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  • 国家药监局综合司 国家卫生健康委办公厅

胶原酶靶点联合硬膜外注射与低温等离子髓核消融术治疗HIZ阳性盘源性腰痛的疗效比较

通讯作者: 王炎, ch2004640029@fy.ahmu.edu.cn
DOI:10.12201/bmr.202610.00068
声明:预印本系统所发表的论文仅用于最新科研成果的交流与共享,未经同行评议,因此不建议直接应用于指导临床实践。

Comparison of intradiscal targeted plus epidural collagenase injection versus coblation nucleoplasty for HIZ-positive discogenic low back pain

Corresponding author: wangyan, ch2004640029@fy.ahmu.edu.cn
  • 摘要:目的:比较CT引导下胶原酶盘内靶点联合硬膜外注射与低温等离子髓核消融术治疗腰椎MRI高信号区(high-intensity zone,HIZ)阳性盘源性腰痛(discogenic low back pain,DLBP)的6个月临床结局。方法: 采用前瞻性随机对照研究设计,将64例符合纳入标准的HIZ阳性盘源性腰痛患者随机分为两组。胶原酶靶点注射组(CO组,n=32)接受CT引导下盘内HIZ靶点(200 IU)联合同侧硬膜外(1000 IU)胶原酶注射;对照组(CN组,n=32)接受CT引导下低温等离子髓核消融术。分别于术前、术后3天、术后1个月、术后3个月、术后6个月随访时采用视觉模拟评分法(Visual Analogue Scale,VAS)记录患者腰腿痛情况、Oswestry功能障碍指数评分 (Oswestry Disability Index,ODI) 评估腰椎功能改善情况和改良 MacNab 标准评价患者的手术疗效。结果: 两组患者基线资料具有可比性。术后各时间点,两组VAS与ODI评分均较术前显著改善(P<0.05),且术后各个时间点两组间无统计学差异(P>0.05)。术后6个月,两组改良MacNab优良率均为87.5%(CN组:优21例、良7例、可4例;CO组:优22例、良6例、可4例),组间优良率差异无统计学意义(χ²=0.000,P=1.000);进一步采用Mann-Whitney U检验分析两组疗效等级整体分布,差异亦无统计学意义(U=496.0,Z=-0.316,P=0.752)。CO组在手术时间及住院费用方面均显著低于CN组(P<0.05)。结论:在本研究6个月随访范围内,两组患者的疼痛和功能评分均较术前改善,组间未检出统计学差异;胶原酶组手术时间和住院费用较低。本研究为探索性比较,不能据此认定两种术式等效或非劣效,远期疗效与安全性仍需验证。关键词: 盘源性腰痛;高信号区;胶原酶化学溶解术;靶点注射

    关键词: 盘源性腰痛;高信号区;胶原酶化学溶解术;靶点注射;; ; ; 

     

    Abstract: AbstractObjective: To compare 6-month clinical outcomes of CT-guided intradiscal targeted plus epidural collagenase injection with coblation nucleoplasty in patients with MRI high-intensity zone (HIZ)-positive discogenic low back pain.Methods: A prospective randomized controlled trial was conducted. Sixty-four patients with HIZ-positive discogenic low back pain who met the inclusion criteria were randomly assigned to two groups. The collagenase group (CO group, n = 32) received CT-guided intradiscal HIZ-targeted collagenase injection (200 IU) combined with ipsilateral epidural collagenase injection (1000 IU). The control group (CN group, n = 32) underwent CT-guided percutaneous coblation nucleoplasty. Visual Analogue Scale (VAS) scores for low back and leg pain, Oswestry Disability Index (ODI), and modified MacNab criteria were assessed preoperatively and at 3 days, 1 month, 3 months, and 6 months postoperatively.Results: Baseline characteristics were comparable between the two groups. At all postoperative time points, VAS and ODI scores improved significantly compared with preoperative values in both groups (P < 0.05), with no statistically significant intergroup differences at any time point (P > 0.05). At the 6-month follow-up, the excellent-and-good rate according to the modified MacNab criteria was 87.5% in both groups (CN group: excellent in 21, good in 7, fair in 4; CO group: excellent in 22, good in 6, fair in 4), and no significant difference was found in the excellent-and-good rate between the groups (χ² = 0.000, P = 1.000). Further analysis using the Mann–Whitney U test revealed no significant difference in the overall distribution of efficacy grades between the two groups (U = 496.0, Z = ?0.316, P = 0.752). Operative time and hospitalization costs in the CO group were significantly lower than those in the CN group (P < 0.05).Conclusions: Within 6 months, pain and function improved in both groups, with no statistically significant between-group difference detected. Operative time and hospitalization costs were lower in the collagenase group. This exploratory study does not establish equivalence or noninferiority; longer follow-up and larger studies are needed.Keywords: discogenic low back pain; high-intensity zone; collagenase chemonucleolysis; target injection

    Key words: discogenic low back pain; high-intensity zone; collagenase chemonucleolysis; target injection

    提交时间:2026-10-30

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  • 序号 提交日期 编号 操作
    1 2026-08-06

    10.12201/bmr.202610.00068V1

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刘欢, 刘宇甲, 汪强, 王炎. 胶原酶靶点联合硬膜外注射与低温等离子髓核消融术治疗HIZ阳性盘源性腰痛的疗效比较. 2026. biomedRxiv.202610.00068

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