Collagenase Chemonucleolysis for Treating Cervical Disc Herniation: An Exploratory, Single-Arm, Open-Label, Multicenter Clinical Trial.

IF 4.1 2区医学 Q1 CLINICAL NEUROLOGY

Pain and Therapy Pub Date : 2024-11-08 DOI:10.1007/s40122-024-00678-3

Zhijian Wang, Bifa Fan, Lili Gu, Xuexue Zhang, Tao Sun, Hui Liu, Rongchun Li, Likui Wang, Kaiqiang Wang, Shun Li, Yong Ma, Haibo You, Daying Zhang

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引用次数: 0

Abstract

Introduction: Cervical disc herniation (CDH) is the most common cause of cervical radiculopathy and causes persistent neck pain and neurological deficits. Collagenase chemonucleolysis has been successfully applied to treat lumbar disc herniation, which has a similar pathological mechanism to CDH. However, its application for CDH remains under-researched, and there is an even greater lack of high-quality clinical evidence. This study aims to evaluate the efficacy and safety of collagenase chemonucleolysis for treating CDH.

Methods: Eligible patients with CDH underwent collagenase chemonucleolysis via anterior cervical intradiscal injection or epidural injection. The primary efficacy endpoint showed an excellent and good rate regarding the Odom criteria, which was not lower than the reference value (≥ 78%) at 6 months postoperatively. The secondary efficacy endpoints were the percentage reduction in Numeric Rating Scale (NRS) and Neck Disability Index (NDI) scores from baseline, which were not lower than the reference values (≥ 40%, ≥ 30%), and improvement in the 36-Item Short Form Health Survey (SF-36) score compared to the preoperative value. The pre- and postoperative CDH index of patients were also compared. Safety endpoints included the incidence of adverse events (AEs) and serious adverse events (SAEs).

Results: An excellent and good rate regarding the Odom criteria 6 months postoperatively was 90.5% (133/147), which was significantly higher than 78% (P < 0.004, 95% confidence interval 85.7-95.2%). The reduction in NRS and NDI scores exceeded 40% (P < 0.001) and 30% (P < 0.001), respectively. The SF-36 scores at 3 months and 6 months postoperatively were significantly higher than those preoperatively (P < 0.001). A significant difference was observed in the pre- and postoperative CDH index (109.6 ± 119.1 vs. 70.8 ± 74.8, P < 0.001). The incidence of AEs was 22.5% (33/147), of which 97.8% were grade 1-2. No collagenase-related AEs and SAEs occurred.

Conclusion: Collagenase chemonucleolysis treatment for CDH exhibited favorable efficacy and safety and may be a better choice for patients in whom conservative treatment is ineffective.

Trial registration: The trial was registered on www.Chictr.org.cn (ChiCTR2200063043).

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胶原酶螯合剂治疗颈椎间盘突出症：一项探索性、单臂、开放标签、多中心临床试验。

简介颈椎间盘突出症（CDH）是颈椎病最常见的病因，会导致持续性颈部疼痛和神经功能障碍。胶原酶螯合作用已成功用于治疗腰椎间盘突出症，其病理机制与 CDH 相似。然而，将其应用于 CDH 的研究仍然不足，更缺乏高质量的临床证据。本研究旨在评估胶原酶螯合剂治疗CDH的有效性和安全性：符合条件的 CDH 患者通过颈椎前路椎间盘内注射或硬膜外注射接受胶原酶髓核溶解术。主要疗效终点显示，根据奥多姆标准，术后6个月的优和良率不低于参考值（≥ 78%）。次要疗效终点为数值评定量表（NRS）和颈部残疾指数（NDI）评分较基线降低的百分比，均不低于参考值（≥ 40%，≥ 30%），以及 36 项简表健康调查（SF-36）评分较术前有所改善。此外，还比较了患者术前和术后的 CDH 指数。安全性终点包括不良事件（AE）和严重不良事件（SAE）的发生率：结果：根据奥多姆标准，术后 6 个月的优秀和良好率为 90.5%（133/147），明显高于 78%（P 结论：术后 6 个月的优秀和良好率为 90.5%（133/147）：胶原酶螯合剂治疗CDH具有良好的疗效和安全性，可能是保守治疗无效患者的更好选择：该试验已在 www.Chictr.org.cn（ChiCTR2200063043）上注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pain and Therapy CLINICAL NEUROLOGY-

CiteScore

6.60

自引率

5.00%

发文量

110

审稿时长

6 weeks

期刊介绍： Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.