Adis, a Wolters Kluwer Business, Mairangi Bay, North Shore, Auckland, New Zealand.
Drugs. 2010 Aug 20;70(12):1603-13. doi: 10.2165/11205470-000000000-00000.
Oral colchicine (Colcrys) is approved in the US for the treatment of acute gout flares in adult patients and the prophylaxis of gout flares in patients aged >16 years. Colchicine is a tricyclic alkaloid that interrupts multiple inflammatory response pathways. Its principal mechanism of action in gout is thought to be inhibition of cytoskeletal microtubule polymerization, an important process in neutrophil functioning. In a phase III, randomized, double-blind, placebo-controlled, multicentre trial, the recommended dosage of Colcrys (1.2 mg at the first sign of the flare, followed by 0.6 mg in 1 hour) was significantly more effective than placebo in treating acute gout flare, as assessed by the proportion of patients experiencing a >or=50% reduction in pain within 24 hours of initiating treatment. In a randomized, double-blind, placebo-controlled, single-centre trial, non-approved colchicine 0.6 mg once or twice daily (up to 6 months) was more effective than placebo in preventing gout flares in patients receiving allopurinol as urate-lowering therapy. At the recommended dosage for the treatment of acute gout flares, Colcrys was as well tolerated as placebo in patients with gout. The incidence of the most common adverse events was similar between recipients of the recommended dosage of Colcrys and placebo.
口服秋水仙碱(Colcrys)在美国获批用于治疗成年患者的急性痛风发作,以及预防年龄>16 岁的患者痛风发作。秋水仙碱是一种三环生物碱,可阻断多种炎症反应途径。其在痛风中的主要作用机制被认为是抑制细胞骨架微管聚合,这是中性粒细胞功能的重要过程。在一项 III 期、随机、双盲、安慰剂对照、多中心试验中,Colcrys(首次出现痛风发作时 1.2mg,1 小时后再服用 0.6mg)的推荐剂量在治疗急性痛风发作方面明显优于安慰剂,表现为在开始治疗后 24 小时内疼痛缓解≥50%的患者比例。在一项随机、双盲、安慰剂对照、单中心试验中,非批准的秋水仙碱 0.6mg 每日一次或两次(长达 6 个月)在预防接受别嘌醇降尿酸治疗的患者痛风发作方面比安慰剂更有效。在治疗急性痛风发作的推荐剂量下,Colcrys 的耐受性与安慰剂相当。接受 Colcrys 推荐剂量和安慰剂的患者最常见的不良反应发生率相似。