血必净注射液治疗重症社区获得性肺炎疗效的随机对照临床试验设计思路与实施过程解读  

Interpretation of design ideas and implementation process of randomized controlled trial of Xuebijing injection in the treatment of severe community-acquired pneumonia

作　　者：白春学 姚晨[2] 商洪才[3] 于学忠[4] 于凯江[5] 姚咏明[6] Bai Chunxue;Yao Chen;Shang Hongcai;Yu Xuezhong;Yu Kaijiang;Yao Yongming(Department of Respiratory Medicine,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Department of Medical Statistics,Peking University First Hospital,Beijing 100000,China;Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Department of Emergency Medicine,Beijing Union Medical College Hospital,Beijing 100032,China;Department of Intensive Care Unit,First Affiliated Hospital of Harbin Medical University,Harbin 150001,Heilongjiang,China;Institute of Field Surgery,General Hospital of PLA,Beijing 100853,China)

机构地区：[1]复旦大学附属中山医院呼吸科,上海200032 [2]北京大学第一医院统计教研室,100000 [3]北京中医药大学东直门医院中医内科学教育部和北京市重点实验室,100700 [4]北京协和医院急诊科,100032 [5]哈尔滨医科大学附属第一医院重症医学科,黑龙江哈尔滨150001 [6]解放军总医院野战外科研究所,北京100853

出　　处：《中华危重病急救医学》2019年第7期811-814,共4页Chinese Critical Care Medicine

摘　　要：按照国际临床试验标准开展多中心盲法随机对照临床试验(RCT),在严格的质量控制条件下评价血必净注射液治疗重症社区获得性肺炎(SCAP)的疗效和安全性.本文通过对血必净注射液治疗SCAP疗效的RCT设计思路及实施过程重点内容进行解读,围绕研究对象选择、研究设计、研究实施以及对研究设计与实施的思考等内容进行阐述,与呼吸及危重病专业同道分享研究经验,以期为危重病领域的未来临床研究提供借鉴.A multicenter blinded randomized controlled trial (RCT) was conducted in accordance with international clinical trial standards to evaluate the efficacy and safety of Xuebijing injection in the treatment of severe community-acquired pneumonia (SCAP) under strict quality control condition. This article aims to illustrate key contents of the design ideas and implementation process of the RCT of Xuebijing injection in the treatment of SCAP, including the selection of research objects, design, implementation, and insights, etc., share experience with researchers of the respiratory and critical care, and provide reference for future studies in critical care.

关 键 词：血必净注射液 重症社区获得性肺炎 随机对照临床试验 

分 类 号：R563.1[医药卫生—呼吸系统]