椎间盘内注射康多酶治疗伴有严重腰痛的腰椎间盘突出症的临床和经济结果：一项多中心研究。
Clinical and Economic Outcomes of Intradiscal Injection of Condoliase for a Treatment of Lumbar Disc Herniation with Severe Low Back Pain: A Multicenter Study.
作者信息
Hirai Takashi, Takahashi Takuya, Takahashi Yohei, Watanabe Kota, Banno Tomohiro, Sakaki Kyohei, Arai Yoshiyasu, Takano Yuichi, Eguchi Yawara, Taniguchi Yuki, Maki Satoshi, Aoki Yasuchika, Fujii Shunichi, Sakaeda Kentaro, Matsukura Yu, Akazawa Tsutomu, Minamide Akihito, Nojiri Hidetoshi, Sakai Kenichiro, Kato Satoshi, Tamai Koji, Suzuki Hidekazu, Miyagi Masayuki, Sato Hiroyuki, Yoshii Toshitaka, Yamada Hiroshi, Kaito Takashi, Hiraizumi Yutaka, Yamagata Masatsune, Nakamura Masaya, Hirakawa Akihiro, Hosogane Naofumi, Ohtori Seiji
机构信息
Department of Orthopedics, Institute of Science Tokyo, Tokyo, Japan.
Department of Orthopedic Surgery, Keio University, Tokyo, Japan.
出版信息
Spine Surg Relat Res. 2024 Dec 20;9(3):368-374. doi: 10.22603/ssrr.2024-0288. eCollection 2025 May 27.
INTRODUCTION
Chemonucleolysis with condoliase (chondroitin sulfate ABC endolyase) has been widely employed to treat patients with lumbar disc herniation (LDH) in Japan. Although it is an effective and relatively safe treatment for radicular neuropathy in patients with LDH, there have been no reports that investigate how severe low back pain (LBP) changes after condoliase injection. In this multicenter study, the effectiveness of condoliase injection for reducing severe LBP in patients with LDH was evaluated.
METHODS
This retrospective study involved patients treated with intradiscal condoliase injection for LDH at nine participating centers. Patients were diagnosed with subligamentous-type herniation based on pretreatment MRI. Patients with severe LBP (defined as a preinjection numeric rating scale [NRS] for LBP greater than or equal to that for leg pain) were categorized into the LBP group. Demographic data, adverse events, treatment costs, and the NRS for LBP and lower extremity pain were analyzed. A 50% response was defined as ≥50% improvement in the NRS at 1 year postinjection. On the basis of the Pfirman classification, the LBP group was divided into less-degenerative (Grades II and III) and degenerative (Grades IV and V) subgroups.
RESULTS
Seventy-nine patients were classified into the LBP group. Of these patients, 61 (77.2%) showed a >50% reduction in LBP, and another 61 (77.2%) demonstrated a >50% reduction in lower extremity pain. Improvement of lower limb pain was considerably better in the less-degenerative group than in the degenerative group, whereas that of low back pain was similar between the two subgroups. Medical costs, which include remuneration for injection, drug fees, inpatient costs, and other expenses, were similar between the LBP group and all cases.
CONCLUSIONS
This retrospective multicenter study revealed that patients with LDH with severe LBP frequently experienced improvement in radicular pain and LBP, which is similar to LDH cases without severe LBP.
引言
在日本，使用软骨素酶（硫酸软骨素ABC内切酶）进行化学髓核溶解术已被广泛用于治疗腰椎间盘突出症（LDH）患者。尽管它是治疗LDH患者神经根性神经病变的一种有效且相对安全的方法，但尚无报告研究软骨素酶注射后严重腰痛（LBP）如何变化。在这项多中心研究中，评估了软骨素酶注射对减轻LDH患者严重LBP的有效性。
方法
这项回顾性研究纳入了在9个参与中心接受椎间盘内注射软骨素酶治疗LDH的患者。根据治疗前的MRI诊断为韧带下型突出的患者。严重LBP患者（定义为注射前LBP的数字评分量表[NRS]大于或等于腿痛的NRS）被归入LBP组。分析了人口统计学数据、不良事件、治疗费用以及LBP和下肢疼痛的NRS。50%的反应定义为注射后1年NRS改善≥50%。根据Pfirman分类，LBP组分为退变较轻（II级和III级）和退变较重（IV级和V级）亚组。
结果
79例患者被归入LBP组。在这些患者中，61例（77.2%）LBP减轻>50%，另外61例（77.2%）下肢疼痛减轻>50%。退变较轻组下肢疼痛的改善明显优于退变较重组，而两个亚组之间腰痛的改善相似。LBP组和所有病例的医疗费用相似，包括注射报酬、药费、住院费用和其他费用。
结论
这项回顾性多中心研究表明，患有严重LBP的LDH患者的神经根性疼痛和LBP经常得到改善，这与没有严重LBP的LDH病例相似。
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