目的 評價柴銀顆粒治療流行性感冒（外感風熱證）的有效性及安全性。方法 采用隨機、雙盲、陽性藥對照、多中心設(shè)計，于2021年3月—2022年3月在中日友好醫(yī)院、郯城縣第一人民醫(yī)院、漯河市中醫(yī)院、臨清市人民醫(yī)院、南寧市第十人民醫(yī)院、冠縣中醫(yī)院、館陶縣人民醫(yī)院、聊城市茌平區(qū)中醫(yī)醫(yī)院共8個臨床研究中心選取符合納入標準的116例流行性感冒（外感風熱證）受試者，以2∶1的比例隨機分配至試驗組與對照組。試驗組78例，對照組38例。對照組患者口服磷酸奧司他韋膠囊，每次1粒，每日2次；柴銀顆粒模擬劑，開水沖服，每次1袋，每日3次。試驗組患者口服柴銀顆粒，開水沖服，每次1袋，每日3次；磷酸奧司他韋膠囊模擬劑，每次1粒，每日2次；療程為5 d。主要療效指標為流感臨床癥狀緩解時間，次要療效指標為疾病的痊愈時間/痊愈率、解熱起效時間、單項癥狀療效、病毒核酸轉(zhuǎn)陰率、并發(fā)癥/重癥/危重癥發(fā)生率，試驗過程中監(jiān)測藥物安全性。結(jié)果 試驗組和對照組的流感臨床癥狀緩解時間分別為3.133 d和2.939 d，兩組差值95%置信區(qū)間（95% CI）為（-0.34，0.33），下限大于非劣界值-0.5，表明試驗組的流感臨床癥狀緩解時間非劣于對照組。試驗組與對照組在疾病痊愈時間、疾病痊愈率、解熱起效時間方面均無統(tǒng)計學差異（P>0.05）。試驗組在改善流感單項臨床癥狀：身熱、咽紅腫痛、頭痛、咳嗽、汗出、口渴、鼻塞、流涕、惡寒等方面，效果與對照組相當。用藥5 d時，試驗組和對照組的病毒核酸轉(zhuǎn)陰率分別為76.32%和68.42%；試驗過程中無并發(fā)癥、重癥及危重癥發(fā)生。結(jié)論 柴銀顆粒在緩解流行性感冒（外感風熱證）臨床癥狀方面非劣于磷酸奧司他韋膠囊，在核酸轉(zhuǎn)陰率方面更有優(yōu)勢，產(chǎn)品安全性良好，值得臨床推廣。

Objective To evaluate the efficacy and safety of Chaiyin Granule in treatment of influenza (exogenous wind heat syndrome). Methods A randomized, double-blind, positive drug control, multicenter design was used to select 116 influenza (exogenous wind-heat syndrome) patients who met the inclusion criteria from March 2021 to March 2022 in eight clinical research centers, including China Japan Friendship Hospital, Tancheng First People's Hospital, Luohe Hospital of Traditional Chinese Medicine, the People's Hospital of Linqing, the Tenth People's Hospital of Nanning, Guanxian Hospital of Traditional Chinese Medicine, Guantao People's Hospital, and Liaocheng Chiping District Hospital of Traditional Chinese Medicine, randomly allocate to the experimental group and control group in a 2∶ 1 ratio. There were 78 cases in the experimental group and 38 cases in the control group. The control group patients received oral administration of Oseltamivir Phosphate Capsules, one capsule per time, twice a day, and Chaiyin Granule Simulator, taken in boiled water, one bag each time, three times a day. The experimental group of patients took Chaiyin Granules orally, taken with boiled water, one bag each time, three times a day, and Olistavir Phosphate Capsules Simulator, one capsule per dose, two times daily. The treatment period is five days. The main efficacy indicator is the time to relieve clinical symptoms of influenza, while the secondary efficacy indicators are the recovery time/recovery rate of the disease, the onset time of antipyretic effects, the efficacy of individual symptoms, the rate of viral nucleic acid negative conversion, the incidence of complications/severe/critical illness, and the monitoring of drug safety during the trial. Results The clinical symptom relief time of the experimental group and the control group were 3.133 days and 2.939 days, respectively. The 95% confidence interval (95% CI) of the difference between the two groups was (-0.34, 0.33), and the lower limit was greater than the non inferior limit of -0.5, indicating that the clinical symptom relief time of the experimental group was not inferior to that of the control group. There was no statistical difference between the experimental group and the control group in terms of disease recovery time, disease recovery rate, and antipyretic onset time (P> 0.05). The experimental group achieved similar results as the control group in improving single clinical symptoms of influenza, such as body heat, sore throat, headache, cough, sweating, thirst, nasal congestion, runny nose, and aversion to cold. After five days of medication, the viral nucleic acid conversion rates of the experimental group and the control group were 76.32% and 68.42%, respectively. During the experiment, there were no complications, severe cases, or critical illnesses. Conclusion Chaiyin Granule is not inferior to Oseltamivir Phosphate Capsule in alleviating the clinical symptoms of influenza (exogenous wind-heat syndrome), and has more advantages in the negative rate of nucleic acid. The product has good safety and is worthy of clinical promotion.

R974