Analgesic efficacy of rofecoxib compared with codeine/acetaminophen using a model of acute dental pain.
Analgesic efficacy of rofecoxib compared with codeine/acetaminophen using a model of acute dental pain.
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DOI：
10.1016/j.tripleo.2005.04.026
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发表时间：
2005-10-01
期刊：
影响因子：
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通讯作者：
King, Thomas
中科院分区：
文献类型：
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作者：
Chang, David J;Bird, Steven R;King, Thomas
目的：为了确定单次口服罗非昔布50 mg与对乙酰氨基酚/可待因600/60 mg的镇痛效果，我们进行了一项双盲、随机、安慰剂和活性对照平行组研究。研究设计：患者（N = 390）在拔出2颗或更多第三磨牙后出现中度或重度疼痛，至少有1例下颌嵌塞，随机分为安慰剂组（N = 30）、罗非昔布组（N = 180）或可待因/对乙酰氨基酚60/600 mg组（N = 180）。记录确认可感知疼痛缓解的时间，以及患者对疼痛强度、疼痛缓解和整体评估的评估。结果：对于超过6小时的总疼痛缓解（主要终点），罗非昔布优于可待因/对乙酰氨基酚（15.5 vs 10.7; P < 0.001）。在TOPAR4、患者总体评估、疼痛峰值缓解和镇痛效果持续时间方面，罗非昔布在统计学上显著优于可待因/对乙酰氨基酚。两种药物的镇痛起效中位数相似。可待因/对乙酰氨基酚组有更多的患者出现1个或更多的不良事件。结论：罗非昔布镇痛效果优于可待因/对乙酰氨基酚，且胃肠道和神经系统不良反应较少。
OBJECTIVE: To determine analgesic efficacy of a single oral dose of rofecoxib 50 mg compared with acetaminophen/codeine 600/60 mg, we conducted a double-blind, randomized, placebo- and active-comparator-controlled, parallel-group study.STUDY DESIGN: Patients (N = 390) experiencing moderate or severe pain postextraction of 2 or more third molars, with at least 1 mandibular impaction, were randomized to placebo (n = 30), rofecoxib (n = 180), or codeine/acetaminophen 60/600 mg (n = 180). Time to confirmed perceptible pain relief, and patient evaluations of pain intensity, pain relief, and global assessments were recorded.RESULTS: For total pain relief over 6 hours (primary end point), rofecoxib was superior to codeine/acetaminophen (15.5 vs 10.7; P < .001). Rofecoxib was statistically significantly superior to codeine/acetaminophen with respect to TOPAR4, patient global assessment, peak pain relief, and duration of analgesic effect. Median onset of analgesia was similar for both drugs. The codeine/acetaminophen group had more patients with 1 or more adverse events.CONCLUSION: Rofecoxib provided superior analgesic efficacy compared with codeine/acetaminophen with fewer gastrointestinal and nervous system adverse events.