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从Cannabis sativa DKJ127获得的全谱提取物用于慢性腰部疼痛:一个第三阶段随机的安慰剂受控试验

Matthias Karst¹, Winfried Meissner², Sabine Sator³

¹Department of Anesthesiology and Intensive Care Medicine, Pain Clinic, Hannover Medical School, Hannover, Germany. karst.matthias@mh-hannover.de.

Nature medicine

|September 30, 2025

概括

VER-01提供了一种新的,安全和有效的慢性腰痛治疗方法. 这一第三阶段试验表明,CLBP患者的疼痛显著减少,神经病症症状改善,耐受性良好.

科学领域:

疼痛管理疼痛管理
临床药理学临床药理学
神经学神经学

背景情况:

慢性腰部疼痛 (CLBP) 是一个影响超过5亿人的全球健康问题.
目前用于CLBP的治疗方法的有效性有限,风险很大.
对于安全有效的CLBP管理,需要新的治疗策略.

研究的目的:

评估VER-01在患有CLBP的成年人中的疗效和安全性.
通过数值评分表 (NRS) 和神经病痛症状来评估疼痛减轻.
确定VER-01.1的长期有效性和安全性.

主要方法:

一个多中心,随机,安慰剂控制的第三期试验,涉及820名患有CLBP的成年人.
一个为期12周的双盲治疗阶段 (A阶段),随后是一个为期6个月的开放式延期 (B阶段).
随后的阶段包括延续 (C阶段) 或随机取消 (D阶段) 以评估治疗持续时间.

主要成果:

与安慰剂相比,VER-01显著降低了NRS疼痛强度的平均值,在A期 (P < 0.001) 与安慰剂相比降低了-1.9点.
在VER-01组中观察到神经病痛症状 (NPSI) 的显著减少 (P = 0.017).
疼痛缓解持续到C阶段,并且退出VER-01导致与安慰剂相比疼痛显著增加.

结论:

在患有CLBP的患者中,VER-01在减少疼痛和神经病症症状方面表现出显著的有效性.
治疗耐受性很好,没有依赖或戒断的迹象,这表明了有利的安全性.
VER-01为治疗慢性腰部疼痛提供了一个有前途的新疗法.

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