扶正化瘀片对COVID-19患者肺部炎症的临床疗效  

Efficacy of Fuzheng Huayu Tablets for Treating Pulmonary Inflammation in COVID-19 Patients

作　　者：景菲 邢枫[1] 范海纳 皮明明 张兴[1] 张炜[1] 肖明中[3] 邱其武[2] 吕靖[1] 刘成海[1,4,5] JING Fei;XING Feng;FAN Hai-na;PI Ming-ming;ZHANG Xing;ZHANG Wei;XIAO Ming-zhong;QIU Qi-wu;LYU Jing;LIU Cheng-hai(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine(TCM),Shanghai 201203,China;Jingmen No.1 People′s Hospital,Jingmen 448000,China;Institute of Liver Diseases,Hubei Provincial Hospital of TCM,Wuhan 430000,China;Shanghai Key Laboratory of Traditional Chinese Clinical Medicine,Shanghai 201203,China;Key Laboratory of Liver and Kidney Diseases,Ministry of Education,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属曙光医院,上海201203 [2]荆门市第一人民医院,湖北荆门448000 [3]湖北省中医院肝病研究所,武汉430000 [4]上海市中医临床重点实验室,上海201203 [5]教育部肝肾疾病重点实验室,上海201203

出　　处：《中国实验方剂学杂志》2022年第11期125-131,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家重点研发计划项目(2020YFC0845000);上海市中医药防治新冠肺炎科研攻关项目(2020XGKY11)。

摘　　要：目的:观察扶正化瘀片治疗新型冠状病毒肺炎(COVID-19)患者肺部炎症的疗效及安全性。方法:招募2020年2月1日至2020年4月15日COVID-19确诊患者70例(失访4例,最终完成66例),根据患者治疗方式分为对照组(35例患者)和观察组(31例患者)。对照组患者接受常规治疗,观察组除常规治疗外加扶正化瘀片治疗。主要疗效指标为观察两组患者治疗14 d后的胸部CT改善率;次要疗效指标包括疾病转归情况,临床症状缓解率(发热、咳嗽、憋喘、乏力)、血常规、C反应蛋白(CRP)、降钙素原(PCT)、血氧饱和度(SPO_(2));评估患者肝肾功能等。结果:治疗14 d后,观察组胸部CT的改善率为100%(31/31),对照组为77.1%(27/35),差异具有统计学意义(χ^(2)=8.063,P<0.01)。观察组与对照组在疾病转归方面,差异无统计学意义。与本组治疗前比较,观察组治疗后咳嗽、憋喘、乏力症状显著减轻(P<0.01),对照组治疗后发热、咳嗽、憋喘症状显著减轻(P<0.01),乏力症状改善差异无统计学意义;与对照组治疗后比较,两组临床症状差异无统计学意义。与本组治疗前比较,观察组患者,白细胞(WBC)、中性粒细胞-淋巴细胞比值(NLR)显著降低(P<0.01),血小板(PLT)水平明显升高(P<0.05),CRP水平明显降低(P<0.05),淋巴细胞(LYM)、血红蛋白(Hb)、SPO_(2)及PCT水平差异无统计学意义;对照组患者WBC、NLR明显降低(P<0.05,P<0.01),PCT水平明显升高(P<0.05),LYM、Hb、PLT、SPO_(2)及CRP水平差异无统计学意义。与对照组治疗后比较,观察组PLT水平明显升高(P<0.05),其他指标差异无统计学意义。两组安全性指标差异无统计学意义。结论:扶正化瘀片可促进COVID-19患者急性期肺部炎症的吸收。Objective:To observe the efficacy and safety of Fuzheng Huayu tablets(FHT)for treating pulmonary inflammation in patients with coronavirus disease 2019(COVID-19).Method:A total of 70(4 cases were lost to follow-up,and 66 cases were finally completed)COVID-19 patients were recruited from February 1to April 15 in 2020.They were assigned to a control group(35 patients)and a FHT group(31 patients).The patients in the control group received routine treatment alone and those in the FHT group received FHT in addition to routine treatment.The primary outcome was the ratio of patients showing improvement in chest computed tomographic manifestations after 14 days.The secondary outcome measures included remission rate or progression rate of critical illness,clinical remission rate of respiratory symptoms,routine blood examination,C-reactive protein(CPR)level,procalcitonin(PCT)level,and blood oxygen saturation(SPO_(2)).The safety was assessed based on liver and kidney functions and adverse events.Result:After the 14-day treatment,the ratio of patients showing improvement in the FHT group(100%)was higher than that in the control group(77.1%)(χ^(2)=8.063,P<0.01).The ratio of disease stages after treatment showed no significant difference between two groups.In the FHT group,the symptoms including cough,dyspnea,and fatigue were alleviated after treatment(P<0.01).In the control group,the symptoms including fever,cough,and dyspnea were alleviated(P<0.01),while the fatigue was not relieved after treatment.No significant difference was observed in the clinical symptoms between the two groups after treatment.After treatment,the FHT group showed decreased white blood cell(WBC)count and neutrophil-to-lymphocyte ratio(NLR)(P<0.01),elevated platelet(PLT)level(P<0.05),lowered CRP level(P<0.05),and no significant difference in lymphocyte(LYM),hemoglobin(Hb),SPO_(2)or PCT level.The control group showed decreased NLR(P<0.05)and WBC count(P<0.01),elevated PCT level(P<0.05),and no significant change in LYM,Hb,PLT,SPO_(2)or CRP level after tre

关 键 词：新型冠状病毒肺炎(COVID-19) 扶正化瘀片 肺部炎症 安全性 临床疗效 

分 类 号：R242[医药卫生—中医临床基础] R969.4[医药卫生—中医学]