目的 观察不同剂量双鱼颗粒治疗流行性感冒（风热犯卫证）的有效性及安全性。方法 采用随机、双盲、安慰剂对照、多中心研究方法，收集流行性感冒（风热犯卫证）患者160例，按照分层、分段方法分为高、中、低剂量组和对照组，高剂量组患者口服双鱼颗粒3袋，中剂量组患者口服双鱼颗粒2袋和模拟药1袋，低剂量组患者口服双鱼颗粒1袋和模拟药2袋，对照组患者口服3袋模拟药，2次/d。4组疗程均为5 d。于治疗前、治疗第3天、治疗后24 h内随访。比较4组患者治疗后疾病缓解时间、退热时间、治疗前后鼻咽分泌物病毒载量变化情况、单项症状消失率、流感症状总评分变化情况、中医证候疗效，并观察安全性指标，记录不良反应发生情况。结果 双鱼颗粒高剂量组在解热时间、流感单项症状（发烧或发冷、疲劳、咳嗽、鼻塞）消失率、流感症状总评分变化、中医证候方面疗效最优。在流感疾病缓解时间、退热起效时间、鼻咽分泌物病毒载量及其余流感单项症状消失率方面表现出剂量越高、疗效越好的趋势。结论 双鱼颗粒治疗流行性感冒（风热犯卫证）可缩短发热持续时间，促进咳嗽、鼻塞、疲劳等症状消失，改善临床症状，临床安全性较好。

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

姜良铎“三名”传承工作室(2023-SZ-F-20)