咽喉清口含片治疗急性咽炎外感风热证的Ⅱ期临床试验研究

The phase Ⅱ clinical trial of Yanhouqing buccal tablets in the treatment of acute pharyngitis of external wind heat type

目的:初步评价咽喉清口含片治疗急性咽炎外感风热证的有效性和安全性,探讨最佳安全的有效剂量。方法:采用随机、双盲、单模拟、安慰剂平行对照、剂量探索的多中心临床试验设计,将288例急性咽炎外感风热证患者分为低剂量组、高剂量组和安慰剂组。以咽痛或吞咽痛、咽干灼热、中医证候、咽部体征等分析为有效性评价指标,观察生命体征、实验室检查指标、不良事件的安全性评价指标。结果:各有效性评价指标高剂量组、低剂量组与安慰剂组比较,差异均有统计学意义(P<0.01);高、低剂量组比较差异无统计学意义(P>0.01)。3组均无严重不良事件发生,一般不良事件和不良反应发生率比较,差异均无统计学意义(P>0.05)。结论:咽喉清口含片治疗急性咽炎外感风热证安全、有效,推荐Ⅲ期临床试验剂量为每天8片,疗程5d。

Objective：The aim of this study is to preliminary evaluate the clinical efficacy and safety of Yanhouqing buccal tablets in the treatment of acute pharyngitis of external wind heat type and explore the safe and effective dose.Method：Design of multi-center clinical trial with randomized,double-blind,single-analog,placebocontrolled,dose exploration.288 patients were divided into three groups：low dose group,high dose group and placebo group.The effectiveness evaluation indexes was analysis of pharyngalgia or odynophagia,throat burning,TCM syndrome and pharyngeal signs,and the safety was evaluated by vital sign,lab examination indexes and adverse events.Result：The results showed that there was the statistically significant difference between high/low dose group and placebo group（P〈0.01）,and no significant difference between high and low dose groups（P〈0.01）among the effectiveness evaluation indexes.There were no serious adverse events.The adverse events and adverse reactions in the three groups has no statistical significance（P〈0.05）.Conclusion：Yanhouqing buccal tablets is safe and effective in the treatment of acute pharyngitis of-external wind heat type.We recommend 8tablets per day and treat for 5days in phaseⅢclinical trials.