Malmstrom Kerstin, Kotey Paul, Cichanowitz Nicole, Daniels Stephen, Desjardins Paul J
Clinical Immunology and Analgesia, Merck Research Laboratories, Rahway, NJ 07065, USA.
Gynecol Obstet Invest. 2003;56(2):65-9. doi: 10.1159/000072735. Epub 2003 Aug 4.
To determine the efficacy of etoricoxib in the treatment of primary dysmenorrhea.
Seventy-three women were randomly assigned to receive single oral doses of etoricoxib 120 mg, placebo, or naproxen sodium 550 mg at the onset of moderate to severe pain associated with menses. During 3 consecutive menstrual cycles in this double-blind, 3-period, crossover study, pain intensity and pain relief were assessed over the 24-hour period following dosing, and global ratings of therapy were made at 8 and 24 h after dosing. Tolerability was assessed by spontaneous reports of adverse experiences.
Etoricoxib 120 mg provided analgesic efficacy superior to placebo for the primary endpoint, total pain relief over 8 h (TOPAR8, p<0.001), and for all secondary endpoints (p<0.050). The analgesic effect of etoricoxib 120 mg over the first 8 h was similar to that of naproxen sodium 550 mg. All treatments were well tolerated.
Etoricoxib 120 mg provided rapid and sustained analgesia that was superior to placebo and similar to that of naproxen sodium 550 mg.
确定依托考昔治疗原发性痛经的疗效。
73名女性在与月经相关的中度至重度疼痛发作时，被随机分配接受单次口服120毫克依托考昔、安慰剂或550毫克萘普生钠。在这项双盲、3阶段、交叉研究的连续3个月经周期中，在给药后的24小时内评估疼痛强度和疼痛缓解情况，并在给药后8小时和24小时进行总体治疗评分。通过自发报告的不良经历评估耐受性。
对于主要终点，即8小时内的总疼痛缓解（TOPAR8，p<0.001）以及所有次要终点（p<0.050），120毫克依托考昔的镇痛效果优于安慰剂。120毫克依托考昔在前8小时的镇痛效果与550毫克萘普生钠相似。所有治疗耐受性良好。
120毫克依托考昔可提供快速且持续的镇痛效果，优于安慰剂，与550毫克萘普生钠相似。
