氢溴酸氘瑞米德韦治疗轻、中型新型冠状病毒感染的疗效和安全性

Efficacy and safety of deuremidevir hydrobromide in treatment of patients with mild and moderate COVID-19

目的 探讨氢溴酸氘瑞米德韦治疗轻、中型新型冠状病毒感染的疗效和安全性。方法 收集2023年5月8日至8月5日嵊州市中医院收治的242例新型冠状病毒感染患者,根据是否接受氢溴酸氘瑞米德韦抗病毒治疗分为观察组(169例)与未服用任何抗新型冠状病毒药物的对照组(73例)。比较两组患者人口学资料、基础疾病、本次感染首次核酸阳性时间及Ct值、疾病严重程度、药品不良反应、首次核酸转阴及临床恢复时间、是否进展为重型等信息。通过Kaplan-Meier生存分析计算病毒转阴及临床恢复时间,采用多因素Cox回归计算各因素的风险比(HR)及95%CI。结果 242例新型冠状病毒感染患者中,轻型134例(55.4%),中型108例(占44.6%);232例(95.9%)具有重型/危重型高危因素,高危因素前3位分别为心脑血管疾病(179例,74.0%)、糖尿病(77例,31.8%)、慢性肺部疾病(42例,17.4%)。两组基线特征比较,观察组患者年龄更大,合并慢性肺部疾病比例更高(均P<0.05)。观察组病毒转阴时间和临床恢复时间均显著短于对照组(均P<0.05)。多因素Cox回归分析发现病毒转阴时间的HR=2.93(95%CI:2.13~4.02),临床恢复时间HR=3.63(95%CI:2.59~5.11),均P<0.01。治疗后观察组有5例(3.0%),对照组有2例(2.7%)进展为重型,两组比较差异无统计学意义(P>0.05)。观察组发生药品不良反应9例,不良反应发生率为5.3%,未发现严重不良反应。结论 氢溴酸氘瑞米德韦是有效的口服抗新型冠状病毒药物,能显著缩短新型冠状病毒感染轻、中型患者病毒转阴及临床恢复时间,并具有较好的安全性。

Objective To investigate the efficacy and safety of deuremidevir hydrobromide in the treatment of patients with mild and moderate corona virus disease 2019(COVID-19).Methods A total of 242 patients with mild and moderate COVID-19 admitted to Shengzhou Hospital of Traditional Chinese Medicine between May 8,2023 and August 5,2023 were enrolled,including 169 cases treated with deuremidevir hydrobromide(study group) and 73 cases did not receive any antiviral treatment(control group).Demographic data,underlying diseases,first positive nucleic acid test time and Ctvalue,disease severity,adverse drug reactions,time of nucleic acid test negative conversion(viral clearance time) and clinical recovery time,and progression to severe disease were compared between two groups.The viral clearance and clinical recovery time were calculated by Kaplan-Meier analysis,and the hazard ratio(HR) and 95%CI of each variate were calculated by multivariate Cox regression.Results Among 242 patients,there were 134 mild cases(55.4%) and 108 mo-derate cases(44.6%);and 232 cases(95.9%) had risk factors of progression to severe/critical disease,including 179 cases of cardiovascular and cerebrovascular diseases(74.0%),77 cases of diabetes(31.8%),and 42 cases of chronic pulmonary diseases(17.4%).Patients in the study group had average older ages and higher proportion of chronic lung disease(both P<0.05).The viral clearance time and clinical recovery time in the study group were significantly shorter than those in the control group(both P<0.05).Multivariate Cox regression analysis showed that the HR of viral clearance time was 2.93(95%CI:2.13-4.02),and the HR of clinical recovery time was 3.63(95%CI:2.59-5.11),both P<0.01.During the hospitalization 5 cases(3.0%) in the study group and 2 cases(2.7%) in the control group progressed to severe cases(P>0.05).Adverse reactions were observed in 9 cases(5.3%) of the study group,but there were no cases of serious adverse reactions.Conclusion Deuremidevir hydrobromide is effective in treatment of mild and moderate COVID-19,which can significantly shorten viral clearance time and clinical recovery time of patients,and has good safety.