痰热清注射液治疗新型冠状病毒感染肺炎真实世界临床研究报告  

Real-world Clinical Study on Tanreqing Injection in the Treatment of Novel Coronavirus-infected Pneumonia

作　　者：陈伟焘[1] 袁天慧[1] 詹少锋[1] 夏欣田[1] 何靖[1] 李培武[1] 温敏勇[1] 孙跃玲 刘小河 余锋[1] 宁怡乐 黄诗淳 刘燕燕[1] 刘南[1] 冼绍祥[1] 杨忠奇[1] CHEN Wei-Tao;YUAN Tian-Hui;ZHAN Shao-Feng;XIA Xin-Tian;HE Jing;LI Pei-Wu;WEN Min-Yong;SUN Yue-Ling;LIU Xiao-He;YU Feng;NING Yi-Le;HUANG Shi-Chun;LIU Yan-Yan;LIU Nan;XIAN Shao-Xiang;YANG Zhong-Qi(The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405 Guangdong,China;Hubei Hospital of Integrated Traditional Chinese and Western Medicine,Wuhan 430010 Hubei,China)

机构地区：[1]广州中医药大学第一附属医院,广东广州510405 [2]湖北省中西医结合医院,湖北武汉430010

出　　处：《广州中医药大学学报》2022年第3期463-468,共6页Journal of Guangzhou University of Traditional Chinese Medicine

基　　金：广东省应急专项(编号:2020A111128037);广州市科技局重点研发计划项目(编号:2060901);国家中医临床研究基地建设项目(国中医药科技函[2018]131号);广东省自然科学基金自由申请项目(编号:2018A030313270、2019A1515011010);广东省中医药局课题面上项目(编号:20192018);广州中医药大学第一附属医院“创新强院”工程科研系列-青年科研人才培优项目(编号:2017QN05)。

摘　　要：【目的】观察痰热清注射液治疗新型冠状病毒感染肺炎的临床疗效及其安全性。【方法】将70例新型冠状病毒感染肺炎(确诊或疑似)患者随机分为试验组(34例)和对照组(36例)。对照组仅给予常规治疗,试验组给予大剂量痰热清注射液联合常规治疗。评价2组患者的有效性指标[体温复常时间、电子计算机断层扫描(CT)影像好转情况、平均住院时间]和安全性指标(实验室指标、不良事件的发生情况和发生率)。【结果】(1)试验组的平均体温复常时间为(1.68±1.07)d[中位数为2.00(1.00,2.00)d],较对照组的(2.76±1.58)d[中位数为3.00(2.00,4.00)d]明显缩短,差异有统计学意义(P<0.01)。(2)试验组的CT影像好转率为52.38%(11/21),对照组为44.44%(8/18),差异无统计学意义(P>0.05)。(3)试验组的平均住院天数为(10.75±2.54)d,较对照组的(14.21±4.28)d明显缩短,差异有统计学意义(P<0.01)。(4)试验组和对照组各有2例患者病亡,试验组的病亡率为5.88%(2/34),对照组为5.56%(2/36),组间比较,差异无统计学意义(P>0.05)。(5)试验组和对照组使用抗病毒类药物分别为40.63%(13/32)、94.12%(32/34),使用抗生素类药物分别为37.50%(12/32)、67.65%(23/34);组间比较,试验组患者的抗病毒类药物和抗生素类药物的使用率均明显低于对照组,差异均有统计学意义(P<0.01);而2组患者的其他药物(如氨溴索、阿斯美等)使用情况比较,差异无统计学意义(P>0.05)。(6)治疗过程中,未发现与痰热清注射液有关的不良反应。【结论】痰热清注射液能缩短体温复常时间,减少住院时间,提高临床疗效;可显著降低抗病毒药物和抗生素药物的使用,减少由这些药物可能带来的肝肾损伤;并且未发现与痰热清注射液相关的不良反应,临床应用安全性良好。Objective To observe the clinical efficacy and safety of Tanreqing Injection in the treatment of novel coronavirus-infected pneumonia(NCIP,COVID-19).Methods Seventy patients of NCIP(confirmed or suspected)were randomly divided into the trial group(34 cases)and the control group(36 cases).The control group was given conventional treatment,while the trial group was given high-dose Tanreqing Injection combined with conventional treatment.The effectiveness indicators of time for body temperature returning to normal,improvement of computed tomography(CT)imaging,and average hospitalization time as well as the safety indicators of laboratory indicators,incidence and prevalence of adverse events were evaluated in the two groups.Results(1)The average time for body temperature returning to normal in the trial group was(1.68±1.07)d[median2.00(1.00,2.00)d],which was significantly shortened compared with that in the control group(2.76±1.58)d[median 3.00(2.00,4.00)d],and the difference was statistically significant(P<0.01).(2)The CT imaging improvement rate in the trial group was 52.38%(11/21),and that in the control group was 44.44%(8/18),the difference being not statistically significant(P>0.05).(3)The average hospitalization time in the trial group was(10.75±2.54)d,which was significantly shortened compared with that in the control group[(14.21±4.28)d],the difference being statistically significant(P<0.01).(4)There were 2 patients died in both of the trial group and the control group,and the mortality of the trial group was 5.88%(2/34)and that of the control group was5.56%(2/36),and there was no statistically significant difference between the two groups(P>0.05).(5)The antiviral drug medication frequency was 40.63%(13/32)and 94.12%(32/34)in the trial group and the control group respectively,and the antibiotics medication frequency was 37.50%(12/32)and 67.65%(23/34),respectively.The intergroup comparison showed that the medication frequency of antiviral drugs and antibiotics in the trial group was significantly lower tha

关 键 词：痰热清注射液 新型冠状病毒感染肺炎 体温复常时间 真实世界临床研究 

分 类 号：R254.3[医药卫生—中医内科学]