Bouroubi Athmane, Donazzolo Yves, Donath Franck, Eccles Ron, Russo Marc, Harambillet Nadine, Gautier Stéphanie, Montagne Agnès
Centre de Recherche et Développement Pierre Fabre, Toulouse, France.
Eurofins Optimed, Gières, France.
Int J Clin Pract. 2017 Sep;71(9). doi: 10.1111/ijcp.12961. Epub 2017 Sep 4.
The aim of this study was to compare the efficacy and safety of a new oromucosal ibuprofen form, ibuprofen 25 mg lozenge, in single and repeat dosing for up to 4 days, to the matched placebo, in the treatment of acute sore throat pain in adults.
In this randomised, double-blind, placebo-controlled trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (≥5 on the objective Tonsillo-Pharyngitis Assessment 21-point scale and ≥60 mm on the subjective 0-100 mm visual analogue Sore Throat Pain Intensity Scale [STPIS]) were assigned ibuprofen 25 mg (n=194) or matching placebo (n=191) lozenge treatment. Efficacy was assessed (at the investigating centre up to 2 hours after first dosing, then on an ambulatory basis) by parameters derived from patient's scores on scales of pain relief, pain intensity, and global efficacy assessment. The primary efficacy end-point was the time-weighted TOTal PAin Relief (TOTPAR) over 2 hours after first dosing using the Sore Throat Relief Scale (STRS). Safety and local tolerability were assessed.
Ibuprofen 25 mg was superior to placebo on numerous pain relief parameters; TOTPAR was significantly higher with ibuprofen 25 mg over 2 hours after first dosing (P<.05), the effect being apparent from the first evaluation at 15 minutes (P<.05). The STPIS reduction in favour of ibuprofen 25 mg was not significant vs placebo. Mean STRS scores and patient's global efficacy assessment both reflected a higher efficacy of ibuprofen 25 mg over the 4-day treatment period with tests of statistical significance up to day 1 evening (P<.05), and, in patients with still clinically significant pain (n=128), after an average 4 days (P<.01). Ibuprofen 25 mg lozenge was well tolerated with a safety profile similar to placebo.
Low-dose ibuprofen 25 mg lozenge in repeat dosing provides in adults more efficacious and rapid relief of sore throat pain and is as well tolerated as placebo.
ClinicalTrials.gov, NCT01785862.
本研究旨在比较一种新型口腔黏膜布洛芬制剂——25毫克布洛芬含片，单次及重复给药长达4天，与匹配的安慰剂相比，在治疗成人急性咽喉疼痛方面的疗效和安全性。
在这项随机、双盲、安慰剂对照试验中，患有非链球菌性咽喉痛且有中度至重度相关疼痛体征（客观扁桃体咽炎评估21分制量表≥5分，主观0 - 100毫米视觉模拟咽喉疼痛强度量表[STPIS]≥60毫米）的成年患者被分配接受25毫克布洛芬（n = 194）或匹配的安慰剂（n = 191）含片治疗。通过患者在疼痛缓解、疼痛强度和总体疗效评估量表上的得分得出的参数来评估疗效（在研究中心首次给药后2小时内，然后在门诊进行评估）。主要疗效终点是使用咽喉痛缓解量表（STRS）在首次给药后2小时内的时间加权总疼痛缓解（TOTPAR）。评估了安全性和局部耐受性。
25毫克布洛芬在众多疼痛缓解参数上优于安慰剂；首次给药后2小时内，25毫克布洛芬的TOTPAR显著高于安慰剂（P <.05），从15分钟时的首次评估就明显可见该效果（P <.05）。与安慰剂相比，有利于25毫克布洛芬的STPIS降低不显著。平均STRS评分和患者的总体疗效评估均反映出在4天治疗期内2毫克布洛芬的疗效更高，直至第1天晚上的统计学显著性检验（P <.05），并且在仍有临床显著疼痛的患者（n = 128）中，平均4天后（P <.01）也是如此。25毫克布洛芬含片耐受性良好，安全性与安慰剂相似。
重复给药的低剂量25毫克布洛芬含片能为成人提供更有效、快速的咽喉疼痛缓解，且耐受性与安慰剂相同。
ClinicalTrials.gov，NCT01785862。
