目的 評價金蓮花軟膠囊治療急性扁桃體炎（外感風(fēng)熱證）的有效性和安全性。方法 采用隨機、雙盲雙模擬、陽性藥平行對照、多中心臨床研究方法，共納入144例患者，按照3：1的比例隨機分為試驗組108例和對照組36例。試驗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），療程均7 d。主要療效指標(biāo)為疾病綜合療效，次要指標(biāo)為單項癥狀療效、咽痛消失時間，安全性指標(biāo)為不良事件及不良反應(yīng)發(fā)生率。結(jié)果 兩組疾病綜合療效總有效率、愈顯率比較差異均有統(tǒng)計學(xué)意義，其中試驗組總有效率明顯高于對照組（96.30% vs 80.56%，P<0.05），愈顯率試驗組明顯高于對照組（86.11% vs 61.11%，P<0.05）。咽痛或吞咽痛、咽干灼熱的總有效率、愈顯率，以及咽黏膜或懸雍垂紅腫愈顯率，且試驗組均高于對照組，兩組間比較差異均有統(tǒng)計學(xué)意義（P<0.05）。試驗組中位消失時間略短于對照組（144 h vs 162 h），但是組間比較差異沒有統(tǒng)計學(xué)意義（P>0.05）。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)計學(xué)意義。結(jié)論 金蓮花軟膠囊治療急性扁桃體炎（外感風(fēng)熱證）療效確切，安全性較好，具有較好的臨床應(yīng)用價值。

Objective Evaluate the efficacy and safety of Jinlianhua Soft Capsule in the treatment of acute tonsillitis (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 to an experimental group of 108 patients and a control group of 36 patients at a 3:1 ratio. The experimental group was treated with Jinlianhua Soft Capsule (2 capsules/d, tid) plus Donglingcao Capsule Simulator (3 capsules/d, tid), and control group was treated with Donglingcao Capsule (3 capsules/d, tid) plus Jinlianhua Soft Capsule Simulator (2 capsules/d, tid) for 7 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 total effective rate of experimental group was significantly higher than that of control group (96.30% vs 80.56%, P<0.05). The effective rate of experimental group was significantly higher than that of control group (86.11% vs 61.11%, P<0.05). In TCM single symptom aspect, the total effective rate and obvious curative rate of pharyngeal pain/swallowing pain and pharyngeal dryness and burning, as well as obvious curative rate of pharyngeal mucosa/uvula redness and swelling, there were statistically significant differences between the two groups (P<0.05), experimental group was higher than control group. Meanwhile, the difference between experimental group and control group in median disappearance time of sore throat (144 h vs 162 h, P<0.5) was not observed. There was no difference in adverse events and adverse reactions between two groups during the study period. Conclusion Jinlianhua Soft Capsule was effective in treating acute tonsillitis (exogenous wind-heat syndrome), which is safe and has good clinical application prospects.

R985