Buprenorphine

Model estimates SUBLOCADE ® may reduce staff time and associated costs compared with other medications for opioid use disorder in jails and prisons RICHMOND, Va., March 31, 2026 (GLOBE NEWSWIRE) -- Indivior Pharmaceuticals, Inc., (Nasdaq: INDV) today announced findings from a new cost impact model published in The Journal of Current Medical Research and Opinion, estimating that the use of extended-release buprenorphine, a monthly injectable commercially available as SUBLOCADE ® , may reduce staff time and associated costs in jails and prisons compared with other medications for opioid use disorder (MOUD). “Correctional facilities face ongoing staffing constraints as the need for MOUD continues to grow,” said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. “These findings highlight how monthly injectable buprenorphine can reduce dosing burden and staff involvement, enabling facilities to operate more efficiently while expanding access to evidence-based care.” The model compared staff time requirements across four MOUD options including methadone, oral buprenorphine, extended-release buprenorphine, and extended-release naltrexone, estimating monthly staffing needs and costs for treating 100 incarcerated patients with OUD. Using national mean wages and administration time estimates from literature, expert input, and manufacturer guidance, the model found: Reduced staff time : Monthly buprenorphine injections required fewer staff hours than other MOUD treatments—318 fewer staff hours vs. methadone; 747 fewer hours vs. oral buprenorphine; 192 hours fewer vs. weekly extended-release buprenorphine, and six hours fewer vs. extended-release naltrexone. Estimated cost savings : Reduced staff time translated to monthly cost savings ranging from $23 to $22,148, with largest savings stemming from the elimination of daily observed dosing and patient escorts. “Investing in more efficient MOUD delivery models can drive meaningful cost savings,” said Vanessa Procter, Executive Vice President of Corporate Affairs at Indivior. “Nearly half of U.S. jails and prisons cite staffing as a primary barrier to providing MOUD. LAIs can help expand access to evidence-based care while reducing operational burden, advancing shared public policy goals of improving health outcomes.” Study limitations include the exclusion of medication acquisition costs and some administration times and escorting procedures were based on assumptions in the absence of available data. Funded by Indivior, the study was conducted with Veradigm and researchers from the University of Kentucky College of Medicine. The full study findings are available here: Staffing Resource Use: Medications for Opioid Use Disorder Cost Impact Model in Carceral Facilities . 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 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 As the leader in long-acting injectable treatments for opioid use disorder (OUD), Indivior is singularly focused on delivering evidence-based treatment and advancing understanding of OUD as a chronic but treatable brain disease. For more than 25 years, we have revolutionized the science of addiction medicine, developing treatments that help people move toward long-term recovery with independence and dignity. Building on this heritage, we are ushering in a new era, renewing our commitment to individuals living with OUD and carrying forward what matters most: compassion, integrity, and science. Together – with science, people living with OUD, public health champions, and communities – we are powering recovery and renewing hope. Visit to learn more. Connect with Indivior on LinkedIn by visiting . For Further Information Investors: Jason Thompson Indivior Pharmaceuticals Tel: 804-402-7123 E-mail: jason.thompson@indivior.com Media: Cassie France-Kelly Indivior Pharmaceuticals Tel: 804-594-0836 E-mail: Indiviormediacontacts@indivior.com

摘要癌痛是恶性肿瘤患者最常见的症状之一，约25%的新诊断癌症患者和超过75%的晚期癌症患者经历不同程度的疼痛。癌痛严重影响患者的生活质量、治疗依从性及生存预后。近年来，癌痛的治疗理念、药物方案及非药物干预手段均取得显著进展。本文综述近三年来癌痛治疗领域的研究进展，涵盖流行病学与病理生理机制、评估方法、药物治疗、非手术治疗及多学科综合管理等各个方面，以期为临床实践提供参考。关键词：癌痛；疼痛管理；阿片类药物；微创治疗；多学科综合治疗 1.引言癌痛是恶性肿瘤患者最常见且最具挑战性的症状之一。研究表明，约25%的新诊断癌症患者和超过75%的晚期癌症患者经历不同程度的癌痛。癌痛不仅严重影响患者的生活质量、治疗依从性和生存预后，还对患者的身心健康造成深远的负面影响。世界卫生组织（WHO）早在1986年提出了三阶梯止痛治疗方案，为癌痛药物治疗奠定了基础。然而，随着肿瘤治疗技术的进步和人们对疼痛机制认识的深入，癌痛治疗理念和方法不断更新。近年来，阿片类药物的合理应用以及多学科姑息疼痛管理模式等方面的研究取得重要进展，经皮肿瘤消融介入技术也获得相关研究进展[1][2]。本文旨在系统综述近三年（2023-2025年）癌痛治疗领域的研究进展，为临床医师提供最新的循证医学证据和实践参考。 2.癌痛的流行病学与病理生理机制2.1 癌痛流行病学特征癌痛的流行病学特征因肿瘤类型、分期及治疗方式的不同而存在显著差异。2026年发表的叙述性综述未涉及实体瘤患者癌痛发生率及不同肿瘤疼痛发生率的相关数据。值得关注的是，癌痛不仅存在于晚期患者，早期癌症患者同样可遭受疼痛困扰。2.2 癌痛的病理生理机制癌痛的发生机制涉及肿瘤对周围组织的侵犯、神经压迫、炎症反应及神经病理性改变等多个方面。肿瘤细胞分泌的炎症介质（如前列腺素、肿瘤坏死因子-α、白细胞介素-1β等）可激活外周伤害性感受器，导致外周敏化。同时，肿瘤侵犯神经或骨髓腔可引起神经病理性疼痛，其特征为痛觉过敏和异常性疼痛。近年来的研究表明，神经胶质细胞的激活在癌痛的发生发展中发挥重要作用。脊髓背角的小胶质细胞和星形胶质细胞被激活后，可释放多种促炎介质，加剧中枢敏化。此外，离子通道（如Nav1.7、Nav1.8、TRPV1等）的异常表达与癌痛的发生密切相关，为靶向镇痛药物的研发提供了新思路。 3.癌痛评估方法有效的癌痛管理建立在准确评估的基础上。近三年来，癌痛评估工具和方法不断优化，主要体现在以下几个方面：3.1 主观评估工具数字评分量表（NRS）、视觉模拟量表（VAS）和面部疼痛量表（FPS-R）等仍是临床最常用的癌痛评估工具。2025年的研究指出，患者报告结局测量信息系统（PROMIS）是用于儿童癌症幸存者疼痛生物心理社会评估的已验证工具[3]。此外，简版疼痛评估量表（BPI）因其简单易行、涵盖疼痛对日常活动的影响等多个维度，在临床实践中广泛应用。3.2 综合评估与动态监测现代癌痛评估强调综合评估和动态监测相结合。生物-心理-社会评估模型可用于儿童癌症幸存者的疼痛评估。移动健康（mHealth）技术的发展使得连续的疼痛监测成为可能，智能手机应用程序可实时记录疼痛强度、用药情况及生活质量指标，为个体化治疗提供了数据支持。 4.药物治疗进展4.1 世界卫生组织三阶梯止痛治疗原则WHO三阶梯止痛治疗原则仍是癌痛药物治疗的基石。第一阶梯使用非甾体抗炎药（NSAIDs）用于轻至中度疼痛；第二阶梯使用弱阿片类药物（如曲马多、可待因）用于中度疼痛；第三阶梯使用强阿片类药物（如吗啡、芬太尼、羟考酮）用于中重度疼痛。近三年的研究表明，在遵循三阶梯原则的基础上，个体化用药和联合用药可进一步优化镇痛效果。2026年发表的一项叙述性综述指出，合理使用阿片类药物仍是中重度癌痛的主要治疗手段，但需关注剂量滴定、不良反应管理及长期安全性等问题[1]。4.2 阿片类药物应用进展4.2.1 阿片类药物的药理学进展阿片类药物通过激动μ-、δ-和κ-阿片受体发挥镇痛作用。近年的研究聚焦于开发更具选择性的阿片类药物，以减少不良反应。部分阿片受体激动剂（如丁丙诺啡）支持更安全、更个体化的阿片类药物处方，在癌痛治疗中具有应用潜力[1]。双重作用机制药物他喷他多（Tapentadol）属于支持更安全、个体化阿片类药物处方的研究进展之一[1]。4.2.2 阿片类药物剂量调整与轮换阿片类药物的剂量调整是实现最佳镇痛效果的关键环节。2024年的临床研究显示，规范化剂量滴定可有效提高疼痛缓解率，同时降低不良反应发生率。阿片类药物轮换是优化阿片类药物使用、支持更安全和更个体化处方的策略之一[1]。4.2.3 阿片类药物相关不良反应阿片类药物的常见不良反应包括便秘、恶心呕吐、嗜睡、呼吸抑制及成瘾等。其中，阿片类药物引起的便秘（OIC）是最常见且棘手的不良反应，2026年的综述详细阐述了OIC的发病机制及管理策略[4]。新型外周μ-阿片受体拮抗剂（如甲基纳曲酮、纳尔地地）对OIC显示出良好的疗效，且不影响阿片类药物的中枢镇痛作用。4.3 辅助镇痛药物4.3.1 抗抑郁药三环类抗抑郁药（如阿米替林）和5-羟色胺-去甲肾上腺素再摄取抑制剂（SNRIs，如度洛西汀、文拉法辛）可用于治疗癌性神经病理性疼痛。2024年的meta分析显示，度洛西汀在治疗化疗诱导的周围神经病变（CIPN）相关疼痛中显示出中等疗效。4.3.2 抗惊厥药加巴喷丁和普瑞巴林是治疗神经病理性疼痛的一线药物。近年的研究表明，普瑞巴林在治疗癌性神经病理性疼痛方面可改善睡眠质量和情绪状态，但其镇痛效果因人而异。4.3.3 糖皮质激素地塞米松等糖皮质激素可通过减轻炎症反应、缓解神经水肿而发挥辅助镇痛作用。糖皮质激素可有效控制肿瘤相关的炎性疼痛和神经压迫性疼痛，但长期使用需注意不良反应的管理。4.4 爆发痛与难治性癌痛爆发痛（breakthroughpain）是指在稳定镇痛基础上突然出现的短暂剧烈疼痛。2025年的研究显示，爆发痛的发生率约为65%，严重影响患者生活质量。速效阿片类药物（如即释吗啡、芬太尼透黏膜制剂）是处理爆发痛的主要手段。对于难治性癌痛，需考虑多种因素，包括肿瘤进展、神经侵犯、心理因素及药物代谢异常等。难治性癌痛患者应尽早转诊至疼痛专科或姑息治疗团队进行综合管理。 5.非药物治疗进展5.1 介入治疗技术5.1.1 神经阻滞神经阻滞是缓解特定区域癌痛的有效方法。2025年的临床研究显示，腹腔神经丛阻滞可有效缓解胰腺癌及其他上腹部恶性肿瘤引起的疼痛。椎旁阻滞、硬膜外阻滞及选择性神经根阻滞等技术也在癌痛管理中发挥重要作用。5.1.2 经皮肿瘤消融技术经皮肿瘤消融技术，包括射频消融（RFA）、微波消融（MWA）、冷冻消融及不可逆电穿孔（IRE）等，已成为缓解骨转移和软组织转移相关疼痛的重要手段。2026年的综述指出，RFA和MWA常用于治疗疼痛性骨转移和软组织转移，而冷冻消融因其可提供更好的影像学显像优势，更适合邻近神经或关键结构的病变[2]。5.1.3 椎体强化技术经皮椎体成形术和椎体后凸成形术是治疗疼痛性椎体转移的标准微创手术。2026年发表的综述指出，双极RFA联合椎体强化在疼痛性脊柱转移的疼痛管理中显示出特定获益[2]。5.2 神经调控疗法5.2.1 周围神经刺激周围神经刺激（PNS）已被证实可有效治疗慢性疼痛。2025年发表的美国疼痛和神经科学学会（ASPN）共识指南，为PNS在慢性疼痛和神经系统疾病治疗中的应用提供了循证医学支持[5]。临时性周围神经刺激（60天）可预测永久性植入后6个月的镇痛效果，为患者提供了一种可逆的治疗选择[6]。5.2.2 脊髓刺激脊髓刺激（SCS）主要用于治疗难治性癌痛，特别是躯干和四肢疼痛。近年来，高频SCS和背根神经节刺激等新技术的发展，进一步提高了镇痛效果并减少了副作用。5.3 心理干预与社会支持癌痛不仅是一种生理体验，还受到心理和社会因素的深刻影响。2026年的综述强调，包含心理干预在内的多模式康复作为药物治疗的补充，可缓解晚期癌痛并改善患者生活质量[7]。社会支持、家庭关怀及姑息治疗团队的参与同样是癌痛综合管理的重要组成部分。5.4 补充与替代疗法5.4.1 运动疗法适度运动已被证实可缓解癌痛并改善功能状态。2026年的研究指出，运动训练作为非药物干预策略之一可辅助缓解晚期癌症疼痛，但并未报道其发挥镇痛作用的具体机制[7]。然而，癌痛患者的运动处方需个体化制定，并考虑肿瘤相关禁忌症。5.4.2 虚拟现实与人工智能虚拟现实（VR）技术作为一种新兴的非药物镇痛手段，在癌痛管理中展现出潜力。2026年的综述聚焦晚期癌症慢性疼痛的非药物干预，未涉及VR缓解急性疼痛的相关内容[7]。人工智能驱动的应用程序可为患者提供个性化的疼痛自我管理支持。 6.多学科综合治疗与未来展望6.1 多学科疼痛管理模式现代癌痛管理强调多学科团队协作，包括肿瘤科医师、疼痛专科医师、姑息治疗医师、护士、药师、物理治疗师及心理医师等。2026年的研究证实，对于晚期癌痛患者，结合非药物策略的多模式康复可有效补充药物管理以缓解癌痛、提高患者生活质量，未证实其可减少阿片类药物用量[7]。6.2 精准医学与个体化治疗随着肿瘤分子分型和疼痛基因组学的发展，精准医学理念正逐步应用于癌痛治疗。未来，基于患者基因型的个体化阿片类药物选择和剂量优化有望实现。6.3 新型治疗技术与药物研发6.3.1 细胞治疗间充质干细胞（MSC）疗法在治疗骨癌痛方面展现出前景。2025年的临床前研究显示，鞘内注射人脐带来源的MSC可有效缓解骨癌痛，且安全性良好[8]。6.3.2 专业化Resolution介质专门化促解决介质（SPMs）是一类来自ω-3和ω-6脂肪酸的生物活性脂质化合物，具有抗炎和炎症解决的双重作用。2025年的综述显示，SPMs（如Resolvin D1、Resolvin E1等）可通过调节神经-免疫相互作用发挥镇痛作用，为非阿片类镇痛药物的研发提供了新方向[9]。6.4 挑战与展望尽管癌痛治疗取得了显著进展，但仍面临诸多挑战，包括：阿片类药物的合理使用与监管平衡、介入治疗的普及性与可及性、基层医疗机构的癌痛管理能力建设、以及资源有限地区患者的疼痛控制等。未来研究应聚焦于：开发更安全有效的镇痛药物和技术、建立规范的癌痛管理指南、加强姑息治疗培训、以及推动癌痛管理的均质化发展。 结论癌痛是恶性肿瘤患者最常见的症状之一，对患者的生活质量和整体预后产生深远影响。近三年来，癌痛治疗领域在药物治疗、非介入治疗、神经调控及多学科综合管理等方面均取得重要进展。阿片类药物仍是中重度癌痛治疗的基石，但需强调合理使用和个体化滴定。介入治疗技术和神经调控疗法为难治性癌痛提供了新的治疗选择。心理干预、运动疗法及补充替代疗法等非药物手段在综合管理中发挥着日益重要的作用。未来，随着精准医学和新型治疗技术的发展，癌痛管理将更加个体化、精准化，从而进一步提高患者的生活质量。 参考文献（略）