新型抗炎咽喉含片布洛芬25mg缓解咽喉疼痛：一项随机、双盲、安慰剂对照的国际III期研究

Pain relief of sore throat with a new anti-inflammatory throat lozenge, ibuprofen 25 mg: A randomised, double-blind, placebo-controlled, international phase III study.

作者信息

Bouroubi Athmane, Donazzolo Yves, Donath Franck, Eccles Ron, Russo Marc, Harambillet Nadine, Gautier Stéphanie, Montagne Agnès

机构信息

Centre de Recherche et Développement Pierre Fabre, Toulouse, France.

Eurofins Optimed, Gières, France.

出版信息

Int J Clin Pract. 2017 Sep;71(9). doi: 10.1111/ijcp.12961. Epub 2017 Sep 4.

DOI:10.1111/ijcp.12961

PMID:28869722

Abstract

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT01785862.

摘要

目的

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。

方法

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。

结果

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。