Schachtel Bernard P, Pan Sharon, Kohles Joseph D, Sanner Kathleen M, Schachtel Emily P, Bey Mary
Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT, USA.
J Clin Pharmacol. 2007 Jul;47(7):860-70. doi: 10.1177/0091270007301621. Epub 2007 May 24.
The sore throat pain model was employed in this randomized, placebo-controlled trial to examine the sensitivity of the model in testing the efficacy of valdecoxib as an acute analgesic drug. Changes were made to the study design by employing a different diagnostic index for tonsillo-pharyngitis, a different rating scale (derived from Lasagna's pain thermometer), and alternative analyses, individual responder rates. Under double-blind conditions, 197 patients with painful pharyngitis were randomly allocated to valdecoxib 20 mg bid (n = 65), valdecoxib 40 mg qd (n = 66), or placebo (n = 66) for 24 hours. The expanded Tonsillo-Pharyngitis Assessment and the Lasagna Pain Scale were validated as sensitive study instruments. Both dosage regimens provided significantly greater pain relief compared with placebo on standard efficacy measures over the 24-hour study (all P < .05). Tests for individual response (eg, percentage of patients with at least moderate relief) confirmed these results, and other response rates identified the high sensitivity of the model itself (eg, only 5% of placebo-treated patients achieved >or=50% of maximum total pain relief over 6 hours). These findings indicate that sore throat is a sensitive model to assess analgesic efficacy.
在这项随机、安慰剂对照试验中采用了咽痛疼痛模型，以检验该模型在测试伐地昔布作为急性镇痛药疗效时的敏感性。通过采用不同的扁桃体咽炎诊断指标、不同的评分量表（源自拉萨尼亚疼痛温度计）以及替代分析方法（个体反应率）对研究设计进行了更改。在双盲条件下，197例咽痛患者被随机分配接受20毫克伐地昔布每日两次（n = 65）、40毫克伐地昔布每日一次（n = 66）或安慰剂（n = 66）治疗24小时。扩展的扁桃体咽炎评估和拉萨尼亚疼痛量表被验证为敏感的研究工具。在24小时的研究中，与安慰剂相比，两种剂量方案在标准疗效指标上均能显著减轻疼痛（所有P < 0.05）。个体反应测试（例如，至少有中度缓解的患者百分比）证实了这些结果，其他反应率也表明该模型本身具有高敏感性（例如，在6小时内，只有5%接受安慰剂治疗的患者实现了≥最大总疼痛缓解的50%）。这些发现表明，咽痛是评估镇痛疗效的敏感模型。
