João Rafael Batista, Tagore Chan Jilly Octoria, João André Batista, Araújo Luísa Mendes, Dantas Julyana Medeiros
Neurology and Neurophysiology Department, Goiânia Neurological Institute, Goiânia, Goiás, Brazil.
Division of Neurology, Department of Internal Medicine, São Vicente de Paulo Charity Hospital, Jundiaí, São Paulo, Brazil.
Eur J Pain. 2025 Nov;29(10):e70112. doi: 10.1002/ejp.70112.
Neuropathic pain (NeP) is a common and debilitating consequence of several neurological conditions. Gabapentinoids are used on a large scale for the treatment of both central and peripheral NeP. Mirogabalin, a novel gabapentinoid, has been proposed as a promising treatment for this condition; however, its efficacy and safety profile still need to be determined in clinical practice. In this systematic review and meta-analysis, we assessed the efficacy on pain intensity reduction, effects on sleep interference by pain, and safety of mirogabalin compared with placebo in patients affected by NeP.
We searched PubMed, Cochrane Library, Embase, Web of Science, and ClinicalTrials.gov databases for randomised controlled trials (RCTs) comparing mirogabalin with placebo in patients experiencing central or peripheral NeP. We computed mean differences (MD) and pooled risk ratios (RR) for continuous and binary outcomes, respectively, with 95% confidence intervals (CI). Pain was measured on a 0 to 10 numerical rating scale.
We included 6 RCTs involving 3048 patients. The mean age was 60.6 years, and 64.7% were male. When compared with placebo, patients treated with mirogabalin had a significant decrease in average daily pain (MD -0.60; 95% CI -0.75 to -0.45; p < 0.001) and in pain-related sleep interference scores (MD -0.66; 95% CI -0.81 to -0.51; p < 0.001). The mirogabalin group showed a higher rate of substantial pain relief (≥ 50%) compared with the placebo group (RR 1.27; 95% CI 1.10 to 1.46; p = 0.001). Nonetheless, treatment with mirogabalin increased the risk of weight gain, peripheral oedema, somnolence and dizziness.
In this meta-analysis of RCTs evaluating patients with central and peripheral NeP, mirogabalin significantly improved pain and decreased sleep interference by pain, as compared with placebo; however, there was an increased risk of adverse events.
This meta-analysis refines the current understanding of mirogabalin by demonstrating modest yet consistent benefits in reducing pain and pain-related sleep interference across neuropathic pain syndromes. The results contribute to ongoing efforts to optimise neuropathic pain management and provide more robust evidence to support clinical decision-making and guideline development.
神经性疼痛（NeP）是多种神经系统疾病常见且使人衰弱的后果。加巴喷丁类药物被广泛用于治疗中枢性和外周性NeP。新型加巴喷丁类药物米罗加巴林已被提议作为治疗这种疾病的有前景的药物；然而，其疗效和安全性仍需在临床实践中确定。在这项系统评价和荟萃分析中，我们评估了米罗加巴林与安慰剂相比，在减轻疼痛强度、缓解疼痛对睡眠的干扰以及安全性方面对NeP患者的疗效。
我们检索了PubMed、Cochrane图书馆、Embase、Web of Science和ClinicalTrials.gov数据库，以查找比较米罗加巴林与安慰剂治疗中枢性或外周性NeP患者的随机对照试验（RCT）。我们分别计算了连续性和二分法结局的平均差（MD）和合并风险比（RR），并给出95%置信区间（CI）。疼痛采用0至10的数字评分量表进行测量。
我们纳入了6项RCT，涉及3048例患者。平均年龄为60.6岁，男性占64.7%。与安慰剂相比，接受米罗加巴林治疗的患者每日平均疼痛显著减轻（MD -0.60；95% CI -0.75至-0.45；p < 0.001），与疼痛相关的睡眠干扰评分也显著降低（MD -0.66；95% CI -0.81至-0.51；p < 0.001）。与安慰剂组相比，米罗加巴林组显著疼痛缓解（≥50%）的发生率更高（RR 1.27；95% CI 1.10至1.46；p = 0.001）。尽管如此，米罗加巴林治疗增加了体重增加、外周水肿、嗜睡和头晕的风险。
在这项对评估中枢性和外周性NeP患者的RCT的荟萃分析中，与安慰剂相比，米罗加巴林显著改善了疼痛并减少了疼痛对睡眠的干扰；然而，不良事件的风险增加。
这项荟萃分析通过证明米罗加巴林在减轻各种神经性疼痛综合征的疼痛及与疼痛相关的睡眠干扰方面具有适度但一致的益处，完善了目前对米罗加巴林的认识。这些结果有助于正在进行的优化神经性疼痛管理的工作，并为支持临床决策和指南制定提供更有力的证据。
