NEJM:Ubrogepant治疗偏头痛的疗效和安全性

2019-12-05 xing.T MedSci原创

由此可见,服用Ubrogepant的受试者比例比服用安慰剂的受试者高,并且在服用2小时后没有最烦人的症状。最常见的不良反应包括恶心、嗜睡和口干。需要进一步的试验来确定Ubrogepant对急性偏头痛治疗的持久性和安全性,并将其与其它偏头痛药物进行比较。

Ubrogepant是口服的小分子降钙素基因相关肽受体拮抗剂,可用于急性偏头痛治疗。近日,顶级医学期刊NEJM上发表了一篇研究文章,研究人员进行了一项随机试验,以评估Ubrogepant的疗效、安全性和副作用。

研究人员随机分配了伴有或没有先兆偏头痛的成人,以1:1:1的比例接受安慰剂、50mg Ubrogepant或100mg Ubrogepant进行单次偏头痛发作治疗。该研究主要疗效的终点是在初始剂量后2小时无疼痛,在2小时时没有最烦人的偏头痛相关症状。次要终点包括疼痛缓解(2小时),持续疼痛缓解(2至24小时),持续摆脱疼痛(2至24小时)以及不存在与偏头痛相关的症状(畏光、恐惧心理和恶心)。

该研究共有1672名参与者;559位患者接受安慰剂,556位患者接受50mg Ubrogepant,557位患者接受100mg Ubrogepant。安慰剂组在2小时内无疼痛的参与者比例为11.8%,50mg Ubrogepant组为19.2%(经多重调整,与安慰剂比较,P=0.002),100mg Ubrogepant组为21.2%(P<0.001)。安慰剂组在2小时内摆脱最烦恼症状的参与者百分比为27.8%,50mg Ubrogepant组为38.6%(P=0.002),100mg Ubrogepant组为37.7%(P=0.002)。在安慰剂组中有12.8%的参与者报告了初次或可选第二剂后48小时内出现不良事件,在50mg Ubrogepant组为9.4%,在100mg Ubrogepant组中为16.3%。最常见的不良事件是恶心、嗜睡和口干(报道为0.4%至4.1%);这些事件在100mg Ubrogepant组中更为频繁(报道为2.1%至4.1%)。 Ubrogepant组在30天内报告的严重不良事件包括阑尾炎、自然流产、心包积液和癫痫发作;给药后48小时内未发生任何不良事件。

由此可见,服用Ubrogepant的受试者比例比服用安慰剂的受试者高,并且在服用2小时后没有最烦人的症状。最常见的不良反应包括恶心、嗜睡和口干。需要进一步的试验来确定Ubrogepant对急性偏头痛治疗的持久性和安全性,并将其与其它偏头痛药物进行比较。 

原始出处:

David W. Dodick, et al.Ubrogepant for the Treatment of Migraine.NEJM.2019.https://www.nejm.org/doi/full/10.1056/NEJMoa1813049

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    2019-12-06 gwc384
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    2019-12-05 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2019-12-05 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

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JAMA:Ubrogepant治疗急性偏头痛

研究认为,在患有偏头痛的成年人中,与安慰剂相比,服用Ubrogepant可显著提高2小时的疼痛缓解率,减少偏头痛相关症状