Rubin Bernard R, Burton Robert, Navarra Sandra, Antigua Joseph, Londoño John, Pryhuber Keith G, Lund Margaret, Chen Erluo, Najarian Daryl K, Petruschke Richard A, Ozturk Zafer E, Geba Gregory P
University of North Texas, Fort Worth, TX, USA.
Arthritis Rheum. 2004 Feb;50(2):598-606. doi: 10.1002/art.20007.
To evaluate the efficacy and safety of etoricoxib and indomethacin in the treatment of patients with acute gout.
A randomized, double-blind, active-comparator study was conducted at 42 sites. A total of 189 men and women (> or =18 years of age) who were experiencing an acute attack (< or =48 hours) of clinically diagnosed gout were treated for 8 days with etoricoxib, 120 mg/day (n = 103), or indomethacin, 50 mg 3 times a day (n = 86). The primary efficacy end point was the patient's assessment of pain in the study joint (0-4-point Likert scale) over days 2-5. Safety was assessed by adverse experiences (AEs) occurring during the trial.
Etoricoxib demonstrated clinical efficacy comparable to that of indomethacin in terms of the patient's assessment of pain in the study joint. The difference in the mean change from baseline over days 2-5 was -0.08 (95% confidence interval -0.29, 0.13) (P = 0.46), which fell within the prespecified comparability bounds of -0.5 to 0.5. Secondary end points over the 8-day study, including the onset of efficacy, reduction in signs of inflammation, and patient's and investigator's global assessments of response to therapy, confirmed the comparable efficacy of the two treatments. The etoricoxib-treated patients had a numerically lower incidence of AEs (43.7%) than did the indomethacin-treated patients (57.0%) and a significantly lower incidence of drug-related AEs (16.5% versus 37.2%; P < 0.05).
Etoricoxib at a dosage of 120 mg once daily was confirmed to be an effective treatment for acute gout. Etoricoxib was comparable in efficacy to indomethacin at a dosage of 50 mg 3 times daily, and it was generally safe and well tolerated.
评估依托考昔和吲哚美辛治疗急性痛风患者的疗效和安全性。
在42个地点进行了一项随机、双盲、活性对照研究。共有189名年龄≥18岁、临床诊断为痛风且急性发作（≤48小时）的男性和女性患者，分别接受依托考昔120毫克/天治疗8天（n = 103）或吲哚美辛50毫克每日3次治疗8天（n = 86）。主要疗效终点是患者在第2至5天对研究关节疼痛的评估（0 - 4级李克特量表）。通过试验期间发生的不良事件（AE）评估安全性。
在患者对研究关节疼痛的评估方面，依托考昔显示出与吲哚美辛相当的临床疗效。第2至5天相对于基线的平均变化差异为-0.08（95%置信区间-0.29, 0.13）（P = 0.46），落在预先设定的可比性界限-0.5至0.5内。8天研究期间的次要终点，包括疗效起效时间、炎症体征减轻以及患者和研究者对治疗反应的整体评估，均证实了两种治疗方法疗效相当。依托考昔治疗的患者不良事件发生率（43.7%）在数值上低于吲哚美辛治疗的患者（57.0%），且药物相关不良事件发生率显著更低（分别为16.5%和37.2%；P < 0.05）。
每日一次服用120毫克剂量的依托考昔被证实是治疗急性痛风的有效方法。依托考昔的疗效与每日3次服用50毫克剂量的吲哚美辛相当，且总体安全、耐受性良好。
