在一项双盲、随机对照试验中评估依托考昔在全膝关节置换手术患者中的应用。
Evaluation of etoricoxib in patients undergoing total knee replacement surgery in a double-blind, randomized controlled trial.
机构信息
Department of Anaesthesiology and Intensive Care, Orebro University Hospital, Örebro, SE 701 85, Sweden.
出版信息
BMC Musculoskelet Disord. 2013 Oct 24;14:300. doi: 10.1186/1471-2474-14-300.
BACKGROUND
Optimal postoperative pain management is important to ensure patient comfort and early mobilization.
METHODS
In this double-blind, placebo- and active-controlled, randomized clinical trial, we evaluated postoperative pain following knee replacement in patients receiving placebo, etoricoxib (90 or 120 mg), or ibuprofen 1800 mg daily for 7 days. Patients ≥18 years of age who had pain at rest ≥5 (0-10 Numerical Rating Scale [NRS]) after unilateral total knee replacement were randomly assigned to placebo (N = 98), etoricoxib 90 mg (N = 224), etoricoxib 120 mg (N = 230), or ibuprofen 1800 mg (N = 224) postoperatively. Co-primary endpoints included Average Pain Intensity Difference at Rest over Days 1-3 (0- to 10-point NRS) and Average Total Daily Dose of Morphine over Days 1-3. Pain upon movement was evaluated using Average Pain Intensity Difference upon Knee Flexion (0- to 10-point NRS). The primary objective was to demonstrate analgesic superiority for the etoricoxib doses vs. placebo; the secondary objective was to demonstrate that the analgesic effect of the etoricoxib doses was non-inferior to ibuprofen. Adverse experiences (AEs) including opioid-related AEs were evaluated.
RESULTS
The least squares (LS) mean (95% CI) differences from placebo for Pain Intensity Difference at Rest over Days 1-3 were -0.54 (-0.95, -0.14); -0.49 (-0.89, -0.08); and -0.45 (-0.85, -0.04) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.05 for etoricoxib vs. placebo). Differences in LS Geometric Mean Ratio morphine use over Days 1-3 from placebo were 0.66 (0.54, 0.82); 0.69 (0.56, 0.85); and 0.66 (0.53, 0.81) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.001 for etoricoxib vs. placebo). Differences in LS Mean Pain Intensity upon Knee Flexion were -0.37 (-0.85, 0.11); -0.46 (-0.94, 0.01); and -0.42 (-0.90, 0.06) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively. Opioid-related AEs occurred in 41.8%, 34.7%, 36.5%, and 36.3% of patients on placebo, etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively.
CONCLUSIONS
Postoperative use of etoricoxib 90 and 120 mg in patients undergoing total knee replacement is both superior to placebo and non-inferior to ibuprofen in reducing pain at rest and also reduces opioid (morphine) consumption.
CLINICAL TRIAL REGISTRATION
NCT00820027.
背景
术后疼痛管理对于确保患者的舒适度和早期活动至关重要。
方法
在这项双盲、安慰剂和活性药物对照、随机临床试验中，我们评估了接受安慰剂、依托考昔（90 或 120mg）或布洛芬 1800mg 每日 1 次连续 7 天的单侧全膝关节置换术后患者的术后疼痛。年龄≥18 岁、单侧全膝关节置换术后静息时疼痛≥5（0-10 数字评定量表[NRS]）的患者被随机分配至安慰剂（n=98）、依托考昔 90mg（n=224）、依托考昔 120mg（n=230）或布洛芬 1800mg（n=224）组。主要终点包括第 1-3 天静息时平均疼痛强度差值（0-10 点 NRS）和第 1-3 天平均每日吗啡总剂量。通过膝关节屈曲时平均疼痛强度差值（0-10 点 NRS）评估运动时疼痛。主要目的是证明依托考昔剂量与安慰剂相比具有镇痛优势；次要目的是证明依托考昔剂量的镇痛效果不劣于布洛芬。评估了不良事件（AE），包括阿片类药物相关 AE。
结果
与安慰剂相比，第 1-3 天静息时疼痛强度差值的最小二乘（LS）均数（95%CI）分别为-0.54（-0.95，-0.14）、-0.49（-0.89，-0.08）和-0.45（-0.85，-0.04）；依托考昔 90mg、依托考昔 120mg 和布洛芬的吗啡使用量差异分别为 0.66（0.54，0.82）、0.69（0.56，0.85）和 0.66（0.53，0.81）（依托考昔与安慰剂相比，p<0.001）。第 1-3 天膝关节屈曲时平均疼痛强度的 LS 均数差异分别为-0.37（-0.85，0.11）、-0.46（-0.94，0.01）和-0.42（-0.90，0.06）；依托考昔 90mg、依托考昔 120mg 和布洛芬的阿片类药物相关 AE 发生率分别为 41.8%、34.7%、36.5%和 36.3%。
结论
在接受单侧全膝关节置换术的患者中，术后使用依托考昔 90 和 120mg 不仅在减轻静息时疼痛方面优于安慰剂，而且在减少阿片类药物（吗啡）消耗方面也不劣于布洛芬。
临床试验注册
NCT00820027。
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