Hirai Takashi, Okawa Atsushi, Takahashi Hiroshi, Shiosakai Kazuhito, Yoshii Toshitaka
Department of Orthopedic Surgery, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
Department of Orthopedic Surgery, Yokohama City Minato Red Cross Hospital, Yokohama, Japan.
Pain Ther. 2025 Jun;14(3):1063-1079. doi: 10.1007/s40122-025-00722-w. Epub 2025 Apr 12.
There are few studies of pharmacotherapy of neuropathic pain in cervical spondylotic radiculopathy (CSR). Miro-Cens aimed to examine the efficacy and safety of mirogabalin for treating pain in patients with CSR on non-steroidal anti-inflammatory drugs (NSAIDs), compared with NSAIDs alone.
Miro-Cens was a 12-week, multicenter, randomized, controlled, open-label, interventional study in Japan. Eligible patients with CSR having upper limb pain (visual analog scale score ≥ 40 mm) were randomly assigned in a 1:1 ratio to the mirogabalin add-on to NSAIDs group and the NSAIDs alone group. The primary endpoint was the change in the weekly average numerical rating scale (NRS) score for upper limb pain from baseline at Week 12.
The mirogabalin add-on group and NSAIDs alone group included 72 and 70 patients, respectively. The mirogabalin add-on group had a significantly greater reduction in the NRS score for upper limb pain than the NSAIDs alone group: estimated changes from baseline at Week 12, - 2.63 [95% confidence interval (CI) - 3.14, - 2.11] in the mirogabalin add-on group; - 1.07 (- 1.62, - 0.53) in the NSAIDs alone group; intergroup difference, - 1.55 (- 2.31, - 0.80; p < 0.001). The responder rate on the NRS score at Week 12 was significantly higher in the mirogabalin add-on group than in the NSAIDs alone group: ≥ 30% improvement, 71.7% vs. 39.6%; ≥ 50% improvement, 58.3% vs. 22.6% (both p < 0.001). The frequent treatment-emergent adverse drug reactions in the mirogabalin add-on group were the known ones (somnolence and dizziness), with most being mild or moderate in severity.
In patients with CSR, combination therapy with mirogabalin and NSAIDs significantly improved neuropathic pain compared with NSAID monotherapy. No new safety concerns were identified, although caution should be exercised regarding somnolence and dizziness. These findings suggest that concomitant use of mirogabalin with NSAIDs could be tolerable and a novel treatment option for CSR patients with insufficient analgesic effects on NSAIDs.
jRCTs031210629.
关于神经根型颈椎病（CSR）神经性疼痛药物治疗的研究较少。Miro-Cens旨在研究与单独使用非甾体抗炎药（NSAIDs）相比，米罗加巴林联合NSAIDs治疗CSR患者疼痛的疗效和安全性。
Miro-Cens是一项在日本进行的为期12周的多中心、随机、对照、开放标签的干预性研究。符合条件的上肢疼痛（视觉模拟量表评分≥40mm）的CSR患者按1:1比例随机分为米罗加巴林联合NSAIDs组和单独使用NSAIDs组。主要终点是第12周时上肢疼痛每周平均数字评定量表（NRS）评分相对于基线的变化。
米罗加巴林联合组和单独使用NSAIDs组分别纳入72例和70例患者。米罗加巴林联合组上肢疼痛的NRS评分降低幅度明显大于单独使用NSAIDs组：第12周相对于基线的估计变化，米罗加巴林联合组为-2.63[95%置信区间（CI）-3.14，-2.11]；单独使用NSAIDs组为-1.07（-1.62，-0.53）；组间差异为-1.55（-2.31，-0.80；p<0.001）。第12周时，米罗加巴林联合组NRS评分的缓解率显著高于单独使用NSAIDs组：改善≥30%，分别为71.7%和39.6%；改善≥50%，分别为58.3%和22.6%（均p<0.001）。米罗加巴林联合组常见的治疗中出现的药物不良反应为已知的不良反应（嗜睡和头晕），大多数为轻度或中度。
在CSR患者中，与NSAIDs单药治疗相比，米罗加巴林与NSAIDs联合治疗可显著改善神经性疼痛。未发现新的安全问题，尽管对嗜睡和头晕应予以注意。这些发现表明，米罗加巴林与NSAIDs联合使用可能是可耐受的，对于NSAIDs镇痛效果不佳的CSR患者是一种新的治疗选择。
jRCTs031210629。
