EarLy Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT): a Parallel Group, Randomized, Double Blind, Placebo Controlled Trial

Most individuals with mild traumatic brain injury (mTBI) experience post-traumatic headaches (PTH). Of PTH, 50% present with a migraine phenotype which is the most disabling type of PTH. Patients with migraine-PTH are at greater risk of persistent symptoms whereby the acute PTH (aPTH) becomes persistent PTH (pPTH) (ie. lasting > 3 months) with a conversion rate of 47-95%. As migraine symptoms become chronic, it becomes treatment resistant. Despite these implications, early preventive medication management of PTH is marred by lengthy trials of multiple medications (2-3 months for each) and adverse effects that aggravate mTBI symptoms (fatigue, nausea, and presyncope). There is a compelling need to establish an effective treatment to prevent this debilitating outcome. Eptinezumab is a calcitonin gene-related peptide (CGRP)-blocking monoclonal antibody that reduces migraine burden in patients with migraines after a single infusion. Patients with PTH have higher serum levels of CGRP and experimental infusion of CGRP to patients with mTBI reproduces migraine PTH symptoms. Given the similarly in CGRP expression between chronic migraines and PTH, an infusion of eptinezumab within 8 weeks of PTH is hypothesized to reduce headache burden 3 months after treatment and prevent pPTH.

开始日期2026-09-30

申办/合作机构

Sunnybrook Health Sciences Centre

ISRCTN59164978

/ Recruiting临床3期IIT

Eptinezumab for the acute treatment of status migrainosus in the emergency department of a community hospital

开始日期2026-07-27

申办/合作机构

Centre Hospitalier de l'Universite de Montreal

NCT07655440

/ Not yet recruiting临床4期IIT

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Many people with migraine also experience tinnitus - a persistent ringing, buzzing, or hissing in the ears - and research suggests these conditions share underlying biological mechanisms, including a protein called calcitonin gene-related peptide (CGRP) that is active in both the brain and the inner ear. COMPACT-PM is a randomized trial comparing two classes of migraine preventive medications in adults with bothersome tinnitus and a history of migraine: anti-CGRP therapies (newer injectable or oral agents that block CGRP or its receptor) versus conventional migraine preventives (antidepressants including amitriptyline, nortriptyline, and venlafaxine; antihypertensives including propranolol, verapamil, and candesartan; and the anticonvulsant topiramate). Participants are randomly assigned - like a coin flip - to one of the two treatment groups; neither group receives a placebo, as both receive active migraine treatment. The study's primary outcome is change in the Tinnitus Functional Index (TFI) over 24 weeks, with additional measures including hearing tests, balance assessments, auditory brainstem response testing, and a comprehensive symptom diary. The study is conducted at the Stanford Ear Institute and is funded by a philanthropic gift to the Department of Otolaryngology - Head & Neck Surgery at Stanford University.

开始日期2026-07-01

申办/合作机构

Stanford University

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100 项与艾普奈珠单抗相关的专利（医药）

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262

项与艾普奈珠单抗相关的文献（医药）

2026-07-01·CEPHALALGIA

Cerebrovascular risk with calcitonin gene-related peptide monoclonal antibodies versus onabotulinumtoxinA in patients with migraine: A real-world pharmacoepidemiologic study in the National Institutes of Health All of Us Research Program

Article

作者: Ong, Bradley ; Thompson, Nicolas ; Gül, Sedat ; Trudeau, Stephen ; Yuan, Hsiangkuo

Aim:

To evaluate whether initiation of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) was non-inferior to initiation of onabotulinumtoxinA with respect to the hazard of ischemic stroke or transient ischemic attack (IS + TIA) in a real-world cohort of adults with migraine.

Methods:

We conducted a retrospective, active-comparator, new-user pharmacoepidemiology study using the NIH All of Us Research Program Registered Tier Dataset (v8). Adults with migraine initiating CGRP mAbs (erenumab, fremanezumab, galcanezumab, eptinezumab) were compared with initiators of onabotulinumtoxinA from January 2018 through September 2023. The primary outcome was IS + TIA occurring more than 90 days after treatment initiation. Inverse probability of treatment weighting (IPTW) with stabilized propensity scores was used to adjust for 23 baseline covariates. Non-inferiority was assessed on the hazard ratio (HR) scale using a prespecified margin of 1.5, with non-inferiority concluded if the upper bound of the 95% confidence interval (CI) was less than 1.5. Prespecified subgroup analyses included migraine with aura and without aura. Prespecified sensitivity analyses included a per-protocol analysis, a crossover-excluded analysis, and an IS-only analysis. Fracture was used as a negative control outcome.

Results:

Among 16,147 patients with migraine in the cohort, the primary comparison included 1,581 CGRP mAb initiators and 947 onabotulinumtoxinA initiators. IPTW achieved a good covariate balance for the primary comparison (maximum standardized mean difference 0.016). For the primary outcome, 14 IS + TIA events occurred among CGRP mAb initiators and 22 among onabotulinumtoxinA initiators. The hazard ratio for IS + TIA was 0.524 (95% CI 0.263–1.046), which met the prespecified statistical criterion for non-inferiority because the upper confidence bound was below 1.5; however, the estimate was imprecise because of the small number of events. In the migraine with aura subgroup, the estimate also met the non-inferiority criterion (HR 0.419, 95% CI 0.163–1.080), whereas the migraine without aura subgroup, per-protocol analysis, and major adverse cardiovascular events analysis were inconclusive for non-inferiority. For major adverse cardiovascular events the HR was 1.068 (95% CI 0.589–1.935). The fracture negative control was also not significantly different (HR, 1.175; 95% CI, 0.692–1.993; p = 0.551), arguing against systematic healthy-user confounding. A formal adjusted comparison with untreated patients was not feasible due to structural confounding inherent to the stepped-care treatment pathway.

Conclusions:

In this real-world diverse cohort, initiation of CGRP mAbs met the prespecified statistical criterion for non-inferiority relative to onabotulinumtoxinA for the primary IS + TIA outcome. However, this finding was based on few events and wide CIs and should be interpreted cautiously as limited evidence against a large relative increase in incident IS + TIA risk, rather than as definitive evidence of equivalent safety, absence of modest harm, or a protective effect. Several secondary, subgroup, and supportive analyses remained inconclusive for non-inferiority. Larger adequately powered comparative safety studies are needed.

2026-06-09·NEUROLOGY

Glaucoma Risk Associated With Calcitonin Gene–Related Peptide Inhibitor Use in Migraine

Article

作者: Weng, Chien-Hsiang ; Wu, Jr-Wei ; Wang, I-Jong ; Lin, Hui-Ju ; Pan, Ssu-Yu ; Chou, Chien-Chih

BACKGROUND AND OBJECTIVES:

Migraine has been linked to an increased risk of glaucoma, and our study aims to assess the temporal association between calcitonin gene-related peptide inhibitors (CGRPi) and the risks of glaucoma in individuals with migraine.

METHODS:

This multinational retrospective cohort study included adults diagnosed with migraine who received migraine preventive medications in 2018-2024. Participants were categorized into the CGRPi group (erenumab, fremanezumab, galcanezumab, eptinezumab, atogepant, or rimegepant) and non-CGRPi group (valproate, topiramate, flunarizine, candesartan, lisinopril, metoprolol, propranolol, nadolol, amitriptyline, and venlafaxine). Crossovers were not allowed, and the non-CGRPi group included only individuals who never used CGRPi. The CGRPi and non-CGRPi groups were propensity score matched in a 1:1 ratio and were followed for up to 3 years to monitor the occurrence of incident glaucoma. The Cox proportional hazards model was used to compare the risk of glaucoma between CGRPi and non-CGRPi users, with results reported as hazard ratios (HRs) and 95% CIs.

RESULTS:

A total of 73,644 individuals were included in the final analysis. Compared with non-CGRPi users, CGRPi users experience a lower risk of glaucoma development (HR 0.75; 95% CI 0.61-0.92) within 3 years since its first prescription. Individuals using CGRPi also exhibit a reduced risk of glaucoma compared with those using topiramate (HR 0.73; 95% CI 0.59-0.90), valproate (HR 0.54; 95% CI 0.35-0.83), propranolol (HR 0.76; 95% CI 0.59-0.98), metoprolol (HR 0.76; 95% CI 0.59-0.98), lisinopril (HR 0.49; 95% CI 0.38-0.62), amitriptyline (HR 0.69; 95% CI 0.54-0.89), and venlafaxine (HR 0.68; 95% CI 0.50-0.91). In the analysis that further classified participants based on the specific CGRPi used, only users of monoclonal antibody CGRPi show a reduced risk of glaucoma compared with non-CGRPi users (HR 0.77; 95% CI 0.61-0.98). The reduced risk of glaucoma associated with CGRPi is also observed in older adults, women, and those with chronic migraine or migraine without aura.

DISCUSSION:

Among adults with migraine receiving preventive treatment, systemic use of CGRPi, particularly monoclonal antibody CGRPi, is associated with a reduced risk of glaucoma compared with the use of other migraine preventive medications.

CLASSIFICATION OF EVIDENCE:

This is a Class II study demonstrating that CGRPi users with migraine have a lower risk of incident glaucoma when compared with non-CGRPi users with migraine.

2026-06-01·Pain and Therapy

Long-Term Reductions in Headache Frequency, Severity, and Disability with Eptinezumab in Adults with Chronic Migraine: Results from the PREVAIL Trial

Article

作者: Grossman, S Wald ; Kudrow, David ; Kapur, Neha ; Starling, Amaal J ; Patel, Foram ; Blumenfeld, Andrew ; Lipton, Richard B ; Ailani, Jessica ; Awad, Susanne F

INTRODUCTION:

Individuals with chronic migraine (CM) experience substantial headache-related disability. Post hoc analyses from the PREVAIL trial assessed the long-term impact of eptinezumab preventive treatment for CM on patient-centered measures of headache frequency, headache pain severity, disability, and quality of life.

METHODS:

In the 104-week, open-label PREVAIL trial, which evaluated long-term safety and patient-reported outcomes, participants received eptinezumab 300 mg intravenously every 12 weeks to week 84 for preventive treatment of CM. The Migraine Disability Assessment (MIDAS) scale was used to evaluate proportions of participants with sustained ≥ 50% and ≥ 75% reductions in mean monthly headache days (MHDs) through 12-week dosing intervals to week 84 and changes in mean MHD frequency category (e.g., 0, 1- < 4 MHDs), Frequency-Severity Index (FSI) scores (composite of MIDAS-derived mean MHDs and headache pain severity), and days with headache-related disability through week 104.

RESULTS:

Over half of participants with ≥ 50% or ≥ 75% reduction in mean MHDs after the first eptinezumab dose (weeks 1-12: 78% and 54%, respectively) or second dose (weeks 13-24: 83% and 69%, respectively) experienced sustained reductions in headache frequency through all subsequent dosing intervals until the last dose (week 84). At baseline, participants reported a mean (standard deviation [SD]) of 15.8 (7.6) MHDs. More than 60% of participants reported < 4 mean MHDs at week 12 and at all subsequent assessments through week 104 (20 weeks after last infusion) after initiating eptinezumab; 23% reported 0 mean MHDs by week 104. The mean FSI score decreased from baseline (11.4) to week 12 (3.5), with decreases maintained through week 104. Monthly days with headache-related impact also decreased from baseline to week 12, with improvements maintained through week 104.

CONCLUSIONS:

Treatment with eptinezumab 300 mg is associated with substantial early and long-term reductions in headache frequency, severity, and disability, indicating its ability to improve multiple aspects of the broader burden of CM. Graphical abstract available for this article.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier: NCT02985398.

189

项与艾普奈珠单抗相关的新闻（医药）

2026-08-31

·传宇神经笔记&AI

头痛先排雷，再分型：避免漏诊的临床诊疗路径

头痛是神经内科门诊最常见的主诉之一，也是急诊最容易漏诊危重疾病的症状之一。对规培生和年轻医师来说，头痛诊疗的难点不在于"见过多少种头痛"，而在于能否在有限的问诊时间内，先排除危险、再精准分型、最后规范治疗。本文基于国际头痛分类第3版（ICHD-3）、中华医学会神经病学分会《中国偏头痛诊断与治疗指南（第一版）》（2023）、欧洲神经病学学会（EAN）丛集性头痛指南（2023）、美国VA/DoD头痛管理临床实践指南（2023）以及近3年顶刊文献，梳理一套可直接落地的头痛临床决策路径。01 先排雷：继发性头痛的红旗征与影像决策头痛诊疗的第一步永远不是"这是哪种原发性头痛"，而是"这是不是继发性头痛"。继发性头痛虽然在门诊中占比不高，但漏诊的代价可能是致命的。SNNOOP10：红旗征筛查清单目前国际广泛使用的红旗征筛查工具是SNNOOP10，涵盖10项高危特征： Systemic symptoms（全身症状）：发热、体重下降、免疫抑制 Neoplasm history（肿瘤病史） Neurologic deficit（神经功能缺损）：包括意识改变 Onset sudden（突发雷击样头痛）：1分钟内达峰 Older age（年龄>50岁新发头痛） Pattern change（头痛模式改变）：原有头痛频率、程度、性质显著变化 Papilledema（视乳头水肿） Positional headache（体位性头痛） Precipitated by Valsalva（Valsalva动作诱发） Pregnancy or puerperium（妊娠或产后） 2024年发表在《Emergency Medicine Journal》的HEAD和HEAD-Colombia多国队列研究（5293例急诊头痛患者）显示，红旗征组合的阴性预测值达93.5%，但特异性仅5.1%。这意味着：没有红旗征可以较大程度排除严重继发性头痛，但有红旗征并不等于一定有器质性病变——它只是提示需要进一步检查。该研究还发现，独立预测严重继发性头痛的四个因素是：新发神经功能缺损、肿瘤病史、年龄>50岁、近期头部外伤（2-7天前）。影像检查的决策逻辑美国放射学会（ACR）2022年更新的头痛影像适宜性标准，将临床场景分为8类，核心原则是：无红旗征的典型原发性头痛不需要常规影像检查。具体决策要点：雷击样头痛：首选头颅CT平扫。发病6小时内由经验丰富的放射科医师阅片，阴性预测值接近100%；超过6小时后CT敏感性下降，阴性结果需结合腰椎穿刺排除蛛网膜下腔出血。疑似颅内压增高：首选头颅MRI（含增强），评估有无占位、静脉窦血栓或脑积水。体位性头痛：警惕低颅压头痛，MRI可显示硬膜强化、脑下垂等特征性表现。发热伴头痛：需排除脑膜炎/脑炎，腰椎穿刺是关键检查，但需先评估有无脑疝风险。 50岁以上新发头痛：需排查颞动脉炎（查血沉、C反应蛋白）和颅内占位。 2024年《JAMA Network Open》发表的一项涵盖19.8万例急诊头痛患者的回顾性研究显示，近年来CT血管造影（CTA）的使用量年均增长18.8%，而腰椎穿刺年均减少11.1%，CTA相对于腰穿的使用比例增加了约6倍，未破裂颅内动脉瘤的检出率相应增加了33%，但蛛网膜下腔出血和细菌性脑膜炎的漏诊率并无显著变化。这提示我们：影像技术的进步不能替代临床判断，检查的选择应基于红旗征而非"防御性开单"。02 精准分型：ICHD-3框架下的原发性头痛诊断排除继发性头痛后，进入原发性头痛的分型诊断。ICHD-3将原发性头痛分为四大类：偏头痛、紧张型头痛、三叉自主神经性头痛（TACs）和其他原发性头痛。诊断的核心是病史采集，而非辅助检查。偏头痛：最需要规范治疗的类型偏头痛的诊断标准（ICHD-3 1.1无先兆偏头痛）：至少5次发作，每次持续4-72小时（未经治疗或治疗无效）头痛具备以下至少2项：单侧性、搏动性、中重度疼痛、日常活动加重头痛期间具备以下至少1项：恶心和/或呕吐、畏光和畏声不能归因于其他ICHD-3诊断有先兆偏头痛（1.2）的关键特征是：至少2次发作，出现完全可逆的视觉、感觉或言语/语言症状，持续5-60分钟，随后60分钟内出现头痛。需要特别注意的是慢性偏头痛的诊断：每月头痛≥15天，持续3个月以上，其中至少8天符合偏头痛特征，且不能归因于其他疾病。慢性偏头痛常与药物过度使用性头痛共存，诊疗时需要同时评估。紧张型头痛：最常见但最易被低估紧张型头痛（TTH）是人群中患病率最高的头痛类型，但在专科门诊中占比相对较低。其核心特征是：双侧、压迫感或紧箍感、轻中度疼痛、日常活动不加重、无恶心呕吐，可有畏光或畏声但不同时存在。 2025年《Headache Pain Research》发表的最新综述指出，TTH的发病机制涉及周围性（颅周肌肉压痛）和中枢性（痛觉调制异常）双重机制，慢性TTH的预防性治疗证据仍然有限，阿米替林是目前证据最充分的预防性药物。物理治疗和有氧运动对TTH有明确获益。三叉自主神经性头痛：丛集性头痛最具代表性丛集性头痛的诊断要点：至少5次重度或极重度单侧眶周/颞部疼痛，持续15-180分钟头痛侧至少出现1项自主神经症状：结膜充血、流泪、鼻塞、流涕、眼睑水肿、额面部出汗、瞳孔缩小和/或上睑下垂发作频率从隔日1次到每日8次分为发作性（丛集期持续7天至1年，缓解期≥3个月）和慢性（缓解期<3个月或无缓解期）丛集性头痛极易被误诊为偏头痛或牙科疾病，关键鉴别点是疼痛的极端程度、严格的单侧性、伴随的自主神经症状以及发作的节律性（常在夜间固定时间发作）。03 偏头痛：急性与预防性治疗的最新证据偏头痛是治疗证据最充分、新药研发最活跃的头痛类型。2023年中华医学会指南和2024年法国头痛学会立场文件均强调了分层治疗和CGRP靶向药物的地位变化。急性治疗：分层选药，尽早干预急性治疗的目标是：在2小时内达到无痛或轻度疼痛，恢复功能，减少复发。第一步：非特异性镇痛药——适用于轻中度发作。布洛芬400-600mg、对乙酰氨基酚1000mg、阿司匹林600-900mg均有A级证据。注意：NSAID空腹服用起效更快（约30分钟 vs 餐后60分钟），但需权衡胃肠道风险。第二步：曲坦类药物——适用于中重度发作或非特异性镇痛药无效者。舒马曲坦50-100mg口服是证据最充分的选择；皮下注射舒马曲坦6mg起效最快（15分钟缓解率可达80%），适用于伴严重恶心呕吐或口服吸收不良的患者。一种曲坦无效不代表另一种也无效，建议尝试至少2种后再判定为曲坦难治。第三步：CGRP受体拮抗剂（gepants）——瑞美吉泮（rimegepant）75mg、乌布吉泮（ubrogepant）和扎维吉泮（zavegepant，鼻喷剂）是新型急性治疗gepant类药物。gepants类药物不作用于5-HT1B/1D受体，无心血管收缩禁忌，因此适用于曲坦类禁忌或不耐受的患者。2024年法国头痛学会立场文件进一步明确提出，CGRP靶向药物（包括单克隆抗体和口服gepants）可作为偏头痛预防性治疗的一线选择，而非传统观念中的末线药物。辅助用药：甲氧氯普胺或丙氯拉嗪等止吐药不仅能缓解恶心，还能促进胃排空、提高镇痛药吸收，建议在伴恶心的发作中早期联用。重要原则：急性治疗药物每月使用不超过10天（曲坦类、复方镇痛药）或15天（NSAID、对乙酰氨基酚），以避免药物过度使用性头痛。阿片类药物不推荐用于偏头痛急性治疗。预防性治疗：把握指征，足量足疗程启动预防性治疗的指征（中国2023指南）：每月偏头痛发作≥4次（不伴失能）、≥3次（伴轻微失能）或≥2次（伴严重失能）急性治疗失败或不耐受存在药物过度使用风险特殊类型偏头痛（偏瘫型、脑干先兆、先兆持续>60分钟、偏头痛性脑梗死）患者主动要求减少发作预防性药物选择（基于中国2023指南推荐等级）： A级证据、I级推荐：普萘洛尔（20-240mg/d）、美托洛尔（50-200mg/d）、丙戊酸盐（500-1500mg/d）、托吡酯（25-200mg/d）、氟桂利嗪（5-10mg/d）。 B级证据：阿米替林（12.5-75mg/d）、文拉法辛（75-150mg/d）、坎地沙坦（8-16mg/d）、阿替洛尔、比索洛尔。 C级证据：左乙拉西坦、赖诺普利、镁剂（24mmol/d）、核黄素（400mg/d）、辅酶Q10（300-400mg/d）。 CGRP靶向药物：包括4种单克隆抗体（erenumab 70-140mg/月皮下注射、fremanezumab 225mg/月或675mg/季度、galcanezumab 240mg负荷后120mg/月、eptinezumab 100mg/季度静脉输注）和口服gepants（atogepant 60mg/d、rimegepant 75mg隔日）。2024年法国头痛学会立场文件明确提出，CGRP靶向药物可作为偏头痛预防性治疗的一线选择，而非传统观念中的"三线末线"。中国指南基于药物可及性与药物经济学因素，将CGRP靶向药物列为新型预防性治疗选择（II级推荐，A级证据）；临床实践中，该类药物多用于传统预防药物疗效不佳或不耐受的患者。疗效评估原则：预防性药物需在足够剂量下使用至少6-8周才能评估疗效；有效后维持至少6个月（慢性偏头痛或MOH需12个月以上），再逐渐减停。疗效判断标准为偏头痛天数减少≥50%，同时结合头痛程度、持续时间、失能改善和生活质量综合评估。04 丛集性头痛与紧张型头痛：容易被忽视的诊疗要点丛集性头痛：急性与预防的"双轨制" 基于2023年EAN丛集性头痛指南，治疗分为急性终止和预防性抑制两条线，必须同时启动。急性治疗（强推荐）： 100%氧气吸入：推荐流量12~15L/min，使用非重复呼吸面罩，持续15-20分钟。-严重慢阻肺伴CO₂潴留（Ⅱ型呼衰）患者禁用高流量纯氧。无明显心血管禁忌，可反复使用，是丛集期的首选急性治疗。皮下注射舒马曲坦6mg：起效最快，15分钟疼痛缓解率显著优于安慰剂。每日最大剂量不超过12mg。替代方案包括佐米曲坦鼻喷剂5mg、舒马曲坦鼻喷剂20mg，但起效慢于皮下注射。无创迷走神经刺激（nVNS）对发作性丛集性头痛有效，但对慢性型证据不足。预防性治疗：维拉帕米：一线预防药物，起始剂量至少240mg/d，根据疗效和耐受性可加量至360-720mg/d。必须定期监测心电图（PR间期、QTc、传导阻滞），尤其在加量过程中。糖皮质激素：作为"桥接治疗"，在维拉帕米起效前快速抑制发作。推荐泼尼松≥100mg/d口服或甲泼尼龙≤500mg/d静脉，连用5天后逐渐减量（每4天减10mg）。锂盐：二线预防，适用于维拉帕米无效或禁忌者。血锂浓度目标0.6-0.8mmol/L，需监测甲状腺和肾功能。 Galcanezumab 300mg/月：基于一项RCT证据，推荐用于发作性丛集性头痛的难治性病例（FDA已批准该适应证，EMA尚未批准）。枕大神经阻滞：推荐作为辅助治疗，可重复进行。 2023年韩国多中心前瞻性观察研究（295例）显示，仅有约1/3的丛集性头痛患者既往接受过循证治疗，提示该病的诊断延迟和治疗不规范问题突出。紧张型头痛：简单但不随意偶发性TTH的急性治疗以NSAID和对乙酰氨基酚为主，与偏头痛类似。但频繁发作性TTH和慢性TTH需要预防性治疗。基于VA/DoD 2023指南，慢性TTH的预防性治疗首选阿米替林（10-75mg睡前服用）。物理治疗（包括颈椎手法治疗、拉伸训练）和有氧运动对TTH有明确的辅助治疗价值，应作为基础干预而非"可选建议"。需要警惕的是，TTH的诊断是"排除性"的——如果头痛频率进行性增加、程度加重或出现新的伴随症状，必须重新评估有无继发性病因。05 药物过度使用性头痛：慢性化的关键拐点药物过度使用性头痛（MOH）是头痛慢性化的最重要可逆因素，在专科门诊中占慢性头痛患者的40%以上。ICHD-3的诊断标准：原有原发性头痛的基础上，每月头痛≥15天规律过度使用急性或症状性头痛药物超过3个月曲坦类、麦角胺、阿片类、复方镇痛药：每月≥10天 NSAID、对乙酰氨基酚（单药）：每月≥15天头痛在过度用药期间发展或显著恶化 MOH的治疗核心是停用过度使用的药物。2023年《Frontiers in Pain Research》的综述总结了三种策略：突然停药+预防性药物：适用于一般情况良好、无严重共病的患者，是最常用的策略。逐渐减量+预防性药物：适用于使用苯二氮䓬类、巴比妥类或阿片类药物的患者，避免戒断反应。仅加用预防性药物，不停药：适用于拒绝停药或无法耐受戒断的患者，但疗效不如停药策略。 "桥接治疗"可用于缓解停药后的戒断症状（头痛加重、恶心、焦虑、睡眠障碍），常用方案包括短期糖皮质激素、NSAID、止吐药或双氢麦角胺。关键临床提醒：在启动偏头痛预防性治疗之前，必须先评估和处理MOH。存在药物过度使用时，预防性药物的疗效会显著降低。多项临床研究显示，停药后数周至数月内，约半数至三分之二的患者头痛频率可获得显著改善。06 临床思维框架：头痛诊疗的五步决策法综合以上内容，将头痛诊疗浓缩为可操作的五步决策法：第一步：排雷——用SNNOOP10筛查红旗征。有红旗征→针对性影像/实验室检查排除继发性头痛；无红旗征→进入原发性头痛分型。第二步：分型——基于ICHD-3标准，通过详细病史（发作频率、持续时间、疼痛特征、伴随症状、诱发缓解因素）确定原发性头痛类型。鼓励患者记录头痛日记，这是诊断和疗效评估的基础工具。第三步：评估慢性化风险——询问急性用药频率。每月≥10天（曲坦/复方/阿片）或≥15天（NSAID/对乙酰氨基酚）→诊断MOH并优先处理。第四步：分层治疗——急性治疗按"非特异性镇痛药→曲坦类→gepants"分层，强调早期足量用药；预防性治疗把握指征，根据共病和耐受性选择药物，CGRP靶向药物的地位正在前移。第五步：随访与调整——预防性药物6-8周评估疗效，有效后维持6-12个月再考虑减停；定期评估急性用药频率，防止MOH；关注共病（焦虑、抑郁、睡眠障碍），必要时多学科协作。头痛诊疗的精髓，不在于记住多少种头痛名称，而在于建立一套从危险排除到精准干预的临床思维闭环。每一位头痛患者都值得被认真问诊——因为那句"头痛"背后，可能是一个需要规范治疗的偏头痛患者，也可能是一个被延误的蛛网膜下腔出血。希望这篇文章能为规培生和年轻医师提供一个清晰的临床起点。在实际工作中，请结合患者具体情况、院内诊疗规范和最新指南更新进行个体化决策。资料来源 1. International Headache Society. International Classification of Headache Disorders, 3rd edition (ICHD-3). 2018. 2. 中华医学会神经病学分会头痛协作组. 中国偏头痛诊断与治疗指南（中华医学会神经病学分会第一版）. 中华神经科杂志, 2023, 56(6). 3. May A, et al. European Academy of Neurology guidelines on the treatment of cluster headache. European Journal of Neurology, 2023. 4. Sico JJ, et al. 2023 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline for the Management of Headache. Annals of Internal Medicine, 2024. 5. Moisset X, et al. Migraine treatment: Position paper of the French Headache Society. Revue Neurologique, 2024. 6. Chu K, et al. Predictive performance of the common red flags in emergency department headache patients: a HEAD and HEAD-Colombia study. Emergency Medicine Journal, 2024. 7. Lebedeva ER, Olesen J. Proposed general diagnostic criteria for secondary headaches. Cephalalgia, 2023. 8. Cheema S, et al. New daily persistent headache: A systematic review and meta-analysis. Cephalalgia, 2023. 9. Puledda F, et al. Migraine: from pathophysiology to treatment. Journal of Neurology, 2023, 270:3654-3666. 10. Lee HJ, et al. Update on Tension-type Headache. Headache Pain Res, 2025, 26(1):38-47. 11. Bentivegna E, et al. Unmet Needs in the Acute Treatment of Migraine. Advances in Therapy, 2024, 41:1-13. 12. Krymchantowski A, et al. Medication-overuse headache—a review of different treatment strategies. Frontiers in Pain Research, 2023. 13. Mark DG, et al. Shifts in Diagnostic Testing for Headache in the Emergency Department, 2015 to 2021. JAMA Network Open, 2024. 14. Utukuri PS, et al. ACR Appropriateness Criteria Headache: 2022 Update. Journal of the American College of Radiology, 2023. 15. 中华医学会神经病学分会头痛协作组, 中国卒中学会头痛分会. 月经性偏头痛诊断与治疗中国专家共识. 中华神经科杂志, 2024, 57(12). 16. Lee MJ, et al. Treatment pattern and response for cluster headache in Korea: A prospective multicenter observation study. Cephalalgia, 2023. 17. National Neurosciences Advisory Group (UK). Optimal clinical pathway for adults: Headache and facial pain. 2023. 18. Grodzka O, et al. Biomarkers in headaches as a potential solution to simplify differential diagnosis of primary headache disorders: a systematic review. The Journal of Headache and Pain, 2025. 免责声明：本文仅提供循证医学信息参考，具体诊疗应结合患者实际情况、检查结果及院内规范，由负责医生综合判断，本文不构成诊疗建议。

2026-08-27

·SeekingAb

J-Bio日报 | 日本药企每日动态 20260827

目录一、BD 与投融资二、临床与研发进展三、商业化合作与业绩四、会议预告一、BD 与投融资本窗口（8/26 全天 + 8/27 10:00 前）未见新的日本药企授权、合作、并购或投融资交易，此类动态暂无新增。二、临床与研发进展 1. 中外製薬（Chugai，东证 4519）vamikibart 向日本 MHLW 提交上市申请中外製薬 8/25 宣布已向日本厚生劳动省（MHLW）提交抗 IL-6 单克隆抗体 vamikibart 的上市申请，用于非感染性葡萄膜炎相关的葡萄膜炎性黄斑水肿（UME）。vamikibart（研发代号 RG6179 / RO7200220，由 Roche/Genentech 开发）为玻璃体内注射制剂，通过抑制白细胞介素-6（IL-6）这一眼部炎症关键细胞因子发挥抗炎作用；此前已于 6/23 获日本孤儿药资格，申报基于全球 III 期 MEERKAT 与 SANDCAT 研究。若获批，将成为日本首个用于该适应症的"抗 IL-6 抗体"疗法，提供非类固醇的局部眼部治疗选择。值得关注：UME 现有治疗以皮质类固醇为主、长期安全性受限；IL-6 通路是眼科抗炎的新兴机制（同类机制在糖尿病黄斑水肿 DME 也在探索），Chugai 作为 Roche 日本主体主导开发，体现其在眼科炎症领域的差异化布局。 2. Belite Bio（NASDAQ: BLTE）tinlarebant 推进日本申报布局 PHARMA JAPAN 8/26 报道，美国临床阶段公司 Belite Bio 的口服疗法 tinlarebant（LBS-008）正借日本 Sakigake（先驱审查）资格加速本土路径。tinlarebant 为 RBP4（视黄醇结合蛋白 4）口服抑制剂，通过降低血液 RBP4 水平、减少维生素 A（视黄醇）进入视网膜，从而减少毒性产物（双视黄醇 bisretinoid）在眼内累积，用于治疗青少年 Stargardt 病（STGD1，ABCA4 基因突变所致的遗传性黄斑变性）及地图样萎缩（GA，晚期干性 AMD）；全球 III 期 DRAGON 研究（12–20 岁）已达主要终点，显著减缓病灶生长约 35%。公司计划 2026 上半年向 FDA 报 NDA，并在日本开展 DRAGON II（含 15 例日本受试者）以满足 PMDA 要求。值得关注：STGD1 目前全球无获批疗法，tinlarebant 有望成为首个；日本 Sakigake 通道或使其较早可及。Belite Bio 为专注退行性视网膜疾病的美国临床阶段生物制药公司，官网 belitebio.com。三、商业化合作与业绩 1. Biocon / Sandoz pegfilgrastim 生物类似药获日本 MHLW 批准 Biocon Biologics（印度）8/25 宣布其 pegfilgrastim 生物类似药获日本 MHLW 营销批准；该药为安进 Neulasta 的生物类似药，用于降低化疗所致中性粒细胞减少症（一种白细胞缺乏）的发生风险。产品由 Biocon 开发生产，日本市场由 Sandoz K.K.（诺华分拆的仿制药/生物类似药巨头日本法人）独家推广、销售与分销。值得关注：日本肿瘤支持治疗（onco-supportive）生物类似药竞争升温；Neulasta 全球销售峰值曾超 50 亿美元，仿制药入场有望压低医疗成本、提升可及性，Sandoz 在日本 biosimilar 版图再下一城。 2. 日本 MHLW 专家分科会 8/26 审议 6 个新分子实体 + Leqembi SC PHARMA JAPAN 报道，日本 MHLW 专家分科会于 8/26 审议一批新药及新增适应症，包括：小野制药（Ono）的 Xcopri（cenobamate，钠通道抑制 + GABA_A 增强，抗癫痫，用于难治性部分性发作）、Lundbeck 的 Vyepti（eptinezumab，抗 CGRP 受体单抗，偏头痛预防）、Viatris 的 Wakix（pitolisant，H3 受体拮抗剂/反向激动剂，发作性睡病）、Alexion 的 gefurulimab 与 anselamimab、礼来（Lilly）的超长效胰岛素 efsitora alfa；另涵盖卫材/Biogen 的 Leqembi SC（lecanemab 皮下制剂，抗 β-淀粉样蛋白（Aβ）单抗，阿尔茨海默病）及 Uplizna（inebilizumab）更广标签。值得关注：Leqembi SC 若获准，将把阿尔茨海默病给药从数小时 IV 输液缩短为皮下注射，大幅提升日本患者门诊可及性；Xcopri 为小野制药在日本补强癫痫治疗线（cenobamate 美国已上市、疗效突出但需监测不良反应）。四、会议预告第85回日本癌学会 JCA2026 —— 9/24–26，京都・国立京都国際会館；日本最大级癌症学术与转化会议。インターフェックスWeek大阪 / 再生医療EXPO大阪 —— 9/30–10/2，インテックス大阪；制药制造技术与再生医疗商业化展示。BioJapan 2026 —— 10/7–9，パシフィコ横浜；日本最大级医药 BD/投融资对接会（partnering 为核心）。第64回日本癌治療学会 JSCO2026 —— 10/22–24，神戸；临床肿瘤治疗学会。BMB2026 —— 12/1–4，パシフィコ横浜；日本分子生物学会年会（含药物研发相关议题）。

2026-08-24

·FiercePharma

Lundbeck strikes expanded pact with Eversana to broaden AI scope across US commercial business

A year after unveiling its AI Agency platform, Eversana has reeled in its first publicly named pharma partner with brain disease specialist Lundbeck signing on to use the AI commercialization digs across its U.S. commercial organization. Lundbeck is going all in on Eversana’s AI agency platform after initially deploying the company’s AI-driven workflows across strategic planning, content development and commercial execution, Eversana explained in an Aug. 25 release. Now, the drugmaker will expand its AI usage to more areas including marketing, medical communications, market access and media operations, as well as explore “additional use cases” with Eversana that could also boost operational performance. "What makes this partnership unique is that we're not simply introducing AI tools into existing workflows," Eversana’s chief innovation officer Faruk Capan said in the release. "Together, we're implementing an AI-powered operating model designed specifically for life sciences. By combining agentic AI, embedded compliance and human expertise, we can help commercial teams accelerate execution while maintaining the quality and scientific rigor the industry demands." Lundbeck, for its part, is looking to build its “bionic capabilities” as a key spoke of how it advances its Focused Innovator R&D strategy, the company’s U.S. EVP and president Tom Gibbs added. By expanding its collaboration with Eversana, Lundbeck can further “scale bionic capabilities responsibly across our commercial organization, improve the speed and quality of execution and ultimately, help us deliver greater value to our customers and patients while maintaining the high standards that define our business,” he said. Eversana’s AI agency is an end-to-end AI-powered commercialization platform that was built with Google Cloud technology. The agency merges together agentic AI, advanced automation and human expertise to foster a scalable framework for strategy development, content creation and omnichannel engagement, according to the release. In other words, Eversana is zeroed in on “pharmatizing AI,” CEO Mark Thierer told Fierce in an interview, “with a focus on patients.” To do so, the company has built the “AI hub of the future,” Thierer said. As Thierer puts it, the pharmaceutical industry is at a point where companies “have got to find new ways of doing business,” pointing to industry-wide patent cliffs and sweeping financial pressure across the board. AI capabilities, the CEO suggests, could be the answer. “What we’re creating is a new way for pharma to do business, spanning marketing, sales, all the way through product launch,” Thierer explained. “Pharmatizing AI is a competitive set of weapons for pharma to win market share, and in the end, get patients on the appropriate therapy.” Thierer is a veteran healthcare leader who spent years as Eversana’s board chairman before taking the CEO reigns upon Eversana’s merger with his digital health company Waltz Health last year. While the wider Eversana company focuses on integrated commercial services, its specialized AI Agency is the first of its kind. With now a year of operations and expansions under its belt, Thierer figures that while others will “catch up over time,” competitors will have to “run fast, because we’re way ahead at this point,” he said. The AI wave continues to touch every corner of the industry, with pharmas big and small deploying the technology for intelligent R&D, assistive workflow help , commercial and corporate operations and more. Eversana’s toolkit builds on a longstanding collaboration with Google and is unique in that it is “not comparable to just using AI tools to enhance copywriting or content creations,” Capan said in a release upon launch last year. Lundbeck’s CEO Charl van Zyl recently told Fierce that the company is capable of “punching above its weight” as a “neuroscience challenger” as the drugmaker continues to build on the momentum of migraine med Vyepti and Otsuka-partnered atypical antipsychotic Rexulti, which drove sales growth of 16% over the first half of the year. When Lundbeck signed on to use Eversana’s AI Agency platform across its U.S. commercialization operations, the company was equally signing up to become a more competitive force, “all the way from marketing to the distribution of product,” Thierer commented. “AI is on the desk of every C-suite member of every pharmaceutical company and services company alike,” Thierer said. “Executives are thinking about how to do this, and we’ve emerged as a partner that can help them.”

100 项与艾普奈珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11303	艾普奈珠单抗	L01XC	DB14040

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
偏头痛	美国	Lundbeck Seattle BioPharmaceuticals, Inc.	2020-02-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
头痛	临床3期	-	H. Lundbeck A/S	2026-06-22
假性脑肿瘤	临床3期	-	H. Lundbeck A/S	2026-06-22
药物引起的头痛	临床3期	美国	H. Lundbeck A/S	2021-02-17
药物引起的头痛	临床3期	韩国	H. Lundbeck A/S	2021-02-17
药物引起的头痛	临床3期	西班牙	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	美国	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	中国	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	韩国	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	西班牙	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	中国台湾	H. Lundbeck A/S	2021-02-17

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临床结果

适应症

分期

评价

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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


EAN2026	N/A	偏头痛	201	Eptinezumab 100 mg	鬱獵淵齋廠廠鏇壓獵餘(醖醖廠齋簾鹽願艱淵艱) = 願構蓋鏇襯顧餘衊衊積繭遞襯鹽艱夢獵壓襯鏇 (鏇範鏇鹹壓窪構網廠窪 ) 更多	积极	2026-06-26
				Eptinezumab 300 mg	襯鑰選鏇醖壓餘夢構襯(遞鹽糧遞積築糧簾願夢) = 鬱蓋餘艱窪遞網顧獵窪醖簾築鹽鏇鹹鹹夢範糧 (夢膚簾窪願鏇醖簾淵製 )
NCT05452239 (RESOLUTION, Pubmed \| J Headache Pain)	临床4期	偏头痛 \| 继发性头痛症	608	Eptinezumab	淵積鹹繭壓鹹壓鹹構鹹(範艱鹹鏇艱糧網顧鏇衊) = 鏇齋製襯遞鹹築鏇獵顧構窪齋網築範衊衊鹹願 (範鏇鏇淵觸淵夢憲衊夢 )	积极	2026-06-13
				Placebo	淵積鹹繭壓鹹壓鹹構鹹(範艱鹹鏇艱糧網顧鏇衊) = 遞築構憲壓簾餘繭繭獵構窪齋網築範衊衊鹹願 (範鏇鏇淵觸淵夢憲衊夢 )
NCT05570149 (EMBRACE III, Pubmed \| Neurol Ther)	N/A	偏头痛	124	Eptinezumab 100 mg	鹹鏇壓廠製夢繭衊積網(製遞遞窪鑰齋遞構鹹壓) = 觸襯鑰夢願鑰襯網膚餘網齋餘醖鹽鑰網網製糧 (網願獵範廠憲繭鏇糧齋 ) 更多	积极	2026-06-09
				Eptinezumab 100 mg	鹹鏇壓廠製夢繭衊積網(製遞遞窪鑰齋遞構鹹壓) = 鑰膚鬱顧壓顧製醖鏇築網齋餘醖鹽鑰網網製糧 (網願獵範廠憲繭鏇糧齋 )
NCT05452239 (RESOLUTION, Pubmed \| Cephalalgia)	临床4期	偏头痛 \| 继发性头痛症	602	Eptinezumab 100 mg (Brief Educational Intervention)	顧鹹膚築鹽廠鹽窪廠網(襯鏇選衊艱糧鹹醖鹽製) = 膚壓衊鑰壓壓構範鏇築鬱窪築鬱糧鏇鹹艱鏇遞 (衊壓觸廠鬱鏇顧構膚製 )	积极	2026-05-01
				Placebo (Brief Educational Intervention)	顧鹹膚築鹽廠鹽窪廠網(襯鏇選衊艱糧鹹醖鹽製) = 蓋衊餘襯觸齋構願艱糧鬱窪築鬱糧鏇鹹艱鏇遞 (衊壓觸廠鬱鏇顧構膚製 ) 更多
NCT02985398 (PREVAIL, Pubmed \| Pain Ther)	临床3期	偏头痛	223	Eptinezumab 300 mg	觸製繭憲願蓋製簾壓壓(齋鏇襯顧構簾鑰壓選積) = 壓築鹽襯願範鑰衊製積蓋築遞獵遞構醖觸壓構 (遞積鬱鑰範製遞願餘築 ) 更多	积极	2026-04-17
NCT04418765 (DELIVER, Pubmed \| Neurol Ther)	临床3期	偏头痛	890	Eptinezumab 100 mg	蓋簾積遞鹽廠築鹽鹽觸(廠壓壓網憲鬱鏇簾鹽繭) = 觸衊遞鑰顧壓醖壓衊願繭鹽鏇艱廠願積衊築獵 (醖築壓襯顧蓋齋衊襯淵 ) 更多	积极	2026-02-11
				Placebo	蓋簾積遞鹽廠築鹽鹽觸(廠壓壓網憲鬱鏇簾鹽繭) = 鏇積壓餘觸網衊衊壓範繭鹽鏇艱廠願積衊築獵 (醖築壓襯顧蓋齋衊襯淵 ) 更多
NEWS 人工标引	N/A	偏头痛	111	Eptinezumab	繭積觸淵獵構鏇觸夢壓(窪鹹觸構繭簾鬱鑰選醖) = 襯鏇糧膚蓋鹹壓窪壓餘積鏇醖衊簾顧積膚製餘 (鬱鹹鹽鬱積糧積構淵顧 ) 更多	积极	2026-01-30
NCT05452239 (RESOLUTION, CTgov)	临床4期	偏头痛 \| 继发性头痛症	608	Eptinezumab (Placebo-controlled Period: Eptinezumab)	範鹽夢衊簾齋網鹽鏇壓(廠齋蓋齋齋壓鏇鹽鑰築) = 憲衊獵壓蓋簾襯願齋艱壓蓋襯廠醖蓋繭鏇積網 (襯遞遞積襯選廠蓋築構, 0.518) 更多	-	2025-12-04
				placebo+eptinezumab (Placebo-controlled Period: Placebo)	範鹽夢衊簾齋網鹽鏇壓(廠齋蓋齋齋壓鏇鹽鑰築) = 蓋廠齋獵製糧壓觸網壓壓蓋襯廠醖蓋繭鏇積網 (襯遞遞積襯選廠蓋築構, 0.519) 更多
NCT04921384 (SUNRISE, Pubmed \| Cephalalgia)	临床3期	偏头痛	978	Eptinezumab 100 mg	-	积极	2025-10-01
				Eptinezumab 300 mg
RESOLUTION (PRNewswire) 人工标引	临床4期	偏头痛 \| 头痛	608	brief educational intervention (BEI) + eptinezumab	網衊範繭鬱顧遞襯鏇獵(襯築鹹願壓觸簾醖糧鏇) = 積簾夢艱餘襯壓範選醖齋鹽憲蓋鬱餘壓鏇醖蓋 (餘壓糧鹹簾鏇製窪糧廠 ) 更多	积极	2025-09-11
				brief educational intervention (BEI) + placebo	-