Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee - A randomized trial
Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee - A randomized trial
复制标题
DOI：
10.1001/jama.287.1.64
复制
发表时间：
2002-01-02
影响因子：
120.7
通讯作者：
Schnitzer, TJ
中科院分区：
文献类型：
--
作者：
Geba, GP;Weaver, AL;Schnitzer, TJ
骨关节炎（OA）通常用非甾体类抗炎药（NSAIDs）、对乙酰氨基酚或特异性环氧合酶2 （COX-2）抑制剂治疗。目的评价罗非昔布、塞来昔布和对乙酰氨基酚治疗成人OA的相对疗效。设计与设置随机、平行、双盲试验，1999年6月至2000年2月在美国29个临床中心进行。患者382例年龄≥40岁的膝关节OA患者，既往用非甾体抗炎药或对乙酰氨基酚治疗。干预措施患者随机分配接受罗非昔布12.5 mg/d (n=96)；罗非昔布25 mg/d (n=95)；塞来昔布，200 mg/d (n=97)；或对乙酰氨基酚，4000 mg/d (n=94)，持续6周。第1至6天和6周的评估包括步行疼痛、夜间疼痛、休息时疼痛和早晨僵硬，测量方法为西安大略麦克马斯特大学骨关节炎指数（100毫米视觉模拟量表[VAS]），并比较4个治疗组对治疗的总体反应。结果79%的患者完成了研究，使用对乙酰氨基酚治疗的患者比使用COX-2抑制剂治疗的患者更早因缺乏疗效而停止治疗（31%比18%-19%）。在治疗前6天的疗效评估中，罗非昔布25mg /d的疗效最好，其次是罗非昔布12.5 mg/d，塞来昔布和对乙酰氨基酚（VAS变化-32.2,-29.0,-26.4和-20.6 mm）， P小于或等于。对乙酰氨基酚和其他所有人是04；25 mg罗非昔布vs塞来昔布P= 0.05)，静息痛(-21.8,-18.6,-15.5和-12.5 mm； P小于或等于。罗非昔布与对乙酰氨基酚的两种剂量的P值均为0.02，罗非昔布25 mg/d与塞来昔布的P值均为0.02)，夜痛（-25.2,-22.0,-18.7和-18.8 mm；罗非昔布25 mg/d与对乙酰氨基酚和塞来昔布的P值均为0.04），晨僵硬(-30.4,-28.4,-25.7和-20.9 mm； P小于或等于。rofecoxib和acetaminophen的剂量均为02)。6周后，罗非昔布25mg /d对夜间疼痛的缓解效果最好(P
Context Osteoarthritis (OA) is often treated with nonsteroidal ant-inflammatory drugs (NSAIDs), acetaminophen, or specific inhibitors of cyclooxygenase 2 (COX-2).Objective To assess the relative therapeutic efficacy of rofecoxib, celecoxib, and acetaminophen in adults with OA.Design and Setting Randomized, parallel-group, double-blind trial, conducted from June 1999 to February 2000, in 29 clinical centers in the United States.Patients Three hundred eighty-two patients aged at least 40 years who had OA of the knee that was previously treated with NSAIDs or acetaminophen.Interventions Patients were randomly assigned to receive rofecoxib, 12.5 mg/d (n=96); rofecoxib 25 mg/d (n=95); celecoxib, 200 mg/d (n=97); or acetaminophen, 4000 mg/d (n=94) for 6 weeks.Main Outcome Measures Assessments over days 1 to 6 and over 6 weeks included pain on walking, night pain, pain at rest, and morning stiffness as measured on a Western Ontario McMaster Universities Osteoarthritis Index (100-mm visual analog scale [VAS]) and global response to therapy compared among 4 treatment groups.Results 79% of patients completed the study, More patients treated with acetaminophen discontinued early due to lack of efficacy than patients treated with COX-2 inhibitors (31% vs 18%-19%). Efficacy assessed in the first 6 days of therapy showed greatest response to rofecoxib, 25 mg/d, followed by rofecoxib, 12.5 mg/d, celecoxib, and acetaminophen, respectively, in terms of relief of pain on walking (-32.2, -29.0, -26.4, and -20.6 mm change on the VAS; P less than or equal to .04 for all others vs acetaminophen; P=.05 for 25-mg rofecoxib vs celecoxib), rest pain (-21.8, -18.6, -15.5, and -12.5 mm; P less than or equal to .02 for either dose of rofecoxib vs acetaminophen and P=.02 for rofecoxib, 25 mg/d, vs celecoxib), night pain (-25.2, -22.0, -18.7, and -18.8 mm; P=.04 for rofecoxib, 25 mg/d, vs both acetaminophen and celecoxib), and morning stiffness (-30.4,-28.4,-25.7, and -20.9 mm; P less than or equal to .02 for either dose of rofecoxib vs acetaminophen). Over 6 weeks, rofecoxib, 25 mg/d, provided greatest response for night pain (P