随机,IIb阶段研究调查oliceridine (TRV130),小说micro-receptor蛋白通路选择性(mu-GPS)调制器,中度到重度急性疼痛管理后腹壁整形术。

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Singla N, Minkowitz HS Soergel DG,伯特哒,Subach RA, Salamea, Fossler MJ, Skobieranda F

随机,IIb阶段研究调查oliceridine (TRV130),小说micro-receptor蛋白通路选择性(mu-GPS)调制器,中度到重度急性疼痛管理后腹壁整形术。

J疼痛研究》2017年10月6日,10:2413 - 2424。doi: 10.2147 / JPR.S137952。eCollection 2017。

PubMed ID

29062240 (在PubMed

]

文摘

背景:Oliceridine (TRV130),小说mu-receptor蛋白通路选择性(mu-GPS)调制器,是为了改善传统的阿片类药物的治疗窗通过激活蛋白信号而导致低beta-arrestin招聘μ受体。这个随机、双盲、病人自控镇痛IIb阶段研究调查效果,安全性和耐受性oliceridine相比吗啡和安慰剂在中度至重度疼痛患者腹壁整形术(NCT02335294;oliceridine是一种试验性药物不经美国食品和药物管理局批准)。方法:患者随机接受静脉注射oliceridine术后治疗方案(加载/病人自控需求剂量(毫克/ mg): 1.5/0.10 (A组);1.5/0.35 (B组))、吗啡(4.0/1.0),或安慰剂治疗开始后4小时内手术,根据需要持续24小时。结果:二百例患者治疗(n = 39, n = 39, n = 83,和n = 39 oliceridine方案,oliceridine方案B,吗啡,和安慰剂组,分别)。患者以女性为主(n = 198[99%]),平均年龄为38.2岁,体重71.2公斤,基线疼痛得分为7.7分(11点数字疼痛量表)。病人接受oliceridine方案减少平均疼痛评分(基于模型的时间加权平均变化量与安慰剂超过24小时)2.3和2.1分,分别为(P = 0.0001, P = 0.0005和安慰剂);接受吗啡的患者也有类似的减少(2.1分;P < 0.0001和安慰剂)。 A lower prevalence of adverse events (AEs) related to nausea, vomiting, and respiratory function was observed with the oliceridine regimens than with morphine (P<0.05). Other AEs with oliceridine were generally dose-related and similar in nature to those observed with conventional opioids; no serious AEs were reported with oliceridine. CONCLUSION: These results suggest that oliceridine may provide effective, rapid analgesia in patients with moderate to severe postoperative pain, with an acceptable safety/tolerability profile and potentially wider therapeutic window than morphine.

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药物

Oliceridine