1Departments of Orthopaedic Surgery (S.E., T.O., and H.H.) and Health Science for Clinical Medicine (Z.Y.), Graduate School of Medicine, University of Yamanashi, Chuo, Yamanashi, Japan 2Department of Orthopaedic Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan 3Departments of Orthopaedic Surgery (T.H. and Y.M.) and Community Health and Preventive Medicine (Y.S. and T.O.), Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan 4Medical Affairs Department, Pharmaceutical Business Administration Division, Asahi Kasei Pharma Corporation, Tokyo, Japan.
J Bone Joint Surg Am. 2017 Mar 1;99(5):365-372. doi: 10.2106/JBJS.16.00230.
For elderly patients, posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) is usually performed to treat lumbar degenerative diseases. However, some patients exhibit pseudarthrosis following such procedures. The anabolic agent teriparatide is an approved treatment for promoting bone formation in osteoporotic patients. Our multicenter, prospective randomized study assessed the role of once-weekly teriparatide administration on patient outcomes following interbody fusion.
Patients were females who were ≥50 years of age, had a bone mineral density (BMD) of <80% of the sex-matched young adult mean and/or previous spinal compression or femoral fractures, and had lumbar degenerative disease. Patients were randomly allocated to receive either weekly teriparatide, administered subcutaneously starting at week 1, for 6 months postoperatively (the teriparatide arm), or no teriparatide (the control arm). Blinded radiographic evaluations were performed using dynamic radiography and computed tomography (CT) and assessed by modified intention-to-treat analysis and per-protocol analysis. Clinical and neurological symptoms were evaluated using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOA-BPEQ) and the Oswestry Disability Index (ODI).
Seventy-five patients were randomized to treatment, and 66 patients completed treatment. At 4 months postoperatively, bone fusion in the 2 center CT slices was significantly higher in the teriparatide arm compared with the control arm in the age-adjusted modified intention-to-treat analysis and was significantly higher at 6 months in the per-protocol analysis. Radiographic examinations showed no disc-space narrowing and no intervertebral disc instability. JOA-BPEQ and ODI results were improved postoperatively in both treatment arms.
Weekly administration of teriparatide promoted bone formation at the surgical fusion site and decreased bone resorption, as indicated by bone metabolic marker results, within the early postoperative period. Our findings suggest that combining lumbar interbody fusion and teriparatide treatment may be an effective option for managing lumbar degenerative disease in elderly patients.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
对于老年患者，后路腰椎间融合术（PLIF）或经椎间孔腰椎间融合术（TLIF）通常用于治疗腰椎退行性疾病。然而，一些患者在这些手术后出现假关节。成骨药物特立帕肽是一种经批准的治疗骨质疏松症患者促进骨形成的药物。我们的多中心、前瞻性随机研究评估了每周一次特立帕肽给药对椎间融合术后患者结局的作用。
患者为年龄≥50 岁的女性，骨密度（BMD）低于同龄正常成人均值的 80%，或有既往脊柱压缩或股骨骨折史，且患有腰椎退行性疾病。患者被随机分配接受每周一次特立帕肽皮下注射治疗，术后 1 周开始，持续 6 个月（特立帕肽组）或不接受特立帕肽治疗（对照组）。使用动态 X 线和计算机断层扫描（CT）进行盲法放射学评估，并进行改良意向治疗分析和方案分析。使用日本矫形协会腰痛评估问卷（JOA-BPEQ）和 Oswestry 残疾指数（ODI）评估临床和神经症状。
75 例患者被随机分配至治疗组，66 例患者完成了治疗。术后 4 个月，改良意向治疗分析中年龄调整后，特立帕肽组的 2 个中心 CT 切片的骨融合率明显高于对照组，且方案分析中 6 个月时的融合率明显更高。放射学检查未显示椎间盘狭窄和椎间盘不稳定。在两个治疗组中，JOA-BPEQ 和 ODI 结果均在术后得到改善。
特立帕肽每周给药可促进术后早期手术融合部位的骨形成，并通过骨代谢标志物结果减少骨吸收。我们的研究结果表明，腰椎椎间融合术联合特立帕肽治疗可能是治疗老年腰椎退行性疾病的有效选择。
治疗性 I 级。欲了解完整的证据等级说明，请参见作者须知。
