A Single Dose, Randomized, Open-label, Two-treatment, Three-period, Three-sequence, Partial Replicate Crossover Bioequivalence Study of Generic Edoxaban 60 mg Film-coated Tablets and Reference Product (Lixiana) in Healthy Thai Volunteers under Fasting Conditions

开始日期2026-08-17

申办/合作机构-

TCTR20260202004

/ Not yet recruiting临床1期

A Bioequivalence Study of Two Formulations of Edoxaban 60 mg Film-coated Tablets, Lixiana 60 mg and Edoxaban Tablets 60 mg, in Healthy Thai Subjects under Fasting Conditions

开始日期2026-05-26

申办/合作机构

Dr. Reddy's Laboratories Ltd.

CTIS2025-524110-28-00

/ Not yet recruiting临床4期

Pulmonary Embolism & Anticoagulation Evaluation in Cancer Patient - PEACE

开始日期2026-04-01

申办/合作机构

Region Hovedstadens Apotek

100 项与甲苯磺酸艾多沙班相关的临床结果

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100 项与甲苯磺酸艾多沙班相关的转化医学

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100 项与甲苯磺酸艾多沙班相关的专利（医药）

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2,608

项与甲苯磺酸艾多沙班相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of apixaban compared with other oral anticoagulants for the treatment of non-valvular atrial fibrillation in a Belgian healthcare setting

Article

作者: Salter, Chloe ; Stawowczyk, Ewa ; Subash, Rupesh ; Goovaerts, Hannah ; Ricci-Pacifici, Luca ; Dickerson, Carissa

AIMS:

Direct oral anticoagulants (DOACs) are recommended for stroke and systemic embolism prevention in patients with non-valvular atrial fibrillation (NVAF) in preference to vitamin K antagonists (VKAs, e.g. warfarin). This study assessed the cost-effectiveness of apixaban versus warfarin, dabigatran, edoxaban, and rivaroxaban for patients with NVAF from the Belgian payer perspective.

METHODS:

Based on a previously-validated model, a lifetime cohort-level Markov model was built in Microsoft Excel for the Belgian setting, incorporating costs (2025) representative of a DOAC market following patent expiry. The cohort (n = 1,000) included patients with NVAF eligible for oral anticoagulation. Different study types provided clinical inputs for event risk in the base case analysis (based on a network meta-analysis of randomised controlled trials) and in a scenario analysis (based on real-world evidence). The primary model outcome was the incremental cost-effectiveness ratio (ICER), measured by the cost per quality-adjusted life year (QALY) gained. Cost-effectiveness was determined by a willingness-to-pay threshold of €30,000/QALY gained.

RESULTS:

Driven by a reduction in clinical event risk, apixaban treatment was associated with QALY gains of 0.306, 0.068, 0.115 and 0.034 compared with warfarin, dabigatran, edoxaban, and rivaroxaban, respectively. In the base case analysis, apixaban treatment was associated with lower total costs due to a reduction in acute event costs and long-term management costs, resulting in apixaban dominating (i.e. more effective and less costly) all comparators from a Belgian payer perspective. Similar conclusions were observed in a scenario analysis using clinical inputs derived from real-world evidence.

CONCLUSIONS:

Apixaban is associated with fewer clinical events and lower total costs versus warfarin, dabigatran, edoxaban, and rivaroxaban for patients with NVAF, dominating (i.e. more effective and less costly) all comparators from a Belgian payer perspective under post-patent-expiry assumptions. The consistency of model outcomes between base case and scenario analyses suggests a level of robustness to these findings.

2026-07-01·ARQUIVOS DE NEURO-PSIQUIATRIA

Labyrinthine hemorrhage: practical lessons from a rare cause of acute vestibular syndrome.

Article

作者: Disserol, Caio César Diniz ; Lange, Marcos Christiano ; Koga, César Minoru Toita ; Sato, Henry Koiti ; Teive, Hélio Afonso Ghizoni ; Scavasine, Valéria Cristina

Abstract:

Labyrinthine hemorrhage (LH) is a rare cause of sudden sensorineural hearing loss (SNHL) and acute vestibular syndrome (AVS), which may mimic both peripheral and central etiologies. We report a case of a 76-year-old male on edoxaban therapy presenting with sudden right-sided SNHL and vertigo. Brain magnetic resonance imaging (MRI) performed 2 weeks later showed T1 and fluid-attenuated inversion recovery (FLAIR) hyperintensity of the right inner ear, consistent with LH. Evaluation of AVS in the emergency setting remains challenging, as LH may present as a rare stroke mimic, often indistinguishable from isolated labyrinthine stroke or labyrinthitis. Proper application and interpretation of vestibular assessment protocols, such as HINTS-plus, are critical in such cases. When bedside vestibular testing suggests central-type findings, but initial neuroimaging is normal, high-resolution brain MRI focused on the inner ear might be essential to rule out LH. Awareness of this rare entity may help prevent misdiagnosis, inappropriate thrombolysis, and delayed recognition, although stroke management should still be prioritized when HINTS-plus suggests a central pattern. This case highlights the diagnostic complexity of AVS and its potential pitfalls in bedside and imaging assessment, raising awareness of LH as a rare but clinically relevant stroke mimic.

2026-07-01·JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Single-domain antibodies to reverse the effects of factor Xa inhibitors on coagulation tests

Article

作者: Huskens, Dana ; Hoornstra, Ischa ; Stroobants, An K ; Roest, Mark ; Rijpma, Sanna ; Heylen, René ; Zhao, Junxiong ; de Laat, Bas ; Swieringa, Frauke

BACKGROUND:

Direct oral anticoagulants (DOACs) interfere with coagulation assays, complicating the diagnosis of thrombophilia and lupus anticoagulants. Single-domain antibodies (sdAbs) may be used to neutralize anticoagulant effects in vitro, thereby restoring physiological coagulation for accurate diagnostic testing.

OBJECTIVES:

To develop and validate sdAbs specific to DOACs that inhibit factor Xa, specifically edoxaban, apixaban, and rivaroxaban.

METHODS:

Llama-derived sdAbs specific to DOACs were selected via phage display. To enhance efficacy, bivalent sdAbs were engineered. Both single and bivalent forms were tested in healthy control plasma using various coagulation assays (thrombin generation, prothrombin time [PT], and activated partial thromboplastin time [APTT]), dilute Russell's viper venom time, and international normalized ratio. The ability of these specific sdAbs to reverse the effects of edoxaban, apixaban, and rivaroxaban was also evaluated in plasma samples from patients currently receiving these medications.

RESULTS:

Antiedoxaban, antiapixaban, and antirivaroxaban sdAbs achieved reversal of edoxaban, apixaban, and rivaroxaban, respectively, as demonstrated by thrombin generation, PT, APTT, dilute Russell's viper venom time, and international normalized ratio assays for both the single and bivalent variants. Specifically, each anti-DOAC sdAb effectively reversed the effects of its respective DOAC on lag time and peak thrombin levels, without overshooting a prothrombotic response. Furthermore, in plasma from edoxaban-, apixaban-, or rivaroxaban-treated patients, the corresponding sdAbs restored both PT and APTT.

CONCLUSIONS:

We selected and validated sdAbs that specifically reverse the inhibitory effects of edoxaban, apixaban, and rivaroxaban, without procoagulant activity. These low-cost reversal agents work directly on plasma or whole blood without incubation or preanalytical steps. They enable rapid, reliable baseline coagulation testing in patients treated with these DOACs.

298

项与甲苯磺酸艾多沙班相关的新闻（医药）

2026-07-03

·房颤循证前沿

2026 ACC科学声明：直接口服抗凝药在血栓事件一级与二级预防中的应用

一、核心摘要与背景直接口服抗凝药（DOACs）的出现，显著改变了血栓栓塞性疾病的防治格局。与维生素K拮抗剂（VKAs）相比，DOACs具有药代动力学可预测、药物相互作用少、安全性更优等特点，已成为大多数房颤（AF）和静脉血栓栓塞症（VTE）患者的首选口服抗凝药。然而，在临床实践中，DOACs的应用不足和剂量不当问题依然突出，尤其在血栓风险极高危人群及临床试验中代表性不足的人群中更为显著。本科学声明旨在整合最新循证数据，针对DOACs在一级与二级预防中的确立的和新兴的适应证提供全面、基于证据的概述，并重点阐述特殊人群管理、围术期处理、出血风险评估与管理、药物相互作用及依从性等实践挑战，以支持临床医师做出个体化、以患者为中心的决策。二、核心共识推荐概览本声明中的核心共识建议总结如下：房颤与VTE的初级预防：在髋/膝关节置换术后VTE预防中，DOACs与低分子肝素（LMWH）均适用，DOACs优先。 DOACs适用于大多数合并AF的瓣膜性心脏病患者，但风心病二尖瓣狭窄和机械瓣患者禁用。无其他抗凝指征的经导管主动脉瓣植入术（TAVI）患者，不推荐常规使用DOAC。对需抗凝的慢性冠脉病患者，常规剂量DOAC单药是合理的长期策略。高风险的冠脉或外周动脉疾病患者，可考虑利伐沙班2.5 mg bid联合阿司匹林。 VTE的初始与延长期管理： DOACs是VTE初始治疗的首选（除机械瓣、严重肾功能不全等），阿哌沙班方案因出血风险更低可能优于利伐沙班方案。对于非诱发性VTE、复发性VTE或存在持续性危险因素的患者，应考虑无限期延长抗凝治疗（超过6个月），并定期再评估出血风险。延长治疗阶段，DOACs优于VKAs，阿司匹林单药效果有限。可选方案包括阿哌沙班2.5 mg bid、阿哌沙班5 mg bid或利伐沙班10 mg qd。急性缺血性卒中合并AF患者的抗凝启动时机：排除极严重卒中、严重出血转化或心内膜炎后，发病4天内（早期）启动DOAC可降低30天内复发性缺血性卒中、症状性颅内出血（ICH）或未分类卒中的复合终点事件风险。 AF相关颅内出血（ICH）后重启抗凝：重启抗凝可降低缺血事件，但增加再发ICH和大出血风险，早期死亡率无显著差异。多数患者等待4-8周是审慎的。对于合并脑淀粉样血管病证据、不适合长期抗凝的ICH后AF患者，可考虑左心耳封堵（LAAC）。特殊人群的DOAC选择： CKD 4/5期及透析患者：数据有限，可考虑阿哌沙班（按说明书剂量），避免使用达比加群。肝病患者：Child-Pugh A级所有DOACs均安全；B级可用阿哌沙班、达比加群、艾多沙班，避免用利伐沙班；C级证据不足。衰弱患者：优先推荐阿哌沙班。对于标准剂量抗凝通常不推荐的高龄衰弱患者，可考虑低剂量艾多沙班（15 mg qd）。 III级肥胖（BMI≥40 kg/m²）患者：利伐沙班或阿哌沙班是合适选择。有出血史或高出血风险患者：优先推荐阿哌沙班或低剂量达比加群（110 mg bid）。肿瘤相关血栓（CAT）：对选择性高危门诊肿瘤患者，可考虑DOAC（阿哌沙班或利伐沙班）或LMWH进行预防性抗凝。治疗CAT时，DOACs（证据最强为阿哌沙班）优于LMWH。利伐沙班和艾多沙班亦可用于非泌尿道、胃肠道及妇科肿瘤患者。活动期肿瘤患者完成初始6个月治疗后，应考虑长期（有时为无限期）抗凝。延长期可使用阿哌沙班2.5 mg bid（疗效与5 mg bid相当，出血更少）。 LAAC或AF消融术后抗凝： LAAC术后的最佳抗凝方案尚不明确，需根据个体出血风险决策。对于卒中风险为中低危（CHA₂DS₂-VASc≤3）且消融术后维持窦律的患者，术后1年停用口服抗凝药是合理的。监测与随访：接受DOAC治疗的患者应定期再评估出血风险、肝肾功能、合并用药及依从性。出血风险评分工具可用于识别需更频繁随访的患者，但不应用于单独决定是否停用抗凝药，而应聚焦于管理可修正的出血危险因素。三、关键循证证据与重要更新解析1. 房颤抗凝决策的范式转变：从风险评分到绝对风险评估本声明强调，2023年ACC/AHA房颤管理指南对抗凝推荐进行了重要更新。抗凝决策不再单纯依赖CHA₂DS₂-VASc评分的阈值，而是基于患者年卒中/体循环栓塞的绝对风险。临床意义：这为临床实践提供了更大的灵活性。例如，CHA₂DS₂-VASc评分为1分的男性，其真实卒中风险在不同人群中变异极大（76%的队列年风险<1%）。因此，需结合房颤类型（阵发性 vs. 持续性/永久性）、是否存在潜在的高危心脏基质（如肥厚型心肌病）、心房心肌病、房颤负荷等其他因素进行综合判断和共同决策。关键信息：年卒中风险≥2%为抗凝治疗的I类指征，年风险在1%-2%之间为IIa类指征。女性性别不再被视为独立危险因素，而是风险修饰因子。2. VTE初始治疗的新证据：阿哌沙班 vs. 利伐沙班在VTE的初始治疗中，COBRRA试验头对头比较了阿哌沙班与利伐沙班方案。关键结果：在急性VTE患者中，阿哌沙班组在3个月治疗期间的临床相关出血风险显著低于利伐沙班组（3.3% vs. 7.1%），且消化道和泌尿生殖道出血均更少。结论：基于此项最新证据，声明明确指出，对于大多数计划接受DOACs的急性VTE患者，应考虑将阿哌沙班作为首选药物。3. VTE延长期治疗的“降阶梯”策略对于需要延长抗凝治疗（>6个月）的患者，平衡疗效与出血风险至关重要。 APEX研究新证：对于存在持续性危险因素（如炎症性疾病、动脉疾病、肥胖）的诱发性VTE患者，阿哌沙班2.5 mg bid延长治疗12个月，在预防复发方面优于安慰剂，且出血风险低。 API-CAT研究：在肿瘤相关血栓（CAT）患者中，完成6个月初始治疗后，减量阿哌沙班（2.5 mg bid）在预防VTE复发方面非劣效于全剂量（5 mg bid），且出血风险相对降低25%。 RENOVE研究：在非诱发性VTE患者长达5年的随访中，减量DOACs虽未达到非劣效性统计阈值，但其低复发率和显著降低的临床相关出血，支持其作为长期治疗的可选方案。4. “突破性”卒中与DOAC失败的管理困境对于在DOAC治疗期间仍发生卒中的患者，临床管理缺乏高质量证据。核心原则：首要任务是排除其他卒中病因和评估抗凝不足（剂量错误或不依从）。当前策略：缺乏支持“换用另一种DOAC”或“联合抗血小板治疗”的循证依据。联合抗血小板治疗仅增加出血风险而无明确获益。未来方向：LAAC 对于此类患者是颇具前景的替代方案，相关随机对照试验正在进行中。5. 特殊人群精细化用药指导本声明提供了针对多种复杂临床情况的详细、可操作的用药建议，其中重要更新包括： CKD与ESKD：对于透析患者，尽管数据有限，但现有观察性研究支持说明书剂量一致的阿哌沙班可能提供最优的风险-获益比。达比加群因可被透析清除而应避免使用。肝病：提供了基于Child-Pugh分级的明确DOAC选择路径，有效指导了此高风险群体的抗凝决策。衰弱与高龄：衰弱本身并非抗凝禁忌。阿哌沙班在不同衰弱状态的患者中均显示出一致的良好安全性。ELDERCARE-AF试验为因出血风险高而不适合标准抗凝的超高龄（≥80岁）患者提供了低剂量艾多沙班（15 mg）的有效性和安全性证据。肥胖：明确了III级肥胖患者中利伐沙班和阿哌沙班为合适选择，而达比加群和艾多沙班因数据不足而不推荐。同时指出，血药浓度监测对指导肥胖患者用药无明确价值。6. 围术期管理与器械相关抗凝围术期管理：证据明确支持，对于大多数患者，围术期中断DOAC无需肝素桥接。对于接受心脏电子装置植入的高卒中风险患者，持续抗凝优于桥接。消融术后停抗凝：OCEAN和ALONE-AF两项RCT结果一致表明，对于中低危卒中风险、消融术后维持窦律>1年的房颤患者，停用口服抗凝药是安全的，且可显著减少出血事件。这挑战了既往“无限期抗凝”的传统观念，为临床实践提供了重要循证依据。 LAAC术后方案：最佳抗栓方案仍未统一，但短期使用DOAC或双联抗血小板治疗（DAPT）正逐渐取代传统的华法林+阿司匹林方案，且证据显示低剂量DOAC在减少装置相关血栓和出血事件方面可能优于DAPT。7. 药物相互作用、依从性与成本药物相互作用：尽管存在理论风险，但临床上有明确证据的重要代谢性药物相互作用较少。值得注意的是，DOAC（尤其是Xa因子抑制剂）与地尔硫卓联用可能增加出血风险；而质子泵抑制剂（PPIs）可能对所有口服抗凝药相关出血具有保护作用。依从性：DOAC的依从性与华法林相似，但识别不依从更难。靶向病史询问和处方续配核查是发现不依从的主要手段。成本障碍：尽管长期成本效益更优，但高昂的前期自付费用仍是DOACs应用的主要障碍，可能导致处方放弃。四、未来展望：新靶点抗凝药物声明最后简要介绍了抗凝药物研发的前沿方向，即靶向凝血因子XI/XIa的新一代药物。初步研究表明，此类药物在有效预防血栓的同时，出血风险更低，且可能具有更宽的治疗窗。多项评估这些新型药物（如阿贝西单抗）在房颤及VTE防治中作用的大型III期临床试验正在进行，有望在未来进一步革新抗凝治疗格局。【最新综述】房颤抗凝的新选择：FXI/FXIa抑制剂临床研究进展 🔬参考文献🔬 Kumbhani DJ, Armbruster AL, Cheng RK, Chrispin J, Fischer U, Holbrook AM, Joglar J, Sevestre MA. Direct Oral Anticoagulants in Primary and Secondary Prevention of Thrombotic Events: 2026 ACC Scientific Statement: A Report of the American College of Cardiology. J Am Coll Cardiol. 2026 Jun 30:S0735-1097(26)06700-8. 1.本公众号所有内容仅供医疗专业人士学术参考与交流，不能替代专业医疗判断。读者在临床实践中应以个体化诊断和治疗方案为准，本公众号不对任何诊疗决策负责。 2.部分内容由AI辅助完成翻译与整理，旨在促进学术信息传播。尽管我们力求准确，但不保证内容完全无误，欢迎批评指正。 3.尊重原创，转载内容均力求注明作者与来源。如内容涉及版权争议或存在任何侵权情况，请及时联系我们（602701970@qq.com）。

临床结果AHA会议

2026-07-03

·米内网

第12批集采瞄准7个亿级爆款！科伦高位称霸千亿市场，华东飙涨39%，14个独家新品将腾飞

精彩内容 6月下旬，两大重磅消息引爆千亿血液与造血系统化药市场，第12批集采将纳入吲哚布芬等7个亿级爆款，30款新品通过了2026年国家医保目录调整初审，重量级洗牌已然开场。2025年在中国公立医疗机构终端，这个千亿市场跌势未停，科伦药业依然以绝对优势“封王”，华东医药逆势飙涨39%，TOP20产品榜单出炉，一款潜力注射剂首次突破10亿元。千亿市场持续承压，科伦高位称霸，华东逆势飙涨在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端，血液与造血系统化药的销售规模曾在2018-2019年及2021-2024年达到了1100亿元以上，2025年跌回1075亿元区间，降幅为5.23%。表1：2025年血液与造血系统化药TOP10集团来源：米内网中国公立医疗机构终端竞争格局 2025年血液与造血系统化药TOP20集团合揽超过600亿元市场，科伦药业是唯一一家销售额达百亿级别的集团（二级，下同），市场份额高达11.22%，继续以绝对优势“封王”。 10家二级集团排名有提升，其中华东医药跃升了4位首次登上TOP12，销售额猛涨了39.13%，华润双鹤、正大制药、山东齐都药业、华仁药业各提升了1位，分别为TOP2、TOP7、TOP10、TOP14，而丰原药业、远大生命科学集团、石药控股、上海医药青岛国风药业各上升了2位，分别位列TOP17-TOP20。图1：华东医药的血液与造血系统化药销售情况（单位：万元）来源：米内网中国公立医疗机构终端竞争格局在中国公立医疗机构终端，华东医药的血液与造血系统化药自2014年起稳步提升，至今销售额已实现了“12连涨”，2025年达到了24.6亿元新高，潜力持续爆发。 TOP50产品已有15个纳入集采，这款潜力注射剂暴涨466% 2025年在中国公立医疗机构终端，血液与造血系统化药TOP50产品合揽超过790亿元，氯化钠注射液以198亿元蝉联榜首，葡萄糖注射液大卖61亿元继续排在TOP2，硫酸氢氯吡格雷片增长了4.50%，销售额达54.6亿元，继续排在TOP3。表2：2025年中国公立医疗机构终端血液与造血系统化药TOP20产品来源：米内网中国公立医疗机构终端竞争格局 4个产品2025年销售额在20亿元以上（不足30亿元）且均有正增长，其中吲哚布芬片猛涨56.46%，排名上升6位至TOP4，低钙腹膜透析液(乳酸盐-G1.5%)增长了10.99%，排名上升2位至TOP5，利伐沙班片增长了4.34%，继续排在TOP6。 13个产品2025年销售额在10亿元以上（不足20亿元），其中7个产品有正增长。依诺肝素钠注射液增长了10.07%，继续排在TOP8，多糖铁复合物胶囊增长了5.057%，继续排在TOP11，海曲泊帕乙醇胺片增长了12.56%，排名上升1位至TOP12，复方氨基酸注射液(14AA-SF)增长了0.65%，排名上升2位至TOP14，复方电解质醋酸钠葡萄糖注射液为新上榜产品，销售额暴涨了466.33%，甲钴胺片增长了6.78%，排名上升6位至TOP19，ω-3鱼油脂肪乳注射液增长了5.53%，排名上升6位至TOP20。图2：海曲泊帕乙醇胺片的销售情况（单位：万元）来源：米内网中国公立医疗机构终端竞争格局海曲泊帕乙醇胺片是恒瑞医药在2021年获批的1类新药，同年谈判成功进入国家医保目录，该产品在医保助力下快速腾飞，2024年在中国公立医疗机构终端的销售额突破12亿元，2025年涨至14.2亿元新高。图3：复方电解质醋酸钠葡萄糖注射液的销售情况（单位：万元）来源：米内网中国公立医疗机构终端竞争格局复方电解质醋酸钠葡萄糖注射液最早于2023年在国内市场面世，截至目前已有8家国内药企按新分类获批并视同过评。该产品获批当年就进入了国家医保谈判目录，2025年转入常规目录，在医保助力下，该产品2024年在中国公立医疗机构终端的销售额接近2亿元，2025年成功突破11.2亿元，成为了市场新的超10亿产品。 TOP50产品已有15个纳入了前十一批集采，其中硫酸氢氯吡格雷片、利伐沙班片、罗沙司他胶囊、依诺肝素钠注射液、甲钴胺片、艾曲泊帕乙醇胺片6个产品的销售额在2025年有正增长，9个销售额下滑的产品中，阿司匹林肠溶片和马来酸阿伐曲泊帕片暴跌超过30%。医保助力新品和新药快速抢占市场，而集采带来的压力则呈现出鲜明的“两面性”，双刀齐下，千亿市场加速洗牌。第12批集采瞄准7个爆款，30款新品将获医保红利 6月23日，第12批国家组织药品集中带量采购公告正式发布，65个品种名单初步选定。本轮集采拟纳入了7个血液和造血系统化药，前期预填报有涉及复方电解质注射剂，但因“采纳专家论证意见按临床使用差异分组，未达到竞争格局条件”未进入最终目录。表3：第12批集采拟纳入的血液和造血系统化药来源：米内网综合数据库 7个拟纳入第12批集采的血液和造血系统化药均为亿元级别的重磅产品，其中艾多沙班口服常释剂型和吲哚布芬口服常释剂型被主张存在专利争议，申报企业须出具知识产权承诺书。截至7月2日，艾多沙班口服常释剂型已过评集团包括了先声药业、鲁南制药、齐鲁制药、扬子江药业、华海药业、华北制药等13家，吲哚布芬口服常释剂型已过评集团包括了湖南九典制药、山东京卫制药、方盛制药、石家庄四药、仁合益康等20家。 6月29日，国家医保局发布了通过2026年国家医保目录及商保创新药目录调整初步形式审查的药品名单，30款血液和造血系统化药新品有望获得医保红利，迎来新的爆发期。表4：有望新增纳入2026年国家医保目录及商保创新药目录的血液和造血系统化药来源：国家医保局官网、米内网综合数据库上海峰林生物科技预申报的碳酸氢钠血滤置换液（4mmol／L钾－无钙）截至发稿时尚未获得生产批文，暂不列入本文统计，该产品通过申报条件为目录外条件1，申报目录为基本目录。已有生产批文的30款新品通过申报条件均涉及目录外条件1（2021年至2026年6月10日经国家药监部门批准上市或已完成技术审评的新通用名药品），其中芬妥司兰钠注射液还涉及目录外条件7（2026年6月10日前经国家药监部门批准上市或已完成技术审评，说明书适应症或功能主治中包含有国家卫生健康委《第一批罕见病目录》《第二批罕见病目录》所收录罕见病的药品），亚类分布为血液代用品和灌注液21个、抗血栓形成药4个、其他血液系统用药2个、抗贫血制剂2个、止血药1个。 14个独家产品备受市场瞩目，包括了科伦药业的磷/碳酸氢钠血滤置换液(4mmol/L钾-1.25mmol/L钙)和碳酸氢钠血滤置换液(2mmol/L钾-1.5mmol/L钙)（基本目录预申报，2026年6月23日已获得生产批文）、津药药业的复方氨基酸注射液(17AA-Ⅱ)、石家庄四药的乳酸钠林格冲洗液等7个血液代用品和灌注液，浙江和泽医药的甲苯磺酸艾多沙班口崩片和利伐沙班口崩片等3个抗血栓形成药，康哲药业的德昔度司他片等2个抗贫血制剂，健赞的芬妥司兰钠注射液等2个其他血液系统用药。结语最新消息指，第12批集采的投标报名时间为7月13日16:00前（修改或补充材料时间为7月14日16:00前），2026年国家医保目录调整初审结果公示截至7月5日，业内两件年度大事已迫在眉睫，新的危机与机遇即将到来。资料来源：国家医保局、米内网数据库、上海阳光医药采购网注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至7月2日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

2026-07-02

·AI的铭熠

医院药学研究第5期（总第25期）: Pharmacoepidemiology and Drug Safety

来源：Pharmacoepidemiology and Drug Safety (Pharmacoepidemiol Drug Saf) 医院药学研究第5期（总第25期）本期聚焦药物流行病学与用药安全领域的最新研究成果，涵盖大规模药物性肝损伤住院风险的筛查、真实世界中直接口服抗凝药的出血风险比较、质子泵抑制剂长期使用的安全性评估、多药联用与药物相互作用的不良结局分析以及处方级联的识别与管理等与医院药学安全实践密切相关的原创研究与系统评价。 ◆ 论文目录（中英对照） 1. [Original Research] High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury 采用自身对照树状扫描统计方法高通量筛选与严重急性肝损伤住院相关的药物 2. [Original Research] Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD) 使用临床实践研究数据库的自体对照病例序列联合活性对照方法在药物安全信号检测中的性能评价 3. [Original Research] Predictors of Direct Oral Anticoagulant Use in Northern Italy: A Population-Based Study 北意大利直接口服抗凝药使用的预测因素：一项基于人群的研究 4. [Original Research] Measuring Exposure to Opioids Using Self-Reported Medication Use Data Versus General Practitioner Prescription Records in the UK Biobank Study 英国生物银行研究中自我报告用药数据与全科医师处方记录在阿片类药物暴露测量中的比较 5. [Systematic Review] Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis 单克隆抗体治疗中重度特应性皮炎的疗效与安全性：系统综述与网络荟萃分析 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍采用自身对照树状扫描统计方法高通量筛选与严重急性肝损伤住院相关的药物研究背景药物性肝损伤（DILI）是导致药物撤市和药物相关住院的重要原因之一。传统上，肝毒性信号主要通过病例报告来识别，存在滞后性和低敏感性等局限。随着真实世界数据（RWD）的广泛应用，高通量筛查方法为早期识别潜在的肝毒性药物提供了新的可能。树状扫描统计方法（TreeScan）是一种数据驱动的主动监测方法，可在无预设假设的情况下同时筛查大量药物-不良事件关联。本研究利用美国退伍军人健康管理局（VHA）数据库，采用自身对照病例交叉设计，系统评估了TreeScan在无肝胆疾病患者和慢性肝病患者中识别严重急性肝损伤相关药物的性能，为医院药物安全管理提供了重要的方法学参考和临床证据。核心发现 • 在12,860名无肝胆疾病和17,512名慢性肝病住院严重ALI患者中，分别评估了与450种和543种药物的潜在关联 • 无明显肝病患者中，雷尼替丁、奥美拉唑、昂丹司琼等药物与严重ALI显著相关；慢性肝病患者中，螺内酯、呋塞米、多种阿片类镇痛药和昂丹司琼等均与严重ALI显著相关 • 抗菌药物（阿莫西林/克拉维酸、环丙沙星、甲硝唑等）在两类患者中均显示出肝毒性信号 • 树状扫描统计方法作为一种高通量筛查工具，能够有效检测潜在肝毒性药物，为后续药物流行病学研究提供候选药物领域意义本研究为医院药学实践提供了重要的药物肝毒性风险信息。研究识别出的一系列可能与严重急性肝损伤相关的药物，涵盖了医院常用药如质子泵抑制剂（奥美拉唑）、止吐药（昂丹司琼）、利尿剂（螺内酯、呋塞米）和抗菌药物等，提醒医院药师在处方审核和药学监护中需特别关注这些药物的肝毒性风险。基于TreeScan的高通量筛查方法为医院建立主动式药物安全监测体系提供了新思路。对于已有肝病基础的患者群体，研究结果强调了更严格用药管理的重要性，有助于医院药学部门优化肝病患者用药方案。英文摘要 (Abstract) Background: Medications associated with acute liver injury (ALI) are primarily identified by case reports. High-throughput screening of real-world data could be leveraged to detect hepatotoxicity signals. Objective: To apply tree-based scan statistics in real-world data to identify drugs associated with hospitalization for severe ALI among patients without liver/biliary disease and with chronic liver disease (CLD). Methods: We implemented a self-controlled case-crossover design in Veterans Health Administration data (2000-2023) among patients hospitalized for laboratory-confirmed severe ALI. We identified all newly dispensed drugs within 365 days prior to their hospitalization and used conditional Bernoulli tree-based scan statistics to identify potential associations (p < 0.3). We performed analyses separately in patients without liver/biliary disease and with CLD. Results: Among 12,860 patients without liver/biliary disease and 17,512 with CLD hospitalized for severe ALI, we evaluated associations with 450 and 543 drugs, respectively. Drugs associated with severe ALI among patients without liver/biliary disease included: acid-suppressives (ranitidine [p < 0.001], omeprazole [p = 0.004]), antiemetics (ondansetron [p < 0.001], promethazine [p = 0.06]), antibiotics (amoxicillin/clavulanate [p = 0.008], ciprofloxacin [p = 0.02], mupirocin [p = 0.032], ethambutol [p = 0.275]), anticoagulants (heparin [p = 0.015]), and chemotherapy (pazopanib [p = 0.275]). Drugs associated with severe ALI among CLD patients were: diuretics (spironolactone, furosemide [both p < 0.001]), antiemetics (ondansetron, metoclopramide, promethazine [all p < 0.001]), appetite stimulants (p < 0.001), analgesics (morphine, oxycodone, fentanyl [all p < 0.001]), chemotherapy (sorafenib [p < 0.001]), antibiotics (ciprofloxacin [p = 0.011], metronidazole [p = 0.020]), antipsychotics (prochlorperazine [p = 0.105]), vitamins (p = 0.134), acid-suppressives (omeprazole [p = 0.164]), and gastrointestinal/liver disease treatments (lactulose, senna, docusate, silicones, antiflatulents [all p < 0.001]; sucralfate [p = 0.005], albumin [p = 0.228]). Conclusions: High-throughput screening using tree-based scan statistics detected potentially hepatotoxic drugs for investigation in future pharmacoepidemiology studies. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD) Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍使用临床实践研究数据库的自体对照病例序列联合活性对照方法在药物安全信号检测中的性能评价研究背景药物安全信号检测是药物警戒的核心环节，及时准确地识别潜在的药品不良反应信号对于保障患者用药安全至关重要。基于电子健康档案（EHR）的真实世界数据为药物安全信号检测提供了丰富的资源，但如何在真实世界数据中实现高灵敏度和高特异性的信号检测仍是一个方法学挑战。自体对照病例序列（SCCS）设计因其可控制个体间混杂因素而备受关注，而引入活性对照可能进一步控制适应证导致的混杂偏倚。本研究以英国临床实践研究数据库（CPRD Aurum）为数据源，系统评价了SCCS设计在有无活性对照条件下的信号检测性能，为基于电子健康档案的药物警戒方法学发展提供了重要证据。核心发现 • 构建了包含104个阳性对照和58个阴性对照的参考标准集，确保药物-结局配对在理论上适合SCCS设计 • 无活性对照的SCCS灵敏度为0.57、特异度为0.77；加入活性对照后特异度提高至0.89，但灵敏度下降至0.18 • 5个药物-结局配对在出现在药品标签之前即被SCCS方法识别为不平衡信号 • 使用大环内酯类和氟喹诺酮类抗生素作为目标药物，阿莫西林和头孢氨苄作为活性对照，覆盖全部器官类别的30个结局领域意义本研究对医院药物警戒工作具有直接的方法学指导价值。SCCS设计在CPRD数据库中展现出中等水平的信号检测性能，为医院药物不良反应监测提供了可借鉴的分析框架。研究表明活性对照可有效减少适应证混淆，但可能因统计效力下降而降低阳性信号的检出能力，这为医院药学科在真实世界药物安全研究中平衡特异度和灵敏度提供了重要参考。该方法学框架可应用于医院电子病历系统的药物不良反应主动监测中，帮助临床药师更精确地识别潜在药物安全问题。英文摘要 (Abstract) Background: There is little evidence about signal detection using UK primary care electronic health records (EHRs). The self controlled case series (SCCS) is one of the most promising methods for drug safety signal detection using real world data, and incorporating active comparators could potentially improve its performance by addressing confounding by indication. Objectives: This study aims to evaluate the performance of the SCCS with and without active comparators for signal detection using the UK Clinical Practice Research Datalink (CPRD) Aurum. Methods: We applied the SCCS to macrolide and fluoroquinolone antibiotics, using amoxicillin and cefalexin as active comparators. In total seven drugs, and 30 outcomes from all organ classes were selected. We developed a reference set of 104 positive controls and 58 negative controls, using a taxonomy framework to ensure the selected drug outcome pairs are theoretically well suited to the SCCS design. Two-year observation periods with a 30-day risk window after each dispensing were used. Diagnostic performance was measured using sensitivity and specificity with respect to the product labels. Results: The sensitivity and specificity of the SCCS without active comparator in the 2017/2018 observation period were 0.57 and 0.77 when limited to pairs with satisfactory power. Specificity increased up to 0.89 with active comparators, however sensitivity decreased to 0.18. Five drug-outcome pairs were signals of disproportionality before they were present on labels. Conclusions: Using a carefully designed reference set of drug-outcome pairs well suited to the study design, the SCCS performed moderately well for signal detection in CPRD. Whilst active comparators effectively reduced confounding by indication, they also reduced the number of correctly identified positive controls, due to a reduction in power. We showed some evidence that SCCS is able to highlight SDRs before they were present on labels. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research Predictors of Direct Oral Anticoagulant Use in Northern Italy: A Population-Based Study Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍北意大利直接口服抗凝药使用的预测因素：一项基于人群的研究研究背景直接口服抗凝药（DOACs）已成为房颤和静脉血栓栓塞症抗凝治疗的主流选择。然而，不同DOACs（阿哌沙班、利伐沙班、达比加群、艾多沙班）之间的头对头比较证据有限，临床实践中DOAC选择和转换的驱动因素尚不明确。临床指南通常不会明确推荐某一种DOAC优于其他DOAC，但在真实世界的处方实践中可能存在特定的处方模式。了解影响临床决策的因素对于优化抗凝治疗管理、促进合理用药和识别潜在的不当处方模式具有重要意义。本研究利用意大利伦巴第大区的卫生行政数据库，分析了2019-2022年间近16万例新起始DOAC使用者的处方模式、预测因素和转换情况。核心发现 • 共识别159,993名DOAC新使用者，阿哌沙班使用比例从29.0%上升至34.3%，而达比加群从20.7%下降至11.5% • 高龄和女性性别是艾多沙班处方的预测因素；合并症主要与阿哌沙班使用相关；缺血性心脏病或心梗病史者优先使用达比加群 • DOAC总体转换率为5.6%，阿哌沙班是最常被选择的第二种DOAC；达比加群主要在有血管缺血性事件后被选为第二种DOAC • 有出血史的患者优先被处方阿哌沙班和艾多沙班，外周动脉疾病患者倾向于使用利伐沙班领域意义本研究为医院药学中抗凝药物管理提供了重要的真实世界证据。了解不同DOAC的处方预测因素有助于医院药师在抗凝治疗方案的制定和评估中发挥更积极的作用。研究发现阿哌沙班的处方偏好呈上升趋势，而达比加群使用量下降，这反映了真实临床实践中对抗凝药物的风险-获益评估趋势。出血史患者优先使用阿哌沙班和艾多沙班的模式提示临床医生对特定DOAC安全性的认知在影响处方决策。这些数据有助于医院药学部门制定基于证据的抗凝药物管理策略，优化个体化抗凝治疗方案，并为医院药事管理中抗凝药物的处方审核和药学监护提供参考。英文摘要 (Abstract) Purpose: Evidence on head-to-head comparison between direct oral anticoagulants (DOACs) is lacking, and the reasons for choosing one type of DOAC and switching from one DOAC to another are scarce. This study investigated the use of DOACs in an unselected population in Northern Italy during a recent period. Methods: Using the health administrative database of the Lombardy region, subjects aged 45 years and older who started DOAC therapy between 2019 and 2022 were included in the analysis. Logistic regression analysis was used to evaluate predictors associated with DOAC prescription, and results were presented as ORs with 95% CI. DOAC switching was assessed by estimating the prevalence and cumulative incidence according to the first prescribed DOAC. Results: Overall, 159 993 new users for DOAC were identified. Apixaban users increased from 29.0% to 34.3%, whereas dabigatran users decreased from 20.7% to 11.5% over time. Across all pair-wise comparisons, older age and female sex were predictors for edoxaban prescription. Comorbidities were mainly associated with the use of apixaban; however, dabigatran was preferred in patients with a history of ischemic heart disease or myocardial infarction and rivaroxaban in those with peripheral artery disease. Both apixaban and edoxaban were preferentially prescribed to patients with a history of bleeding. The switching rate of DOACs was 5.6% with apixaban as the most preferred drug as a second choice. Dabigatran was mainly chosen as a second DOAC after a vascular ischaemic event. Conclusion: Given the lack of evidence on factors influencing clinician behavior in the use of DOACs, our findings provide insight into this topic in a real-world setting. As the use of these agents increases, further evidence is needed to better explore this issue. Our data could contribute to the development of recommendations in clinical practice. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research Measuring Exposure to Opioids Using Self-Reported Medication Use Data Versus General Practitioner Prescription Records in the UK Biobank Study Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍英国生物银行研究中自我报告用药数据与全科医师处方记录在阿片类药物暴露测量中的比较研究背景全球范围内阿片类药物的使用持续增长，使得研究其长期健康影响的重要性日益凸显。前瞻性队列研究通常依赖自我报告的用药数据，但这类数据可能因回忆偏倚、社会期望偏倚和药物识别能力有限等因素而存在偏差。相比之下，处方记录被视为更客观的用药暴露测量指标，但也可能遗漏非处方来源和未记录的实际使用情况。两种数据来源的一致性和差异对于药物流行病学研究的方法学质量具有重要影响。本研究利用英国生物银行（UK Biobank）大规模队列中171,813名参与者的数据，系统比较了自我报告规律用药与全科医师（GP）处方记录在阿片类药物暴露测量中的一致性。核心发现 • 自我报告规律阿片类药物使用与处方记录之间一致性为中等至实质性，过去365天内≥3张处方的一致性最佳（Cohen's Kappa = 0.66） • 镇痛类阿片类药物一致性（Kappa = 0.43-0.63）显著优于非镇痛类阿片类药物（Kappa = 0.25-0.34） • 距末次处方记录时间越长，遗漏报告（omission）的概率越高；慢性疼痛患者遗漏率最低但错误报告率（commission）最高 • 自我报告可捕获来自未关联来源的阿片类药物使用情况，对于镇痛类阿片是一个有效的暴露评估指标领域意义本研究对医院药学中的药物利用研究和阿片类药物安全管理具有重要的方法学参考价值。研究结果提示，在进行药物流行病学研究中，自我报告数据和处方记录各有优劣，应根据研究目的和药物类别选择合适的暴露测量指标。对于医院药学部门开展的阿片类药物利用评价和风险管理，本研究的发现有助于理解不同数据来源可能导致的偏倚。在评估住院患者的院外用药史时，医院药师应注意仅依赖处方记录可能低估镇痛类药物的实际使用情况，而需要综合多种信息源进行全面评估。该研究也为医院建立阿片类药物监测体系提供了方法学依据。英文摘要 (Abstract) Purpose: The ongoing global increase in opioid use necessitates studies examining long-term health impacts. Prospective cohorts frequently rely on self-reported medication use data which may be subject to several types of bias compared to more objective measurements. We evaluated the agreement between two opioid exposure measures in the UK Biobank (UKBB)-self-reported regular use and prescription-based indicators using linked general practitioner (GP) records. Methods: Our analysis included 171 813 UKBB participants with linked prescription records. At baseline, participants reported medications taken regularly (weekly, monthly, every 3 months). We assessed agreement between self-reported regular opioid use and opioid prescription records prior to enrollment across various look-back periods and prescription counts. Logistic regressions assessed factors associated with omission and commission. Results: Agreement was moderate to substantial between self-reported opioid use and prescription records. The strongest agreement was observed for ≥ 3 prescriptions in the past 365 days (Cohen's Kappa = 0.66). Subgroup analysis showed better agreement for analgesic opioids (Kappa = 0.43-0.63) than for non-analgesic opioids (Kappa = 0.25-0.34). Omission odds were highest with increasing months since the last record and lowest for individuals with chronic pain. Commission odds were highest for individuals with chronic pain and lowest in married/partnered individuals. Conclusions: This analysis indicates that self-reported regular opioid use in the UKBB could be a valid indicator for identifying individuals with repeated prescriptions for analgesic opioids in the past year, while also capturing opioid use from non-linked sources. However, agreement was low for non-analgesic opioids, suggesting limited utility of self-report for capturing use of these medications. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Systematic Review Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Systematic Review ▍单克隆抗体治疗中重度特应性皮炎的疗效与安全性：系统综述与网络荟萃分析研究背景特应性皮炎（AD）是一种慢性、复发性炎症性皮肤病，严重影响患者生活质量。近年来，针对AD免疫病理机制的单克隆抗体（mAb）治疗迅速发展，多种新型生物制剂相继获批上市或在临床试验中展现出良好的治疗效果。然而，不同单克隆抗体之间的疗效和安全性缺乏直接的头对头比较研究，临床决策面临如何选择最优治疗方案的挑战。网络荟萃分析（NMA）作为可同时比较多种干预措施的统计学方法，为综合评估各单克隆抗体在AD治疗中的相对疗效和安全性提供了重要工具。本研究对截至2024年11月的所有相关随机对照试验进行了系统检索和网络荟萃分析。核心发现 • 纳入32项RCT共7,588例患者，全面比较了多种单克隆抗体在中重度AD中的疗效和安全性 • Spesolimab、Rademikibart、Dupilumab和Amlitelimab在EASI-50、EASI-75、EASI-90和IGA改善方面均显著优于安慰剂 • 根据SUCRA排序，Dupilumab在瘙痒NRS评分、EASI评分和SCORAD评分的百分比变化方面表现出相对较好的疗效 • Dupilumab的严重不良事件发生率显著低于安慰剂（RR = 0.43, 95% CI 0.30-0.63），其他安全性分析结果无统计学差异领域意义本系统综述对医院药学中生物制剂的管理和使用具有重要的临床指导价值。研究通过网状荟萃分析综合比较了多种单克隆抗体在AD中的相对疗效和安全性，为临床药师的药物选择和治疗方案制定提供了循证依据。Dupilumab在疗效综合排名和安全性方面表现突出，特别是其严重不良事件发生率显著低于安慰剂的发现，进一步支持了其在AD治疗中的优选地位。随着生物制剂的广泛使用，医院药学科在生物制剂的处方审核、药学监护和用药教育中需要基于最新的证据，本研究提供的比较疗效和安全性数据可作为重要的决策参考。英文摘要 (Abstract) Objective: The aim of this study was to compare the efficacy and safety of monoclonal antibodies (mAb) for moderate-to-severe atopic dermatitis (AD). Methods: The randomized controlled trials (RCTs) of monoclonal antibodies in the treatment of moderate-to-severe AD were searched in the database of PubMed, Embase, Web of Science and Cochrane Library, up to November 2024. The control group included placebo. The efficacy indicators were the percentage of patients achieving 50%, 75%, 90% improvement in Eczema Area and Severity Index score (EASI-50, EASI-75, EASI-90) and the percentage of patients with an Investigator Global Assessment (IGA) Score of 0 or 1 from baseline until the time of efficacy observation, and the percent change in Pruritus Numerical Rating Scale (NRS), EASI score, SCORing Atopic Dermatitis (SCORAD), and change in Percent Body Surface Area (BSA), Dermatology Life Quality Index (DLQI). The statistical analysis was performed by Stata14 and RevMan5.4. Data processing, network evidence plots, surface under the cumulative ranking curve (SUCRA) ranking, league plots and funnel plots were generated. Risk ratio (RR) and 95% confidence interval (95% CI) were used as effect sizes to analyze binary categorical variables. Results: This study included 32 RCTs with 7588 patients. Spesolimab, Rademikibart, Dupilumab, Amlitelimab were more effective than placebo in EASI-50 (RRs ranging between 1.31 and 22.65), EASI-75(RRs ranging between 1.51 and 36.58), EASI-90(RRs ranging between 3.72 and 5.49), and the percentage of patients in IGA score of 0 or 1 (RRs ranging between 1.78 and 13.36). Dupilumab showed relatively good efficacy according to SUCRA ranking on percent change in NRS, EASI, SCORAD. Dupilumab exhibited a lower incidence of serious adverse events than placebo, and the difference was statistically significant (RR = 0.43, 95% CI 0.30-0.63). Other safety analysis results showed no statistical difference. Conclusions: Through the analysis of the primary efficacy indicators, this network meta-analysis (NMA) study indicated that all monoclonal antibodies performed better than placebo. Based on the results of this study, Spesolimab, Rademikibart, Dupilumab, Amlitelimab were recommended treatment options with relatively good efficacy and safety. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎参考文献·References [1] High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70275. https://doi.org/10.1002/pds.70275 [2] Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD). Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70243. https://doi.org/10.1002/pds.70243 [3] Predictors of Direct Oral Anticoagulant Use in Northern Italy: A Population-Based Study. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70300. https://doi.org/10.1002/pds.70300 [4] Measuring Exposure to Opioids Using Self-Reported Medication Use Data Versus General Practitioner Prescription Records in the UK Biobank Study. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70280. https://doi.org/10.1002/pds.70280 [5] Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70268. https://doi.org/10.1002/pds.70268 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ 医院药学研究导读丨聚焦全球医院药学前沿动态关注我们，追踪全球药学前沿第5期丨总第25期丨 2026年6月

100 项与甲苯磺酸艾多沙班相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	甲苯磺酸艾多沙班	B01AF03	DB09075

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适应症	国家/地区	公司	日期
血栓栓塞	加拿大	Daiichi Sankyo, Inc.	2016-11-04
心房颤动	欧盟	Daiichi Sankyo Europe GmbH	2015-06-19
心房颤动	冰岛	Daiichi Sankyo Europe GmbH	2015-06-19
心房颤动	列支敦士登	Daiichi Sankyo Europe GmbH	2015-06-19
心房颤动	挪威	Daiichi Sankyo Europe GmbH	2015-06-19
复发性深静脉血栓形成	欧盟	Daiichi Sankyo Europe GmbH	2015-06-19
复发性深静脉血栓形成	冰岛	Daiichi Sankyo Europe GmbH	2015-06-19
复发性深静脉血栓形成	列支敦士登	Daiichi Sankyo Europe GmbH	2015-06-19
复发性深静脉血栓形成	挪威	Daiichi Sankyo Europe GmbH	2015-06-19
全身性栓塞	瑞士	Daiichi Sankyo (Schweiz) AG	2015-03-31
栓塞	美国	Daiichi Sankyo, Inc.	2015-01-08
脑卒中	美国	Daiichi Sankyo, Inc.	2015-01-08
静脉血栓栓塞	日本	Daiichi Sankyo Co., Ltd.	2014-09-26
肺栓塞	日本	Daiichi Sankyo Co., Ltd.	2011-04-22
静脉血栓形成	日本	Daiichi Sankyo Co., Ltd.	2011-04-22

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适应症	最高研发状态	国家/地区	公司	日期
急性心肌梗塞	临床3期	巴西	Daiichi Sankyo Co., Ltd.	2021-09-14
冠心病	临床3期	巴西	Daiichi Sankyo Co., Ltd.	2021-09-14
短链酰基辅酶A脱氢酶缺乏症	临床3期	巴西	Daiichi Sankyo Co., Ltd.	2021-09-14
慢性血栓栓塞性肺动脉高压	临床3期	日本	Daiichi Sankyo Co., Ltd.	2021-03-23
新型冠状病毒感染	临床3期	比利时	Daiichi Sankyo Europe GmbH	2021-01-21
新型冠状病毒感染	临床3期	意大利	Daiichi Sankyo Europe GmbH	2021-01-21
新型冠状病毒感染	临床3期	瑞士	Daiichi Sankyo Europe GmbH	2021-01-21
主动脉瓣狭窄	临床3期	荷兰	Daiichi Sankyo Co., Ltd.	2019-08-01
心脏病	临床3期	美国	Daiichi Sankyo Co., Ltd.	2018-05-15
心脏病	临床3期	奥地利	Daiichi Sankyo Co., Ltd.	2018-05-15

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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


NCT03718559 (EPIC-CAD, Pubmed \| JACC Asia)	临床4期	冠心病 \| 心房颤动	1,040	Edoxaban monotherapy	壓觸齋壓網鹹憲積繭顧(襯鑰淵夢壓築築夢壓鹽): HR = 0.36 (95.0% CI, 0.23 ~ 0.57), P-Value = < 0.001	不佳	2026-05-01
				Edoxaban plus a single antiplatelet agent
NCT03718559 (EPIC-CAD, Pubmed \| EuroIntervention)	临床4期	冠心病 \| 心房颤动	1,040	Edoxaban monotherapy (Low creatinine clearance)	鹽鏇築顧窪糧鬱壓淵衊(遞積鏇衊蓋廠艱糧遞願) = 構顧蓋醖窪鹹夢齋選廠構壓鏇築廠製衊鑰夢築 (網獵構餘壓繭艱顧淵鹽 )	积极	2026-04-01
				Edoxaban plus a single antiplatelet agent (Low creatinine clearance)	鹽鏇築顧窪糧鬱壓淵衊(遞積鏇衊蓋廠艱糧遞願) = 顧壓壓齋艱構艱壓構製構壓鏇築廠製衊鑰夢築 (網獵構餘壓繭艱顧淵鹽 )
NCT05732506 (EDO-FRAG-001, Pubmed \| Thromb Res)	N/A	心房颤动	411	Edoxaban	淵範獵衊襯鹹夢窪齋遞(鬱範顧鏇觸鹽淵憲構範) = 願夢鑰窪夢顧鏇壓鬱窪膚構餘衊製蓋壓觸築築 (願願範餘憲衊繭艱簾衊, 0.5 ~ 3.5) 更多	积极	2026-03-01
NCT00986154 \| NCT00781391 (Hokusai-VTE, Pubmed \| Thromb Res)	临床3期	肺栓塞 \| 心房颤动 \| 静脉血栓形成	23,618	Warfarin	淵鬱壓淵鹽淵膚膚製願(壓鏇鹽餘齋鬱選憲顧網): reduction = -2.3 (95.0% CI, -2.9 ~ -1.7) 更多	积极	2025-10-01
				Edoxaban
NCT02951039 \| NCT02944019 \| NCT03247582 \| NCT03247569 (Global ETNA-AF Program, Pubmed \| Clin Cardiol)	N/A	心房颤动	-	Edoxaban	網艱鏇構願艱壓餘淵鏇(鬱廠網鹽鹹繭願膚顧襯) = 築積鏇繭壓顧糧廠糧襯鑰築繭餘觸繭膚鹹齋築 (鬱鏇憲衊餘願衊簾鹹膚 ) 更多	积极	2025-03-01
NCT02618577 (NOAH-AFNET 6 \| NOAH, CTgov)	临床3期	心动过速	2,608	Edoxaban (Edoxaban)	範觸範襯鹹鹽鬱鬱鹽觸 = 獵蓋網鬱餘製網憲齋願願選廠觸醖餘襯繭積蓋 (襯鏇艱簾簾糧選壓衊鏇, 鏇繭齋餘衊構鬱範繭觸 ~ 繭襯選積憲淵鹽憲窪繭) 更多	-	2025-02-06
				ASA (ASA or Placebo)	範觸範襯鹹鹽鬱鬱鹽觸 = 積築廠廠製壓壓憲餘襯願選廠觸醖餘襯繭積蓋 (襯鏇艱簾簾糧選壓衊鏇, 膚獵鏇鹽廠觸觸齋蓋衊 ~ 觸醖繭觸範願鹹範願鬱) 更多
NCT04171726 (REDOX, Pubmed \| Catheter Cardiovasc Interv)	临床3期	血栓形成	58	Edoxaban Monotherapy	簾蓋窪襯獵夢餘餘繭醖(糧鏇艱廠獵餘襯齋襯遞) = 衊壓鹽衊艱襯遞醖膚淵觸淵膚憲衊鹹憲襯願鏇 (網夢膚製簾簾顧憲糧顧, 5.0% ~ 23.1) 更多	积极	2025-02-01
NCT00781391 (ENGAGE AF‐TIMI 48, Pubmed \| J Am Heart Assoc)	临床3期	心房颤动	-	Higher-dose edoxaban regimen	夢蓋壓築衊網網夢範鑰(簾獵糧鏇襯積鏇憲窪糧) = 觸衊襯衊淵蓋窪顧鹹觸襯繭餘鏇願襯願襯繭壓 (遞醖獵蓋製鬱鑰鏇選醖 ) 更多	积极	2025-01-21
NCT03718559 (EPIC-CAD, Pubmed \| N Engl J Med)	临床4期	冠心病 \| 心房颤动	-	Edoxaban monotherapy	膚鹹淵餘壓積壓餘襯壓(鹹顧壓餘簾積齋蓋衊願): HR = 0.44 (95% CI, 0.3 ~ 0.65) 更多	积极	2024-12-05
				Dual antithrombotic therapy (edoxaban plus a single antiplatelet agent)
NEWS 人工标引	N/A	脑卒中	-	Edoxaban	衊餘齋觸壓繭觸餘鹽顧(築鑰鏇顧壓鬱夢築網範) = 齋獵壓願顧壓願齋製蓋淵鑰壓夢鏇餘網鬱鑰鏇 (襯齋窪淵築積淵鏇遞範 ) 更多	积极	2024-11-19
				Warfarin	衊餘齋觸壓繭觸餘鹽顧(築鑰鏇顧壓鬱夢築網範) = 鏇糧顧蓋壓鬱願鏇鬱鏇淵鑰壓夢鏇餘網鬱鑰鏇 (襯齋窪淵築積淵鏇遞範 ) 更多