Cooper S A, Reynolds D C, Reynolds B, Hersh E V
Department of Clinical Research, Whitehall-Robins Healthcare, Madison, NJ, USA.
J Clin Pharmacol. 1998 Feb;38(2S):11S-18S. doi: 10.1002/j.1552-4604.1998.tb04412.x.
This double-blind, randomized, parallel-group study compared the analgesic efficacy and safety of single doses of (R)- ketoprofen 25 mg and 100 mg to that of acetaminophen 1,000 mg and placebo in 177 patients experiencing moderate to severe pain after surgical removal of their impacted third molars. Both (R)- ketoprofen 100 mg and acetaminophen 1,000 mg were significantly (P < 0.05) more efficacious than placebo for all summary analgesic measures. Other than a more rapid analgesic onset (45 minutes versus 60 minutes) for acetaminophen 1,000 mg, (R)- ketoprofen 100 mg and acetaminophen 1,000 mg were statistically equivalent to each other. The 25 mg dose of (R)- ketoprofen appeared to approach the analgesic threshold dose, being numerically but not statistically superior to placebo for all summary measures. There were no serious adverse events observed in this study, with the overall incidence of side effects being somewhat less in the (R)- ketoprofen groups than in the acetaminophen 1,000 mg group. (R)- Ketoprofen possesses analgesic activity and an acceptable side-effect profile in the oral surgery pain model.
这项双盲、随机、平行组研究比较了单剂量25毫克和100毫克的（R）-酮洛芬与1000毫克对乙酰氨基酚及安慰剂对177例拔除阻生第三磨牙后出现中度至重度疼痛患者的镇痛效果和安全性。对于所有总体镇痛指标，100毫克的（R）-酮洛芬和1000毫克的对乙酰氨基酚均显著（P<0.05）优于安慰剂。除了1000毫克对乙酰氨基酚的镇痛起效更快（45分钟对60分钟）外，100毫克的（R）-酮洛芬和1000毫克的对乙酰氨基酚在统计学上彼此等效。25毫克剂量的（R）-酮洛芬似乎接近镇痛阈值剂量，在所有总体指标上数值上优于安慰剂，但无统计学意义。本研究未观察到严重不良事件，（R）-酮洛芬组的副作用总发生率略低于1000毫克对乙酰氨基酚组。在口腔手术疼痛模型中，（R）-酮洛芬具有镇痛活性和可接受的副作用特征。
