Schachtel Bernard, Aspley Sue, Shephard Adrian, Shea Timothy, Smith Gary, Schachtel Emily
Department of Epidemiology & Public Health, Yale University School of Medicine, 60 College Street, New Haven, CT 06520-8034, USA.
Trials. 2014 Jul 3;15:263. doi: 10.1186/1745-6215-15-263.
The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. The model used here was designed to study the multiple-dose safety and efficacy of lozenges containing flurbiprofen at 8.75 mg.
Adults (n=198) with moderate or severe acute sore throat and findings of pharyngitis on a Tonsillo-Pharyngitis Assessment (TPA) were randomly assigned to use either flurbiprofen 8.75 mg lozenges (n=101) or matching placebo lozenges (n=97) under double-blind conditions. Patients sucked one lozenge every three to six hours as needed, up to five lozenges per day, and rated symptoms on 100-mm scales: the Sore Throat Pain Intensity Scale (STPIS), the Difficulty Swallowing Scale (DSS), and the Swollen Throat Scale (SwoTS).
Reductions in pain (lasting for three hours) and in difficulty swallowing and throat swelling (for four hours) were observed after a single dose of the flurbiprofen 8.75 mg lozenge (P<0.05 compared with placebo). After using multiple doses over 24 hours, flurbiprofen-treated patients experienced a 59% greater reduction in throat pain, 45% less difficulty swallowing, and 44% less throat swelling than placebo-treated patients (all P<0.01). There were no serious adverse events.
Utilizing the sore throat pain model with multiple doses over 24 hours, flurbiprofen 8.75 mg lozenges were shown to be an effective, well-tolerated treatment for sore throat pain. Other pharmacologic actions (reduced difficulty swallowing and reduced throat swelling) and overall patient satisfaction from the flurbiprofen lozenges were also demonstrated in this multiple-dose implementation of the sore throat pain model.
This trial was registered with ClinicalTrials.gov, registration number: NCT01048866, registration date: January 13, 2010.
不同临床研究人员采用咽痛模型在单剂量随机临床试验中证明急性镇痛药的疗效。此处使用的模型旨在研究含8.75毫克氟比洛芬的含片的多剂量安全性和疗效。
198名患有中度或重度急性咽痛且扁桃体咽炎评估（TPA）显示有咽炎表现的成年人在双盲条件下被随机分配使用8.75毫克氟比洛芬含片（n = 101）或匹配的安慰剂含片（n = 97）。患者根据需要每三至六小时含服一片含片，每天最多五片，并在100毫米量表上对症状进行评分：咽痛强度量表（STPIS）、吞咽困难量表（DSS）和咽喉肿胀量表（SwoTS）。
服用一剂8.75毫克氟比洛芬含片后，疼痛（持续三小时）、吞咽困难和咽喉肿胀（持续四小时）均有所减轻（与安慰剂相比，P < 0.05）。在24小时内使用多剂后，与安慰剂治疗的患者相比，氟比洛芬治疗的患者咽痛减轻59%，吞咽困难减轻45%，咽喉肿胀减轻44%（均P < 0.01）。未出现严重不良事件。
在24小时内使用多剂的咽痛模型中，8.75毫克氟比洛芬含片被证明是治疗咽痛的一种有效且耐受性良好的疗法。在咽痛模型的这种多剂量应用中，还证明了氟比洛芬含片的其他药理作用（减轻吞咽困难和减轻咽喉肿胀）以及患者的总体满意度。
本试验已在ClinicalTrials.gov注册，注册号：NCT01048866，注册日期：2010年1月13日
