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Abstract：
BACKGROUND: For chronic pain after thoracic surgery, optimal timing of its diagnosis and effective treatment remains unresolved, although several treatment options are currently available. We examined the efficacy and safety of mirogabalin, in combination with conventional pain therapy (nonsteroidal anti-inflammatory drugs and/or acetaminophen), for treating peripheral neuropathic pain (NeP) after thoracic surgery.
METHODS: In this multicenter, randomized, open-label, parallel-group study, patients with peripheral NeP were randomly assigned 1:1 to mirogabalin as add-on to conventional therapy or conventional treatment alone.
RESULTS: Of 131 patients of consent obtained, 128 were randomized (mirogabalin add-on group, 63 patients; conventional treatment group, 65 patients). The least squares mean changes (95% confidence interval [CI]) in Visual Analogue Scale (VAS) score for pain intensity at rest from baseline to Week 8 (primary endpoint) were - 51.3 (- 54.9, - 47.7) mm in the mirogabalin add-on group and - 47.7 (- 51.2, - 44.2) mm in the conventional group (between-group difference: - 3.6 [95% CI: - 8.7, 1.5], P = 0.161). However, in patients with Self-administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) score (used for the screening of NeP) ≥ 12 at baseline, the greater the S-LANSS score at baseline, the greater the decrease in VAS score in the mirogabalin add-on group, while no such trend was observed in the conventional treatment group (post hoc analysis). This between-group difference in trends was statistically significant (interaction P value = 0.014). Chronic pain was recorded in 7.9% vs. 16.9% of patients (P = 0.171) at Week 12 in the mirogabalin add-on vs. conventional treatment groups, respectively. Regarding activities of daily living (ADL) and quality of life (QOL), changes in Pain Disability Assessment Scale score and the EQ-5D-5L index value from baseline to Week 8 showed significant improvement in the mirogabalin add-on group vs. conventional treatment group (P < 0.001). The most common adverse events (AEs) in the mirogabalin add-on group were dizziness (12.7%), somnolence (7.9%), and urticaria (3.2%). Most AEs were mild or moderate in severity.
CONCLUSIONS: Addition of mirogabalin to conventional therapy did not result in significant improvement in pain intensity based on VAS scores, but did result in significant improvement in ADL and QOL in patients with peripheral NeP after thoracic surgery.
BACKGROUND: Japan Registry of Clinical Trials jRCTs071200053 (registered 17/11/2020).
METHODS: In this multicenter, randomized, open-label, parallel-group study, patients with peripheral NeP were randomly assigned 1:1 to mirogabalin as add-on to conventional therapy or conventional treatment alone.
RESULTS: Of 131 patients of consent obtained, 128 were randomized (mirogabalin add-on group, 63 patients; conventional treatment group, 65 patients). The least squares mean changes (95% confidence interval [CI]) in Visual Analogue Scale (VAS) score for pain intensity at rest from baseline to Week 8 (primary endpoint) were - 51.3 (- 54.9, - 47.7) mm in the mirogabalin add-on group and - 47.7 (- 51.2, - 44.2) mm in the conventional group (between-group difference: - 3.6 [95% CI: - 8.7, 1.5], P = 0.161). However, in patients with Self-administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) score (used for the screening of NeP) ≥ 12 at baseline, the greater the S-LANSS score at baseline, the greater the decrease in VAS score in the mirogabalin add-on group, while no such trend was observed in the conventional treatment group (post hoc analysis). This between-group difference in trends was statistically significant (interaction P value = 0.014). Chronic pain was recorded in 7.9% vs. 16.9% of patients (P = 0.171) at Week 12 in the mirogabalin add-on vs. conventional treatment groups, respectively. Regarding activities of daily living (ADL) and quality of life (QOL), changes in Pain Disability Assessment Scale score and the EQ-5D-5L index value from baseline to Week 8 showed significant improvement in the mirogabalin add-on group vs. conventional treatment group (P < 0.001). The most common adverse events (AEs) in the mirogabalin add-on group were dizziness (12.7%), somnolence (7.9%), and urticaria (3.2%). Most AEs were mild or moderate in severity.
CONCLUSIONS: Addition of mirogabalin to conventional therapy did not result in significant improvement in pain intensity based on VAS scores, but did result in significant improvement in ADL and QOL in patients with peripheral NeP after thoracic surgery.
BACKGROUND: Japan Registry of Clinical Trials jRCTs071200053 (registered 17/11/2020).
摘要：
背景：对于胸外科手术后的慢性疼痛，其诊断和有效治疗的最佳时机仍未解决，尽管目前有几种治疗选择。我们检查了米罗加巴林的疗效和安全性，与常规疼痛治疗（非甾体抗炎药和/或对乙酰氨基酚）联合使用，用于治疗胸外科手术后的周围神经性疼痛（NeP）。
方法：在这个多中心中，随机化，开放标签，平行组研究,外周NeP患者被随机分配1:1接受米罗加巴林,作为常规治疗或单独接受常规治疗的附加治疗.
结果：在获得同意的131名患者中，128例随机分组(米罗加巴林添加组，63例；常规治疗组，65名患者）。从基线到第8周（主要终点），静息时疼痛强度的视觉模拟评分（VAS）评分的最小二乘均值变化（95％置信区间[CI]）米罗加巴林添加组为-51.3（-54.9，-47.7）mm，常规组为-47.7（-51.2，-44.2）mm（组间差异：-3.6[95％CI：-8.7，1.5]，P=0.161）。然而,在基线时自我治疗的利兹神经病变症状和体征评估（S-LANSS）评分（用于NeP筛查）≥12的患者中，基线时的S-LANSS评分越大，添加米罗加巴林组的VAS评分下降幅度越大，而在常规治疗组中没有观察到这种趋势（事后分析）。这种组间趋势差异具有统计学意义（交互作用P值=0.014）。慢性疼痛记录为7.9％与16.9%的患者（P=0.171）在第12周时加入米罗加巴林与常规治疗组,分别。关于日常生活活动(ADL)和生活质量(QOL)，从基线到第8周，疼痛残疾评估量表评分和EQ-5D-5L指数值的变化表明，米罗加巴林添加组与常规治疗组(P<0.001)。在添加米罗加巴林的组中最常见的不良事件(AE)是头晕(12.7%),嗜睡(7.9%),和荨麻疹(3.2%)。大多数AE的严重程度为轻度或中度。
结论：在常规治疗基础上添加米罗加巴林并没有显著改善基于VAS评分的疼痛强度，但确实导致胸外科手术后周围NeP患者的ADL和QOL明显改善。
背景：日本临床试验注册jRCTs071200053（注册于2020年17月11日）。
方法：在这个多中心中，随机化，开放标签，平行组研究,外周NeP患者被随机分配1:1接受米罗加巴林,作为常规治疗或单独接受常规治疗的附加治疗.
结果：在获得同意的131名患者中，128例随机分组(米罗加巴林添加组，63例；常规治疗组，65名患者）。从基线到第8周（主要终点），静息时疼痛强度的视觉模拟评分（VAS）评分的最小二乘均值变化（95％置信区间[CI]）米罗加巴林添加组为-51.3（-54.9，-47.7）mm，常规组为-47.7（-51.2，-44.2）mm（组间差异：-3.6[95％CI：-8.7，1.5]，P=0.161）。然而,在基线时自我治疗的利兹神经病变症状和体征评估（S-LANSS）评分（用于NeP筛查）≥12的患者中，基线时的S-LANSS评分越大，添加米罗加巴林组的VAS评分下降幅度越大，而在常规治疗组中没有观察到这种趋势（事后分析）。这种组间趋势差异具有统计学意义（交互作用P值=0.014）。慢性疼痛记录为7.9％与16.9%的患者（P=0.171）在第12周时加入米罗加巴林与常规治疗组,分别。关于日常生活活动(ADL)和生活质量(QOL)，从基线到第8周，疼痛残疾评估量表评分和EQ-5D-5L指数值的变化表明，米罗加巴林添加组与常规治疗组(P<0.001)。在添加米罗加巴林的组中最常见的不良事件(AE)是头晕(12.7%),嗜睡(7.9%),和荨麻疹(3.2%)。大多数AE的严重程度为轻度或中度。
结论：在常规治疗基础上添加米罗加巴林并没有显著改善基于VAS评分的疼痛强度，但确实导致胸外科手术后周围NeP患者的ADL和QOL明显改善。
背景：日本临床试验注册jRCTs071200053（注册于2020年17月11日）。
