RESUMO
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.