The Department of Rheumatology, the Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen.
The Department of Rheumatology, the Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine, Guiyang.
Rheumatology (Oxford). 2021 Sep 1;60(9):4199-4204. doi: 10.1093/rheumatology/keaa908.
Our objective was to determine whether initiation of febuxostat during an acute gout flare prolongs the current episode.
In this randomized, placebo-controlled, single-blinded, multicentre trial, patients with acute gout flares within 72 h were randomized (1:1) to the placebo and febuxostat (40 mg/day) groups. All patients were administered diclofenac (150 mg/day) for 7 days and then open-labelled on the eighth day. Febuxostat 40 mg daily and diclofenac 75 mg daily were administered from day 8 through 28 for the remission period. The dose of diclofenac was 150 mg/day before remission in both arms, and the original protocol was maintained until remission. The primary outcome was 'days to resolution'.
We randomized 140 patients, 70 into each arm. The mean days to resolution was 5.98 days [median 7.00, interquartile range (IQR) 2.45 days] for the placebo and 6.50 days (median 7.00, IQR 3.67 days) for the febuxostat group (P = 0.578). The rate of resolution within 7 days was 84.38% for the placebo group and 76.92% for the febuxostat group (P = 0.284). There were no statistically significant differences in joint pain, swelling, tenderness and erythema scores at days 1, 3, 5 and 7. The mean serum uric acid levels were 507.54 and 362.62 μmol/l for the placebo and febuxostat group, respectively, on day 7 (P = 0.000). The rate of recurrent gout flares was 10.00% for the placebo group and 6.56% for the febuxostat group from day 8 through 28 (P = 0.492).
Initiation of febuxostat administration during an acute gout flare did not prolong the duration of acute flares.
Chinese Clinical Trial Registry, http://www.chictr.org.cn/, ChiCTR1800015962.
本研究旨在确定急性痛风发作时起始使用非布司他是否会延长当前发作期。
这是一项随机、安慰剂对照、单盲、多中心试验，纳入 72 小时内出现急性痛风发作的患者，按 1:1 比例随机分至安慰剂和非布司他（40mg/天）组。所有患者均接受 7 天的双氯芬酸（150mg/天）治疗，然后在第 8 天开放标签治疗。缓解期内，非布司他 40mg 每日 1 次和双氯芬酸 75mg 每日 1 次治疗 28 天。在缓解期前，两组中双氯芬酸的剂量均为 150mg/天，且原方案一直维持到缓解期结束。主要结局为“缓解时间”。
本研究共纳入 140 例患者，每组 70 例。安慰剂组和非布司他组的平均缓解时间分别为 5.98 天[中位数 7.00，四分位距（IQR）2.45 天]和 6.50 天（中位数 7.00，IQR 3.67 天）（P=0.578）。安慰剂组 7 天内缓解率为 84.38%，非布司他组为 76.92%（P=0.284）。第 1、3、5 和 7 天，两组关节疼痛、肿胀、触痛和红斑评分无统计学差异。第 7 天，安慰剂组和非布司他组的血清尿酸水平分别为 507.54 和 362.62 μmol/L（P=0.000）。第 8 天至第 28 天，安慰剂组和非布司他组的复发性痛风发作率分别为 10.00%和 6.56%（P=0.492）。
急性痛风发作时起始使用非布司他并未延长急性发作期的持续时间。
中国临床试验注册中心，http://www.chictr.org.cn/，ChiCTR1800015962。
