目的 評(píng)價(jià)金蓮花軟膠囊治療急性咽炎（外感風(fēng)熱證）的有效性和安全性。方法 采用隨機(jī)、雙盲雙模擬、陽性藥平行對(duì)照、多中心臨床研究方法，納入從2015年6月-2015年9月符合標(biāo)準(zhǔn)的患者144例，按照3：1比例隨機(jī)分為試驗(yàn)組108例和對(duì)照組36例。試驗(yàn)組給予金蓮花軟膠囊（2粒/次，3次/d）+冬凌草膠囊模擬劑治療（3粒/次，3次/d）；對(duì)照組給予冬凌草膠囊（3粒/次，3次/d）+金蓮花軟膠囊模擬劑治療（2粒/次，3次/d），療程5 d。主要療效指標(biāo)為疾病綜合療效，次要療效指標(biāo)為單項(xiàng)癥狀療效、咽痛消失時(shí)間，安全性觀察指標(biāo)為不良事件及不良反應(yīng)發(fā)生率。結(jié)果 治療后兩組疾病綜合愈顯率比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05），單項(xiàng)癥狀中咽痛/吞咽痛、咽黏膜/懸雍垂紅腫、咽干灼熱總有效率，差異具有統(tǒng)計(jì)學(xué)意義（P<0.05），且試驗(yàn)組均高于對(duì)照組。試驗(yàn)組中位咽痛消失時(shí)間略短于對(duì)照組，兩組組間比較差異無統(tǒng)計(jì)學(xué)意義。研究期間兩組不良事件及不良反應(yīng)發(fā)生率比較，差異均無統(tǒng)計(jì)學(xué)意義。結(jié)論 金蓮花軟膠囊治療急性咽炎（外感風(fēng)熱證）療效確切，使用安全，具有較好的臨床應(yīng)用前景。

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.