中西医结合治疗46例重型/危重型新型冠状病毒肺炎单臂临床研究

Single Arm Clinical Study on 46 Severe or Critical Cases of COVID-19 Treated by Integrated Traditional Chinese and Western Medicine

目的评价中西医结合治疗方案对重型/危重型新型冠状病毒肺炎(简称"新冠肺炎")患者的临床疗效。方法采用前瞻性单臂临床研究设计,纳入2020年1月21日至2月24日河南省8家新冠肺炎定点医院收治的重型和危重型新冠肺炎患者,采用西医联合中医辨证治疗的中西医结合治疗方案于患者住院期间进行全程治疗。观察患者新型冠状病毒核酸转阴情况、疾病转归情况、住院时间以及肺部影像学变化,并分别于治疗前及治疗7天、14天对患者主要临床症状和体征进行评分。结果纳入分析46例。病毒核酸转阴41例(89.1%),转阴时间中位数为12天;出院41例(89.1%),死亡5例(10.9%);住院时间中位数为12天;与治疗前比较,治疗7天、治疗14天的发热、胸闷、气短、乏力评分均明显降低(P<0.01);治疗14天咳嗽评分明显降低(P<0.01),且治疗14天咳嗽评分较治疗7天明显下降(P<0.01)。完成出院时影像学检查的患者胸片影像学好转率为58.3%(7例/12例),CT影像学好转率为66.7%(16例/24例)。结论中西医结合治疗新冠肺炎具有较好疗效,可改善临床症状、促进肺部炎症吸收,但尚需大样本临床随机对照试验验证。

Objective To evaluate the effect of integrated traditional Chinese and Western medicine for treating severe or critical cases of coronavirus disease 2019(COVID-19).Methods A prospective single arm clinical study was designed.Severe or critical cases of COVID-19 were recruited from eight designated hospitals for COVID-19 in Henan Province from January 21,2020 to February 24,2020.All the patients were treated with integrated traditional Chinese and Western medicine.The negative conversion of viral nucleic acid,disease outcome,length of hospital stays,and lung imaging were observed.Clinical symptoms and signs were assessed before treatment and after 7 and 14 days treatment.Results Totally,46 cases were included in the analysis.Forty-one cases(89.1%)were reported of negative conversion of viral nucleic acid,and the median time to negative conversion was 12 days.Forty-one cases(89.1%)were discharged from hospital,and five cases(10.9%)died.The median time of hospital stay was 12 days.The scores of fever,chest tightness,shortness of breath and fatigue after 7 and 14 days treatment significantly decreased than before treatment(P<0.01);the score of cough on the 14 th days after treatment significantly decreased than before treatment(P<0.01),as well as than the 7 th day after treatment(P<0.01).The improvement rate of chest imaging and computed tomography(CT)imaging in those who completed the imaging examination at the time of discharge was 58.3%(7/12)and 66.7%(16/24),respectively.Conclusion The integrated traditional Chinese and Western medicine has a good effect for treating COVID-19,which can improve the clinical symptoms and promote the absorption of pulmonary inflammation.However,large sample size controlled clinical trials are needed for further verification.