柴银颗粒治疗流行性感冒(外感风热证)的临床研究

Clinical study of Chaiyin Granules in treatment of influenza (exogenous windheatsyndrome)

目的 评价柴银颗粒治疗流行性感冒(外感风热证)的有效性及安全性。方法 采用随机、双盲、阳性药对照、多中心设计,于2021年3月—2022年3月在中日友好医院、郯城县第一人民医院、漯河市中医院、临清市人民医院、南宁市第十人民医院、冠县中医院、馆陶县人民医院、聊城市茌平区中医医院共8个临床研究中心选取符合纳入标准的116例流行性感冒(外感风热证)受试者,以2∶1的比例随机分配至试验组与对照组。试验组78例,对照组38例。对照组患者口服磷酸奥司他韦胶囊,每次1粒,每日2次;柴银颗粒模拟剂,开水冲服,每次1袋,每日3次。试验组患者口服柴银颗粒,开水冲服,每次1袋,每日3次;磷酸奥司他韦胶囊模拟剂,每次1粒,每日2次;疗程为5 d。主要疗效指标为流感临床症状缓解时间,次要疗效指标为疾病的痊愈时间/痊愈率、解热起效时间、单项症状疗效、病毒核酸转阴率、并发症/重症/危重症发生率,试验过程中监测药物安全性。结果 试验组和对照组的流感临床症状缓解时间分别为3.133 d和2.939 d,两组差值95%置信区间(95%CI)为(-0.34, 0.33),下限大于非劣界值-0.5,表明试验组的流感临床症状缓解时间非劣于对照组。试验组与对照组在疾病痊愈时间、疾病痊愈率、解热起效时间方面均无统计学差异(P>0.05)。试验组在改善流感单项临床症状:身热、咽红肿痛、头痛、咳嗽、汗出、口渴、鼻塞、流涕、恶寒等方面,效果与对照组相当。用药5 d时,试验组和对照组的病毒核酸转阴率分别为76.32%和68.42%;试验过程中无并发症、重症及危重症发生。结论 柴银颗粒在缓解流行性感冒(外感风热证)临床症状方面非劣于磷酸奥司他韦胶囊,在核酸转阴率方面更有优势,产品安全性良好,值得临床推广。

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.