强身抗疫冲剂预防性干预新型冠状病毒肺炎感染的临床研究

Chmcal Study on the Preventive Effect of Qiangshen Kangyi Decoction on COVID-19 Infection

目的观察强身抗疫冲剂对新型冠状病毒肺炎(COVID-19)感染的预防作用,并客观评价其安全性和不良反应。方法采用整群随机、对照设计:将纳入受试者分为中药干预的治疗组和未进行干预的对照组分别详细询问并记录患者的各项症状、体征,新冠病毒核酸检测阳性例数,干预措施的保护率。结果完成随访共9206例,其中共有149例出现阳性,对照组(4821例)133例阳性,治疗组(4385例)阳性16例;强身抗疫冲剂干预后保护率为86.96%;治疗组感染率为0.33%,显著低于对照组的3.03%(P<0.01)。结论强身抗疫冲剂能有效预防COVID-19感染,其机制有待进一步研究。

Olyective:To observe the preventive effect of Qiangshen Kangyi Decoction on COVID-19 infection and to objectively evaluate its safety and adverse effects.Methods:A Cluster-randomized and controlled design was adopted.The included subjects were divided into the treatment group of traditional Chinese medicine intervention and the control group without intervention,and the symptoms and signs of patients,the number of positive cases of new coronavirus nucleic acid test,and the protection rate of the intervention were recorded in detail.Results:A total of 9206 cases were followed,of which 149 were positive,with 133 cases in the control group(totaling 4821 cases),and 16 in the treatment group(0.33%)(totaling 4385 cases).The protection rate after the intervention was 86.96%,and the infection rate in the treatment group was significantly lower than that of the control group(3.03%)(P<0.01).Conclusion:Qiangshen Kangyi Decoction can effectively prevent COVID-19 infection,and its mechanism needs to be further studied.