Kobayashi Kazuyoshi, Sato Koji, Morita Yoshinori
Department of Orthopaedic Surgery, Japan Red Cross Aichi Medical Center Nagoya Daini Hospital, Myokencho 2-9, Syowa-Ku, Nagoya, Aichi, 466-8650, Japan.
J Orthop Surg Res. 2024 Dec 30;19(1):890. doi: 10.1186/s13018-024-05405-4.
Low back pain is often caused by lumbar disc herniation (LDH). Treatment of LDH is possible using chemonucleolysis of the nucleus pulposus with condoliase injection. However, onset of the therapeutic effect varies among patients, with improvement from an early stage to 3 months post-injection. This study was performed to identify the characteristics of early responders to condoliase therapy.
A retrospective cohort study was performed in 371 consecutive patients (259 males, 112 females; age, 49.9 ± 18.7 years; follow-up period, 13.1 ± 7.4 months) treated with condoliase injection for LDH between August 2018 and January 2024. Chemonucleolysis was performed with 1 mL of condoliase (1.25 U/mL) injected into the intervertebral nucleus pulposus. Clinical assessments were made before injection and 1 day, and 1, 4 and 12 weeks post-injection. Pain was measured on a visual analogue scale. Herniation parameters were evaluated on axial MRI. The herniated disc volume was measured on plain lumbar radiography. Demographic and clinical data were taken from medical charts. Multivariate logistic regression analysis was used to identify factors with independent relationships with treatment efficacy.
Improvement of leg pain from baseline by ≥ 50% occurred in 21% of cases within one day after condoliase treatment. Patients with this improvement at 1 week post-injection were defined as early responders (n = 142, 38.3%). In multivariate analysis, age < 40 years (p = 0.022, odds ratio (OR): 1.71, 95% confidence interval (CI): 1.12-4.35), Pfirrmann Grade II or III at baseline (p = 0.032, OR: 1.86, 95% CI: 1.17-5.41), and a high intensity MRI signal in the herniation (p = 0.041, OR: 1.87, 95% CI: 1.06-5.27) were significantly associated with early improvement. No patients had anaphylactic shock or neurologic sequelae.
This study confirms the safety and efficacy of chemonucleolysis with condoliase for treating patients with painful LDH. Age, high-intensity MRI signals, and baseline Pfirrmann grade were significant factors associated with early improvement.
腰痛通常由腰椎间盘突出症（LDH）引起。使用木瓜凝乳蛋白酶注射进行髓核化学溶解术可用于治疗LDH。然而，治疗效果的出现因患者而异，从早期到注射后3个月会有所改善。本研究旨在确定对木瓜凝乳蛋白酶治疗早期有反应者的特征。
对2018年8月至2024年1月期间连续371例接受木瓜凝乳蛋白酶注射治疗LDH的患者（259例男性，112例女性；年龄49.9±18.7岁；随访期13.1±7.4个月）进行回顾性队列研究。将1mL木瓜凝乳蛋白酶（1.25U/mL）注入椎间髓核进行化学溶解术。在注射前、注射后1天、1周、4周和12周进行临床评估。使用视觉模拟量表测量疼痛程度。在轴向MRI上评估突出参数。在腰椎平片上测量突出椎间盘体积。人口统计学和临床数据来自病历。采用多因素logistic回归分析确定与治疗效果具有独立关系的因素。
木瓜凝乳蛋白酶治疗后1天内，21%的病例腿痛较基线改善≥50%。注射后1周出现这种改善的患者被定义为早期有反应者（n=142，38.3%）。在多因素分析中，年龄<40岁（p=0.022，比值比（OR）：1.71，95%置信区间（CI）：1.12-4.35）、基线时Pfirrmann分级为II级或III级（p=0.032，OR：1.86，95%CI：1.17-5.41）以及突出部位MRI信号强度高（p=0.041，OR：1.87，95%CI：1.06-5.27）与早期改善显著相关。无患者发生过敏性休克或神经后遗症。
本研究证实了木瓜凝乳蛋白酶化学溶解术治疗疼痛性LDH患者的安全性和有效性。年龄、MRI高信号强度和基线Pfirrmann分级是与早期改善相关的重要因素。
