长效德克萨米他粘凝 (SP-102) 跨内注射用于腰部 sacral 根部疼痛
Nebojsa Nick Knezevic1,2,3, Conor George1,4, Daniela A Ferrer Gonzalez1
1Department of Anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, IL, USA.
Pain management
|December 3, 2025
概括
在第三阶段试验中,SP-102是一种新型的外围注射类固醇注射,有效地减少了 lumbosacral 根部疼痛,并改善了功能. 与安慰剂相比,这种新配方显示出显著的疼痛缓解和更长的效果持续时间,具有有利的安全性.
科学领域:
- 疼痛医学 医学 疼痛医学
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
背景情况:
- 腰部神经根部疼痛 (LRP) 导致显著的疼痛和残疾.
- 外周注射类固醇注射 (ESI) 是常见的LRP,但缺乏特定的FDA批准外周使用.
- 由于配方的非标签性使用,现有的ESI存在安全问题.
研究的目的:
- 为了评估SP-102的疗效和安全性,德克萨米他粘性凝配方,用于治疗LRP.
- 评估SP-102对LRP患者疼痛评分和功能障碍的影响.
主要方法:
- 一项III期临床试验,将SP-102与LRP患者的安慰剂进行比较.
- 使用腿部疼痛得分评估疼痛缓解和使用奥斯威斯特残疾指数 (ODI) 评估功能改善.
- 监测安全性和耐受性,包括严重的不良事件.
主要成果:
- 与安慰剂相比,SP-102显著减少了腿部疼痛 (减少幅度大于1.1个点,p < 0.001).
- 在SP-102 (84天) 与安慰剂 (58天) 相比,重复注射的中位时间更长.
- 与安慰剂相比,SP-102提高了ODI得分 (8.9比5.5分,p=0.015),没有严重的注射相关不良事件.
结论:
- 在LRP患者中,SP-102在减少疼痛和改善功能方面表现出有效性.
- 该配方提供了一个潜在的更安全和更有效的外周类固醇注射选择.
- 进一步的研究可能会支持SP-102作为LRP的向治疗.
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