Jackson I D, Heidemann B H, Wilson J, Power I, Brown R D
Edinburgh Dental Institute, Lauriston Building, Lauriston Place, Edinburgh EH3 9YW, UK.
Br J Anaesth. 2004 May;92(5):675-80. doi: 10.1093/bja/aeh131. Epub 2004 Mar 19.
Rofecoxib, a selective cyclooxygenase-2 inhibitor, and dexketoprofen trometamol, a single isomer non-steroidal anti-inflammatory drug (NSAID), are available for the treatment of acute pain. Both are claimed to have fewer adverse effects than traditional NSAIDs. We have compared them in a clinical setting.
We performed a double-blind randomized controlled trial involving 120 patients undergoing surgical removal of a single mandibular third molar at the Edinburgh Dental Institute. Those who developed moderate pain within 4 h of the procedure were allocated to one of three groups: rofecoxib 50 mg (Group RO, n=37); dexketoprofen trometamol 25 mg (Group DE, n=42); or placebo (Group PL, n=41). Participants monitored pain intensity and pain relief for 24 h using visual analogue scales (VAS) and verbal rating scales (VRS). The summed, time-weighted pain relief score to 8 h derived from the VRS (TOTPAR 8) was used as the primary outcome variable.
No significant difference was demonstrated between Groups RO and DE using TOTPAR 8 as the primary outcome variable. Both drugs were significantly different compared with placebo. Rescue analgesia during the trial period was required by only 15 out of 37 subjects in Group RO, but 35 out of 42 subjects in Group DE. The median times to use of rescue medication were 150 (Group PL), 398 (Group DE) and 1440 min (Group RO). Both drugs were well tolerated and adverse events reported were mild to moderate in severity.
Rofecoxib and dexketoprofen trometamol are effective treatments for acute pain using a dental pain model and are well tolerated. Rofecoxib has a longer duration of action as a single dose and gave adequate analgesia for over half of that study group; patients in the dexketoprofen trometamol group needed more rescue analgesia.
罗非昔布，一种选择性环氧化酶 -2 抑制剂，以及右酮洛芬氨丁三醇，一种单一异构体非甾体抗炎药（NSAID），可用于治疗急性疼痛。二者均声称比传统 NSAIDs 具有更少的不良反应。我们在临床环境中对它们进行了比较。
我们在爱丁堡牙科研究所进行了一项双盲随机对照试验，涉及 120 例接受单颗下颌第三磨牙手术拔除的患者。那些在手术 4 小时内出现中度疼痛的患者被分配到三个组之一：罗非昔布 50 毫克（RO 组，n = 37）；右酮洛芬氨丁三醇 25 毫克（DE 组，n = 42）；或安慰剂（PL 组，n = 41）。参与者使用视觉模拟量表（VAS）和语言评定量表（VRS）监测 24 小时的疼痛强度和疼痛缓解情况。从 VRS 得出的至 8 小时的累计、时间加权疼痛缓解评分（TOTPAR 8）用作主要结局变量。
以 TOTPAR 8 作为主要结局变量时，RO 组和 DE 组之间未显示出显著差异。与安慰剂相比，两种药物均有显著差异。在试验期间，RO 组 37 名受试者中只有 15 人需要解救镇痛，但 DE 组 42 名受试者中有 35 人需要。使用解救药物的中位时间分别为 150 分钟（PL 组）、398 分钟（DE 组）和 1440 分钟（RO 组）。两种药物耐受性良好，报告的不良事件严重程度为轻度至中度。
在牙科疼痛模型中，罗非昔布和右酮洛芬氨丁三醇是治疗急性疼痛的有效药物，且耐受性良好。罗非昔布单剂量的作用持续时间更长，该研究组超过半数患者获得了充分镇痛；右酮洛芬氨丁三醇组的患者需要更多的解救镇痛。
