生物补充疗法可改善腰椎减压手术后的临床疗效。

Orthobiologic Supplementation Improves Clinical Outcomes Following Lumbar Decompression Surgery.

作者信息

Kamson Solomon, Smith DuPreez

机构信息

Spine Institute Northwest, Bothell, WA, USA.

Royal College of Surgeons, Dublin, Ireland.

出版信息

J Clin Med Res. 2020 Feb;12(2):64-72. doi: 10.14740/jocmr3972. Epub 2020 Feb 1.

DOI:10.14740/jocmr3972

PMID:32095175

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7011941/

Abstract

BACKGROUND

Endoscopic-assisted lumbar decompression is a minimally invasive spine surgery which has been touted to reduce collateral tissue damage, incisional pain, recovery time and complications. Residual back or leg pain and recurrent herniation are commonly reported post-operative outcomes. It has been suggested that injecting orthobiologics like cryopreserved amniotic-derived products (ADPs) and bone marrow aspiration (BMA) into the surgery site would have additional benefit on patient outcomes. This is a Western Institutional Review Board (WIRB)-approved level 1, randomized controlled trial of prospectively collected patient demographic and outcomes data for endoscopic-assisted lumbar decompression surgery. The primary goal of this study was to compare patient outcomes of orthobiologic supplementation during endoscopic-assisted lumbar decompression surgery.

METHODS

Following WIRB approval, 269 patients underwent lumbar endoscopic-assisted decompressive surgery between January 2011 and October 2017. Patients were randomized to receive ADP, BMA, both, or no supplementation (control group). Outcomes were measured by post-operative questionnaires (visual analog scale (VAS), Oswestry disability index (ODI), 36-item short-form health survey (SF-36)) over 12 months.

RESULTS

Mean VAS-leg for either BMA or ADP group displayed statistically significant improvements at 2 weeks (3.55 vs. 4.77, P = 0.002), 6 months (2.34 vs. 3.37, P = 0.026), and 9 months (2.18 vs. 3.57, P = 0.01) compared to no supplementation group (control group). Similarly, improvements in mean VAS-back were significant at 2 weeks (3.98 vs. 5.01, P = 0.011), 2 months (3.22 vs. 3.93, P = 0.04), 9 months (2.38 vs. 4.11, P = 0.004), and 12 months (2.23 vs. 3.58, P = 0.011) compared to no supplementation group (control group). There were statistically significant differences in the ODI (2 weeks, 42.19 vs. 31.11, P = 0.014) and SF-36 (4 months, 85 vs. 63, P = 0.043 for ADP only), but these differences did not subsist over time. Two patients (one control, one ADP) re-herniated at the same level.

CONCLUSIONS

Orthobiologic BMA and ADP resulted in improved pain control during early post-operative periods.

摘要

背景

内镜辅助下腰椎减压术是一种微创脊柱手术，据称可减少附带组织损伤、切口疼痛、恢复时间和并发症。残留的背部或腿部疼痛以及复发性疝是常见的术后结果。有人提出，将诸如冷冻保存的羊膜衍生产品（ADP）和骨髓抽吸物（BMA）等骨科生物制剂注入手术部位对患者预后可能有额外益处。这是一项经西方机构审查委员会（WIRB）批准的1级前瞻性随机对照试验，收集了内镜辅助下腰椎减压手术患者的人口统计学和预后数据。本研究的主要目的是比较内镜辅助下腰椎减压手术中补充骨科生物制剂后的患者预后。

方法

经WIRB批准，269例患者在2011年1月至2017年10月期间接受了腰椎内镜辅助减压手术。患者被随机分为接受ADP、BMA、两者都接受或不补充（对照组）。通过术后12个月的问卷调查（视觉模拟量表（VAS）、Oswestry功能障碍指数（ODI）、36项简短健康调查问卷（SF-36））来测量结果。

结果

与不补充组（对照组）相比，BMA组或ADP组的平均腿部VAS在术后2周（3.55对4.77，P = 0.002）、6个月（2.34对3.37，P = 0.026）和9个月（2.18对3.57，P = 0.01）时显示出统计学上的显著改善。同样，与不补充组（对照组）相比，平均背部VAS在术后2周（3.98对5.01，P = 0.011）、2个月（3.22对3.93，P = 0.04）、9个月（2.38对4.11，P = 0.004）和12个月（2.23对3.58，P = 0.011）时也有显著改善。ODI（2周时，42.19对31.11，P = 0.014）和SF-36（4个月时，仅ADP组为85对63，P = 0.043）存在统计学上的显著差异，但这些差异并未随时间持续存在。两名患者（一名对照组，一名ADP组）在同一节段复发疝。