A Ushida, Takahiro %A Katayama, Yoichi %A Hiasa, Yoichi %A西原，Makoto %A Tajima, Fumihiro %A Katoh, Shinsuke %A Tanaka, Hirotaka %A Maeda, Takeshi %A Furusawa, Kazunari %A Richardson, Mary %A Kakehi, Yoshihiro %A Kikumori, Kunika %A Kuroha, Masanori %T Mirogabalin治疗脊髓损伤后中枢神经性疼痛的随机，双盲，安慰剂对照，亚洲3期研究%D 2023 %R 10.1212/WNL。背景和目的脊髓损伤(SCI)患者通常会经半岛投注体育官网历中枢神经性疼痛(CNeP)，这是一种具有挑战性的治疗。米罗巴林对外周神经性疼痛有效，但缺乏CNeP的证据。这项随机、双盲、安慰剂对照的三期研究探讨了米巴林治疗创伤性脊髓损伤患者CNeP的有效性和安全性。来自日本、韩国和台湾120个地点的成年患者被随机(1:1)接受安慰剂或米罗巴林(5 mg，每天两次[BID] 1周，10 mg BID 1周，10或15 mg BID 12周)。中度肾损害的患者接受一半的剂量。主要疗效终点为第14周的周平均每日疼痛评分(ADPS)与基线相比的变化。次要终点包括ADPS应答者率、简式麦吉尔疼痛问卷(SF-MPQ)、平均每日睡眠干扰评分(ADSIS)和神经性疼痛症状量表(NPSI)。对不良事件进行安全监测。结果每治疗组150例。米罗巴林在第14周的周ADPS较基线有统计学和临床相关的改善(与安慰剂相比，最小二乘平均差[95% CI]为−0.71[−1.08至−0.34]，p = 0.0001)。 Responder rates at week 14 were higher for mirogabalin than those for placebo (odds ratio [95% CI] 1.91 [1.11–3.27] for the ≥30% responder rate; 2.52 [1.11–5.71] for the ≥50% responder rate). Statistical improvements (i.e., least-squares mean difference [95% CI] vs placebo) were also observed in the SF-MPQ (−2.4 [−3.8 to −1.1]), ADSIS −0.71 (−1.04 to −0.38), and NPSI −7.7 (−11.1 to −4.4) scores. Most treatment-emergent adverse events were mild; no serious adverse drug reactions were reported.Discussion Mirogabalin elicited clinically relevant decreases in pain and was well tolerated, suggesting that mirogabalin is a promising treatment for patients with CNeP due to SCI.Trial Registration Information ClinicalTrials.gov (NCT03901352); first submitted April 3, 2019; first patient enrolled March 14, 2019; available at clinicaltrials.gov/ct2/show/NCT03901352.Classification of Evidence This study provides Class I evidence that in adult patients with CNeP due to traumatic SCI, mirogabalin, 10 or 15 mg BID, effectively improves weekly ADPS at week 14.ADPS=average daily pain score; ADR=adverse drug reaction; ADSIS=average daily sleep interference score; AE=adverse event; BID=twice daily; CNeP=central neuropathic pain; CrCL=creatinine clearance; DPNP=diabetic peripheral neuropathic pain; EQ-5D-5L=EuroQoL 5 Dimensions 5 Levels; LS=least-squares; mITT=modified intention-to-treat; NPSI=Neuropathic Pain Symptom Inventory; OR=odds ratio; PGIC=Patient Global Impression of Change; PHN=postherpetic neuralgia; PNeP=peripheral neuropathic pain; QoL=quality of life; SCI=spinal cord injury; SF-MPQ=Short-form McGill Pain Questionnaire; TEAE=treatment-emergent adverse event; VAS=visual analog scale %U //www.ebmtp.com/content/neurology/100/11/e1193.full.pdf

map