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精氨酸布洛芬能有效缓解术后牙痛,且起效比布洛芬更快。

Ibuprofen arginate provides effective relief from postoperative dental pain with a more rapid onset of action than ibuprofen.

作者信息

Desjardins Paul, Black Peter, Papageorge Maria, Norwood Tom, Shen Danny D, Norris Lonnie, Ardia Alfredo

机构信息

Scirex Corporation, 3200 Red River Suite, Suite 300, Austin, TX 78705, USA.

出版信息

Eur J Clin Pharmacol. 2002 Sep;58(6):387-94. doi: 10.1007/s00228-002-0491-0. Epub 2002 Aug 2.

Abstract

Ibuprofen is a safe and effective analgesic, but some formulations have a slow onset of action. Ibuprofen arginate is a rapidly absorbed salt designed to promote more rapid onset of analgesia. A clinical trial was conducted in 226 patients with postoperative dental pain to assess the analgesic efficacy and speed of onset of the arginine salt of ibuprofen compared with one of the commercially available forms of ibuprofen. Patients were administered a single dose of either ibuprofen arginate (200 mg or 400 mg), ibuprofen (200 mg or 400 mg), or placebo in this double-blind, randomized trial. To determine the onset of action of the study medication patients were required to note time to "any" pain relief and then time to "meaningful" pain relief, using the two-stopwatch method. Pain intensity and relief were assessed using traditional categorical scales over a 6-h period. Meaningful pain relief was achieved in 42 min and 24 min for ibuprofen arginate 200 mg and 400 mg, respectively, compared with 50 min and 48 min for ibuprofen 200 mg and 400 mg, respectively ( P<0.05). The results for the measurements of analgesic effectiveness [sum of pain intensity difference, total pain relief (TOTPAR), peak pain relief and overall evaluation of treatment] all showed that both doses of ibuprofen arginate and both doses of ibuprofen were significantly better than placebo and both 200-mg and 400-mg ibuprofen arginate doses were significantly better than ibuprofen 200 mg for peak pain relief. Mean plasma ibuprofen concentrations at 30 min and 60 min, respectively, were: ibuprofen arginine 200 mg, 13.9 micro g/ml and 15.7 micro g/ml; ibuprofen arginine 400 mg, 29.5 micro g/ml and 29.3 micro g/ml; ibuprofen 200 mg 2.5 micro g/ml and 5 micro g/ml; ibuprofen 400 mg, 2.3 micro g/ml and 7.4 micro g/ml. ( P<0.05). Adverse event profiles were similar across treatment groups. These results overall suggest that ibuprofen arginate when taken at doses equivalent to commercially available ibuprofen formulations produces analgesia that is faster in onset.

摘要

布洛芬是一种安全有效的镇痛药,但某些制剂起效缓慢。精氨酸布洛芬是一种吸收迅速的盐类,旨在促进镇痛作用更快起效。开展了一项针对226例牙科术后疼痛患者的临床试验,以评估布洛芬精氨酸盐与一种市售布洛芬剂型相比的镇痛效果和起效速度。在这项双盲随机试验中,患者单次服用精氨酸布洛芬(200毫克或400毫克)、布洛芬(200毫克或400毫克)或安慰剂。为确定研究药物的起效时间,要求患者使用双秒表法记录达到“任何”疼痛缓解的时间,然后记录达到“显著”疼痛缓解的时间。在6小时内使用传统分类量表评估疼痛强度和缓解情况。布洛芬精氨酸200毫克和400毫克分别在42分钟和24分钟时实现显著疼痛缓解,相比之下,布洛芬200毫克和400毫克分别在50分钟和48分钟时实现显著疼痛缓解(P<0.05)。镇痛效果测量结果[疼痛强度差值总和、总疼痛缓解(TOTPAR)、最大疼痛缓解和治疗总体评估]均显示,两种剂量的布洛芬精氨酸盐和两种剂量的布洛芬均显著优于安慰剂,且200毫克和400毫克布洛芬精氨酸盐剂量在最大疼痛缓解方面均显著优于200毫克布洛芬。布洛芬精氨酸200毫克在30分钟和60分钟时的平均血浆布洛芬浓度分别为13.9微克/毫升和15.7微克/毫升;布洛芬精氨酸400毫克分别为29.5微克/毫升和29.3微克/毫升;布洛芬200毫克分别为2.5微克/毫升和5微克/毫升;布洛芬400毫克分别为2.3微克/毫升和7.4微克/毫升。(P<0.05)。各治疗组的不良事件情况相似。总体而言,这些结果表明,与市售布洛芬制剂等效剂量的布洛芬精氨酸产生的镇痛起效更快。

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