目的 评价鼻渊丸治疗急性鼻窦炎风邪犯肺证的有效性和安全性。方法 采用分层随机双盲双模拟、阳性药平行对照、多中心临床研究的方法。440例患者按3：1的比例分为试验组与对照组，分别服用鼻渊丸和香菊片，疗程为10 d。以临床疾病疗效为主要观察指标。结果 PPS（FAS）分析试验组疾病疗效愈显率、总有效率分别为59.87%（58.93%）、92.04%（90.60%），对照组51.40%（50.93%）、84.11%（83.33%），两组总有效率比较差异显著（P<0.05），试验组优于对照组。试验组中医证候疗效愈显率为64.65%（63.64%），对照组为51.40%（50.93%），两组比较差异显著（P<0.05），试验组优于对照组。治疗后两组单项中医症状均得到了显著改善，且试验组对鼻塞、头痛改善优于对照组（P<0.05）。试验组有9例，对照组有1例不良事件，两组均未发现与研究药物有关的有临床意义的实验室指标异常改变。结论 鼻渊丸治疗急性鼻窦炎风邪犯肺证有效，优于对照药，且安全性较好。

Objective To observe the efficacy and safety of Biyuan Pills in treating acute sinusitis with syndrome of wind pathogen invading lung. Methods A method with randomized, positive-drug, parallel-controlled, doubled-blind, double-dummy, and multi-center trial was designed in the clinical study. The 330 cases were served as treatment group, taking Biyuan Pills for 10 d, 110 cases as control group, receiving Xiangju Capsule for 10 d. The curative effectiveness clinical diseases were the main observing parameter. Results Markedly effective rate and total effective rate of test group was 59.87% (58.93%) and 92.04% (90.60%), and that of control group was 51.40% (50.93%) and 84.11% (83.33%). Two groups total effective comparative differences were statistically significant (P < 0.05), the experimental group was better than the control group. The healing rate of TCM syndromes was 64.65% (63.64%) in the experimental group and 51.40% (50.93%) in the control group. The difference between the two groups was statistically significant (P < 0.05), and the experimental group was superior to the control group. After treatment, the symptoms of TCM in the two groups were significantly improved, and the improvement of nasal congestion and headache in the experimental group was better than that in the control group (P < 0.05). In the experiment, there were nine adverse events in the experimental group and one adverse event in the control group. No abnormal changes in clinical laboratory indicators related to the study drugs were found in either group. Conclusion Biyuan Pills is safe and effective in treating acute sinusitis with syndrome of wind pathogen and invading lung.