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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Double-blind, single-dose comparison of bromfenac sodium, tramadol, and placebo after oral surgery.
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Double-blind, single-dose comparison of bromfenac sodium, tramadol, and placebo after oral surgery.

机译：口服手术后的溴芬酸钠，曲马多和安慰剂的双盲，单剂量比较。

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This double-blind, parallel-group study was performed at a single site in patients with moderate or severe pain after oral surgery to remove one or more impacted third molars. Patients recorded their pain intensity at baseline and were then assigned to receive a single dose of bromfenac sodium (25 mg or 50 mg), tramadol (100 mg), or placebo, using a randomized double-blind code. At regular intervals for up to 8 hours after study drug administration, pain intensity and pain relief were recorded and were used to derive the efficacy variables, total pain relief (TOTPAR), pain intensity difference (PID), and summed pain intensity difference (SPID). Both doses of bromfenac were superior to tramadol and placebo in terms of hourly and peak pain relief and PID. The 3-hour and 8-hour TOTPAR and SPID results for both doses of bromfenac also were significantly superior to those for tramadol and placebo, whereas the scores for tramadol did not show superiority to placebo. Similarly, both doses of bromfenac were superior to tramadol and placebo as measured by patient global assessment, time to meaningful pain relief, and duration of pain relief. Bromfenac was well tolerated and was equivalent to placebo with respect to treatment-emergent study events. Overall, significantly more study events (total), digestive events (particularly nausea and vomiting), and nervous system events (particularly dizziness) occurred in patients treated with tramadol than in those in other treatment groups. Single oral doses of bromfenac were more effective, longer-acting, and better tolerated than single doses of tramadol in providing pain relief after oral surgery.
机译：这项双盲，平行组研究是在口腔手术后中度或重度疼痛的患者的单个部位进行的，以去除一个或多个受影响的第三磨牙。患者在基线时记录了他们的疼痛强度，然后使用随机双盲代码分配接受单剂量的溴芬酸钠（25 mg或50 mg），曲马多（100 mg）或安慰剂。在研究药物给药后的8个小时内定期记录疼痛强度和缓解疼痛，并用于得出功效变量，总缓解疼痛（TOTPAR），疼痛强度差异（PID）和总疼痛强度差异（SPID） ）。就每小时和峰值疼痛缓解和PID而言，两种剂量的溴芬酸均优于曲马多和安慰剂。两种剂量的溴芬酸的3小时和8小时TOTPAR和SPID结果也显着优于曲马多和安慰剂，而曲马多的得分并未显示出优于安慰剂。同样，通过患者总体评估，有效缓解疼痛的时间以及缓解持续时间，两种剂量的溴芬酸均优于曲马多和安慰剂。溴芬酸具有很好的耐受性，并且在治疗紧急的研究事件方面等同于安慰剂。总体而言，曲马多治疗的患者发生的研究事件（总数），消化事件（尤其是恶心和呕吐）和神经系统事件（尤其是头晕）的发生率明显高于其他治疗组。口服单剂量的溴芬酸比单剂量的曲马多更有效，更长效且耐受性更好，可在口腔手术后缓解疼痛。

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