Adis, a Wolters Kluwer Business, Auckland, New Zealand.
Drugs. 2010 Jul 30;70(11):1423-31. doi: 10.2165/11205850-000000000-00000.
Ecallantide, a recombinant protein that is a selective, highly potent and reversible inhibitor of human plasma kallikrein, is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients aged >or=16 years. In the randomized, double-blind, placebo-controlled, multicentre, phase III trial EDEMA3, mean symptom response to treatment at 4 hours (assessed using the Treatment Outcome Score [TOS]; primary endpoint) was significantly greater with a single subcutaneous dose of ecallantide 30 mg than with placebo in patients with acute, moderate to severe attacks of HAE. In addition, the mean change from baseline in symptom severity at 4 hours (assessed using the Mean Symptom Complex Severity [MSCS] scale) was significantly greater with ecallantide than with placebo. At 4 hours in the similarly designed EDEMA4 trial, the mean change from baseline in MSCS score (primary endpoint) and mean TOS were both significantly greater in recipients of a single subcutaneous dose of ecallantide 30 mg than in placebo recipients. Subcutaneous ecallantide 30 mg was generally well tolerated in patients with acute attacks of HAE in the EDEMA3 and EDEMA4 trials. Adverse events were mostly of mild to moderate severity, and no event that was more common in ecallantide than placebo recipients occurred in >10% of patients.
依卡兰肽是一种重组蛋白，是一种选择性、高效和可逆的人血浆激肽释放酶抑制剂，用于治疗 >or=16 岁的遗传性血管性水肿（HAE）急性发作。在 EDEMA3 这一随机、双盲、安慰剂对照、多中心、III 期试验中，使用治疗结局评分（TOS；主要终点）评估，与安慰剂相比，单次皮下给予依卡兰肽 30mg 治疗，患者的症状应答在 4 小时时显著更大。此外，与安慰剂相比，依卡兰肽治疗 4 小时时症状严重程度的平均变化（使用平均症状综合严重程度[MSCS]量表评估）显著更大。在同样设计的 EDEMA4 试验中，在 4 小时时，单次皮下给予依卡兰肽 30mg 的患者的 MSCS 评分（主要终点）和 TOS 的平均变化均显著大于安慰剂组。在 EDEMA3 和 EDEMA4 试验中，急性 HAE 发作的患者接受依卡兰肽 30mg 皮下注射通常具有良好的耐受性。不良反应大多为轻至中度，且没有任何事件在依卡兰肽组比安慰剂组更常见（发生率大于 10%）。
