Daniels Stephen, Reader Sandie, Berry Phillip, Goulder Michael
Premier Research Group, Clinical Research Center, 3200 Red River, Austin, TX 78705, USA.
Eur J Clin Pharmacol. 2009 Apr;65(4):343-53. doi: 10.1007/s00228-009-0614-y. Epub 2009 Feb 28.
To compare the onset of action and efficacy of sodium ibuprofen (ibuprofen sodium dihydrate) and ibuprofen acid incorporating poloxamer (ibuprofen/poloxamer) with that of acetaminophen and placebo in patients with post-operative dental pain.
A double-blind, randomised, placebo-controlled, active comparator, two-centre study assessing the analgesic efficacy of sodium ibuprofen (512 mg, equivalent to 400 mg ibuprofen acid), ibuprofen/poloxamer (containing 400 mg ibuprofen acid and 120 mg poloxamer 407), acetaminophen (1000 mg) and placebo in patients with moderate-to-severe pain after third molar extraction (n = 322). Onset of action was assessed using the two-stopwatch technique, and pain intensity and relief were measured using validated traditional descriptor scales.
Significantly more patients achieved confirmed perceptible pain relief and meaningful pain relief with sodium ibuprofen (96.3%, P < 0.0001) and ibuprofen/poloxamer (90.0%, P = 0.0005) than with acetaminophen (67.5%). The onset of action of both ibuprofen formulations was comparable with that of acetaminophen up to 45 min post-dose; a marked divergence in onset times in favour of the ibuprofen formulations occurred from 45 min onward. Mean values for the area under the pain relief and pain intensity differences curve (0-6 h) were significantly greater for sodium ibuprofen (3.46) and ibuprofen acid (3.49) than for acetaminophen (2.25) (P < 0.001). Other pain relief and pain intensity endpoints favoured both ibuprofen formulations over acetaminophen. Distractibility from pain (6 h) was significantly greater with the ibuprofen formulations than with acetaminophen (P = 0.008 for sodium ibuprofen; P = 0.03 for ibuprofen/poloxamer). In patients receiving ibuprofen, pain interfered less with daily activities (at 1 and 6 h) than in those receiving acetaminophen (P <or= 0.015). Both ibuprofen formulations had significantly better mean global assessment scores than acetaminophen (P < 0.001). Tolerability profiles of the ibuprofen formulations were comparable with that of acetaminophen.
Compared with acetaminophen, sodium ibuprofen was associated with significantly greater analgesic efficacy, pain relief in a greater proportion of patients and greater patient satisfaction.
比较布洛芬钠（二水合布洛芬钠）和含泊洛沙姆的布洛芬酸（布洛芬/泊洛沙姆）与对乙酰氨基酚及安慰剂在术后牙痛患者中的起效时间和疗效。
一项双盲、随机、安慰剂对照、活性药物对照的双中心研究，评估布洛芬钠（512毫克，相当于400毫克布洛芬酸）、布洛芬/泊洛沙姆（含400毫克布洛芬酸和120毫克泊洛沙姆407）、对乙酰氨基酚（1000毫克）和安慰剂对322例拔除第三磨牙后中重度疼痛患者的镇痛效果。采用双秒表技术评估起效时间，使用经过验证的传统描述性量表测量疼痛强度和缓解情况。
与对乙酰氨基酚（67.5%）相比，使用布洛芬钠（96.3%，P<0.0001）和布洛芬/泊洛沙姆（90.0%，P = 0.0005）实现可确认的明显疼痛缓解和有效疼痛缓解的患者显著更多。两种布洛芬制剂在给药后45分钟内的起效时间与对乙酰氨基酚相当；从45分钟起，起效时间出现明显差异，有利于布洛芬制剂。布洛芬钠（3.46）和布洛芬酸（3.49）的疼痛缓解和疼痛强度差异曲线下面积（0 - 6小时）的平均值显著高于对乙酰氨基酚（2.25）（P<0.001）。其他疼痛缓解和疼痛强度终点指标显示，两种布洛芬制剂均优于对乙酰氨基酚。布洛芬制剂在6小时时从疼痛中分散注意力的能力显著高于对乙酰氨基酚（布洛芬钠P = 0.008；布洛芬/泊洛沙姆P = 0.03）。在接受布洛芬治疗的患者中，疼痛对日常活动的干扰在1小时和6小时时均少于接受对乙酰氨基酚治疗的患者（P≤0.015）。两种布洛芬制剂的平均总体评估得分均显著优于对乙酰氨基酚（P<0.001）。布洛芬制剂的耐受性与对乙酰氨基酚相当。
与对乙酰氨基酚相比，布洛芬钠具有显著更高的镇痛效果，更多患者实现疼痛缓解，患者满意度更高。
