Analgesic efficacy and safety of nonprescription doses of naproxen sodium compared with acetaminophen in the treatment of osteoarthritis of the knee.
Analgesic efficacy and safety of nonprescription doses of naproxen sodium compared with acetaminophen in the treatment of osteoarthritis of the knee.
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DOI：
10.1097/00045391-200403000-00002
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发表时间：
2004-03-01
影响因子：
4.2
通讯作者：
Minic, Milos
中科院分区：
文献类型：
--
作者：
Golden, Harvey E;Moskowitz, Roland W;Minic, Milos
对非处方剂量的萘普生钠、对乙酰氨基酚和安慰剂进行了比较，以确定它们在膝骨性关节炎中的有效性和安全性。在两项相同的多中心、随机、双盲、安慰剂对照、多剂量、平行设计研究中，年龄(平均+/-SD)为60.6+/-12.8岁的骨关节炎患者被随机分成三组，每天服用660毫克的萘普生钠(患者年龄为440毫克，或65岁)、4000毫克的对乙酰氨基酚，或服用安慰剂，疗程为7天。与安慰剂相比，萘普生钠(440/660 mg)对休息时疼痛、被动运动、负重、休息后僵硬(早晨)、昼夜疼痛的改善作用显著增强，对静息疼痛的缓解作用明显优于对乙酰氨基酚(P<；0.05)。与安慰剂相比，对乙酰氨基酚对白天疼痛的改善作用明显更大。日常评估显示，萘普生钠(440/660毫克)比对乙酰氨基酚具有更好的止痛效果，在减少行走几个街区的困难以及弯曲、抬起和弯腰困难方面明显优于对乙酰氨基酚。萘普生钠(440/660毫克)和对乙酰氨基酚(4000毫克)在改善活动水平、家务以及行走和弯曲方面明显比安慰剂有效。与安慰剂相比，萘普生钠和对乙酰氨基酚组的患者和研究人员的评估得分显著更高；在积极的治疗之间没有观察到差异。萘普生钠和对乙酰氨基酚的安全性与安慰剂相似。非处方剂量的萘普生钠(440/660毫克)有效缓解疼痛和其他骨关节炎症状。在骨性关节炎的初始治疗中，萘普生钠是一种替代方案，在中度或重度疼痛的患者中，它可能比对乙酰氨基酚更适合作为一线治疗。
Nonprescription doses of naproxen sodium, acetaminophen, and placebo were compared to determine their efficacy and safety in osteoarthritis of the knee. In two identical multicenter, randomized, double-blind, placebo-controlled, multidose, parallel-design studies, patients with osteoarthritis aged (mean +/- SD) 60.6 +/- 12.8 years were randomized to daily doses of 660 mg naproxen sodium (440 mg naproxen sodium in patients >or=65 years), 4000 mg acetaminophen, or placebo for 7 days. Naproxen sodium (440/660 mg) provided significantly greater improvements in pain at rest, on passive motion, on weight-bearing, stiffness after rest (morning), day and night pain compared with placebo, and significantly greater relief from resting pain than acetaminophen (P < 0.05). Acetaminophen provided significantly greater improvements in day pain compared with placebo. Daily evaluations showed naproxen sodium (440/660 mg) provided superior pain relief to acetaminophen and was significantly better than acetaminophen at reducing difficulties experienced in walking several blocks and difficulties in bending, lifting, and stooping. Naproxen sodium (440/660 mg) and acetaminophen (4000 mg) were significantly more effective than placebo in improving mobility level, household tasks, and walking and bending. Patient and investigator evaluation scores were significantly higher in naproxen sodium and acetaminophen groups compared with placebo; no differences were observed between active treatments. Naproxen sodium and acetaminophen had similar safety profiles to placebo. Nonprescription doses of naproxen sodium (440/660 mg) effectively relieve pain and other symptoms of osteoarthritis. Naproxen sodium is an alternative in the initial treatment of osteoarthritis and may be preferred to acetaminophen as first-line therapy in patients with moderate or severe pain.