曲马多治疗术后疼痛的III期临床数据

2018-05-23 MedSci MedSci原创

Avenue Therapeutics近日表示,与安慰剂相比,静脉(IV)注射曲马多的III期研究达到了统计学意义上的显著改善(48小时内疼痛强度,SPID48),包括中度至重度的术后疼痛

Avenue Therapeutics近日表示,与安慰剂相比,静脉(IV)注射曲马多的III期研究达到了统计学意义上的显著改善(48小时内疼痛强度,SPID48),包括中度至重度的术后疼痛。

在试验中,409名先前接受了囊炎切除术的患者随机接受了曲马多治疗(剂量为25 mg50 mg)或安慰剂。除主要终点外,次要终点还包括SPID24。结果显示高剂量曲马多达到主要终点和所有次要终点,数据表明该剂量在给药后30分钟即可显著减轻疼痛。与此同时,Avenue Therapeutics表示,较低剂量的效果介于较高剂量和安慰剂之间。

研究调查人员Harold Minkowitz指出,静脉注射曲马多在美国以外地区在术后环境中被广泛使用,III期研究结果表明该药可能是治疗患者术后疼痛的一种全新疗法。该公司解释说,静脉注射曲马多在较高剂量时的总体安全性与先前的研究结果一致,并且似乎比类似人群中静脉注射阿片类药物的历史数据更好。Avenue Therapeutics补充说,该研究的全部结果将在未来的研究会议上提交或在期刊上发表。


原始出处:

http://www.firstwordpharma.com/node/1566987?tsid=4#axzz5GE3RkkZJ

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    2018-07-06 juliusluan78
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    2018-05-24 lhlxtx
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