新型非阿片类镇痛药苏泽曲林治疗中重度急性疼痛的系统评价与Meta分析

A Systematic Review and Meta-Analysis of the Novel Non-Opioid Analgesic suzetrigine for the Moderate-to-Severe Acute Pain

关键词:  苏泽曲林、中重度疼痛、氨酚氢可酮、安全性、有效性

Key words:  Suzetrigine  Moderate-to-Severe Pain  Hydrocodone Bitartrate-Acetaminophen  Safety  Efficacy

摘要:

目的：本研究旨在评估新型非阿片类镇痛药苏泽曲林治疗中重度疼痛患者中的疗效与安全性。方法：系统检索建库至2025年09月的医学数据库，纳入所有评估苏泽曲林对中重度疼痛患者疗效与安全性的随机对照试验（RCT）。主要结局指标为24/48小时内疼痛强度差时间加权总和（SPID24/SPID48）和48小时内静息NRS评分降低率，以及恶心、呕吐等所有不良事件的发生率。结果：共计纳入4项RCT，2599例患者，舒泽曲林组1009例，氨酚氢可酮组1015例，安慰剂组575例。分析结果显示，与对照组相比，苏泽曲林可显著降低SPID24/48和48小时内静息NRS评分降低率，腹壁成形术患者的疗效尤为显著。与安慰剂组相比，苏泽曲林的镇痛治疗效果非常显著；且与氨酚氢可酮的镇痛效果相当。苏泽曲林的安全性特征优于对照组，表现为所有不良事件、恶心、呕吐和头晕的风险比明显降低，但长期用药的疗效和安全性尚不明确。结论：本系统综述与Meta分析表明，对于中重度疼痛患者，苏泽曲林是一种有效且安全的非阿片类镇痛药，能快速产生不劣于氨酚氢可酮的镇痛作用，且安全性良好。然而，由于纳入研究数量有限且异质性较高，仍需进一步的多维度疼痛管理临床研究予以验证。

Abstract:

Objective: This study aimed to evaluate the efficacy and safety of the novel non-opioid analgesic Suzetrigine in patients with moderate-to-severe pain. Methods: A systematic review of medical databases was conducted from inception until September 2025. All randomized controlled trials (RCTs) evaluating the efficacy and safety of Suzetrigine in patients with moderate-to-severe pain were included. Primary outcome measures included 24/48-hour period the time-weighted sum of pain-intensity difference(SPID24/SPID48) and the reduction rate of resting Numeric Pain Rating Scale (NRS) scores within 48 hours, as well as the incidence of all adverse events, including nausea and vomiting. Results:A total of 4 RCTs involving 2599 patients were included (Suzetrigine group: n=1009; hydrocodone bitartrate-acetaminophen group: n=1015; placebo group: n=575). The analysis revealed that compared to control groups, Suzetrigine significantly reduced SPID24/SPID48 and increased the reduction rate of resting NRS scores within 48 hours, with particularly notable efficacy observed in the abdominoplasty. Compared to the placebo group, the analgesic effect of Suzetrigine was highly significant and comparable to that of hydrocodone bitartrate-acetaminophen group. The safety profile of Suzetrigine was more favorable than that of the control groups, as evidenced by significantly lower risk ratios for all adverse events, nausea, vomiting, and dizziness. However, the long-term efficacy and safety profile remains unclear. Conclusion: This systematic review and meta-analysis indicates that Suzetrigine is an effective and safe non-opioid analgesic for patients with moderate-to-severe pain, providing rapid analgesia non-inferior to hydrocodone bitartrate-acetaminophen with a favorable safety profile. Nevertheless, due to the limited number of included studies and high heterogeneity, further clinical studies incorporating multidimensional pain management assessments are warranted for validation.