Camu Frederic, Beecher Tessa, Recker David P, Verburg Kenneth M
Academisch Ziekenhuis, Vrije Universiteit Brussel, Brussels, Belgium.
Am J Ther. 2002 Jan-Feb;9(1):43-51. doi: 10.1097/00045391-200201000-00009.
Opioid agents are highly effective analgesics after orthopedic surgery but are associated with several adverse effects. Valdecoxib is a new, highly selective cyclooxygenase (COX)-2-specific inhibitor with a rapid onset of action and significant analgesic properties that is being developed for the management of acute pain. The objective of this study was to demonstrate the opioid-sparing efficacy of valdecoxib as part of a multimodal treatment of pain associated with hip arthroplasty. This multicenter, multiple-dose, double-blind, parallel-group study compared the opioid-sparing effects, analgesic efficacy, and safety of 20- and 40-mg doses of valdecoxib twice daily with placebo in patients receiving morphine by patient-controlled analgesia after hip arthroplasty. Study medication was first administered 1 to 3 hours preoperatively. The total amount of morphine administered, pain intensity, and patient's global evaluation of study medication were assessed over a period of 48 hours. Patients receiving 20 or 40 mg valdecoxib twice daily required on average 40% less morphine than those receiving placebo after hip arthroplasty. Pain intensity levels and patient satisfaction were significantly improved in both valdecoxib groups compared with placebo. Valdecoxib and placebo were equally well tolerated. Pre- and postoperative administration of valdecoxib reduces the amount of morphine required for postoperative pain relief and provides greater analgesic efficacy compared with morphine alone. Thus, valdecoxib has significant clinical utility for acute pain management in orthopedic surgery patients.
阿片类药物是骨科手术后高效的镇痛药,但会产生多种不良反应。伐地昔布是一种新型、高选择性的环氧化酶(COX)-2特异性抑制剂,起效迅速且具有显著的镇痛特性,目前正被开发用于治疗急性疼痛。本研究的目的是证明伐地昔布作为髋关节置换术相关疼痛多模式治疗的一部分具有节省阿片类药物的疗效。这项多中心、多剂量、双盲、平行组研究,比较了髋关节置换术后采用患者自控镇痛法使用吗啡的患者,每日两次服用20毫克和40毫克伐地昔布与安慰剂相比,在节省阿片类药物效果、镇痛疗效及安全性方面的差异。研究药物在术前1至3小时首次给药。在48小时内评估吗啡的给药总量、疼痛强度以及患者对研究药物的总体评价。髋关节置换术后,每日两次服用20毫克或40毫克伐地昔布的患者,平均所需吗啡量比服用安慰剂的患者少40%。与安慰剂组相比,两个伐地昔布组的疼痛强度水平和患者满意度均有显著改善。伐地昔布和安慰剂的耐受性相当。术前和术后使用伐地昔布可减少术后缓解疼痛所需的吗啡量,与单独使用吗啡相比,镇痛效果更佳。因此,伐地昔布在骨科手术患者急性疼痛管理方面具有显著的临床应用价值。