目的 评价小儿肺热咳喘颗粒治疗流行性感冒（热毒袭肺证）的疗效及其安全性。方法 采用分层区组随机、阳性药平行对照、多中心临床试验设计。随机将纳入的240例受试儿童分为治疗组和对照组。治疗组给予小儿肺热咳喘颗粒，对照组给予磷酸奥司他韦颗粒。观察两组中医证候疗效，临床痊愈时间，加拿大急性呼吸道疾病和流感量表（Canadian acute respiratory illness and flu scale，CARIFS）评分，完全退热时间，咳嗽、咯痰缓解时间，咳嗽、咳痰疼痛数字评价量表（NRS-11）评分，并发症、重症及危重症转化率及安全性指标。结果 共240例进入全分析数据集（full analysis set，FAS），两组各120例。治疗组中医证候疗效愈显率明显优于对照组（P＜0.05）。治疗后，治疗组临床痊愈时间明显短于对照组（P＜0.05）。两组CARIFS症状维度、功能维度、对父母影响维度评分相比于治疗前显著下降（P＜0.05），且治疗组的CARIFS评分显著低于对照组（P＜0.05）。治疗组完全退热时间、咳嗽缓解时间、咯痰缓解时间明显短于对照组（P＜0.05）。两组咳嗽、咯痰NRS-11评分相比于治疗前显著下降（P＜0.05），且治疗组显著低于对照组（P＜0.05）。两组并发症、重症及危重症转化率组间比较差异均无统计学意义（P＞0.05）。两组安全性指标差异均无统计学意义（P＞0.05）。结论 小儿肺热咳喘颗粒可有效缓解儿童流行性感冒（热毒袭肺证）的发热、咳嗽、咯痰症状，缩短病程，临床应用安全性好。

Objective To evaluate the efficacy and safety of Xiaoer Feire Kechuan Granules (小儿肺热咳喘颗粒, XFK) in the treatment of influenza (f heat toxin attacking lung syndrome). Methods Adopting a stratified block randomization, positive drug parallel control, and multicenter clinical trial design, 240 enrolled children were randomly divided into a treatment group and a control group. The treatment group was given XFK, while the control group was given oseltamivir phosphate granules. The efficacy of two groups of traditional Chinese medicine syndromes, clinical recovery time, Canadian Acute Respiratory Disease and Flu Scale (CARIFS) score, complete fever reduction time, cough and expectoration relief time, cough and sputum pain digital evaluation scale (NRS-11) score, complication, severe and critical illness conversion rate, and safety indicators were observed. Results A total of 240 cases were included in the full analysis set (FAS), with 120 cases in the experimental group and 120 cases in the control group. The effective rate of traditional Chinese medicine syndrome in the treatment group was better than that in the control group (P < 0.05). The clinical recovery time of the treatment group was shorter than that of the control group after treatment (P < 0.05). The scores of the symptom dimension, functional dimension, and parental impact dimension of CARIFS of the two groups were significantly reduced compared to before treatment (P < 0.05), and the CARIFS scores of the treatment group were lower than those of the control group (P < 0.05). The complete fever reduction time, cough relief time, expectoration relief time of the treatment group were shorter than the control group (P < 0.05). The NRS-11 scores for cough and sputum in both groups decreased significantly compared to before treatment (P < 0.05), and the treatment group was lower than the control group (P < 0.05). There was no statistically significant difference in the incidence of complications, severe illness, and critical illness conversion rate between the two groups (P > 0.05). There was no statistically significant difference in safety indicators between the two groups (P > 0.05). Conclusion XFK can effectively relieve the symptoms of fever, cough and expectoration of children with influenza (heat toxin attacking lung syndrome), shorten the course of disease, and has good safety in clinical application.

R285.64

国家自然科学基金面上项目（82374521）;国家中医药管理局中医药干预儿童肺系病证研究项目（2022-304）;国家中医药传承创新中心重点病种项目：中医药防治小儿肺炎基础与临床研究（2023-247）;王雪峰全国名老中医专家传承工作室建设项目（2023-1）