Saag K, van der Heijde D, Fisher C, Samara A, DeTora L, Bolognese J, Sperling R, Daniels B
Division of Clinical Immunology and Rheumatology, University of Alabama, Birmingham, USA.
Arch Fam Med. 2000 Nov-Dec;9(10):1124-34. doi: 10.1001/archfami.9.10.1124.
Rofecoxib, a cyclooxygenase 2 inhibitor (sometimes known as a specific cyclooxygenase 2 inhibitor or Coxib), is used in osteoarthritis (OA). Published information indicates rofecoxib's improved gastrointestinal safety profile over nonselective nonsteroidal anti-inflammatory agents (NSAIDs).
To evaluate the efficacy and safety of rofecoxib in treating OA in 2 studies.
Two randomized, double-blind, parallel-group studies in patients with OA of the knee or hip were conducted using identical entry criteria and end points. A 6-week placebo-controlled trial in 736 patients compared 12.5 and 25 mg of rofecoxib once daily with 800 mg of ibuprofen 3 times daily, and a 1-year study compared 12.5 and 25 mg of rofecoxib once daily with 50 mg of diclofenac 3 times daily in 693 patients.
Rofecoxib, at 12.5 and 25 mg, demonstrated efficacy clinically comparable with ibuprofen, assessed by 3 primary end points according to predefined comparability criteria. Both rofecoxib doses and ibuprofen provided significantly greater efficacy than placebo on all primary end points at 6 weeks. Both rofecoxib doses and diclofenac showed similar efficacy over 1 year. All treatments were well tolerated.
Rofecoxib is effective in treating OA with once-daily dosing for 6 weeks and 1 year. Rofecoxib was generally safe and well-tolerated in OA patients for 6 weeks and 1 year. Arch Fam Med. 2000;9:1124-1134
罗非昔布是一种环氧化酶-2抑制剂（有时也被称为特异性环氧化酶-2抑制剂或昔布类药物），用于治疗骨关节炎（OA）。已发表的信息表明，与非选择性非甾体抗炎药（NSAIDs）相比，罗非昔布具有更好的胃肠道安全性。
在两项研究中评估罗非昔布治疗OA的疗效和安全性。
对膝或髋骨关节炎患者进行了两项随机、双盲、平行组研究，采用相同的纳入标准和终点。一项为期6周的安慰剂对照试验，纳入736例患者，比较每日一次服用12.5mg和25mg罗非昔布与每日三次服用800mg布洛芬的疗效；另一项为期1年的研究，纳入693例患者，比较每日一次服用12.5mg和25mg罗非昔布与每日三次服用50mg双氯芬酸的疗效。
根据预定义的可比性标准，通过3个主要终点评估，12.5mg和25mg的罗非昔布在临床上显示出与布洛芬相当的疗效。在6周时，罗非昔布的两个剂量组和布洛芬在所有主要终点上均比安慰剂具有显著更高的疗效。罗非昔布的两个剂量组和双氯芬酸在1年的时间里显示出相似的疗效。所有治疗的耐受性均良好。
罗非昔布每日一次给药6周和1年治疗OA有效。在OA患者中，罗非昔布在6周和1年的时间里总体上是安全且耐受性良好的。《家庭医学文献》。2000年；9：1124 - 1134
