机构：[1]Department of Respiratory Medicine, Zhongshan Hospital, Fudan University,Shanghai, China[2]Department of Medical Statistics, Peking University First Hospital, Beijing,China[3]Institute of Field Surgery, Chinese People’s Liberation Army GeneralHospital, Beijing, China[4]Department of Emergency Medicine, Chinese People’s Liberation ArmyGeneral Hospital, Beijing, China[5]Department of Emergency Medicine, First Affiliated Hospital of ChinesePeople’s Liberation Army General Hospital, Beijing, China[6]Department of Intensive Care Unit, Second Affiliated Hospital of HarbinMedical University, Harbin, China[7]Department of Intensive Care Unit, Yuhuangding Hospital Affiliated toQingdao University, Yantai, China[8]Department of Emergency Medicine, First People’s Hospital of YunnanProvince, Kunming, China[9]Department of Intensive Care Unit, The First Hospital of Jilin University,Changchun, China[10]Department of Intensive Care Unit, Renmin Hospital of Wuhan University,Wuhan, China[11]Department of Respiratory Medicine, People’s Liberation Army GeneralHospital of Rocket Forces, Beijing, China[12]Department of Respiratory Medicine, People’s Liberation Army GeneralHospital of Shenyang Military Command, Shenyang, China[13]Department of Respiratory Medicine, Luoyang Central Hospital Affiliatedto Zhengzhou University, Luoyang, China[14]Department of Intensive Care Unit, Qilu Hospital of Shandong University,Jinan, China[15]Department of Emergency Medicine, Wuhan General Hospital of GuangzhouMilitary Command, Wuhan, China[16]Department of Intensive Care Unit, Guangdong Provincial Hospital ofTraditional Chinese Medicine, Guangzhou, China[17]Department of Emergency Medicine, Xin Hua Hospital Affiliated toShanghai Jiaotong University School of Medicine, Shanghai, China[18]Department of Emergency Medicine, Tianjin Medical University GeneralHospital, Tianjin, China[19]Department of Intensive Care Unit, Central Hospital Affiliated to ShenyangMedical College, Shenyang, China[20]Department of Respiratory Medicine, The First Affiliated Hospital of TheFourth Military Medical University, Xi'an, China[21]Department of Respiratory Medicine, Beijing Shijitan Hospital, CapitalMedical University, Beijing, China[22]Department of Respiratory Medicine, People’s Liberation Army Air ForceGeneral Hospital, Beijing, China[23]Department of Respiratory Medicine, West China Hospital of SichuanUniversity, Sichuan, China[24]Department of Emergency Medicine, Beijing Union Medical CollegeHospital, Beijing, China[25]Department of Emergency Medicine, The First Affiliated Hospital ofAnhui Medical University, Hefei, China[26]Department of Respiratory Medicine, The Fourth Affiliated Hospital ofChina Medical University, Shenyang, China[27]Department of Anesthesiology and Critical Care Medicine, ZhongnanHospital, Wuhan University, Wuhan, China[28]Department of Intensive Care Unit, First Affiliated Hospital of DalianMedical University, Dalian, China大连医科大学附属第一医院[29]Department of Respiratory Medicine, Taihe Hospital, Hubei University ofMedicine, Shiyan, China[30]Department of Emergency Medicine, The Second Hospital of HebeiMedical University, Shijiazhuang, China[31]Department of Emergency, Hunan Provincial People’s Hospital, Hunan,China[32]Department of Biostatistics, Peking University Clinical Research Institute, Beijing, China[33]Evidence Based Medicine Center, Tianjin University of Traditional ChineseMedicine, Tianjin, China[34]General Office, China Academy of Chinese Medical Sciences, Beijing,China[35]State Key Laboratory of Respiratory Diseases, first Affiliated Hospital,Guangzhou Medical University, Guangzhou, China[36]Key Laboratory of Chinese Internal Medicine of Ministry of Educationand Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine,Beijing, China
Objectives: To investigate whether XueBiJing injection improves clinical outcomes in critically ill patients with severe community-acquired pneumonia. Design: Prospective, randomized, controlled study. Setting: Thirty-three hospitals in China. Patients: A total of 710 adults 18-75 years old with severe community-acquired pneumonia. Interventions: Participants in the XueBiJing group received XueBiJing, 100mL, q12 hours, and the control group received a visually indistinguishable placebo. Measurements and Main Results: The primary outcome was 8-day improvement in the pneumonia severity index risk rating. Secondary outcomes were 28-day mortality rate, duration of mechanical ventilation and total duration of ICU stay. Improvement in the pneumonia severity index risk rating, from a previously defined endpoint, occurred in 203 (60.78%) participants receiving XueBiJing and in 158 (46.33%) participants receiving placebo (between-group difference [95% CI], 14.4% [6.9-21.8%]; p < 0.001). Fifty-three (15.87%) XueBiJing recipients and 84 (24.63%) placebo recipients (8.8% [2.4-15.2%]; p = 0.006) died within 28 days. XueBiJing administration also decreased the mechanical ventilation time and the total ICU stay duration. The median mechanical ventilation time was 11.0 versus 16.5 days for the XueBiJing and placebo groups, respectively (p = 0.012). The total duration of ICU stay was 12 days for XueBiJing recipients versus 16 days for placebo recipients (p = 0.004). A total of 256 patients experienced adverse events (119 [35.63%] vs 137 [40.18%] in the XueBiJing and placebo groups, respectively [p = 0.235]). Conclusions: In critically ill patients with severe community-acquired pneumonia, XueBiJing injection led to a statistically significant improvement in the primary endpoint of the pneumonia severity index as well a significant improvement in the secondary clinical outcomes of mortality, duration of mechanical ventilation and duration of ICU stay.
基金：
Supported, in part, by a Tianjin Science and Technology committee grant
(14ZXLJSY00230) and National Natural Science Foundation of China
(81630001,81490533).
第一作者机构：[1]Department of Respiratory Medicine, Zhongshan Hospital, Fudan University,Shanghai, China
通讯作者：
推荐引用方式(GB/T 7714)：
Song Yuanlin,Yao Chen,Yao Yongming,et al.XueBiJing Injection Versus Placebo for Critically Ill Patients With Severe Community-Acquired Pneumonia: A Randomized Controlled Trial[J].CRITICAL CARE MEDICINE.2019,47(9):E735-E743.doi:10.1097/CCM.0000000000003842.
APA：
Song, Yuanlin,Yao, Chen,Yao, Yongming,Han, Hui,Zhao, Xiaodong...&Bai, Chunxue.(2019).XueBiJing Injection Versus Placebo for Critically Ill Patients With Severe Community-Acquired Pneumonia: A Randomized Controlled Trial.CRITICAL CARE MEDICINE,47,(9)
MLA：
Song, Yuanlin,et al."XueBiJing Injection Versus Placebo for Critically Ill Patients With Severe Community-Acquired Pneumonia: A Randomized Controlled Trial".CRITICAL CARE MEDICINE 47..9(2019):E735-E743
医学