Fricke James, Varkalis John, Zwillich Sam, Adler Rebecca, Forester Eliot, Recker David P, Verburg Kenneth M
PPD Development, Dental Center, Austin, Texas, USA.
Am J Ther. 2002 Mar-Apr;9(2):89-97. doi: 10.1097/00045391-200203000-00003.
Inhibition of the cyclooxygenase (COX)-2 enzyme has been shown previously to reduce pain and inflammation. Valdecoxib is a new highly selective COX-2 inhibitor with a rapid onset of action and significant analgesic properties. This study compared the analgesic efficacy of valdecoxib and rofecoxib in treating postoperative pain in patients undergoing oral surgery. This randomized, double-blind, placebo-controlled study compared the efficacy of 40 mg valdecoxib with that of 50 mg rofecoxib and placebo. Efficacy was assessed by the onset of analgesia, pain intensity levels, and pain relief over 24 hours, time-weighted sum of total pain, sum of pain intensity difference, the percentage of patients requiring rescue medication and experiencing regimen failure, and patients' global evaluation. Patients receiving valdecoxib experienced a significantly quicker onset of analgesia, significantly improved pain relief, and lower pain intensity compared with patients receiving rofecoxib and greater satisfaction with their study medication after a single dose. Valdecoxib also demonstrated efficacy that was superior to that of rofecoxib with respect to the percentage of patients requiring rescue medication or experiencing regimen failure (p < or =.05). Valdecoxib, rofecoxib, and placebo were equally well tolerated. This study demonstrates that valdecoxib provides significantly greater analgesic efficacy than rofecoxib in the management of pain after oral surgery.
先前已证明,抑制环氧化酶(COX)-2可减轻疼痛和炎症。伐地昔布是一种新型的高选择性COX-2抑制剂,起效迅速,具有显著的镇痛特性。本研究比较了伐地昔布和罗非昔布在治疗口腔手术患者术后疼痛方面的镇痛效果。这项随机、双盲、安慰剂对照研究比较了40毫克伐地昔布与50毫克罗非昔布及安慰剂的疗效。通过镇痛起效时间、疼痛强度水平、24小时内的疼痛缓解情况、疼痛时间加权总和、疼痛强度差值总和、需要急救药物和治疗失败的患者百分比以及患者的总体评价来评估疗效。与接受罗非昔布的患者相比,接受伐地昔布的患者单次给药后镇痛起效明显更快,疼痛缓解显著改善,疼痛强度更低,对研究药物的满意度更高。在需要急救药物或治疗失败的患者百分比方面,伐地昔布的疗效也优于罗非昔布(p≤0.05)。伐地昔布、罗非昔布和安慰剂的耐受性相当。本研究表明,在口腔手术后疼痛的管理中,伐地昔布的镇痛效果明显优于罗非昔布。