目的 觀察不同劑量雙魚顆粒治療流行性感冒（風(fēng)熱犯衛(wèi)證）的有效性及安全性。方法 采用隨機(jī)、雙盲、安慰劑對照、多中心研究方法，收集流行性感冒（風(fēng)熱犯衛(wèi)證）患者160例，按照分層、分段方法分為高、中、低劑量組和對照組，高劑量組患者口服雙魚顆粒3袋，中劑量組患者口服雙魚顆粒2袋和模擬藥1袋，低劑量組患者口服雙魚顆粒1袋和模擬藥2袋，對照組患者口服3袋模擬藥，2次/d。4組療程均為5 d。于治療前、治療第3天、治療后24 h內(nèi)隨訪。比較4組患者治療后疾病緩解時(shí)間、退熱時(shí)間、治療前后鼻咽分泌物病毒載量變化情況、單項(xiàng)癥狀消失率、流感癥狀總評(píng)分變化情況、中醫(yī)證候療效，并觀察安全性指標(biāo)，記錄不良反應(yīng)發(fā)生情況。結(jié)果 雙魚顆粒高劑量組在解熱時(shí)間、流感單項(xiàng)癥狀（發(fā)燒或發(fā)冷、疲勞、咳嗽、鼻塞）消失率、流感癥狀總評(píng)分變化、中醫(yī)證候方面療效最優(yōu)。在流感疾病緩解時(shí)間、退熱起效時(shí)間、鼻咽分泌物病毒載量及其余流感單項(xiàng)癥狀消失率方面表現(xiàn)出劑量越高、療效越好的趨勢。結(jié)論 雙魚顆粒治療流行性感冒（風(fēng)熱犯衛(wèi)證）可縮短發(fā)熱持續(xù)時(shí)間，促進(jìn)咳嗽、鼻塞、疲勞等癥狀消失，改善臨床癥狀，臨床安全性較好。

Objective To observe the efficacy and safety of different doses of Shuangyu Granules in the treatment of influenza（windheat syndrome）. Methods A randomized, double-blind, placebo-controlled, multicenter study was conducted to collect 160 patients with influenza（wind-heat syndrome） and divided into 4 groups according to the hierarchical and segmented method, namely high-dose group, medium-dose group, low-dose group and placebo group. Patients in the high-dose group were po administered with 3 bags of Shuangyu Granules, patients in the middle-dose group were po administered with 2 bags of Shuangyu Granules and 1 bag of simulated medicine, patients in the low-dose group were po administered with 1 bags of Shuangyu Granules and 2 bags of simulated medicine, and patients in the control group were po administered with 3 bags of simulated medicine, twice daily. The treatment cycle was 5 days, and follow-up was conducted before treatment, the third day of treatment and within 24 h after treatment. The duration of disease remission, duration of fever reduction（onset time of fever reduction, duration of fever reduction）, changes in viral load of nasopharyngeal secretions before and after treatment, disappearance rate of single symptoms, changes in total score of influenza symptoms, and efficacy of traditional Chinese medicine syndromes were compared in the 4 groups after treatment, and safety indexes were observed and adverse reactions were recorded. Results High dose group had the best efficacy in antipyrexia time, the disappearance rate of single symptoms of influenza（fever or chills, fatigue, cough, nasal congestion）, the change of total score of influenza symptoms, and traditional Chinese medicine syndromes. The higher dose, the better the curative effect was in the remission time, the onset time of fever, the viral load of nasopharyngeal secretions and the disappearance rate of other single symptoms of influenza. Conclusion Shuangyu Granules in treatment of influenza can shorten the duration of fever, promote the disappearance of cough, nasal congestion, fatigue and other symptoms, improve clinical symptoms, clinical safety is good.

R974

姜良鐸“三名”傳承工作室(2023-SZ-F-20)