宣肺败毒颗粒治疗奥密克戎毒株感染新型冠状病毒肺炎临床疗效评价研究

Clinical efficacy evaluation of Xuanfei Baidu Granule in the treatment of Omicron virus infection with COVID-19

[目的]评价宣肺败毒颗粒治疗奥密克戎毒株感染的新型冠状病毒肺炎(COVID-19)的有效性及安全性。[方法]研究共纳入180例奥密克戎毒株感染的轻型/普通型COVID-19患者。根据患者意愿分组,试验组接受宣肺败毒颗粒联合常规治疗(120例),对照组接受常规治疗(60例)。主要疗效评价指标为病毒核酸转阴时间、住院时间,次要指标为7 d症状消失率、重症率及病死率,安全性指标为不良事件。[结果]试验组的病毒核酸转阴时间为8(6,10)d,住院时间为11(9,13)d,均短于对照组的10(7,11)d与12(10.5,13.5)d,组间差异有统计学意义(P<0.05)。在咳嗽、咯痰、咽喉不适、口干等症状消失率方面,试验组优于对照组,两组均未发生重症及死亡,亦未观察到治疗相关不良事件。[结论]在奥密克戎毒株感染COVID-19的治疗中,宣肺败毒颗粒能缩短病毒核酸转阴时间,促进症状消失,具有良好的安全性。

[Objective]To evaluate the efficacy and safety of Xuanfei Baidu Granule(XFBD)in the treatment of COVID-19 infected with Omicron virus strain.[Methods]A total of 180 patients with mild/normal COVID-19 infected with Omicron strain were included.Patients were assigned into two groups according to their wishes:the experimental group received XFBD combined with conventional treatment(120 cases),the control group received conventional treatment(60 cases).The primary outcomes were virus nucleic acid negative conversion time and length of hospital stay.The secondary outcomes were symptom disappearance rate,severe case rate and mortality rate.The safety outcomes were adverse events.[Results]The time of virus nucleic acid turning negative in the experimental group was 8(6,10)d,and the length of hospital stay was 11(9,13)d,which was shorter than the control group[10(7,11)days,12(10.5,13.5)d],the difference between groups was statistically significant(P<0.05).The disappearance rate of cough,phlegm,throat discomfort,xerostomia and other symptoms in the experimental group was better than that in the control group.No severe cases or death occurred in the two groups,and no treatment-related adverse events were observed.[Conclusion]In the treatment of Omicron virus strain infected COVID-19,XFBD can relieve the symptoms,shorten the time of viral nucleic acid negative conversion safely.