目的 評價小兒肺熱咳喘顆粒治療流行性感冒（熱毒襲肺證）的療效及其安全性。方法 采用分層區(qū)組隨機、陽性藥平行對照、多中心臨床試驗設(shè)計。隨機將納入的240例受試兒童分為治療組和對照組。治療組給予小兒肺熱咳喘顆粒，對照組給予磷酸奧司他韋顆粒。觀察兩組中醫(yī)證候療效，臨床痊愈時間，加拿大急性呼吸道疾病和流感量表（Canadian acute respiratory illness and flu scale，CARIFS）評分，完全退熱時間，咳嗽、咯痰緩解時間，咳嗽、咳痰疼痛數(shù)字評價量表（NRS-11）評分，并發(fā)癥、重癥及危重癥轉(zhuǎn)化率及安全性指標。結(jié)果 共240例進入全分析數(shù)據(jù)集（full analysis set，F(xiàn)AS），兩組各120例。治療組中醫(yī)證候療效愈顯率明顯優(yōu)于對照組（P＜0.05）。治療后，治療組臨床痊愈時間明顯短于對照組（P＜0.05）。兩組CARIFS癥狀維度、功能維度、對父母影響維度評分相比于治療前顯著下降（P＜0.05），且治療組的CARIFS評分顯著低于對照組（P＜0.05）。治療組完全退熱時間、咳嗽緩解時間、咯痰緩解時間明顯短于對照組（P＜0.05）。兩組咳嗽、咯痰NRS-11評分相比于治療前顯著下降（P＜0.05），且治療組顯著低于對照組（P＜0.05）。兩組并發(fā)癥、重癥及危重癥轉(zhuǎn)化率組間比較差異均無統(tǒng)計學意義（P＞0.05）。兩組安全性指標差異均無統(tǒng)計學意義（P＞0.05）。結(jié)論 小兒肺熱咳喘顆?？捎行Ь徑鈨和餍行愿忻埃岫疽u肺證）的發(fā)熱、咳嗽、咯痰癥狀，縮短病程，臨床應(yīng)用安全性好。

Objective To evaluate the efficacy and safety of Xiaoer Feire Kechuan Granules (小兒肺熱咳喘顆粒, 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

國家自然科學基金面上項目（82374521）;國家中醫(yī)藥管理局中醫(yī)藥干預(yù)兒童肺系病證研究項目（2022-304）;國家中醫(yī)藥傳承創(chuàng)新中心重點病種項目：中醫(yī)藥防治小兒肺炎基礎(chǔ)與臨床研究（2023-247）;王雪峰全國名老中醫(yī)專家傳承工作室建設(shè)項目（2023-1）