Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study

doi:10.1007/s40263-021-00890-1

科研成果详情

题名	Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study
作者	Luo, Zhen 1; Tu, Hong 1; Zhang, Xiang 1; Wang, Xiao 1; Ouyang, Wen 2; Wei, Xinchuan 3; Zou, Xiaohua 4; Zhu, Zhaoqiong 5; Li, Yalan 6; Shangguan, Wangning7; Wu, Hui 8; Wang, Yaping 9; Guo, Qulian 10
发表日期	2022-03
发表期刊	CNS DRUGS 影响因子和分区
语种	英语
原始文献类型	Article ; Early Access
其他关键词	FLEXIBLE BRONCHOSCOPY ; MODERATE SEDATION ; INJECTION ; PAIN ; MIDAZOLAM ; PLACEBO
摘要	Background Fiberoptic bronchoscopy is a complex procedure with the need for sufficient patient anesthesia/sedation while maintaining safety. This trial aimed to evaluate the efficacy, safety, and pharmacokinetics of HSK3486 during fiberoptic bronchoscopy. Methods This multicenter, double-blind, randomized, non-inferiority, parallel-group phase 3 trial was conducted in patients who underwent fiberoptic bronchoscopy. Patients randomly received HSK3486 0.4 mg/kg (N = 134) or propofol 2.0 mg/kg (N = 133). The primary efficacy endpoint was the successful rate of fiberoptic bronchoscopy, and secondary efficacy endpoints included successful induction of anesthesia/sedation, duration, time to being fully alert, and time to patient discharge. Safety assessments and drug concentrations were also measured. Results A total of 267 patients completed fiberoptic bronchoscopy, with a success rate of 100% and a 95% confidence interval of - 2.8 to 2.8% for the difference between the groups, which met the predesigned criteria of > - 8%, confirming the non-inferiority of anesthesia/sedation produced by HSK3486 compared to propofol. Among the secondary efficacy endpoints, only time to full alertness (median 8.50 vs. 6.00 min, P = 0.012) and time to discharge (median 13.00 vs. 9.87 min, P = 0.002) were slightly longer in the HSK3486 group. The incidence of adverse events was significant lower in the HSK3486 group (52.6 vs. 76.5%, P < 0.001) mainly because of less pain on injection (4.4 vs. 39.4%, P < 0.001) compared to the propofol group. HSK3486 had a similar terminal elimination half-life as propofol. Conclusions HSK3486 exhibited non-inferiority anesthesia/sedation compared to propofol in patients undergoing fiberoptic bronchoscopy, and had a good safety profile with a lower incidence of pain on injection.
资助项目	Haisco Pharmaceutical Group Co., Ltd.
出版者	ADIS INT LTD
出版地	NORTHCOTE
ISSN	1172-7047
EISSN	1179-1934
卷号	36 期号:3 页码:301-313
DOI	10.1007/s40263-021-00890-1
页数	13
WOS类目	Clinical Neurology ; Pharmacology & Pharmacy ; Psychiatry
WOS研究方向	Neurosciences & Neurology ; Pharmacology & Pharmacy ; Psychiatry
WOS记录号	WOS:000755103500002
收录类别	SCIE ; SCOPUS ; PUBMED
URL	查看原文
Pubmed记录号	35157236
Scopus记录号	2-s2.0-85124739171
通讯作者地址	[Wang, Xiao]Department of Anesthesiology,West China Hospital,Sichuan University,No. 37 Guoxue Lane, Sichuan,Chengdu,610041,China
scopus学科分类	Neurology (clinical);Psychiatry and Mental Health;Pharmacology (medical)
引用统计	被引频次：4[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/20171
专题	第二临床医学院、附属第二医院、育英儿童医院附属第二医院附属第一医院_麻醉科第一临床医学院（信息与工程学院）、附属第一医院_麻醉科
通讯作者	Wang, Xiao
作者单位	1.Department of Anesthesiology,West China Hospital,Sichuan University,No. 37 Guoxue Lane, Sichuan,Chengdu,610041,China; 2.Department of Anesthesiology,The Third Xiangya Hospital of Central South University,Changsha,China; 3.Department of Anesthesiology,Sichuan Provincial People’s Hospital,Chengdu,China; 4.Department of Anesthesiology,The Affiliated Hospital of Guizhou Medical University,Guiyang,China; 5.Department of Anesthesiology,Affiliated Hospital of Zunyi Medical University,Zunyi,China; 6.Department of Anesthesiology,The First Affiliated Hospital of Jinan University,Guangzhou,China; 7.Department of Anesthesiology,The 2nd Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University,Wenzhou,China; 8.Department of Anesthesiology,The First Affiliated Hospital of Wenzhou Medical University,Wenzhou,China; 9.Department of Anesthesiology,The Second Xiangya Hospital of Central South University,Changsha,China; 10.Department of Anesthesiology,Xiangya Hospital Central South University,Changsha,China
推荐引用方式 GB/T 7714	Luo, Zhen,Tu, Hong,Zhang, Xiang,et al. Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study[J]. CNS DRUGS,2022,36(3):301-313.
APA	Luo, Zhen., Tu, Hong., Zhang, Xiang., Wang, Xiao., Ouyang, Wen., ... & Guo, Qulian. (2022). Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study. CNS DRUGS, 36(3), 301-313.
MLA	Luo, Zhen,et al."Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study".CNS DRUGS 36.3(2022):301-313.