Abstract: Objective　To investigate the efficacy and safety of Bi Dou Yan oral liquid in the treatment of children with acute rhinosinusitis. Methods　A multi-center，randomized，double-blind，controlled clinical research method was adopted. From September 2016 to February 2019，480 children with acute rhinosinusitis from 17 centers in China were enrolled，and were randomly divided into two groups with 240 cases in each one. The experimental group was given conventional treatment and Bi Dou Yan oral liquid；the control group was given conventional treatment and placebo；the efficacy and safety were evaluated. Results　The disappearance time of main symptoms in the experimental group （5 days） was shorter than that of the control group （7 days） （P<0.01）. The objective quantitative score of nasal endoscopy （P<0.01） and traditional Chinese medicine （TCM） syndrome score （P<0.01） were significantly lower in the experimental group than those in control group（P<0.01）；the total effective rate of TCM syndromes in the experimental group was significantly higher than that in the control group（P<0.01）. The recurrence rate of major symptoms （P>0.05） and the Visual Analogue Scale （VAS） score （P>0.05） were lower inthe experimental group than in control group，but there was no statistical difference between the two groups. There was no significant difference in the incidence of adverse events or drug-related adverse reactions between the two groups （P>0.05）. Conclusion　Bi Dou Yan oral liquid has significant effect and good safety in the treatment of pediatric acute rhinosinusitis，and is worthy of widespread application in pediatric clinical medication.

Key words: Bi Dou Yan oral liquid, acute rhinosinusitis, child, efficacy, safety

摘要： 目的　探讨鼻窦炎口服液治疗儿童急性鼻-鼻窦炎的有效性及安全性。方法　采用多中心、随机、双盲、对照的临床研究方法，于2016年9月至2019年2月纳入国内17个中心480例病例，其中试验组和对照组各240例，试验组给予常规治疗+鼻窦炎口服液，对照组给予常规治疗+安慰剂，对药物疗效和安全性进行评价。结果　试验组主要症状消失时间为5d低于对照组7d（P<0.01），鼻内镜检查客观量化评分（P<0.01）与中医证候积分（P<0.01）均显著低于对照组；中医证候总有效率试验组（P<0.01）明显高于对照组；试验组主要症状复发率与VAS评分数值都低于对照组，但两组间均无统计学差异（P>0.05）。试验组不良事件发生率与药物相关不良反应发生率均与对照组无统计学差异（P>0.05）。结论　鼻窦炎口服液治疗儿童急性鼻-鼻窦炎效果显著，安全性好，值得儿科临床用药广泛推广。

关键词: 鼻窦炎口服液, 急性鼻-鼻窦炎, 儿童, 有效性, 安全性