金莲花软胶囊治疗急性咽炎（外感风热证）多中心临床研究

目的 评价金莲花软胶囊治疗急性咽炎（外感风热证）的有效性和安全性。方法 采用随机、双盲双模拟、阳性药平行对照、多中心临床研究方法，纳入从2015年6月-2015年9月符合标准的患者144例，按照3：1比例随机分为试验组108例和对照组36例。试验组给予金莲花软胶囊（2粒/次，3次/d）+冬凌草胶囊模拟剂治疗（3粒/次，3次/d）；对照组给予冬凌草胶囊（3粒/次，3次/d）+金莲花软胶囊模拟剂治疗（2粒/次，3次/d），疗程5 d。主要疗效指标为疾病综合疗效，次要疗效指标为单项症状疗效、咽痛消失时间，安全性观察指标为不良事件及不良反应发生率。结果 治疗后两组疾病综合愈显率比较差异有统计学意义（P<0.05），单项症状中咽痛/吞咽痛、咽黏膜/悬雍垂红肿、咽干灼热总有效率，差异具有统计学意义（P<0.05），且试验组均高于对照组。试验组中位咽痛消失时间略短于对照组，两组组间比较差异无统计学意义。研究期间两组不良事件及不良反应发生率比较，差异均无统计学意义。结论 金莲花软胶囊治疗急性咽炎（外感风热证）疗效确切，使用安全，具有较好的临床应用前景。

Multicenter clinical research on Jinlianhua Soft Capsule in treatment of acute pharyngitis (exogenous wind-heat syndrome)

Objective Evaluate the efficacy and safety of Jinlianhua Soft Capsule in the treatment of acute pharyngitis (exogenous wind-heat syndrome). Methods A randomized, double-blind, double-simulation, positive parallel control, multicenter clinical trial design method was used. A total of 144 patients were enrolled and randomized from June 2015 to September 2015. 108 patients were assigned to the experimental group treated with Jinlianhua Soft Capsule (two capsules/time, three times daily) and Donglingcao Capsule simulator (three capsules/time, three times daily) for 5 days; 36 patients were assigned to the controled group treated with Donglingcao Capsule (three capsules, three times/d) and Jinlianhua Soft Capsule simulator (two capsules/time, three times daily) for 5 days. The primary end point was the comprehensive curative effect of disease. Secondary end points were single symptom efficacy and disappearance time of pharyngeal pain. Meanwhile, the incidence of adverse events/adverse reactions. as safety indexes, were monitored. Results The disease'' comprehensive marked recovery rate of Jinlianhua Soft Capsule was superior to Donglingcao Capsule. There were significant differences between the two groups (P<0.05) in the comprehensive effective rate of single symptom in sore throat/swallowing pain, pharyngeal mucosa/uvula redness, total dryness were higher than the control group (P<0.05). Median sore throat disappeared of the experimental group was slightly shorter than that in the control group. There was no significant difference in the incidence of adverse events and adverse reactions between the two groups during the study period. Conclusion Jinlian Soft Capsule is effective in treating acute pharyngitis (exogenous wind-heat syndrome), safe in use and has good clinical application prospects.