TY -的T1 Mirogabalin中央脊髓损伤后神经性疼痛JF -神经学乔-神经病学SP - e1193 LP - e1206做- 10.1212 / WNL。首页0000000000201709六世- 100 - 11盟孝宏Ushida AU -片山洋一盟Yoichi Hiasa AU - Makoto Nishihara盟Fumihiro日本田岛AU - Shinsuke Katoh盟田中Hirotaka AU - Maeda武盟夫妇Furusawa AU -玛丽·理查森盟喜田岛Kakehi盟Kunika Kikumori AU - Masanori Kuroha Y1 - 2023/03/14 UR - //www.ez-admanager.com/content/100/11/e1193.abstract N2 -背景和目标脊髓损伤(SCI)患者通常经验中枢神经性疼痛(CNeP),这是具有挑战性的治疗。首页对周围神经性疼痛Mirogabalin是有效的,但缺乏CNeP的证据。这个方法随机、双盲、安慰剂对照,第三阶段研究调查mirogabalin治疗的有效性和安全性CNeP创伤患者。成人患者从120年网站在日本,韩国,台湾被随机分配(1:1)接受安慰剂或mirogabalin(5毫克每日两次报价为1周,10毫克竞购1周,和10或15毫克竞购12周)。中度肾功能损害患者接受剂量的一半。主要疗效终点是变化的基线每周平均每天疼痛评分(adp)在14周。第二端点包括adp应答率,形式上麦吉尔疼痛问卷(SF-MPQ),平均每日睡眠干扰得分(adsi)和神经性疼痛症状量表(NPSI)。不良事件监测的安全。结果每个治疗组由150名患者。 Mirogabalin elicited a statistical and clinically relevant improvement in change from baseline in the weekly ADPS at week 14 (least-squares mean difference [95% CI] vs placebo −0.71 [−1.08 to −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 ER -