目的 探讨金莲花软胶囊治疗急性上呼吸道感染外感风热证的临床疗效。方法 选取2015年1月—2015年9月陕西中医药大学第二附属医院等6家医院就诊的急性上呼吸道感染外感风热证患者192例，随机分为对照组（42例）和治疗组（128例）。对照组患者口服穿心莲胶囊，3粒/次，3次/d。同时口服金莲花软胶囊模拟剂，2粒/次，3次/d。治疗组患者口服金莲花软胶囊，2粒/次，3次/d。同时口服穿心莲胶囊模拟剂，3粒/次，3次/d。两组患者连续服用3 d。观察两组的临床疗效，比较两组单项症状恶风发热、流浊涕、咳嗽的疗效。结果 治疗后，对照组和治疗组综合疗效的愈显率、总有效率分别为51.11%、72.06%，91.11%、99.26%，两组愈显率、总有效率比较差异有统计学意义（P < 0.05）。治疗后，对照组和治疗组恶风发热、流浊涕、咳嗽单项症状的总有效率分别为82.22%、91.91%，68.18%、87.60%，68.18%、82.95%，两组比较差异均有统计学意义（P < 0.05）。结论 金莲花软胶囊治疗急性上呼吸道感染外感风热证具有良好的临床疗效，尤其是在改善恶风发热、流浊涕、咳嗽等症状方面效果明显，具有一定的推广应用价值。

Objective To evaluate the clinical efficacy of Jinlianhua Soft Capsules in treatment of acute upper respiratory tract infections exogenous wind heat syndrome. Methods Patients (201 cases) with acute upper respiratory tract infections exogenous wind heat syndrome in 6 hospitals, such as Second Affiliated Hospital of Shaanxi University of Chinese Medicine from January 2015 to September 2015 were randomly divided into the control group (42 cases) and the treatment group (128 cases). Patients in the control group were po administered with Chuanxinlian Capsules, 3 grains/time, three times daily. They were also po administered with simulation of Jinlianhua Soft Capsules, 2 grains/time, three times daily. Patients in the treatment group were po administered with Jinlianhua Soft Capsules, 3 grains/time, three times daily. They were also po administered with simulation of Chuanxinlian Capsules, 2 grains/time, three times daily. Patients in two groups were treated for 3 d. After treatment, the clinical efficacy was evaluated, and the effects of fever with aversion to wind, nasal discharge, and cough in two groups before and after treatment were compared. Results After treatment, the efficacy rate and total effective rate in the control and treatment groups were 51.11% and 72.06%, 91.11% and 99.26%, respectively, and there was difference between two groups (P < 0.05). After treatment, the total effective rate of fever with aversion to wind, nasal discharge, and cough in control and treatment groups were 82.22% and 91.91%, 68.18% and 87.60%, 68.18% and 82.95%, respectively, and there was difference between two groups (P < 0.05).Conclusion Jinlianhua Soft Capsules has good clinical curative effect in treatment of acute upper respiratory tract infections exogenous wind heat syndrome, especially improving the symptoms in fever with aversion to wind, nasal discharge, and cough, which has a certain clinical application value.