一项在III期试验中对接受孔道成形术治疗的腰椎间盘突出症患者进行十年预后的临床研究。

A clinical study of ten-year prognosis in patients with lumbar disc herniation treated with condoliase in a phase III trial.

作者信息

Matsuyama Yukihiro, Banno Tomohiro, Imabayashi Hideaki, Takatsu Tetsuro, Oha Fumihiro, Tsuji Takashi, Watanabe Tetsuya, Tatsumura Masaki, Sakaki Kyohei, Ogura Yoji, Suzuki Yoshihisa, Ohara Tetsuya, Komatsubara Tadashi, Hyakumachi Takahiko, Hoshino Masahiro, Sakuma Yoshio, Chino Kozo, Ando Kei, Yamada Kiyotaka, Watanabe Ippei, Sato Miwako, Shirogane Taiichi, Chiba Kazuhiro

机构信息

Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan.

出版信息

J Orthop Sci. 2025 Jul 14. doi: 10.1016/j.jos.2025.05.006.

DOI:10.1016/j.jos.2025.05.006

PMID:40664535

Abstract

BACKGROUND

Condoliase is a chemonucleolytic agent approved in Japan for the treatment of lumbar disc herniation (LDH). There had been no follow-up evaluation of its long-term effects on discs covering a period exceeding 10 years.

METHODS

The present study evaluated the 10-year post-dose outcomes of patients treated with condoliase during the phase III trial in terms of neurological results, Oswestry Disability Index (ODI), X-ray findings (disc height, posterior intervertebral angle, vertebral body translation), and magnetic resonance image findings (Modic classification, Pfirrmann grade).

RESULTS

Among the 82 patients treated with condoliase during the phase III trial, 37 (45.1 %) were available for the 10-year post-dose follow-up in the present study. At 10 years post-dose, low back pain and leg pain were observed in 15 (40.5 %) and 6 (16.2 %) of 37 patients, and the number of patients with positive straight leg raise test, hypesthesia, muscle weakness, and deep tendon hyporeflexia were 1 (2.7 %), 2 (5.4 %), 0 (0 %), and 8 (21.6 %), respectively; mean ODI was 8.6, with 32/37 (86.5 %) patients having ODI of 0 %-20 %; 8 (21.6 %) patients had disc height decreased by ≥ 30 %; 1 patient had posterior intervertebral angle of ≥5° and 1 had vertebral body translation of ≥3 mm. Although 5 patients (13.5 %) underwent lumbar surgery after receiving condoliase, no patient underwent surgery for spinal instability. In the Modic classification, the number of patients with "Type 0," "Type 1," and "Type 3" decreased, while those with "Type 2" increased compared to evaluations conducted at 1-year post-dose. For Pfirrmann grade, the number of patients with "Grade IV" decreased and those with "Grade V″ increased from 1 to 10 years post-dose.

CONCLUSIONS

No significant imaging findings necessitating surgery were observed, suggesting that chemonucleolysis with condoliase remains a safe and effective treatment option for LDH over the long term.

摘要

背景

软骨素酶是一种在日本被批准用于治疗腰椎间盘突出症（LDH）的化学核溶解剂。此前尚无对其超过10年的椎间盘长期影响的随访评估。

方法

本研究评估了在III期试验中接受软骨素酶治疗的患者在给药后10年的结果，包括神经学结果、奥斯维斯特里残疾指数（ODI）、X线检查结果（椎间盘高度、椎间后角、椎体移位）和磁共振成像结果（Modic分型、Pfirrmann分级）。

结果

在III期试验中接受软骨素酶治疗的82例患者中，37例（45.1%）可用于本研究的给药后10年随访。给药后10年，37例患者中有15例（40.5%）出现腰痛，6例（16.2%）出现腿痛，直腿抬高试验阳性、感觉减退、肌肉无力和跟腱反射减弱的患者分别为1例（2.7%）、2例（5.4%）、0例（0%）和8例（21.6%）；平均ODI为8.6，32/37例（86.5%）患者的ODI为0%-20%；8例（21.6%）患者的椎间盘高度降低≥30%；1例患者的椎间后角≥5°，1例患者的椎体移位≥3 mm。尽管5例患者（13.5%）在接受软骨素酶治疗后接受了腰椎手术，但没有患者因脊柱不稳而接受手术。在Modic分型中，与给药后1年的评估相比，“0型”“1型”和“3型”患者数量减少，而“2型”患者数量增加。对于Pfirrmann分级，从给药后1年到10年，“IV级”患者数量减少，“V级”患者数量增加。