Multicenter Retrospective Analysis of Intradiscal Condoliase Injection Therapy for Lumbar Disc Herniation

Oshita, Yusuke; Matsuyama, Daisuke; Sakai, Daisuke; Schol, Jordy; Shirasawa, Eiki; Emori, Haruka; Segami, Kazuyuki; Takahashi, Shu; Yagura, Kazumichi; Miyagi, Masayuki; Saito, Wataru; Imura, Takayuki; Nakazawa, Takahiro; Inoue, Gen; Hiyama, Akihiko; Katoh, Hiroyuki; Akazawa, Tsutomu; Kanzaki, Koji; Sato, Masato; Takaso, Masashi; Watanabe, Masahiko

doi:10.3390/medicina58091284

Cited by 10 publications

(25 citation statements)

References 30 publications

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“…We initially retrieved 202 ( Figure 1 ) and deleted 96 duplicate articles. A total of 10 articles were included in this study through screening ( Chiba et al, 2018 ; Matsuyama et al, 2018 ; Ishibashi et al, 2020 ; Nakajima et al, 2020 ; Hirai et al, 2021 ; Inoue et al, 2021 ; Okada et al, 2021 ; Banno et al, 2022 ; Kobayashi et al, 2022 ; Oshita et al, 2022 ).…”

Section: Resultsmentioning

confidence: 99%

“…The included studies included two RCT ( Chiba et al, 2018 ; Matsuyama et al, 2018 ), two prospective ( Inoue et al, 2021 ; Banno et al, 2022 ), and six retrospective studies ( Ishibashi et al, 2020 ; Nakajima et al, 2020 ; Hirai et al, 2021 ; Okada et al, 2021 ; Kobayashi et al, 2022 ; Oshita et al, 2022 ). A placebo was used as a control group in both RCT studies.…”

Section: Resultsmentioning

confidence: 99%

“…Therefore, condoliase can specifically degrade proteoglycan-rich NP tissues, whereas the surrounding tissue remains largely unaffected ( Ishibashi et al, 2019 ). The drug regulatory authority in Japan approved condoliase for the treatment of LDH in 2018, and multiple clinical trials have shown its safety and efficacy ( Chiba et al, 2018 ; Matsuyama et al, 2018 ; Nakajima et al, 2020 ; Hirai et al, 2021 ; Inoue et al, 2021 ; Okada et al, 2021 ; Banno et al, 2022 ; Kobayashi et al, 2022 ; Oshita et al, 2022 ). Intradiscal injection of condoliase may help patients to return to society sooner.…”

Section: Introductionmentioning

confidence: 99%

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The efficacy and safety of condoliase for lumbar disc herniation: a systematic review and meta-analysis

Huang,

Xu,

Liu

et al. 2023

Front. Pharmacol.

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Background: Chemonucleolysis is a minimally invasive treatment of lumbar disc herniation (LDH). However, the low specificity of the enzyme and the existence of serious adverse events limit the application of chemonucleolysis. Clinical studies in recent years have shown that Chondroitin sulfate ABC endolyase (condoliase) is a potential therapeutic enzyme for LDH. Aim. A meta-analysis was conducted to determine the efficacy and safety of condoliase in LDH treatment.Methods: We searched Web of Science, Embase, PubMed, and Cochrane Library databases. Two reviewers independently screened articles, extracted data, and assessed the risk of bias. The outcomes were the total effective rate, Oswestry Disability Index (ODI) score change, the proportion of lumbar surgery after condoliase treatment, herniated mass volume change, Pfirrmann grade change, and adverse events. Review Manager 5.3 and Stata 12.0 were used for meta-, sensitivity, and bias analysis.Results: Ten studies were included. A single-arm meta-analysis showed that the total effective rate was 78% [95% confidence interval (CI) 75%–81%], the proportion of surgery was 9% (95% CI 7%–12%), the proportion of Pfirrmann grade change was 43% (95%CI 38%–47%), and the adverse events were 4% (95% CI 2%–6%) after condoliase treatment. The two-arm meta-analysis showed that the ODI score change [standardized mean difference (SMD) −2.46, 95% CI −3.30 to −1.63] and the herniated mass volume change (SMD −16.97, 95% CI −23.92 to −10.03) of the condoliase treatment group were greater than those of the placebo control group, and there was no difference in adverse events between the two groups (OR 1.52, 95% CI 0.60–3.85). The results of sensitivity and publication bias analyses showed that the results were robust.Conclusion: Condoliase intradiscal injection has excellent eutherapeutic and safety for LDH, thus, has considerable potential as a treatment option besides conservative treatment and surgical intervention for LDH.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022375492, PROSPERO (CRD42022375492).

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The efficacy and safety of condoliase for lumbar disc herniation: a systematic review and meta-analysis

Huang,

Xu,

Liu

et al. 2023

Front. Pharmacol.

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“…30 While it has been reported that higher rates of improvement for lower Pfirrmann classifications, 30 , 31 Oshita et al reported that condoliase appeared more effective for patients with Pfirrmann grade IV compared to grade III patients. 32 , 33 , 34 Regardless of the therapeutic effect of condoliase, we selected patients with Pfirrmann grade III, apart from one of the 12 patients in this study. However, we did not evaluate the action of condoliase on the nucleus pulposus clinically, for example, measurement of the hernia size before and after condoliase administration.…”

Section: Discussionmentioning

confidence: 99%

Histological analysis of nucleus pulposus tissue from patients with lumbar disc herniation after condoliase administration

Minamisawa,

Shirogane,

Watanabe

et al. 2024

JOR Spine

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BackgroundCondoliase is an enzyme used as a treatment for lumbar disc herniation (LDH). This enzyme degrades chondroitin sulfate (CS) in the nucleus pulposus of the intervertebral disc (IVD). However, there are cases in which symptoms do not improve, despite condoliase administration. This study reports histological analysis of lumbar disc tissue of LDH patients who underwent surgery because condoliase had no therapeutic effect.MethodsBetween March 2019 and August 2019, 12 LDH patients who underwent full endoscopic spine surgery (FESS) discectomy at the Dezawa Akira PED Clinic were the subjects of the study. There are two study groups: six cases underwent FESS after condoliase administration, while six underwent FESS without condoliase administration. The average duration from drug administration to surgery was 152 days. Herniated disc removed at surgery was evaluated by histological staining including immunohistochemistry by anti‐CS antibodies.ResultsMultiple large clusters (40–120 μm in diameter) were observed in the nucleus pulposus of those who received condoliase, but no clusters were observed in those who did not. The lumbar disc tissues, including the nucleus pulposus of recipients, were stained with anti‐CS antibodies that recognize the CS unsaturated disaccharide, but non‐administration tissue was not stained. These findings suggest that the enzyme acted on the nucleus pulposus, even in cases where symptoms were not improved by condoliase administration. Furthermore, there was no histological difference between stained images of the extracellular matrix in those who did or did not receive condoliase, suggesting that condoliase acted specifically on CS in the nucleus pulposus.ConclusionsWe demonstrated that CS in the nucleus pulposus was degraded in patients in whom condoliase did not have a therapeutic effect. Moreover, condoliase acts in human IVD without causing necrosis of chondrocytes and surrounding tissues.

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“…Previous studies were retrieved from three major academic databases (PubMed, Scopus, and Web of Science) using the appropriate search term combinations, including “condoliase” OR “chondroitinase ABC” OR “chondroitin sulfate ABC endolyase” AND “lumbar disc herniation.” Basic research and review articles were excluded. Ultimately, 19 articles were selected, including three randomized controlled trials [ 9 , 10 , 17 ], 14 case series [ 12 , 13 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 ], and two case reports [ 11 , 30 ] ( Figure 2 ). Patient demographics were examined, including age, sex, LDH level, Pfirrmann grade, efficacy rate, and post-treatment surgical rate in patients with LDH treated with 1.25 units of condoliase.…”

Section: Methodsmentioning

confidence: 99%

Intradiscal Condoliase Injection Therapy for Recurrent Lumbar Disc Herniation: Case Series and Literature Review

Fukui,

Kamei,

Fujiwara

et al. 2023

Medicina

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Background and objectives: Although chemonucleolysis with condoliase for lumbar disc herniation (LDH) has become common, few reports have described its application in the treatment of recurrent LDH. Therefore, this study aimed to evaluate the safety and efficacy of condoliase treatment in six patients with recurrent LDH and review the available literature on condoliase treatment for LDH. Materials and Methods: Six patients (four men and two women; mean age, 64.7 years) with recurrent LDH who were treated with condoliase at our hospital between 2019 and 2022 were included. The clinical records and images of the patients were retrospectively evaluated. In addition, the available English literature on condoliase treatment for LDH was retrieved and reviewed. Results: Among the six patients included in the study, three showed >50% improvement in leg pain after treatment, which is a lower efficacy rate than that in previous reports. In addition, two patients required surgery after treatment, which is a higher rate than that in previous reports. The mean intervertebral disc height significantly decreased from 8.4 mm before treatment to 6.9 mm after treatment, consistent with the results of previous studies. None of the cases showed Modic type I changes on magnetic resonance imaging. Conclusions: Although the efficacy of condoliase treatment for recurrent LDH may be lower than that for primary LDH, this treatment was found to be safe and applicable for recurrent LDH.

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Multicenter Retrospective Analysis of Intradiscal Condoliase Injection Therapy for Lumbar Disc Herniation

Cited by 10 publications

References 30 publications

The efficacy and safety of condoliase for lumbar disc herniation: a systematic review and meta-analysis

The efficacy and safety of condoliase for lumbar disc herniation: a systematic review and meta-analysis

Histological analysis of nucleus pulposus tissue from patients with lumbar disc herniation after condoliase administration

Intradiscal Condoliase Injection Therapy for Recurrent Lumbar Disc Herniation: Case Series and Literature Review

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