Abstract: Objective    To evaluate the clinical efficacy and safety of Danmu extract syrup in the treatment of children with influenza. Methods    A stratified block randomization，positive drug parallel control，and multicenter clinical trial design was used to enroll 480 children from 6 centers with influenza. They were randomly divided into a treatment group and a control group，with 240 cases in each group. The treatment group was treated with Danmu extract syrup，while the control group was treated with oseltamivir phosphate granules，both for 5 days. Observe the clinical recovery time，complete fever relief time，resolution time of main symptoms （pharyngalgia，cough，headache），Canadian Acute Respiratory Disease and Influenza Scale （CARIFS） score，traditional Chinese medicine syndrome efficacy，incidence rate of complications，severe and critical illness，and safety indicators of the two groups of children. Results    The FAS results showed that the main efficacy indicators were as follows.  The clinical recovery time of both groups was 4 days，and the complete fever relief time of both groups was 36 hours. After COX regression analysis，the inter-group HR and 95% CI were estimated，and after adjusting for the influence of central factors，0.67 was used as the non-inferiority standard. The treatment group was not inferior to the control group. Secondary efficacy indicators were as follows. The disappearance time of pharyngeal pain symptoms in the treatment group was 3 days， lower than that in the control group （4 days），with a statistically significant difference （P<0.01）. There was no statistically significant difference in the disappearance time of cough and headache symptoms between the two groups （P>0.05）. After medication，the CARIFS symptom dimension score in the treatment group was better than that in the control group，with a statistically significant difference （P<0.01）. The scores in CARIFS functional dimension and influencing parental dimension in the treatment group were better than those in the control group，but there was no statistically significant difference between the two groups （P>0.05）. The recovery rate of traditional Chinese medicine syndrome in the treatment group was 75.32%， higher than that in the control group，which was 60.50%，with a statistically significant difference （P<0.01）. There was no statistically significant difference in the total effective rate of traditional Chinese medicine syndrome between the two groups （P>0.05）. In addition，there was no statistically significant difference in the incidence of complications，severe and critical illnesses，or adverse events and reactions between the two groups （P>0.05）. Conclusion    Danmu extract syrup has a significant effect on children's influenza，which is not inferior to oseltamivir phosphate granules，and helps to alleviate the symptoms of sore throat，shorten the course of influenza，and improve the health of children. Its clinical application is safe， and it is suitable for popularization.

Key words: Danmu extract syrup, influenza, child, clinical efficacy, safety

摘要： 目的    评价胆木浸膏糖浆治疗儿童流行性感冒的临床疗效及安全性。方法    采用分层区组随机临床试验设计，设置阳性药平行对照。共纳入6个中心480例流感患儿，随机分为治疗组和对照组，每组240例。治疗组予胆木浸膏糖浆，对照组予磷酸奥司他韦颗粒，疗程5 d。观察两组患儿疾病临床痊愈时间、完全退热时间、主要症状（咽痛、咳嗽、头痛）的消退时间，加拿大急性呼吸道疾病和流感量表（CARIFS）评分，中医证候疗效，并发症、重症及危重症发生率及安全性指标。结果    全分析数据集（FAS）结果显示，主要疗效指标：两组疾病临床痊愈时间均为4 d，两组完全退热时间均为36 h，经COX回归分析，估计组间风险比（HR）及95%置信区间（CI），校正中心因素的影响后，以0.67为非劣标准，治疗组非劣效于对照组。次要疗效指标中治疗组咽痛症状消退时间为3 d低于对照组4 d，差异有统计学意义（P<0.01），两组咳嗽、头痛症状消退时间比较，差异均无统计学意义（P>0.05）；治疗组用药后CARIFS症状维度评分优于对照组，差异有统计学意义（P<0.01），治疗组用药后CARIFS功能维度及影响父母维度评分优于对照组，但两组间差异均无统计学意义（P>0.05）；治疗组中医证候愈显率75.32%优于对照组60.50%，差异有统计学意义（P<0.01），两组中医证候总有效率比较，差异无统计学意义（P>0.05）；此外，两组并发症、重症及危重症发生率比较、两组不良事件与不良反应发生率比较，差异均无统计学意义（P>0.05）。结论    胆木浸膏糖浆治疗儿童流行性感冒疗效显著，非劣于磷酸奥司他韦颗粒，有助于缓解咽痛症状，缩短流感病程，临床应用的安全性较好，适合推广使用。

关键词: 胆木浸膏糖浆, 流行性感冒, 儿童, 临床疗效, 安全性