前还没有发现无并发症的剂量。似乎剂量越低,严重并发症的发生率越低。至于非BMP骨生物学,每个骨生物学的研究都非常有限,因此必须单独和谨慎地得出结论。