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NEJM:艾替班特可用于治疗ACE-抑制剂-诱导的血管性水肿

2015-02-16 范伟译 MedSci原创

背景 由采用血管紧张素转换酶(ACE)抑制剂治疗诱导产生的血管性水肿占急诊血管性水肿病例的三分之一;它通常表现在上呼吸道和头部以及颈部区域。对于这一潜在的危及生命的症状目前尚无批准的治疗对策。 方法 在这个多中心的,双盲的,双模拟的随机II期研究中,我们指定那些ACE-抑制剂-诱导的上呼吸消化道血管性水肿的病人,30毫克艾替班特皮下注射治疗,选择性血管舒缓激肽B2受体拮抗剂,或采用静脉注射强的松

背景 由采用血管紧张素转换酶(ACE)抑制剂治疗诱导产生的血管性水肿占急诊血管性水肿病例的三分之一;它通常表现在上呼吸道和头部以及颈部区域。对于这一潜在的危及生命的症状目前尚无批准的治疗对策。

方法 在这个多中心的,双盲的,双模拟的随机II期研究中,我们指定那些ACE-抑制剂-诱导的上呼吸消化道血管性水肿的病人,30毫克艾替班特皮下注射治疗,选择性血管舒缓激肽B2受体拮抗剂,或采用静脉注射强的松(500毫克)加上克立马汀(2毫克)作为当前未标示的标准治疗。主要疗效终点是完全消除水肿的中位期。

结果 按预前方案完全消除水肿的所有27个病人。完全消除水肿艾替班特的中位期为8.0小时(四分位差,3.0至16.0)相比于标准治疗(P = 0.002)的27.1小时(四分位差,20.3到48.0)。三个病人接受标准治疗需要艾替班特和强的松的干预;一个病人进行气管切开术。接受艾替班特治疗组的患者相比于标准治疗组的4小时内完全消除水肿(13人中5个相比于14人中0个,P = 0.02)。发病症状缓解的中位期艾替班特治疗组明显比标准治疗组短(2.0小时相比于11.7小时,P = 0.03)。当对患者症状评分时结果也是类似的。

结论 ACE-抑制剂-诱导的血管性水肿病人,艾替班特治疗组与联合了糖皮质激素和抗组胺剂的治疗组相比,水肿完全消除的时间明显更短。

原始出处

Baş M1, Greve J, Stelter K, Havel M, Strassen U, Rotter N, Veit J, Schossow B, Hapfelmeier A, Kehl V, Kojda G, Hoffmann TK. A randomized trial of icatibant in ACE-inhibitor-induced angioedema. N Engl J Med. 2015 Jan 29;372(5):418-25. doi: 10.1056/NEJMoa1312524.

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    2015-09-14 jklm09
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    2015-08-07 shanyongle
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    2015-02-18 小华子
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(资料图)   8月25日,美国食品和药物管理局(FDA)批准Firazyr (通用名:艾替班特)注射剂治疗年龄≥18岁成人的一种罕见疾病——遗传性血管性水肿(HAE)的急性发作。   HAE是由于一种称为C1抑制剂的蛋白水平低或功能障碍引起的,这种蛋白涉及免疫系统的调节和凝血通路的功能。病人通常有该病的家族史。美国的HAE患者不到3万人。   HAE病人可出现手、足、四肢、面部、

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