腰椎融合术中应用重组人骨形态发生蛋白2辅助治疗腰椎退行性疾病

Application of recombinant human bone morphogenetic protein-2 as an adjuvant therapy for lumbar degenerative diseases in lumbar fusion

目的评价腰椎融合术中应用重组人骨形态发生蛋白2(rhBMP-2)辅助治疗腰椎退行性疾病(LDD)的可行性及安全性。方法回顾性分析2016年1月—2019年12月采用腰椎融合术治疗的LDD患者136例,其中57例术中采用rhBMP-2辅助治疗(试验组),79例术中未使用rhBMP-2辅助治疗(对照组)。采用疼痛视觉模拟量表(VAS)评分、Oswestry功能障碍指数(ODI)、并发症发生情况、影像学融合结果评估2组患者临床疗效。并进一步统计并发症发生率与rhBMP-2剂量的相关性。结果所有手术顺利完成,患者随访(4.68±1.70)年。术后1个月、末次随访时2组VAS评分和ODI较术前显著改善,差异均有统计学意义(P<0.05);末次随访时2组ODI较术后1个月进一步改善,对照组VAS评分较术后1个月进一步改善,差异均有统计学意义(P<0.05)。术后1个月2组VAS评分差异有统计学意义(P<0.05),其余各时间点2组VAS评分和ODI差异无统计学意义(P>0.05)。试验组并发症发生率为12.3%,对照组为13.9%,2组并发症发生率差异无统计学意义(P>0.05);rhBMP-2剂量增加与并发症发生率无显著相关性。183个椎间隙术后Lenke分级,试验组优于对照组,差异有统计学意义(P<0.05)。结论腰椎融合术中应用rhBMP-2辅助治疗LDD可改善融合情况,使用时须充分评估适应证、谨慎选择剂量以降低相关并发症的发生风险。

Objective To evaluate the feasibility and safety of using recombinant human bone morphogenetic protein-2(rhBMP-2)as an adjuvant therapy for lumbar degenerative disease(LDD)in lumbar fusion surgery.Methods From January 2016 to December 2019,136 patients with LDD were treated with lumbar fusion.Among them,57 patients received rhBMP-2 adjuvant therapy during surgery(experiment group),and 79 did not receive rhBMP-2 adjuvant therapy during surgery(control group).The visual analogue scale(VAS)score,Oswestry disability index(ODI),incidence of complications,and imaging fusion results were used to evaluate the clinical efficacy of the 2 groups.The correlation between complication rate and rhBMP-2 dose was further analyzed.Results All the operations were completed successfully,and the patients were followed up for(4.68±1.70)years.The VAS score and ODI of the 2 groups were improved significantly at postoperative 1 month and at the final follow-up compared to pre-operation,with a statistical significance(P<0.05).The ODI of the 2 groups was further improved at the final follow-up compared to postoperative 1 month,while the VAS score of the control group was further improved at the final follow-up compared to postoperative 1 month,all with a statistical significance(P<0.05).There was a statistically significant difference in VAS score between the 2 groups at postoperative 1 month(P<0.05),while there was no statistically significant difference in VAS score and ODI between the 2 groups at other time points(P>0.05).The incidence of complications was 12.3%in the experiment group and 13.9%in the control group,and there was no significant difference between the 2 groups(P>0.05).There was no significant correlation between the increased dose of rhBMP-2 and the complication rate.The Lenke grading of 183 intervertebral spaces after surgery was better in the experiment group than in the control group,with a statistically significant difference(P<0.05).Conclusion The application of rhBMP-2 as an adjuvant therapy for LDD during lumbar fusion can improve the fusion situation,but it is necessary to fully evaluate the indications and carefully choose the dosage to reduce the risk of related complications.