Institute of Forensic Medicine, University of Freiburg, Albertstr. 9, 79104, Freiburg, Germany.
Eur Arch Otorhinolaryngol. 2012 Feb;269(2):571-7. doi: 10.1007/s00405-011-1802-9. Epub 2011 Oct 21.
Benzocaine lozenges are popular in symptomatic treatment of acute sore throat. The aim of this study was to evaluate if sucking a benzocaine lozenge was superior to a placebo lozenge in patients with pain while swallowing. Volunteers with acute, uncomplicated sore throat received randomly and double-blind either a benzocaine 8 mg or a placebo lozenge. Pain was assessed on a numerical visual rating scale. The primary outcome measure was the sum of the pain intensity differences (SPID) over 2 h. Secondary outcome measures included the number of patients who reported 50% or more of their baseline pain score (responders) and those with worthwhile and complete pain relief, the times to worthwhile/complete pain relief and to pain recurrence and the occurrence of any adverse effects. A predefined interim analysis after including 50 patients revealed the superiority of benzocaine versus placebo in the SPID (p = 0.0086). At this time, a total of 165 patients had been recruited (full analysis set, FAS) and underwent statistical analysis. In the FAS, median SPID had significantly more decreased in patients receiving benzocaine compared to placebo (-12 vs. - 5, p = 0.001). There were significantly more responders and patients with worthwhile pain relief in group benzocaine. The number of patients with complete pain relief was very small. Median time to worthwhile pain relief was 20 min (benzocaine) and >45 min (placebo). Adverse events were not observed. Benzocaine lozenges are superior to placebo lozenges and a useful, well-tolerated treatment option to reduce painful pharyngeal discomfort.
苯佐卡因含片在急性咽痛的对症治疗中很受欢迎。本研究旨在评估在吞咽疼痛的患者中，含苯佐卡因的含片是否优于安慰剂含片。患有急性、不复杂的咽痛的志愿者随机且双盲接受 8mg 苯佐卡因或安慰剂含片。疼痛通过数字视觉评分量表进行评估。主要观察指标为 2 小时内疼痛强度差异总和（SPID）。次要观察指标包括报告疼痛评分基线降低 50%或更多的患者比例（应答者）、有显著和完全疼痛缓解的患者比例、达到显著和完全疼痛缓解以及疼痛复发的时间以及任何不良反应的发生。在纳入 50 例患者后进行的预设中期分析显示，苯佐卡因在 SPID 方面优于安慰剂（p=0.0086）。此时，共有 165 例患者（全分析集，FAS）入组并进行了统计学分析。在 FAS 中，接受苯佐卡因治疗的患者的 SPID 中位数显著降低（-12 比-5，p=0.001）。苯佐卡因组的应答者和有显著疼痛缓解的患者比例明显更高。完全缓解疼痛的患者数量非常少。达到显著疼痛缓解的中位时间为 20 分钟（苯佐卡因）和>45 分钟（安慰剂）。未观察到不良反应。苯佐卡因含片优于安慰剂含片，是一种有用且耐受良好的治疗选择，可减轻咽部疼痛不适。
