用于治疗成人术后急性中重度疼痛的新型非阿片镇痛药——Suzetrigine

doi:10.12092/j.issn.1009-2501.2025.10.004

中国临床药理学与治疗学 ›› 2025, Vol. 30 ›› Issue (10): 1319-1325.doi: 10.12092/j.issn.1009-2501.2025.10.004

• “术后疼痛管理前沿及进展”专栏 • 上一篇下一篇

用于治疗成人术后急性中重度疼痛的新型非阿片镇痛药——Suzetrigine

田婕1，2，江晟2，常惠礼2

1广州医科大学药学院，广州 510000，广东；2广州医科大学附属清远医院（清远市人民医院）药学部，清远 511500，广东

收稿日期:2025-04-09 修回日期:2025-05-09 出版日期:2025-10-26 发布日期:2025-10-15
通讯作者: 常惠礼，男，主任药师，硕士生导师，研究方向：医院药事管理。 E-mail： 10057723@qq.com
作者简介:田婕，女，硕士研究生，研究方向：医院药学。 E-mail： tj20010919@163.com
基金资助:
广东省外科药学围术期焦虑/疼痛管理专项研究基金项目（2024WO1008）

Suzetrigine: A novel non-opioid analgesic for the treatment of moderate-to-severe acute pain in adults

TIAN Jie1,2, JIANG Sheng2, CHANG Huili2

1School of Pharmacy, Guangzhou Medical University, Guangzhou 510000, Guangdong, China; 2Department of Pharmacy, The Affiliated Qingyuan Hospital of Guangzhou Medical University (Qingyuan People's Hospital), Qingyuan 511500, Guangdong, China

Received:2025-04-09 Revised:2025-05-09 Online:2025-10-26 Published:2025-10-15

摘要/Abstract

摘要：

Suzetrigine是首个被批准上市的NaV1.8通道选择性阻滞剂。2025年1月30日，美国食品药品管理局（FDA）批准Suzetrigine用于口服治疗中重度急性疼痛。在Suzetrigine的两项Ⅲ期临床试验（NAVIGATE-1与NAVIGATE-2）中，其在主要疗效终点［48 h内NPRS评分疼痛强度差异的时间加权总和（SPID48）］上相较于安慰剂均显示出具有统计学意义的改善，最小二乘均值差分别为29.3（95% CI: 14.0～44.6；P=0.000 2）和48.4（95% CI: 33.6～63.1；P<0.000 1），提示其有明确的镇痛疗效。此外，由于Suzetrigine对NaV1.8的高度选择性，Suzetrigine在安全性和耐受性方面表现良好，可有效减少传统阿片类镇痛药常见的恶心呕吐、药物成瘾等不良反应，具有较大的临床意义。

关键词: Suzetrigine, 钠通道阻滞剂, 急性疼痛, 镇痛药

Abstract:

Suzetrigine is the first approved selective NaV1.8 channel inhibitor. On January 30, 2025, the U.S. FDA approved Suzetrigine for the oral treatment of moderate to severe acute pain. In two phase III clinical trials (NAVIGATE-1 and NAVIGATE-2), Suzetrigine demonstrated statistically significant improvements in the primary efficacy endpoint, time-weighted sum of pain intensity differences over 48 hours (SPID48), compared with placebo. The least squares mean differences were 29.3 (95% CI: 14.0-44.6; P=0.000 2) and 48.4 (95% CI: 33.6-63.1; P<0.000 1), respectively, confirming its robust analgesic efficacy. Furthermore, owing to its high selectivity for NaV1.8, Suzetrigine exhibited favorable safety and tolerability profiles, with notably lower incidences of nausea, vomiting, and drug dependence compared to conventional opioid analgesics, underscoring its substantial clinical value.

Key words: Suzetrigine, sodium channel blockers, acute pain, analgesics

中图分类号:

田婕, 江晟, 常惠礼. 用于治疗成人术后急性中重度疼痛的新型非阿片镇痛药——Suzetrigine[J]. 中国临床药理学与治疗学, 2025, 30(10): 1319-1325.

TIAN Jie, JIANG Sheng, CHANG Huili. Suzetrigine: A novel non-opioid analgesic for the treatment of moderate-to-severe acute pain in adults[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2025, 30(10): 1319-1325.

用于治疗成人术后急性中重度疼痛的新型非阿片镇痛药——Suzetrigine

Suzetrigine: A novel non-opioid analgesic for the treatment of moderate-to-severe acute pain in adults

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