金花清感颗粒治疗成人新型冠状病毒肺炎患者的多中心前瞻性队列研究

A multicenter prospective cohort study on the treatment of adult COVID-19 with Jinhua Qinggan Granules

目的探讨金花清感颗粒应用于成人新型冠状病毒肺炎(coronavirus disease 2019,COVID-19)患者的有效性和安全性。方法选取2020年1月27日至3月23日北京地区15家医院收治的成人COVID-19患者245例,建立前瞻性研究队列,服用金花清感颗粒≥3 d的队列为观察组,常规治疗的队列为对照组。收集所有患者的临床资料,比较两组各指标的差异。结果观察组71例(29.0%),对照组174例(71.0%)。治疗后观察组咳嗽好转率和倦怠乏力好转率,显著优于对照组[65.9%比38.4%,87.0%比54.4%],差异有统计学意义(P<0.05)。观察组新型冠状病毒核酸平均转阴时间显著低于对照组[(13.85±7.96)d比(17.90±8.89)d],差异有统计学意义(P<0.05)。Kaplan-Meier曲线和log-rank检验提示观察组有较低的新冠病毒核酸阳性率(χ^(2)=10.337,P<0.05)。观察组与对照组的住院时间和病死率比较,差异无统计学意义(P>0.05)。两组均未出现明显的不良事件。结论金花清感颗粒治疗COVID-19不改变病死率和住院时间,但可以缩短患者咳嗽、倦怠乏力等症状的持续时间,并可以缩短新型冠状病毒核酸转阴时间。

Objective To study the efficacy and safety of Jinhua Qinggan Granules in adult patients with coronavirus disease 2019(COVID-19).Methods From January 27 to March 23,2020,a prospective cohort of adult patients with COVID-19 in 15 hospitals in Beijing was established.The observation group was treated with Jinhua Qinggan Granules for more than three days,and the control group was treated with routine treatment.The clinical data of all eligible patients were collected,and the differences of each index in different cohort were compared.Results A total of 245 patients with COVID-19 were included,71 cases(29.0%)in the observation group and 174 cases(71.0%)in the control group.After the treatment,the improvement rate of cough in the observation group was 65.9%,and that in the control group was 38.4%(P<0.05).The improvement rate of fatigue in the observation group was 87.0%,and that in the control group was 54.4%(P<0.05).The average viral shedding time in the observation group was significantly less than that in the control group[(13.85±7.96)d vs.(17.90±8.89),P<0.05].Kaplan-Meier curve and log-rank test showed that the observation group had a lower viral positive incidence(χ^(2)=10.337,P<0.05).There was no significant difference of hospitalization days and mortality between the two groups(P>0.05).No severe adverse events occured in the two groups.Conclusions The treatment of COVID-19 with Jinhua Qinggan Granules doesn’t change the mortality and hospitalization days,but could shorten the duration of cough,fatigue and other symptoms,reduce the shedding time of 2019-nCoV.