预约演示

更新于：2025-05-08

Fentanyl

芬太尼

更新于：2025-05-08

概要

基本信息

简介芬太尼是一种合成阿片类药物，非常有效地用于治疗严重的疼痛，特别是癌症患者。它通过结合中枢神经系统中的阿片受体来产生镇痛作用。芬太尼有多种剂型，包括贴片、含片和注射溶液。但由于其强效性，芬太尼具有高度的成瘾性、呼吸抑制和过量的风险。因此，它在美国被归类为II级受控物质。目前的研究重点是开发更安全和更有效的芬太尼给药途径，如抗滥用制剂和新颖的给药途径。

药物类型

小分子化药

别名

AeroLEF、Fentany Transdermal System、Fentanyl (JAN/USP/INN)

+ [38]

靶点

Opioid receptors

作用方式

激动剂

作用机制

Opioid receptors激动剂(阿片样受体激动剂)

治疗领域

神经系统疾病其他疾病肿瘤

在研适应症

癌症疼痛慢性疼痛疼痛+ [1]

非在研适应症

急性疼痛晚期癌症突出痛+ [11]

原研机构

Janssen Global Services LLC

在研机构

Janssen Pharmaceutical KK

Janssen Pharmaceutica NV

Nippon Zoki Pharmaceutical Co. Ltd.

+ [5]

非在研机构

Janssen Pharmaceuticals, Inc.

INSYS Therapeutics, Inc.

ALZA Corp.

+ [3]

权益机构

Terumo Corp. /Hemodialyzer Marketing Operations/

Nutriband, Inc.

Kindeva Drug Delivery LP

+ [4]

最高研发阶段批准上市

首次获批日期

美国 (1990-08-07),

通气不足术后疼痛

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C22H28N2O

InChIKeyPJMPHNIQZUBGLI-UHFFFAOYSA-N

CAS号437-38-7

关联

1,187

项与芬太尼相关的临床试验

NCT06953453

/ Not yet recruiting临床1期

A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With Malignant Tumors

This study is a single-dose, open-label, 2-cycle crossover design, comparing the pharmacokinetic parameters and safety of Inhaled Fentanyl Aerosol and intravenous fentanyl injection.

开始日期2025-12-20

申办/合作机构

李氏大药厂控股有限公司

NCT06696586

/ Not yet recruiting临床4期IIT

Comparison Between Effect of Systemic Fentanyl Infusion and Fentanyl Added as An Adjuvant to Lidocaine in Bier Block For Controlling Pain in Patients Undergoing Hand Surgeries

Injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain.
Various techniques of regional anesthesia are frequently used for upper extremity surgery. Specifically, intravenous regional anesthesia, the Bier block, is an effective anesthetic technique. This technique, developed by Dr August Bier in 1908, provides complete anesthesia, a bloodless field, and eliminates the need for general anesthesia. However, it was not until the 1960s that this technique was reintroduced and used in upper extremity surgery due to several disadvantages and reports of major complications. Because of the dose of lidocaine and tourniquet time, there is potential for cardiac and neurological complications such as arrhythmias, seizures, and compartment syndrome the aim of this study To evaluate the effect of Systemic Fentanyl Infusion compared to addition of Fentanyl as An Adjuvant to Lidocaine in Bier Block for Controlling Pain in Patients Undergoing Hand Surgeries

开始日期2025-07-01

申办/合作机构

Assiut University

NCT06793358

/ Not yet recruiting临床4期IIT

Use of Remimazolam and Fentanyl for Procedural Sedation in Patients Undergoing Dental Extraction

The goal of this clinical trial is to learn if a combination of the two established sedation drugs remimazolam and fentanyl, can put the subject to sleep during a scheduled extraction procedure. The combined use of these drugs has been used in other studies involving IV sedation when the procedure is scheduled for 30 minutes or less. However, the combined use of the IV sedation drugs has not been used in a dental extraction procedure before.
The main questions it aims to answer are:
1. Can the combined drugs effectively put the patient to sleep during the procedure
2. How quickly will they come out of the sedation after the procedure
Participants will:
1. Receive the combined drugs during a scheduled extraction procedure anticipated to take less than 30 minutes
2. Answer survey questions related to their study experience after the extraction visit (in person) and again about 24 hours after the visit (by telephone).

开始日期2025-03-30

申办/合作机构

Indiana University

[+1]

100 项与芬太尼相关的临床结果

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100 项与芬太尼相关的转化医学

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100 项与芬太尼相关的专利（医药）

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29,848

项与芬太尼相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Respiratory depression in women receiving propofol/esketamine versus propofol/fentanyl for abortion surgery or curettage: a randomized clinical trial

Article

作者: Chen, Huihe ; Guan, Xuehai ; Luo, Jiaxin ; Wu, Xiaoshan ; Cao, Huiyu ; Lan, Hongmeng ; Lin, Yuliu ; Zhang, Cuiwen ; Liao, Yeqing ; Huang, Xiaofang

BACKGROUND:

A combination of opioids with propofol is a popular approach to non-intubated general anaesthesia; however, this method usually results in higher incidence of respiratory depression. We compared the incidence of esketamine- and fentanyl-induced respiratory depression in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.

METHODS:

This study included 176 women (aged 18-60 years) scheduled for abortion surgery or curettage. Patients were randomized into the fentanyl or esketamine groups. Patients in the fentanyl group received fentanyl (1 µg/kg) combined with propofol intravenously. Patients in the esketamine group received subanaesthetic doses of esketamine (0.15 mg/kg) combined with propofol intravenously. The primary outcome was the incidence of respiratory depression during anaesthesia. Secondary outcomes included respiratory rate, pulse oximetry, blood pressure, heart rate, propofol dose, duration of surgery, duration of anaesthesia, and adverse events.

RESULTS:

The incidence of respiratory depression in the esketamine group was significantly lower than that in the fentanyl group (11% vs. 45%; p < .0001). Propofol administration was lower with esketamine than fentanyl. Respiratory rate, SpO₂ and blood pressure were more stable in the esketamine group than in the fentanyl group. The incidences of hypotension, propofol-induced injection pain and chin lifting in the esketamine group were lower than those in the fentanyl group. The incidence of nightmares was higher in the esketamine than in the fentanyl group.

CONCLUSIONS:

The incidence of respiratory depression was lower with subanaesthetic doses of esketamine than with fentanyl in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.KEY MESSAGESOpioids combined with propofol is a popular method for non-intubated general anaesthesia; however, this method usually results in higher incidence of respiratory depression.At subanaesthetic doses, esketamine provides an analgesic effect by antagonizing the N-methyl-d-aspartate receptor.In this trial, the incidence of respiratory depression was lower with subanaesthetic doses of esketamine than with fentanyl in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.

2025-09-01·TALANTA

SERS detection of analgesics in serum based on Ag nanocubes for perioperative monitoring

Article

作者: Qin, Lei ; Han, Lin ; Ji, Yinghe ; Wu, Jing ; Wang, Yunpeng ; Zhu, Zhuo ; Li, Yang ; Sun, Tingting

Prompt and personalized perioperative analgesia management relies on sensitive and convenient monitoring of analgesics. We report a strategy for sensitive and reproducible SERS detection of analgesics based on Ag nanocubes, which have abundant intragranular hot spots on sharp corners and interparticle hot spots between gaps. Both theoretical simulations and R6G detection experiments indicated that the enhancement factor of Ag nanocube SERS platform reach to 10⁶ level. Quantitative and reproducible determination capabilities of this platform for six different analgesics with LOD as low as 500 pg mL^-1 were verified. Pharmacokinetic experiment of fentanyl in rat serum samples by SERS detection within 4 h presented consistent results with the UHPLC-MS/MS method. Valid examples of SERS detection for single or multiple analgesics in clinical patients' serums further proved the feasibility of this platform for perioperative analgesic monitoring.

2025-09-01·NEUROPHARMACOLOGY

Navigating nitazenes: A pharmacological and toxicological overview of new synthetic opioids with a 2-benzylbenzimidazole core

Review

作者: Stove, Christophe P ; Vandeputte, Marthe M

Since the first identification of isotonitazene on the recreational drug market in 2019, new synthetic opioids (NSOs) with a 2-benzylbenzimidazole core (colloquially known as 'nitazene' opioids) have increased in prevalence. At the end of 2024, 22 different analogues had been identified in Europe, and worrying trends indicate their increasing presence at the street level. Nitazene analogues originate from a series of research articles from the 1950-60s, but were never marketed as analgesics. Recent pharmacological research has shown that different analogues are highly active, with several being more potent than fentanyl in their ability to activate the μ-opioid receptor and produce opioid effects. This high potency, combined with their unpredictability on the recreational drug market, legal status in some regions, and economic appeal to drug producers, has contributed to a growing number of intoxications and fatalities involving nitazene analogues worldwide. This literature review focuses on the pharmaco-toxicology of nitazene opioids and the characteristics of their emergence on the NSO and broader recreational drug markets from 2019 onwards. Aspects that are covered include (a) a systematic approach to the naming of nitazene analogues, (b) trends, prevalence and identifications on the recreational drug market, (c) structure-activity relationships derived from recent in vitro, in vivo, and in silico research, (d) strategies for detection in biological samples and drug material, and (e) the current legal framework. Finally, innovative approaches to navigate this complex landscape are discussed, together with an outlook for the future.

505

项与芬太尼相关的新闻（医药）

2025-05-07

·丁香园

全球哮喘管理和预防策略 2025 版重磅更新！

昨日，由全球哮喘协会（GINA）编写的最新版《全球哮喘管理和预防策略》报告正式发布。哮喘是最常见的慢性非传染性疾病之一，全球每年影响超过 2.6 亿人，造成超过 45 万人死亡。哮喘发作会给患者及其护理人员带来极大的痛苦，并可能导致入院治疗，有时甚至导致死亡。含吸入性皮质类固醇的药物可通过治疗诱发哮喘的潜在炎症来预防哮喘发作。以下为最新版指南的重点摘要： ▶ 2 型炎症生物标志物的作用1、关于 2 型生物标志物（尤其是血液嗜酸性粒细胞和呼出一氧化氮分数[FeNO]）在哮喘诊断、评估和管理中的相关信息，已从 GINA 报告的多个部分整理出来，并扩展为一项新资源添加在报告尾部的附录 A 中（p217）。2、报告还添加了可导致血液嗜酸性粒细胞计数和 FeNO 变异相关因素的信息，包括血液嗜酸性粒细胞和 FeNO 显著、但相反的昼夜节律变化 ▶ 成人和青少年严重急性加重风险因素1、在评估患者未来恶化风险时，应考虑包括 2 型炎症生物标志物在内的多种因素（框 2～2B，P37）2、GINA 认为有必要在真实世界的人群中开展与 ORACLE2 相似的研究，并评估基于已识别的风险因素实施有针对性的风险降低策略时的效果3、哮喘急性发作和住院人数在 COVID-19 封闭管理期间（P121），以及一些夏季奥运会空气质量改善期间大幅减少（P64） ▶ 气候变化和极端天气影响新版指南认为，极端天气可通过影响卫生基础设施及其直接作用对哮喘患者产生不良后果（P130）。极端高温和极端低温都与患者的哮喘加重风险或急诊需求增加相关。 ▶ 5 岁及以下儿童哮喘诊断方法和标准1、反复的急性喘息发作，有或无间歇性哮喘样症状2、经评估，替代诊断不太可能导致相关的症状或体征3、对哮喘治疗及时响应，包括服用 SABA 后几分钟内症状改善（在医疗机构或家中），或在每天服用 ICS + 按需使用 SABA，持续 2～3 个月的诊断试验期间 ▶ 5 岁及以下儿童哮喘的治疗目前对于 ≤ 2 天/周有哮喘症状，且无严重喘息发作病史的儿童，几乎没有选择余地。但几项使用低剂量 ICS-福莫特罗作为抗炎缓解剂用于儿童哮喘治疗的研究正在进行中，其中包括了 5 岁或年龄更小的儿童（P189）。 ▶ 5 岁及以下儿童哮喘急性发作的治疗1、基于进一步的循证依据，支持对中度或重度急性加重静脉使用硫酸镁，但不再推荐雾化使用2、更新了急性发作期间吸入药物的剂量（P204）3、儿童患者的氧饱和度目标已从 94%～98% 更新为 ≥ 94%，并提醒（其他年龄段也是如此）要考虑肤色对氧饱和度测量结果的影响，并在必要时调整其目标值（P201） ▶ 成人和青少年哮喘的诊断1、症状的可变性和呼气气流的可变性是哮喘的两个显著特征，因此，评估肺功能仍然是确认诊断的第一选择2、之前是在脚注和文本中描述的生物标志物在哮喘诊断中的（有限）作用，已被添加到诊断流程图中，以提高其可视性3、在新的附录中，增加了关于生物标志物在哮喘诊断中作用的更多细节（P217） ▶ 哮喘的诊断标准1、新版指南将「可变性呼气气流受限」一词调整为「可变性呼气气流」2、对于（未经治疗的）哮喘患者，肺功能具有特征性的可变性，因此气流受限可能在某些时候存在，而在其他时候不存在。 ▶ 个性化哮喘护理在添加 ICS，且依从性和吸入器技术等常见的基础问题已得到解决后，再来考虑生物标志物，可能更有效。 ▶ 人群层面和个性化患者层面的治疗决策1、人口层面的建议，如在指导方针和处方决策中，都是基于高质量的群体级证据2、患者层面的决策，临床医生应考虑多种因素，包括合并症、患者观点和实际问题。先前的相关表格已转换为图表以获得更好的可视性（P54，框 3～4） ▶ 成人和青少年的治疗建议1、使用 ICS-福莫特罗抗炎药的路径 1，仍然是首选治疗方法（如果可用）2、如果需要高剂量 ICS-LABA，应尽可能将其使用限制在 3～6 个月内3、糠酸氟替卡松的日剂量已被重新分类为中、低剂量（100 mcg）、中等偏高剂量（200 微克）4、「其他治疗选项」：与标准治疗相比较，之前显示在路径 1 和 2 各个治疗步骤下方灰色框中方法的疗效和/或安全性证据较少5、芬太尼已被添加到非推荐的支气管扩张剂列表中 ▶ 吸入器选择的共同决策医疗服务提供者和个体患者可以考虑不同吸入器装置对于环境的相对影响。但第一步是选择对患者来说是最好的首选药物；其次是患者可以取得并正确使用这种吸入器装置。图片、内容来源：《全球哮喘管理和预防策略》报告（GINA 2025）本文首发于丁香园旗下专业平台：丁香园呼吸时间投稿邮箱：wangmeichao@dxy.cn

临床结果

2025-05-06

·肿瘤界

秦叔逵教授专访｜指南引领：加强癌痛全程管理，氢吗啡酮为患者创造“无痛”生活

点击蓝字关注我们癌痛作为癌症患者最常见的并发症之一，其有效控制直接关系到患者的治疗依从性、生活质量乃至生存期。随着肿瘤治疗手段的日益丰富，患者的生存期显著延长，如何实现癌痛的全程化、个体化管理，提升生活质量是临床上特别关注的问题。值此2025年CSCO指南大会召开之际，肿瘤界特别邀请到中国临床肿瘤学会（CSCO）指导委员会主委、中国药科大学附属南京天印山医院的秦叔逵教授，简要分享癌痛全程管理理念和实践经验，积极助力推动癌痛规范化诊断治疗。专家简介秦叔逵教授中国药科大学附属南京天印山医院院长、首席专家、主任医师中国药科大学、南京医科大学和南京中医药大学教授、博士生导师国家统计源期刊《临床肿瘤学杂志》主编亚洲临床肿瘤学联盟（FACO）前任主席和现任常务理事国际肿瘤免疫学会（SITC）和亚洲临床肿瘤学会（ACOS）常务理事中国临床肿瘤学会（CSCO）前任理事长和现任指导委员会主任委员北京CSCO基金会前任理事长和现任监事长国家药监局血液和肿瘤药物咨询委员会核心专家国家卫健委肿瘤学能力建设与继续教育专家委员会主任委员江苏省抗癌协会候任理事长CSCO指南会作为国内肿瘤领域中的重磅会议，不仅为临床医生提供最新的诊疗指南，还推动了我国肿瘤学领域的多层次交流。您能否简要介绍一下2025年CSCO指南发布的意义以及推广计划？秦叔逵：众所周知，恶性肿瘤已经成为临床常见且高发的疾病，严重地威胁全人类的生命健康。据统计，2022年全球癌症新增病例 1874 万例，因为癌症死亡病例 967 万例；其中我国癌症新增病例约 480 万（占比全球总数的 24%），癌症死亡病例约 260 万（占比全球总数的 26.7%），双双位居第一。因此，党和国家高度重视肿瘤防治工作。中国临床肿瘤学会（CSCO）成立于1997年4月30日，其成立初衷就是促进中国肿瘤防治事业的进步，包含四项主要任务：一是开展临床肿瘤继续教育；二是推动国内、外学术交流；三是积极推动多学科合作和多中心协作研究；四是规范临床实践，提高诊疗和研究水平。近年来，根据国家卫健委的要求，CSCO还增加了患者教育和人文关怀，总之致力于落实“健康中国”，推动肿瘤诊断的标准化、规范化、专业化及个体化进程。2004年，CSCO在昆明召开了第八届CSCO全国大会，参会人员首次超过万人，影响巨大。会上，储大同教授和孙燕院士提出，CSCO学会应该进一步积极推动临床诊断治疗规范化，制定专家共识和指南。然而，当时国内存在诸多困难，比如临床医师专业分工不明确，研究水平低下，缺乏大规模临床试验及高级别的循证医学证据支持，且对共识指南的制定程序和方法不熟悉。因此，学会办公室调研了国外的ASCO、ESMO及NCCN等指南，决定先引进NCCN指南，与其合作制定中文版，提高对临床指南的认识并且学习制定方法。经过数年的合作，CSCO积累了一定的经验，但是也发现了NCCN指南的局限性。于是，CSCO学会决定自主地开展自己的专家共识和指南制定工作，2008年第一版《中国黑色素瘤诊断治疗共识》率先发布，北京大学肿瘤医院的郭军教授发挥了重要作用。随后，CSCO陆续制定了一系列的专家共识和指南。2015年，在国务院领导批准和支持下，CSCO由前身的二级学术组织“中国抗癌协会临床肿瘤学协作专业委员会”正式升格为国家一级学术团体“中国临床肿瘤学会”，吴一龙教授和李进教授分别担任了前两届的理事长，高度重视和积极改版，全面推动CSCO指南的完善和发展。如今，CSCO指南已经成为规范临床行为的重要参考书，涵盖了临床肿瘤学各个瘤种以及常见热点问题，如疼痛、骨髓抑制、血小板减少以及白细胞减少等；同时，CSCO指南也是国家有关部门，包括卫健委、医保局和药监局，等制定肿瘤防治政策方针时的重要参考，对中国肿瘤诊疗研究的发展和“健康中国”建设发挥了重要作用。2025年CSCO指南会议主要是对原有指南的更新发布，此次更加注重结合中国国情和患者特点，纳入中国专家和学者的研究成果，这些成果更贴近中国临床实际，具有很强的指导性和实用性。这是与国家高度重视人民健康、与经济建设和医疗卫生事业发展的整体战略完全相一致的。因此，2025年CSCO指南的更新具有重要意义。癌痛控制与肿瘤患者的生存期紧密相连，有效的镇痛治疗对于提升患者生活质量至关重要。请您谈一谈我国癌痛的治疗现状，以及目前在癌痛规范化治疗方面做了哪些工作？秦叔逵：癌痛是恶性肿瘤患者的常见症状，包括肿瘤本身发生发展过程中引起的疼痛，如骨转移导致的剧烈疼痛，以及肿瘤治疗过程中因为毒副反应或者并发症产生的疼痛，如治疗药物带来的痛苦。中国癌痛治疗可以追溯至20世纪90年代初，当时李同度教授、孙燕院士、罗爱伦教授和蔡志基等前辈专家响应世界卫生组织（WHO)号召，在广州、天津和北京等地举办一系列的培训班，积极学习推广“WHO癌痛三阶梯治疗”原则，推动国内医学界逐渐重视癌痛的处理。1994年，李同度教授牵头组织，我和刘爱国教授具体落实，在黄山成立中国抗癌协会癌症康复与姑息治疗专业委员会（ CRPC)，31年来，做了大量的卓有成效的继续教育和学术交流活动，极大地推动癌痛规范化诊断治疗。2017年，CSCO也成立了肿瘤支持与康复治疗专家委员会，将癌痛诊断治疗作为重要的工作内容。尽管如此，我国癌痛治疗仍然面临严峻的挑战。临床上，大多数中晚期肿瘤患者都会受到疼痛干扰，但是只有不到30%的患者接受了规范化治疗。在国家层面高度重视癌痛治疗，国家卫生健康委员会（包括前身的原国家卫生部）多次主持召开癌痛规范诊疗会议，推动学科发展。2011年，全国范围内开展了癌痛“无痛病房”活动，积极宣传和推动规范建设。2018年，国家卫生健康委员会支持和颁布《癌症疼痛诊疗规范（2018年版）》，同时CSCO也制定了《癌痛临床实践指南》，成为行业标准和参考，在全国宣传推广，提高了医务人员、患者及家属对癌痛的认知，诊断治疗水平不断提升。过去，由于历史原因，中国社会对于阿片类药物存在特殊的恐惧，使其在癌痛治疗中使用受限，给患者带来许多不便。但是随着研究深入，国家认识到阿片类药物在临床合理使用中成瘾性极低，主要需要防范其社会滥用风险，而口服阿片类药物制剂使用方便，不易成瘾，且在合理使用下可有效解决癌痛问题。2011年起，国家推动癌痛规范化诊疗，进一步细化无痛病房推广工作，提出癌痛综合管理试点工作方案，将癌痛患者诊疗满意度纳入临床诊疗评估指标，要求医院建立完善疼痛综合管理制度及优化流程等。CSCO积极响应国家号召，举办学习班、培训会和研讨会议等，宣传和落实指南，推动了癌痛规范化治疗的发展。癌痛的全程管理在肿瘤治疗过程中具有重要意义，需要多学科合作，包括肿瘤科、疼痛科、麻醉科、药剂科以及心理精神科等，贯穿于肿瘤治疗的全过程。在癌痛全程管理中，需要特别注意以下几点：一是进行患者教育，切实提高患者及其家属对癌痛的认识，不要忍着不治，鼓励患者积极告知、配合和接受相关治疗；二是癌痛治疗要与抗肿瘤治疗相结合，通过全程管理癌痛，降低副反应和并发症的发生率，提高患者的生活质量和生存期；三是要考虑可及性和经济性，控制医疗费用支出，减少住院时间，降低患者和家属的经济负担；四是注重人文关怀，癌痛本身给患者带来焦虑、抑郁等问题，癌痛处理不仅仅是止痛药的问题，还需要结合其他辅助药物和心理支持等全方位干预。药物治疗在癌痛管理中占据重要地位，近年来，有哪些镇痛药物的新进展值得关注？2024年氢吗啡酮缓释片上市即纳入国谈医保目录，您对其在癌痛领域的应用有哪些期待？秦叔逵：药物治疗在癌痛管理中扮演着至关重要的角色，也是癌痛治疗的主要手段之一。阿片类药物作为癌痛治疗基石，其应用和研究不断取得进展，从吗啡到羟考酮、芬太尼，再到氢吗啡酮等，显著地改善患者生活质量，提高了治疗有效性、安全性和耐受性。近年来，在党和政府支持关心下，我国民族制药企业与临床机构精诚合作，不断提高科技能力，自主研发阿片类药物取得重要进展。以氢吗啡酮缓释片为例，其为半合成阿片类镇痛药，主要作用于μ阿片受体，具有镇痛药效强、不良反应少的优点，已经获得ESMO、NCCN指南以及国内学术团体指南和专家共识推荐。在Ⅲ期临床头对头研究中，氢吗啡酮缓释片对比羟考酮缓释片达到了非劣效研究终点，而安全性方面具有明显优势，显著地减少了便秘、尿潴留、头昏甚至呼吸抑制等不良反应。此外，该药物每日仅需用药一次，更加便捷，患者依从性也更高。因此，氢吗啡酮缓释片与吗啡缓释片相比，则能更大限度地降低患者疼痛评分，不良反应更轻，其获批上市以及纳入医保报销范围，极大地提高药物的可及性，可为更多癌痛患者提供治疗选择。未来，期待民族制药企业继续发扬光大，不断进步，研发更多创新性或便捷性镇痛药，为癌痛患者带来更好治疗体验，为临床医生提供更多优选药物。您参与编写的《癌痛合理用药指南》及《癌症疼痛诊疗规范（2018年版）》在推动我国癌症疼痛规范化治疗进程中发挥了重要作用。近年来，随着新型阿片类药物研究的蓬勃发展，该领域取得了诸多突破性进展。在此背景下，能否请您结合国际前沿趋势，谈谈阿片类药物在癌痛治疗中的核心价值及规范化应用策略？秦叔逵：在李同度教授、孙燕院士等老一代专家的指引下，以及同辈专家学者的共同努力下，多年来我们参与了癌痛防治的诸多工作。从90年代初，筹备建立CRPC到后来CSCO肿瘤支持和康复治疗专家委员会的运作过程，积极普及了癌痛防治控制知识及相关问题认识，提升了全国医务人员对癌痛防治的认识和诊疗水平。如前所述，癌痛是临床常见的抗肿瘤治疗并发症，也与肿瘤本身及治疗过程均相关。国际、国内学术组织均重视癌痛治疗领域，WHO在20世纪80年代提出“癌痛三阶梯治疗”原则，ASCO、ESMO、NCCN、中国国家卫生健康委员会和CSCO指南中，都明确要求高度重视癌痛治疗并推荐相关治疗方法，尤其是中重度癌痛需使用阿片类药物，特别是强阿片类药物。阿片类药物是非常古老的药物，很早就用于治疗疼痛、腹泻等，如今仍然是癌痛治疗基本药物，可以缓解患者疼痛、改善生活质量、有助于保证抗肿瘤治疗顺利进行。但阿片类药物存在便秘、尿潴留、呼吸抑制等毒副作用，需要加强研究，推陈出新。例如氢吗啡酮，属于新型阿片类药物，与过去的传统药物相比，在保障有效性的同时，安全性大幅提升，临床使用更方便，已经迅速进入医保报销。未来，加强癌痛控制，需要从两大方面入手：一方面，要结合抗肿瘤治疗的本身，进行综合管理；另一方面，要注重症状改善，通过良好的疼痛控制，争取实现无痛，切实改善患者生活质量，进而延长其生存期。目前，我们正在与国家卫生健康委员会汇报沟通，建议对《癌症疼痛诊疗规范（2018年版）》进行修订，以补充纳入新的治疗方法、药物和治疗理念。同时，CSCO也在定期进行癌痛治疗指南的更新，以适应临床实践的需要。相信，随着新型阿片类药物的陆续上市和广泛应用，必将有助于患者实现无痛生存。我们期待通过对CSCO指南的更新、宣讲和推广，以及国家卫生健康委员会相关政策、方针和指导原则的指导支持，必将推动中国癌痛管理水平进一步提升，为患者带来更多的希望。声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。编辑：阿希雅审核：秦叔逵教授

CSCO会议

2025-05-01

·PRNewswire

New Study Highlights Monthly SUBLOCADE® as a Potential Treatment Option for Opioid Use Disorder During and After Pregnancy

SUBLOCADE use during pregnancy showed no increased risk of birth defects, miscarriage, or maternal complications compared to general population rates RICHMOND, Va., May 1, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) today announced the publication of a study "Monthly Buprenorphine Depot Injection (SUBLOCADE) for Opioid Use Disorder During Pregnancy" in the American Journal on Addictions, evaluating the use of SUBLOCADE for the treatment of opioid use disorder (OUD) during pregnancy and postpartum. Three sources of data evaluated in this retrospective study illustrated that the use of monthly SUBLOCADE during pregnancy demonstrated no increased risk and is consistent with the established buprenorphine safety profile.1 This retrospective study includes clinical case studies from four pregnant patients treated with monthly SUBLOCADE, postmarketing surveillance data covering more than five years, and a targeted literature review. In total, 322 reports of pregnancy exposures to SUBLOCADE were identified. Of the four patients included in the clinical practice case studies, all delivered full-term infants with normal birthweight, no fetal anomalies, and no need for treatment for neonatal opioid withdrawal syndrome (NOWS). "The findings shared in this manuscript support perinatal, patient-centered decision-making," said Melinda Ramage, FNP-BC, CARN-AP, LCAS, Director of the North Carolina Perinatal Substance Use Disorder Network and lead author of the publication. "Treatment is not one-size-fits-all, and it is important to explore safe and effective options for the mother–baby dyad." Between 2010 and 2017, opioid use during pregnancy dramatically increased, with a 131% increase in opioid use-related diagnoses at delivery in the U.S.2 The U.S. national maternal morbidity and mortality data reveal mental health and substance use disorders are the leading underlying cause of pregnancy-related deaths in 36 states. While pregnancy-associated overdose deaths have been steadily rising since 2007, those involving fentanyl and other synthetic opioids markedly increased from 5.73 to 9.47 deaths per 100,000 in a span of just 3 years (2017–2020), with most deaths occurring post-delivery.3 This study helps address the current knowledge gap with relevant experience from patients and prescribers who used monthly SUBLOCADE during pregnancy and/or postpartum. In addition to the case studies, the postmarketing surveillance data showed live births with no reported birth defects in the majority of known cases and rates of spontaneous abortion and other outcomes consistent with or lower than general population rates. Review of relevant literature also aligned with the findings from postmarketing and clinical data sources. These data highlight buprenorphine's established safety profile and offers practical insights into clinical care. "OUD patients who are pregnant run the risk of experiencing a number of negative health consequences, such as infection, overdose, severe maternal morbidity, postpartum readmission, and even death, and using opioids during pregnancy has been linked to poor results for both the fetus and the newborn," said Christian Heidbreder, Chief Scientific Officer at Indivior. "As public health professionals and policymakers look for ways to reduce maternal overdose deaths, this study offers important new information about how long-acting medications like SUBLOCADE might be incorporated into a broader strategy to increase access and enhance outcomes for families affected by OUD." Treatment decisions during pregnancy and postpartum should reflect a shared decision-making approach between providers and patients, aligning with clinical guidance and product labeling. The patient-centered model is especially critical when managing chronic conditions, like OUD, in the perinatal period. These data support consideration of using SUBLOCADE as part of evidence-based treatment options, which include offering or continuing perinatal medications for OUD, prioritizing patient stability when considering a change of existing pharmacotherapy in pregnancy and postpartum, and assessing the benefits and risks in a patient-centered framework. This is the largest amount of data available regarding the experience of pregnant patients on SUBLOCADE. Limitations of the study include limited descriptive data for case studies obtained from a small patient cohort and 21% of pregnancies reported outcomes for postmarketing surveillance. Disclosure: This work was funded by Indivior Inc., with the exception of the case studies and the time and contributions of Melinda Ramage, which were not supported by Indivior. About SUBLOCADE® SUBLOCADE ® (buprenorphine extended-release) injection, for subcutaneous use, CIII INDICATION AND HIGHLIGHTED SAFETY INFORMATION INDICATION SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. HIGHLIGHTED SAFETY INFORMATION WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. CONTRAINDICATIONS Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE. WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. Risk of Serious Injection Site Reactions: Likelihood of may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration and necrosis. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE. Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. ADVERSE REACTIONS Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit . About Opioid Use Disorder (OUD) Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences. OUD may affect the parts of the brain that are necessary for life-sustaining functions. About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit to learn more. Connect with Indivior on LinkedIn by visiting . References: Ramage M, Bishop B, Mangano V, Mankabady B. Monthly Buprenorphine Depot Injection (SUBLOCADE®) for Opioid Use Disorder During Pregnancy. Am J Addict. 2025. Hirai AH, Ko JY, Owens PL, Stocks C, Patrick SW. Neonatal abstinence syndrome and maternal opioid-related diagnoses in the US, 2010–2017. JAMA. 2021; 325(2): 146-155. doi:10.1001/jama.2020.24991 Bruzelius E, Martins SS. US trends in drug overdose mortality among pregnant and postpartum persons, 2017–2020. JAMA. 2022; 328(21): 2159-2161. doi:10.1001/jama.2022.17045 SOURCE Indivior PLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床研究

100 项与芬太尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00320	芬太尼	N02AB03 N01AH01	DB00813

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
癌症疼痛	日本	Janssen Pharmaceutical KK	2011-02-01
疼痛	澳大利亚	Janssen-Cilag Pty Ltd.	2005-11-23
急性疼痛	美国	Janssen Pharmaceuticals, Inc.	2005-02-04
慢性疼痛	美国	Janssen Pharmaceuticals, Inc.	2005-02-04
通气不足	美国	Janssen Pharmaceuticals, Inc.	1990-08-07
术后疼痛	美国	Janssen Pharmaceuticals, Inc.	1990-08-07

未上市

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适应症	最高研发状态	国家/地区	公司	日期
粘膜炎	临床3期	美国	INSYS Therapeutics, Inc.	2009-10-01
实体瘤	临床3期	美国	INSYS Therapeutics, Inc.	2009-10-01
口腔炎	临床3期	美国	INSYS Therapeutics, Inc.	2009-10-01
腰痛	临床3期	日本	Janssen Pharmaceuticals, Inc.	2009-01-01
骨关节炎	临床3期	日本	Janssen Pharmaceuticals, Inc.	2009-01-01
复杂性局部疼痛综合征	临床3期	日本	Janssen Pharmaceuticals, Inc.	2008-12-01
疱疹后神经痛	临床3期	日本	Janssen Pharmaceuticals, Inc.	2008-12-01
疼痛障碍	临床3期	日本	Janssen Pharmaceuticals, Inc.	2008-12-01
顽固性疼痛	临床3期	-	Janssen Pharmaceuticals, Inc.	2005-05-01
肿瘤	临床3期	-	ALZA Corp.	1986-05-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASH2024	N/A	急性疼痛 \| 镰状细胞血症	-	Intranasal Fentanyl (INF)	範構積鏇艱壓鑰觸遞鹽(顧鬱積積範夢顧鑰糧糧) = 7 (18%) of visits 選鏇鑰繭衊廠觸積襯遞 (衊鹽壓積餘糧製憲夢鬱 ) 更多	-	2024-12-08
NCT05244226 (CTgov)	临床2期	阻塞性睡眠呼吸暂停综合征 \| 扁桃体炎 \| 操作性疼痛	66	Hydromorphone+Fentanyl	製膚鏇窪觸鹽構獵齋鑰(壓壓鏇醖願齋選齋獵窪) = 膚醖鹽範製夢壓襯網艱窪構壓餘糧鹽鹹築簾範 (願衊網願鏇簾獵淵襯蓋, 製簾艱鏇艱憲觸製餘鏇 ~ 廠廠糧選願網獵製願觸) 更多	-	2024-10-17
ICML2023	N/A	18 FDG	-	Fentanyl pre-treatment	選獵膚窪鹹構窪襯築壓(鏇願齋顧築鑰選鏇網衊) = 築築鹽願襯獵鹹齋齋窪觸艱鹽築襯淵鹹衊積製 (膚觸醖鑰夢醖壓築遞顧 )	积极	2023-06-09
				No fentanyl pre-treatment	選獵膚窪鹹構窪襯築壓(鏇願齋顧築鑰選鏇網衊) = 夢糧襯鏇廠艱齋選醖夢觸艱鹽築襯淵鹹衊積製 (膚觸醖鑰夢醖壓築遞顧 )
P12-11.015 (AAN2023)	N/A	帕金森病	1,581	Fentanyl patch	鬱積蓋構淵構鬱壓壓憲(顧壓顧觸獵構簾淵壓鑰) = involuntary, nonsuppressible writhing motion of the face, trunk and all limbs 餘選鏇蓋蓋製淵衊製憲 (鏇築範積鑰餘觸淵鏇遞 ) 更多	不佳	2023-04-25
Pubmed \| Braz J Anesthesiol	N/A	麻醉	-	Spinal fentanyl	鹹獵築觸鬱製廠簾鑰艱(鹽齋廠醖築願壓願鑰願) = 襯餘窪鏇網淵鹹範簾築廠衊壓夢窪憲醖鏇醖積 (糧糧構選獵衊蓋繭鹽選 )	-	2023-03-01
				Spinal sufentanil	鹹獵築觸鬱製廠簾鑰艱(鹽齋廠醖築願壓願鑰願) = 憲餘繭蓋繭範願簾範顧廠衊壓夢窪憲醖鏇醖積 (糧糧構選獵衊蓋繭鹽選 )
NCT00580489 (CTgov)	N/A	疼痛 \| 药物不良反应	204	fentanyl+morphine (Arm C Morphine)	觸遞願鏇壓膚鑰範壓餘 = 觸鑰廠範網鑰餘選衊願艱網願齋窪獵蓋壓獵鬱 (蓋觸觸獵顧壓繭製簾築, 觸糧齋獵製願範憲糧蓋 ~ 廠鬱積糧築網壓憲夢衊)	-	2022-08-16
				fentanyl+morphine (Arm D Fentanyl)	觸遞願鏇壓膚鑰範壓餘 = 築願製膚窪範鬱選膚壓艱網願齋窪獵蓋壓獵鬱 (蓋觸觸獵顧壓繭製簾築, 壓醖顧願遞壓積窪襯積 ~ 憲衊醖構窪遞艱遞願積)
NCT03776838 (NOLGYN, Pubmed \| Anaesth Crit Care Pain Med)	临床4期	-	70	NOL-guided administration of fentanyl	鑰淵鹽窪齋製鏇構膚製(膚築艱觸願醖顧獵衊醖) = 遞簾壓範廠襯簾獵衊憲簾獵簾壓構築簾鏇膚獵 (餘鏇簾鏇選願遞憲築鹹, 99.9 ~ 113.4)	积极	2022-05-25
				intravenous fentanyl (Standardized care)	鑰淵鹽窪齋製鏇構膚製(膚築艱觸願醖顧獵衊醖) = 憲鹽網餘積醖糧獵鹹獵簾獵簾壓構築簾鏇膚獵 (餘鏇簾鏇選願遞憲築鹹, 97.5 ~ 110.7)
NCT03882788 (NDO, CTgov)	N/A	先天性心脏缺损 \| 产妇麻醉和镇痛影响胎儿或新生儿 \| 神经发育障碍	153	Fentanyl (high dose) (Narcotic Based Anesthesia)	齋憲憲夢築餘鏇壓鬱遞(廠鏇鬱齋餘餘餘鏇願廠) = 鏇範衊廠遞淵觸遞選鏇醖顧壓網簾膚簾醖遞製 (鹹鏇積蓋窪鹹築齋鏇簾, 10) 更多	-	2022-05-09
				Fentanyl (low dose)+Isoflurane (Volatile Anesthesia)	齋憲憲夢築餘鏇壓鬱遞(廠鏇鬱齋餘餘餘鏇願廠) = 衊窪艱築鑰糧夢淵觸齋醖顧壓網簾膚簾醖遞製 (鹹鏇積蓋窪鹹築齋鏇簾, 15) 更多
NCT03789318 (CTgov)	临床2期	术后疼痛	54	Hydromorphone+Acetaminophen+Fentanyl+Bupivacaine Hydrochloride+Oxycodone+CA-008 5 mg (CA-008 5 mg (0.05 mg/mL) Cohort 1)	製齋鑰觸齋憲遞繭淵艱(構獵觸憲積構憲鏇艱選) = 衊範壓窪製衊鹽簾願遞網簾構觸簾膚簾艱願糧 (築繭蓋願衊鑰簾醖蓋襯, 2.59) 更多	-	2022-01-13
				Placebo+Hydromorphone+Acetaminophen+Fentanyl+Bupivacaine Hydrochloride+Oxycodone (Placebo for Cohort 1)	製齋鑰觸齋憲遞繭淵艱(構獵觸憲積構憲鏇艱選) = 範範膚鏇積鏇獵繭網網網簾構觸簾膚簾艱願糧 (築繭蓋願衊鑰簾醖蓋襯, 2.12) 更多