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西普罗福:丙泊酚在临床静脉麻醉中的一种新选择?

Ciprofol: A Novel Alternative to Propofol in Clinical Intravenous Anesthesia?

机构信息

Department of Pharmacy, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei Province 050000, China.

出版信息

Biomed Res Int. 2023 Jan 19;2023:7443226. doi: 10.1155/2023/7443226. eCollection 2023.

DOI:10.1155/2023/7443226
PMID:36714027
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9879693/
Abstract

Ciprofol is a novel compound that was independently developed in China. According to the Chinese product instructions approved by the China National Medical Products Administration and the information of official website, indications for ciprofol include sedation and anesthesia during the surgical/procedure of nontracheal intubation, induction and maintenance of general anesthesia, and sedation during intensive care. Ciprofol is a short-acting intravenous sedative based on the structural modification of propofol. Ciprofol has high efficacy, good selectivity, and fewer adverse reactions, indicating good clinical application potential. A series of clinical studies have been conducted to evaluate the sedative effect of ciprofol in various procedures and settings, including gastroscopy and colonoscopy, fiber-optic bronchoscopy, general anesthesia in elective surgeries, and mechanical ventilation in intensive care units. This review summarizes the chemical structure, pharmacodynamics, and pharmacokinetic properties of ciprofol. We also assessed the efficacy and safety of ciprofol by synthesizing the relevant clinical trial data.

摘要

西普罗夫是一种新型化合物,由中国自主研发。根据中国国家药品监督管理局批准的中文产品说明书和官方网站信息,西普罗夫的适应证包括非气管插管手术/程序中的镇静和麻醉、诱导和维持全身麻醉以及重症监护期间的镇静。西普罗夫是一种基于丙泊酚结构修饰的短效静脉镇静剂。西普罗夫具有高效、选择性好、不良反应少的特点,显示出良好的临床应用潜力。已经进行了一系列临床研究来评估西普罗夫在各种程序和环境中的镇静效果,包括胃镜和结肠镜检查、纤维支气管镜检查、择期手术中的全身麻醉以及重症监护病房中的机械通气。本综述总结了西普罗夫的化学结构、药效学和药代动力学特性。我们还通过综合相关临床试验数据来评估西普罗夫的疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0ea/9879693/2c5633a27fff/BMRI2023-7443226.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0ea/9879693/ee7355bd60b8/BMRI2023-7443226.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0ea/9879693/2c5633a27fff/BMRI2023-7443226.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0ea/9879693/ee7355bd60b8/BMRI2023-7443226.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0ea/9879693/2c5633a27fff/BMRI2023-7443226.002.jpg

相似文献

1
Ciprofol: A Novel Alternative to Propofol in Clinical Intravenous Anesthesia?西普罗福:丙泊酚在临床静脉麻醉中的一种新选择?
Biomed Res Int. 2023 Jan 19;2023:7443226. doi: 10.1155/2023/7443226. eCollection 2023.
2
Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study.比较西普鲁福用于择期手术患者全身麻醉诱导与丙泊酚的效果:一项 3 期、多中心、随机、双盲、对照研究。
Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1607-1617. doi: 10.26355/eurrev_202203_28228.
3
Efficacy and safety of Ciprofol compared with Propofol during general anesthesia induction: A systematic review and meta-analysis of randomized controlled trials (RCT).全身麻醉诱导期间丙泊酚与环泊酚的疗效和安全性比较:一项随机对照试验(RCT)的系统评价和荟萃分析
J Clin Anesth. 2024 Jun;94:111425. doi: 10.1016/j.jclinane.2024.111425. Epub 2024 Feb 26.
4
Efficacy and safety of Ciprofol for procedural sedation and anesthesia in non-operating room settings.丙泊酚在非手术室环境中用于程序性镇静和麻醉的有效性和安全性。
J Clin Anesth. 2023 May;85:111047. doi: 10.1016/j.jclinane.2022.111047. Epub 2023 Jan 2.
5
Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial.西普福与异丙酚用于机械通气重症监护病房患者镇静的安全性和有效性:一项多中心、开放标签、随机、2 期临床试验。
Chin Med J (Engl). 2022 May 5;135(9):1043-1051. doi: 10.1097/CM9.0000000000001912.
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Comparison of ciprofol (HSK3486) versus propofol for the induction of deep sedation during gastroscopy and colonoscopy procedures: A multi-centre, non-inferiority, randomized, controlled phase 3 clinical trial.比较西普鲁福(HSK3486)与异丙酚用于胃镜和结肠镜检查中深度镇静诱导的效果:一项多中心、非劣效性、随机、对照 3 期临床试验。
Basic Clin Pharmacol Toxicol. 2022 Aug;131(2):138-148. doi: 10.1111/bcpt.13761. Epub 2022 Jun 10.
7
The efficacy and safety of ciprofol use for the induction of general anesthesia in patients undergoing gynecological surgery: a prospective randomized controlled study.西普罗酚用于妇科手术全身麻醉诱导的疗效和安全性:一项前瞻性随机对照研究。
BMC Anesthesiol. 2022 Aug 3;22(1):245. doi: 10.1186/s12871-022-01782-7.
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Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials.西普罗尔在结肠镜检查镇静/麻醉中的疗效和安全性:Ⅱa 期和Ⅱb 期多中心临床试验。
Eur J Pharm Sci. 2021 Sep 1;164:105904. doi: 10.1016/j.ejps.2021.105904. Epub 2021 Jun 8.
9
Comparison of Ciprofol-Based and Propofol-Based Total Intravenous Anesthesia on Microvascular Decompression of Facial Nerve with Neurophysiological Monitoring: A Randomized Non-Inferiority Trial.基于西普罗酚和依托咪酯的全静脉麻醉在神经生理监测下面神经微血管减压术的比较:一项随机非劣效性试验。
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Pharmacol Res Perspect. 2023 Apr;11(2):e01066. doi: 10.1002/prp2.1066.

引用本文的文献

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Effect of Ciprofol on Postoperative Cognitive Function in Patients Undergoing Cardiac Surgery with Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial.丙泊酚对体外循环心脏手术患者术后认知功能的影响:一项前瞻性、随机、对照试验。
Drug Des Devel Ther. 2025 Aug 29;19:7541-7552. doi: 10.2147/DDDT.S536225. eCollection 2025.
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Comparison of ciprofol and propofol for endoscopic retrograde cholangio-pancreatography anesthesia: a systematic review and meta-analysis.环丙泊酚与丙泊酚用于内镜逆行胰胆管造影术麻醉的比较:一项系统评价与荟萃分析
Front Pharmacol. 2025 Aug 15;16:1592781. doi: 10.3389/fphar.2025.1592781. eCollection 2025.
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本文引用的文献

1
Comparison and Clinical Value of Ciprofol and Propofol in Intraoperative Adverse Reactions, Operation, Resuscitation, and Satisfaction of Patients under Painless Gastroenteroscopy Anesthesia.无痛胃肠镜麻醉中患者术中不良反应、手术、复苏以及满意度比较及西普罗和丙泊酚的临床价值。
Contrast Media Mol Imaging. 2022 Jul 18;2022:9541060. doi: 10.1155/2022/9541060. eCollection 2022.
2
The efficacy and safety of ciprofol use for the induction of general anesthesia in patients undergoing gynecological surgery: a prospective randomized controlled study.西普罗酚用于妇科手术全身麻醉诱导的疗效和安全性:一项前瞻性随机对照研究。
BMC Anesthesiol. 2022 Aug 3;22(1):245. doi: 10.1186/s12871-022-01782-7.
3
Potential of ciprofol as an alternative to propofol in elderly patients undergoing gastrointestinal endoscopy: a meta-analysis and trial sequential analysis.
环丙泊酚在老年患者接受胃肠镜检查时替代丙泊酚的潜力:一项荟萃分析和试验序贯分析
Front Pharmacol. 2025 Aug 11;16:1644182. doi: 10.3389/fphar.2025.1644182. eCollection 2025.
4
An Innovative Strategy for Sustainability Assurance in Orthopedic Surgery.骨科手术可持续性保障的创新策略。
Med Sci (Basel). 2025 Jul 22;13(3):93. doi: 10.3390/medsci13030093.
5
Ciprofol exerts anti-tumour effects in hepatocellular carcinoma through the Raf-MEK-ERK signalling pathway.环丙泊酚通过Raf-MEK-ERK信号通路在肝细胞癌中发挥抗肿瘤作用。
Transl Gastroenterol Hepatol. 2025 May 13;10:52. doi: 10.21037/tgh-24-115. eCollection 2025.
6
Alleviative Effects of Ciprofol on Hepatic Ischemia/Reperfusion Injury Through Inhibiting Macrophage Polarization.丙泊酚通过抑制巨噬细胞极化对肝脏缺血/再灌注损伤的缓解作用
Immun Inflamm Dis. 2025 Jul;13(7):e70235. doi: 10.1002/iid3.70235.
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Ciprofol suppresses glycolysis and EMT in colorectal cancer cells by activating APC to modulate the Wnt/β-catenin signaling pathway.环丙泊酚通过激活腺瘤性息肉病蛋白(APC)来调节Wnt/β-连环蛋白信号通路,从而抑制结肠癌细胞的糖酵解和上皮-间质转化。
Sci Rep. 2025 Jul 20;15(1):26354. doi: 10.1038/s41598-025-08652-5.
8
The novel ciprofol versus propofol during gastroenteroscopy in Chinese patients: a meta-analysis.中国患者在胃镜检查期间新型环丙泊酚与丙泊酚的对比:一项荟萃分析。
Front Med (Lausanne). 2025 Jun 25;12:1598268. doi: 10.3389/fmed.2025.1598268. eCollection 2025.
9
Safety and efficacy of ciprofol for general anesthesia induction in elderly patients undergoing lumbar surgery.环丙泊酚用于老年腰椎手术患者全身麻醉诱导的安全性和有效性。
Front Med (Lausanne). 2025 Jun 25;12:1525973. doi: 10.3389/fmed.2025.1525973. eCollection 2025.
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Sedation in endoscopy: Current practices and future innovations.内镜检查中的镇静:当前实践与未来创新
World J Gastrointest Endosc. 2025 Jun 16;17(6):106604. doi: 10.4253/wjge.v17.i6.106604.
Effect of ciprofol on induction and maintenance of general anesthesia in patients undergoing kidney transplantation.
西普鲁酚对肾移植患者全麻诱导和维持的影响。
Eur Rev Med Pharmacol Sci. 2022 Jul;26(14):5063-5071. doi: 10.26355/eurrev_202207_29292.
4
Comparison of ciprofol (HSK3486) versus propofol for the induction of deep sedation during gastroscopy and colonoscopy procedures: A multi-centre, non-inferiority, randomized, controlled phase 3 clinical trial.比较西普鲁福(HSK3486)与异丙酚用于胃镜和结肠镜检查中深度镇静诱导的效果:一项多中心、非劣效性、随机、对照 3 期临床试验。
Basic Clin Pharmacol Toxicol. 2022 Aug;131(2):138-148. doi: 10.1111/bcpt.13761. Epub 2022 Jun 10.
5
Esketamine as an Adjuvant to Ciprofol or Propofol Sedation for Same-Day Bidirectional Endoscopy: Protocol for a Randomized, Double-Blind, Controlled Trial With Factorial Design.艾氯胺酮作为丙泊酚或异丙酚镇静辅助药物用于同日双向内镜检查:一项析因设计的随机、双盲、对照试验方案
Front Pharmacol. 2022 Mar 18;13:821691. doi: 10.3389/fphar.2022.821691. eCollection 2022.
6
Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study.比较西普鲁福用于择期手术患者全身麻醉诱导与丙泊酚的效果:一项 3 期、多中心、随机、双盲、对照研究。
Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1607-1617. doi: 10.26355/eurrev_202203_28228.
7
Efficacy and safety of HSK3486 for the induction and maintenance of general anesthesia in elective surgical patients: a multicenter, randomized, open-label, propofol-controlled phase 2 clinical trial.HSK3486 用于择期手术患者全身麻醉诱导和维持的有效性和安全性:一项多中心、随机、开放标签、丙泊酚对照的 2 期临床试验。
Eur Rev Med Pharmacol Sci. 2022 Feb;26(4):1114-1124. doi: 10.26355/eurrev_202202_28101.
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Pharmacodynamics and Pharmacokinetics of HSK3486, a Novel 2,6-Disubstituted Phenol Derivative as a General Anesthetic.新型2,6-二取代苯酚衍生物HSK3486作为全身麻醉药的药效学和药代动力学
Front Pharmacol. 2022 Feb 3;13:830791. doi: 10.3389/fphar.2022.830791. eCollection 2022.
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Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study.HSK3486 用于纤维支气管镜检查患者麻醉/镇静的有效性和安全性:一项多中心、双盲、丙泊酚对照、随机、3 期研究。
CNS Drugs. 2022 Mar;36(3):301-313. doi: 10.1007/s40263-021-00890-1. Epub 2022 Feb 14.
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Propofol Anesthesia: A Leap into the Void?丙泊酚麻醉:跳入虚空?
Anesthesiology. 2022 Mar 1;136(3):405-407. doi: 10.1097/ALN.0000000000004110.