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Safety, tolerability, pharmacokinetics, and efficacy of kukoamine B in patients with sepsis: A randomized phase IIa trial

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收录情况： ◇ SCIE

作者：
Hu Xiao-Yun[1,2] * ; Zhang Weiwen[3] ; Wang Difen[4] ; Sun Yunbo[5] ; Hu Zhenjie[6] ; Zang Bin[7] ; Feng Yongwen[8] ; Wang Huaxue[9] ; Zhou Jianxin[10] ; Zhao Qian[2,11] ; Liu Hongzhong[2,11] ; Wang Teng[12] ; Jiang Wei[1,2] ; Wang Chun-Yao[1,2] ; Jin Chunyan[13] ; Dong Kai[13] ; Chen Shuai[13] ; Yao Xiaoqing[13] ; Hu Pei[2,11] ; Du Bin[1,2,*1] ;
机构： [1]Medical ICU, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, 1 Shuai Fu Yuan, Beijing 100730, China [2]State Key Laboratory of Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, 1 Shuai Fu Yuan, Beijing 100730, China [3]Department of Critical Care Medicine, The Quzhou Affiliated Hospital of Wenzhou Medical University, Quzhou People’s Hospital, No. 100 Minjiang Road, Kecheng District, Quzhou, Zhejiang 324000, China [4]Department of Critical Care Medicine, The Affiliated Hospital of Guizhou Medical University, 28 Guiyi Street, Guiyang, Guizhou 550004, China [5]Department of Critical Care Medicine, The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Shinan District, Qingdao, Shandong Province 266003, China [6]Department of Intensive Care Unit, The Fourth Hospital of Hebei Medical University and Hebei Cancer Hospital, 12 Jiankang Road, Shijiazhuang, Hebei Province 050011, China [7]Department of Critical Care Medicine, Shengjing Hospital of China Medical University, 36 Sanhao Street, Shenyang, Liaoning Province 110004, China [8]Department of Critical Care Medicine, Shenzhen Second People’s Hospital, 3002 Sungang West Road, Futian District, Shenzhen, Guangdong Province 518035, China [9]Department of Critical Care Medicine, The First Affiliated Hospital of Bengbu Medical College, 287 Changhuai Road, Bengbu, Anhui Province 233004, China [10]Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, 119 South Fourth Ring West Road, Fengtai District, Beijing 100070, China [11]Clinical Pharmacology Research Center, Peking Union Medical College Hospital, State Key Laboratory of Complex Severe and Rare Diseases, NMPA Key Laboratory for Clinical Research and Evaluation of Drug, Beijing Key Laboratory of Clinical PK & PD Investigation for Innovative Drugs, Chinese Academy of Medical Sciences & Peking Union Medical College, No. 1 Shuaifuyuan, Dongcheng District, Beijing 100730, China [12]Clinical Trial Center, West China hospital of Sichuan University, Chengdu, Sichuan Province, China [13]Clinical Research Center for Innovative Drugs, Tianjin Chasesun Pharmaceutical Co., Ltd., 20 Quan Fa Road, WuQing District, Tianjin 301700, China
出处：
DOI： 10.1016/j.jcrc.2023.154294
ISSN：

关键词： Sepsis Kukoamine B Sequential organ failure assessment Safety Pharmacokinetics

摘要：
To evaluate the safety, tolerability, pharmacokinetics, and efficacy of kukoamine B (KB), an alkaloid compound with high affinity for both lipopolysaccharide (LPS) and oligodeoxynucle-otides containing CpG motifs (CpG DNA), in patients with sepsis-induced organ failure.This was a multicenter, randomized, double-blind, placebo-controlled phase IIa trial. Patients with sepsis-induced organ failure were randomized to receive either KB (0.06, 0.12, or 0.24 mg/kg) or placebo, every 8 h for 7 days. Primary endpoint was safety, and secondary endpoints included pharmacokinetic (PK) parameters, changes in inflammatory mediators' level, and prognostic parameters.Of 44 patients enrolled, adverse events occurred in 28 patients [n = 20, 66.7% (KB pooled); n = 8, 57.1% (placebo)], while treatment emergent adverse events were reported in 14 patients [n = 10, 33.3% (KB pooled); n = 4, 28.6% (placebo)]. Seven patients died at 28-day follow-up [n = 4, 13.3% (KB pooled); n = 3, 21.4% (placebo)], none was related to study drug. PK parameters suggested dose-dependent drug exposure and no drug accumulation. KB did not affect clinical outcomes such as ΔSOFA score, vasopressor-free days or ventilator-free days.In patients with sepsis-induced organ failure, KB was safe and well tolerated. Further investigation is warranted.http://ClinicalTrials.gov, NCT03237728.Copyright © 2023. Published by Elsevier Inc.

基金：
This work was supported by the National Science and Technology Major Program (2018ZX09736-018); Chinese Academy of Medical Sciences Innovation Fund (2019-I2M-1-001 and 2020-I2M-2-005); and Tianjin Chasesun Pharmaceutical Co., Ltd., China as well.
语种：
外文
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中科院分区：
出版当年[2023]版：
大类 | 3 区 医学
小类 | 3 区 危重病医学
最新[2025]版：
大类 | 3 区 医学
小类 | 3 区 危重病医学
JCR分区：
出版当年[2023]版：
Q2 CRITICAL CARE MEDICINE
最新[2024]版：
Q2 CRITICAL CARE MEDICINE

影响因子： 最新[2024版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版] 出版后一年[2024版]

第一作者：
第一作者机构： [1]Medical ICU, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, 1 Shuai Fu Yuan, Beijing 100730, China [2]State Key Laboratory of Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, 1 Shuai Fu Yuan, Beijing 100730, China
通讯作者：
通讯机构： [1]Medical ICU, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, 1 Shuai Fu Yuan, Beijing 100730, China [2]State Key Laboratory of Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, 1 Shuai Fu Yuan, Beijing 100730, China [11]Clinical Pharmacology Research Center, Peking Union Medical College Hospital, State Key Laboratory of Complex Severe and Rare Diseases, NMPA Key Laboratory for Clinical Research and Evaluation of Drug, Beijing Key Laboratory of Clinical PK & PD Investigation for Innovative Drugs, Chinese Academy of Medical Sciences & Peking Union Medical College, No. 1 Shuaifuyuan, Dongcheng District, Beijing 100730, China [*1]Medical Intensive Care Unit, Peking Union Medicine Collage Hospital, 1 Shuai Fu Yuan, Beijing 100730, China.
推荐引用方式(GB/T 7714)：
Hu Xiao-Yun,Zhang Weiwen,Wang Difen,et al.Safety, tolerability, pharmacokinetics, and efficacy of kukoamine B in patients with sepsis: A randomized phase IIa trial[J].JOURNAL OF CRITICAL CARE.2023,76:doi:10.1016/j.jcrc.2023.154294.
APA：
Hu Xiao-Yun,Zhang Weiwen,Wang Difen,Sun Yunbo,Hu Zhenjie...&Du Bin.(2023).Safety, tolerability, pharmacokinetics, and efficacy of kukoamine B in patients with sepsis: A randomized phase IIa trial.JOURNAL OF CRITICAL CARE,76,
MLA：
Hu Xiao-Yun,et al."Safety, tolerability, pharmacokinetics, and efficacy of kukoamine B in patients with sepsis: A randomized phase IIa trial".JOURNAL OF CRITICAL CARE 76.(2023)

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