Lehmann Reiner, Brzosko Marek, Kopsa Petr, Nischik Ruth, Kreisse Andreas, Thurston Helen, Litschig Stephane, Sloan Victor S
Klinische Forschung Berlin Buch, Berlin, Germany.
Curr Med Res Opin. 2005 Apr;21(4):517-26. doi: 10.1185/030079905x38196.
To determine the efficacy and safety of lumiracoxib for knee osteoarthritis (OA).
This was a 13-week, multicentre, randomized, double-blind, double-dummy, placebo-controlled study. Males or females aged >/= 18 years with primary knee OA received lumiracoxib 100 mg od, lumiracoxib 100 mg od with a loading dose of 200 mg od for the first two weeks, celecoxib 200 mg od, or placebo.
Co-primary variables, assessed at week 13, were OA pain intensity in the target knee, patient's global assessment of disease activity and the WOMAC total score. Other variables included OMERACT-OARSI responder rates and WOMAC subscale scores. Safety and tolerability were evaluated.
All active treatments were superior to placebo for all co-primary variables. No significant differences were observed between any active treatments. Mean reductions from baseline to week 13 for lumiracoxib 100mg od, 100mg od with loading dose, celecoxib and placebo, respectively, were: OA pain intensity in the target knee: 26.8, 26.2, 26.6 and 21.4mm (all p < 0.01 vs. placebo); patient's global assessment of disease activity: 25.1, 21.9, 22.9 and 18.9 mm (all p < 0.05 vs. placebo); WOMAC total score: 15.2, 14.8, 14.7 and 11.3 (all p < 0.01 vs. placebo). Lumiracoxib was superior to placebo and similar to celecoxib for OMERACT-OARSI response and WOMAC subscale scores. Lumiracoxib was well tolerated. The incidence of adverse events was similar across groups.
Lumiracoxib 100 mg od provided effective relief from the pain of knee OA, with efficacy similar to celecoxib 200 mg od, and was well tolerated.
确定鲁米昔布治疗膝骨关节炎（OA）的有效性和安全性。
这是一项为期13周的多中心、随机、双盲、双模拟、安慰剂对照研究。年龄≥18岁的原发性膝OA男性或女性患者接受鲁米昔布100mg每日一次、鲁米昔布100mg每日一次且前两周给予200mg每日一次的负荷剂量、塞来昔布200mg每日一次或安慰剂治疗。
在第13周评估的共同主要变量为目标膝关节的OA疼痛强度、患者对疾病活动的整体评估以及WOMAC总分。其他变量包括OMERACT - OARSI缓解率和WOMAC子量表评分。对安全性和耐受性进行了评估。
对于所有共同主要变量，所有活性治疗均优于安慰剂。在任何活性治疗之间未观察到显著差异。从基线到第13周，鲁米昔布100mg每日一次、100mg每日一次且有负荷剂量、塞来昔布和安慰剂的平均降低值分别为：目标膝关节的OA疼痛强度：26.8、26.2、26.6和21.4mm（与安慰剂相比，所有p < 0.01）；患者对疾病活动的整体评估：25.1、21.9、22.9和18.9mm（与安慰剂相比，所有p < 0.05）；WOMAC总分：15.2、14.8、14.7和11.3（与安慰剂相比，所有p < 0.01）。在OMERACT - OARSI反应和WOMAC子量表评分方面，鲁米昔布优于安慰剂且与塞来昔布相似。鲁米昔布耐受性良好。各组不良事件的发生率相似。
鲁米昔布100mg每日一次可有效缓解膝OA疼痛，疗效与塞来昔布200mg每日一次相似，且耐受性良好。
