预约演示
更新于：2026-02-27
Clopidogrel Bisulfate
硫酸氢氯吡格雷
更新于：2026-02-27
概要
基本信息
简介Clopidogrel Bisulfate 是一种商标为 Plavix® 的药物，在1997年于美国批准上市，由施贵宝研发。其作用机制是抑制P2Y12受体，从而减少血小板活化和聚集。这随后降低了血栓的风险及其潜在的致命后果。氯吡格雷适用于治疗心肌梗塞、中风、外周血管疾病、冠状动脉疾病和脑血管疾病。由于其作为抗血小板药物的作用，氯吡格雷被证明在预防血栓引起的严重并发症（如心脏病发作、中风甚至死亡）方面具有无可估量的价值。该药物在心血管事件的管理和预防方面显示出疗效，使其成为现代医学的基本药物。 |
药物类型 小分子化药 |
别名 clopidogrel、Clopidogrel Bisufate、Clopidogrel bisulfate (USP) + [33] |
作用方式 拮抗剂 |
作用机制 P2Y12 receptor拮抗剂(嘌呤P2Y12受体拮抗剂) |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
登录后查看时间轴
结构/序列
分子式C16H18ClNO6S2 |
InChIKeyFDEODCTUSIWGLK-RSAXXLAASA-N |
CAS号120202-66-6 |
关联
687
项与 硫酸氢氯吡格雷 相关的临床试验CTIS2025-523065-16-00
Tailored antiplatelet secondary prevention in non-cardioembolic ischemic stroke: a phase IV gender-stratified randomized controlled trial (TAILOR trial)
开始日期2026-02-16 |
申办/合作机构- |
ChiCTR2600115896
Comparison of Efficacy and Safety of Transcatheter Closure Versus Medical Therapy in Patients with Patent Foramen Ovale and Migraine: A Multicenter, Open-Label, Parallel-Group, Randomized Controlled Trial
开始日期2026-01-01 |
申办/合作机构- |
ChiCTR2600119101
Study on the treatment of early neurological deterioration in patients with perforating artery infarction using GPⅡb/Ⅲa receptor antagonists
开始日期2025-12-01 |
申办/合作机构 |
100 项与 硫酸氢氯吡格雷 相关的临床结果
登录后查看更多信息
100 项与 硫酸氢氯吡格雷 相关的转化医学
登录后查看更多信息
100 项与 硫酸氢氯吡格雷 相关的专利（医药）
登录后查看更多信息
6,438
项与 硫酸氢氯吡格雷 相关的文献（医药）2026-03-01·Operative Neurosurgery
Safety and Effectiveness of Flow-Diversion for Flow-Related Aneurysms in Patients With Brain Arteriovenous Malformations: A Case Series and Review of Literature
Review
作者: Huang, Judy ; Feghali, James ; Hung, Alice L. ; Jackson, Christopher C. ; Caplan, Justin M. ; Gonzalez, L. Fernando ; Tamargo, Rafael J. ; Xu, Risheng ; Yang, Wuyang
BACKGROUND AND OBJECTIVES::
Flow-diversion for aneurysm is widely adopted. However, reports on flow-diversion for flow-related aneurysms (FA) in brain arteriovenous malformations (bAVM) are scarce. We aim to introduce our institutional experience in this case series.
METHODS::
We compiled all patients with bAVMs and FA from an institutional database, among which those treated with flow-diverters were extracted. Patient demographics, clinical presentation, aneurysm, and AVM characteristics were summarized. Management of both FA and bAVM were listed. Associated bleeding with dual antiplatelet therapy, aneurysm and bAVM obliteration, and follow-up hemorrhage of bAVM were reported as outcomes of interest.
RESULTS::
From a database of 1066 patients with bAVMs, a total of 5 patients with 7 FAs treated with pipeline embolization device (PED) were included. All aneurysm treatment preceded bAVM management. Spetzler-Martin grades were the following: II (n = 2.40%), III (n = 2.40%), and V (n = 1.20%), among which 1 presented with hemorrhage. Only 2 bAVMs (40%) were treated with radiosurgery, and none were obliterated at last follow-up. A total of 9 aneurysms were identified, with just 7 (77.8%) being flow-related and treated with flow-diversion. Three FA treatments (42.9%) received preprocedural Brilinta + Aspirin, with the rest being Plavix + Aspirin, and none of the bAVMs had ruptured while on dual-antiplatelet therapy. With average follow-up duration of 4.8 years, 85.7% (n = 6) of the treated aneurysms were obliterated at follow-up.
CONCLUSION::
PED use to treat for FAs in bAVMs demonstrated favorable risk profile. The effectiveness of FA obliteration with flow-diversion is also favorable and on par with regular non-bAVM aneurysms. The current data suggest PED as an option to manage FAs in bAVMs.
2026-02-01·Pharmacology Research & Perspectives
Effect of
Spinacia oleracea
on In Vitro Disintegration and Dissolution of Clopidogrel Bisulfate Tablets
Article
作者: Muqedi, Ramzi H. M. ; Sadaqa, Dana ; Rabba, Abdullah K. ; Naseef, Hani A. ; Radwan, Asma
ABSTRACT:
Drug–food interactions may compromise therapeutic efficacy, particularly for life‐saving medications such as anticoagulants. Changes in gastric fluid properties, including pH modification and surface film formation, can alter drug dissolution and release. This study evaluated a potential interaction between clopidogrel and spinach and explored the underlying mechanisms. In vitro disintegration and dissolution studies were conducted using HCl and phosphate buffers with and without 5% and 7.5% spinach extract. Drug release was quantified by high‐performance liquid chromatography (HPLC), with six media conditions analyzed in triplicate. Disintegration testing was performed in simulated gastric and intestinal fluids and in the presence of spinach leaves to assess the effect of film formation on tablet wetting and disintegration. In vitro–in vivo extrapolation (IVIVE) was assessed using GastroPlus software. Clopidogrel dissolution decreased with increasing spinach concentration in both media. In HCl buffer, dissolution declined from 99% to 94% and 89%, while in phosphate buffer it decreased from 71% to 66% and 56%. These effects were associated with increased pH (HCl: 1.91, 2.83, 2.98; phosphate: 6.81, 8.83, 6.84), increased solution viscosity, 17.63 to 17.67 and 17.70 in HCl buffer, and from 17.44 to 17.50 and 17.54 in phosphate buffer. Moreover, reduced fluid penetration was due to spinach leaves coverage. IVIVE analysis showed weak correlations (
R2
= 0.74 in HCl and 0.69 in phosphate buffer). Spinach reduced clopidogrel dissolution in vitro, with statistically significant effects at 5% spinach in HCl buffer (ANOVA test,
p
‐value 0.019) and 7.5% in phosphate buffer (ANOVA test,
p
‐value < 0.001). This interaction appears to be mediated by pH alteration, physical film formation, and potentially metal–drug complexation. Confirmation through in vivo studies is warranted.
2026-01-06·Journal of the American Heart Association
Differential Effect of Ticagrelor Versus Clopidogrel by Causative Classification of Stroke Classification and Vascular Cellular Adhesion Molecule‐1 Level on the Risk of Recurrent Stroke: A Post Hoc Analysis of the CHANCE‐2 Trial
Article
作者: Xia, Xue ; Xu, Qin ; Meng, Xia ; Wang, Yongjun ; Li, Hui ; Wang, Anxin
Background:
VCAM‐1 (vascular cellular adhesion molecule‐1) is an inflammatory biomarker linked to the occurrence and recurrence of stroke. However, it is uncertain if dual antiplatelet treatments may have distinct benefit for patients with varied stroke causes and VCAM‐1 levels.
Methods:
This post hoc study of the CHANCE‐2 (Ticagrelor or Clopidogrel in High‐Risk Patients With Acute Nondisabling Cerebrovascular Events II) trial included 5651 patients in total. All patients were classified using the Causative Classification of Stroke system categorization as well as the mean of baseline VCAM‐1 level. The primary outcome was any stroke within 90 days. During the 90‐day follow‐up period, the cumulative incidence of outcomes between 2 dual antiplatelet treatments was compared using the Kaplan–Meier analysis and log‐rank test. The Cox proportional hazards model was used to further assess the hazard ratios (HRs) and 95% CIs for the associations of small artery occlusion cause and VCAM‐1 level with efficiency and safety outcomes.
Results:
The median age of 5651 patients was 64.8 years, 1908 of whom were women. Among all the subtypes, patients with nonelevated VCAM‐1 (<1715.9 ng/mL) and small artery occlusion subtype (N=1252) got more benefit from aspirin‐ticagrelor therapy to reduce recurrent stroke within 90 days (7.5% versus 2.9%, hazard ratio [HR], 0.37 [95% CI, 0.22–0.64],
P
<0.001). Regarding safety outcomes, the risk of mild bleeding was increased in the ticagrelor‐aspirin group (1.4% versus 6.7%, HR, 4.85 [95% CI, 2.36–9.96]), but no significant difference was found between the 2 groups in moderate or severe bleeding (0.6% versus 0.5%, HR, 0.75 [95% CI, 0.17–3.35]).
Conclusions:
VCAM‐1 level combined with ischemic stroke cause classification subtypes might predict the effect of ticagrelor‐aspirin or clopidogrel‐aspirin dual antiplatelet therapy in preventing recurrent stroke within 90 days in patients with minor ischemic stroke or transient ischemic attack carrying
CYP2C19
loss‐of‐function alleles. Patients with small artery occlusion subtype and nonelevated VCAM‐1 received more clinical benefit from ticagrelor‐aspirin versus clopidogrel‐aspirin.
Registration:
URL:
http://www.clinicaltrials.gov
; Unique Identifier: NCT04078737.
462
项与 硫酸氢氯吡格雷 相关的新闻（医药）2026-02-25
注册号：
Registration number：
ChiCTR2600119266 最近更新日期：
Date of Last Refreshed on：
2026-02-25 09:33:22 注册时间：
Date of Registration：
2026-02-25 00:00:00 注册号状态：
预注册Registration Status：
Prospective registration注册题目：
评价CMS-D001在中度至重度特应性皮炎患者中的有效性和安全性的多中心、 随机、双盲、安慰剂对照的Ⅱ期临床研究Public title：
A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study evaluating the efficacy and safety of CMS-D001 in patients with moderate to severe atopic dermatitis注册题目简写：English Acronym：研究课题的正式科学名称：
评价CMS-D001在中度至重度特应性皮炎患者中的有效性和安全性的多中心、 随机、双盲、安慰剂对照的Ⅱ期临床研究Scientific title：
A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study evaluating the efficacy and safety of CMS-D001 in patients with moderate to severe atopic dermatitis研究课题代号(代码)：
Study subject ID：在二级注册机构或其它机构的注册号：
The registration number of the Partner Registry or other
register：申请注册联系人：
陈权
研究负责人：
崔勇 Applicant：
Chen Quan
Study leader：
Cui yong 申请注册联系人电话：
Applicant telephone：
+86 177 0885 7150
研究负责人电话：
Study leader's telephone：
+86 157 0162 5913申请注册联系人传真 ：
Applicant Fax：
研究负责人传真：
Study leader's fax：申请注册联系人电子邮件：
Applicant E-mail：
chenquan@cms.net.cn
研究负责人电子邮件：
Study leader's E-mail：
wuhucuiyong@vip.163.com申请单位网址(自愿提供)：
Applicant website(voluntary supply)：
研究负责人网址(自愿提供)：
Study leader's website(voluntary supply)：申请注册联系人通讯地址：
中国广东省深圳市南山区南头街道马家龙社区南山大道3186号莲花广场B栋801
研究负责人通讯地址：
中国北京市朝阳区文学馆路47号Applicant address：
Room 801, Building B, Lianhua Plaza, 3186 Nanshan Avenue, Majalong Community, Nantou Street, Nanshan District, Shenzhen, Guangdong, China
Study leader's address：
No. 47, Wenxueguan Road, Chaoyang District, Beijing, China申请注册联系人邮政编码：
Applicant postcode：
研究负责人邮政编码：
Study leader's postcode：申请人所在单位：
海南德镁医药科技有限责任公司Applicant's institution：
Hainan Dermavon Pharmaceutical Technology Co., Ltd.研究负责人所在单位：
中日友好医院Affiliation of the Leader：
China-Japan Friendship Hospital是否获伦理委员会批准：
是Approved by ethic committee：
Yes伦理委员会批件文号：
Approved No. of ethic committee：
YW2025-097-01
伦理委员会批件附件：
Approved file of Ethical Committee：
查看附件View批准本研究的伦理委员会名称：
中日友好医院药物（器械）临床试验伦理委员会Name of the ethic committee：
Ethics Committee for Drug (Device) Clinical Trials at Sino-Japanese Friendship Hospital伦理委员会批准日期：
Date of approved by ethic committee：
2025-12-29 00:00:00伦理委员会联系人：
郤思远Contact Name of the ethic committee：
Xi Siyuan伦理委员会联系地址：
中国北京市朝阳区樱花东街2号制剂楼415Contact Address of the ethic committee：
No. 415, Preparation Building, Yinghua Dong Street, Chaoyang District, Beijing, China伦理委员会联系人电话：
Contact phone of the ethic committee：
+86 10 8420 6086
伦理委员会联系人邮箱：
Contact email of the ethic committee：研究实施负责（组长）单位：
中日友好医院Primary sponsor：
China-Japan Friendship Hospital研究实施负责（组长）单位地址：
中国北京市朝阳区文学馆47号Primary sponsor's address：
No. 47, Wenxueguan Road, Chaoyang District, Beijing, China试验主办单位(项目批准或申办者)：
Secondary sponsor：
国家：
中国
省(直辖市)：
海南
市(区县)：
Country：
China
Province：
Hainan
City：
单位(医院)：
海南德镁医药科技有限责任公司
具体地址：
中国海南省海口市国家高新技术产业开发区科技大道22号海口国科中心C座6楼整层
Institution
hospital：
Hainan Dermavon Pharmaceutical Technology Co., Ltd.
Address：
6th Floor, Block C, Haikou National Science and Technology Center, No. 22 Science and Technology Avenue, National High tech Industrial Development Zone, Haikou, Hainan, China经费或物资来源：
海南德镁医药科技有限责任公司Source(s) of funding：
Hainan Dermavon Pharmaceutical Technology Co., Ltd.研究疾病：
特应性皮炎 Target disease：
Atopic dermatitis研究疾病代码：Target disease code：研究类型：
干预性研究Study type：
Interventional study研究所处阶段：
II期临床试验 Study phase：
2研究设计：
随机平行对照 Study design：
Parallel 研究目的：
主要目的：
评价CMS-D001在中度至重度特应性皮炎参与者中的初步有效性。
次要目的：
评价CMS-D001在中度至重度特应性皮炎参与者中的安全性和耐受性。
评价CMS-D001及其主要代谢产物（如适用）在中度至重度特应性皮炎参与者中的药代动力学（PK）特征。
评价CMS-D001及其主要代谢产物（如适用）在中度至重度特应性皮炎参与者中的暴露-效应（E-R）关系。 Objectives of Study：
Primary Objective:
To evaluate the preliminary efficacy of CMS-D001 in participants with moderate to severe atopic dermatitis.
Secondary objective:
Evaluate the safety and tolerability of CMS-D001 in participants with moderate to severe atopic dermatitis.
Evaluate the pharmacokinetic (PK) profile of CMS-D001 and its major metabolites (if applicable) in participants with moderate to severe atopic dermatitis.
Evaluate the exposure-response (E-R) relationship of CMS-D001 and its major metabolites (if applicable) in participants with moderate to severe atopic dermatitis.药物成份或治疗方案详述：
Description for medicine or protocol of treatment in
detail：
纳入标准：
入选标准：
参与者必须符合下列所有标准才能参加试验：
(1) 自愿签署知情同意书（ICF），能够和研究者进行良好的沟通，并且理解和遵守本研究的各项要求和限制条件；
(2) 签署ICF时，年龄≥18周岁且≤75周岁，性别不限；
(3) 筛选/基线访视时按照Hanifin & Rajka标准（1980）经研究者确诊为AD（附录1），且自首次出现AD相关皮疹/症状至筛选时病程≥1年；
(4) 筛选和基线时，根据研究者评估，符合中重度AD标准：
湿疹面积和严重程度指数（EASI）评分≥16；
研究者总体评估（IGA）评分≥3；
受累体表面积（BSA）≥10%；
瘙痒数字评分量表（Itch NRS）评分≥4；
(5) 经研究者判断，参与者具有对外用皮质类固醇（TCS）或外用钙调神经磷酸酶抑制剂（TCI）治疗反应不佳或不耐受的病史，或其他医学上考虑不建议进行外用治疗；
(6) 能够且愿意从基线前至少7天开始，仅使用由申办者统一提供的不含影响疗效评价成分的润肤剂，并在研究期间持续使用；
(7) 所有具有生育潜能的女性参与者及所有男性参与者需自签署ICF至研究末次给药后至少3个月无怀孕或捐精计划，必须遵守避孕的相关规定，至少采用一种高效的避孕方法避孕。（注：与有生育潜能的女性伴侣同居的男性参与者，必须愿意在其伴侣使用高效避孕方法的基础上再使用安全套）。Inclusion criteria
Inclusion criteria:
Participants must meet all of the following criteria to participate in the trial:
(1) Voluntarily sign an informed consent form (ICF), be able to communicate well with the researcher, and understand and comply with the requirements and limitations of this study;
(2) When signing the ICF, the age should be between 18 and 75 years old, with no gender restrictions;
(3) During screening/baseline visits, the patient was diagnosed with AD by the researcher according to Hanifin&Rajka criteria (1980) (Appendix 1), and the disease duration from the first appearance of AD related rash/symptoms to screening was >= 1 year;
(4) During screening and baseline, according to the researcher's evaluation, it meets the criteria for moderate to severe Alzheimer's disease:
Eczema area and severity index (EASI) score >= 16;
Researcher's overall assessment (IGA) score >= 3;
Affected body surface area (BSA) >= 10%;
Itch NRS score >= 4;
(5) According to the researchers' judgment, the participants have a history of poor response or intolerance to external corticosteroids (TCS) or external calcineurin inhibitors (TCI) treatment, or other medical considerations do not recommend external treatment;
(6) Able and willing to use only moisturizers provided by the sponsor that do not contain ingredients that affect efficacy evaluation, starting at least 7 days before baseline, and continue to use them during the study period;
(7) All female participants with reproductive potential and all male participants must sign the ICF and have no pregnancy or sperm donation plan for at least 3 months after the last dose of the study. They must comply with contraception regulations and use at least one highly effective contraceptive method . (Note: Male participants who cohabit with female partners with reproductive potential must be willing to use condoms on the basis of their partner's use of efficient contraceptive methods).排除标准：
排除标准：
必须排除符合下列任一排除标准的参与者：
(1) 患有其他混淆AD诊断或影响疗效评估的其他皮肤病（如全身性红皮病、银屑病、红斑狼疮、Netherton综合征等）、皮肤感染，或在患处有色素沉着、瘢痕、胎斑、纹身等情况经研究者判断可能影响对皮肤病变的评价；
(2) 有严重带状疱疹或严重单纯疱疹既往史（包括但不限于播散型带状疱疹、泛发型带状疱疹、中枢神经系统带状疱疹、眼带状疱疹、复发性带状疱疹（2年内发生2次或以上）或有单纯疱疹、带状疱疹感染现病史；
(3) 首次给药前3个月内存在需住院或静脉抗感染治疗的细菌、真菌或病毒感染史；
(4) 首次给药前4周内存在需口服抗感染治疗的细菌、真菌或病毒感染史；
(5) 首次给药前7天内，存在活动性感染或急性疾病状态（如发热、恶心、呕吐或腹泻）；
(6) 筛选或基线时，存在慢性或复发性感染性疾病者，包括但不限于慢性肾脏感染、复发性尿路感染、慢性胸部感染、真菌感染（指甲浅表真菌感染除外）或感染性的皮肤伤口或溃疡，经研究者评估可能增加参与者安全性风险；
(7) 符合以下任一项结核筛查标准：
有活动性结核感染的现病史或既往病史；
在筛选期间，研究者判断存在活动性结核病的体征或症状；
胸部CT提示当前或既往活动性结核感染；
γ-干扰素释放试验结果显示潜伏性结核感染证据，定义为：筛选时γ-干扰素释放试验检测呈阳性或连续两次γ-干扰素释放试验结果不确定，且无临床症状。除非有记录表明参与者已经完成充分的结核潜伏感染的治疗，或者在首次给药前至少4周开始预防性治疗，并且同意完成后续预防性治疗疗程，预防措施的整个疗程不必在首次给药前完成。
注：
1）不允许使用利福平或利福喷丁进行结核预防。
2）如结核检测结果为不确定者，可进行1次复测。
(8) 首次给药前4周内接种减毒活疫苗，或计划在治疗期间的任何时间或研究完成后8周内接种减毒活疫苗者；
(9) 首次给药前6个月内存在重大或不稳定的消化/肝胆、肾脏/泌尿、心血管、呼吸、内分泌、血液、免疫、中枢神经系统疾病者，根据研究者判断不具备临床研究条件者，例如但不限于胰腺炎、不稳定型心绞痛、心肌梗死、症状性充血性心力衰竭（纽约心脏病协会III级或IV级）、需要治疗的心律失常、药物控制不佳的高血压（收缩压≥160mmHg，舒张压≥100mmHg）、肺动脉高压、呼吸衰竭、脑卒中（包含短暂性脑缺血发作）、肝硬化、静脉血栓栓塞症等；
(10) 首次给药前5年内患有恶性肿瘤（经过彻底治疗且没有任何复发迹象的皮肤原位鳞癌、基底细胞癌和原位宫颈癌除外）或淋巴组织增生性疾病；
(11) 目前患有其它自身免疫性疾病（如类风湿性关节炎、系统性红斑狼疮、炎症性肠病等）；
(12) 患有或疑似先天性或获得性免疫缺陷病史者，或研究者认为会损害参与者免疫状态的情况（如脾切除术史、原发性免疫缺陷）；
(13) 患有精神相关疾病或病史（如抑郁症），影响用药依从性或研究者从临床上判断有自杀风险者；
(14) 既往接受过或计划接受器官移植手术且需服用免疫抑制剂的参与者（如肝肾移植）；
15．筛选时任何显著的临床和实验室异常，研究者认为可能影响参与者安全者，包括但不限于：
血常规：白细胞＜3.0×10^9/L，中性粒细胞＜1.5×10^9/L，淋巴细胞计数<0.5×10^9/L；血小板计数＜100.0×10^9/L，血红蛋白＜100g/L；
肾功能：估算的肾小球滤过率（eGFR）＜60mL/min/1.73m^2；
肝功能：丙氨酸转氨酶（ALT）或天冬氨酸转氨酶（AST）≥2×ULN（正常值上限）；总胆红素≥1.5×ULN；
任何其它实验室检查结果异常且有临床意义，经研究者评估如果参与研究将可能对参与者构成不可接受的风险；
(16) 筛选或基线时，生命体征、体格检查、12-导联心电图、胸部CT（可接受1个月内的CT检查结果）异常且有临床意义，经研究者评估如果参与研究将可能对参与者构成不可接受的风险；
(17) 筛选访视时存在下列任一感染者：
乙型肝炎：表面抗原（HBsAg）阳性；或核心抗体（HBcAb）阳性，且乙型肝炎病毒脱氧核糖核酸（HBV-DNA）拷贝数阳性（定义为超过研究中心检测值正常范围上限）；
丙型肝炎（HCV）抗体阳性，且HCV-RNA拷贝数阳性（定义为超过研究中心检测值正常范围上限）；
人类免疫缺陷病毒抗体（HIV Ab）阳性；
梅毒特异性抗体试验阳性（梅毒非特异性抗体RPR或TRUST结果为阴性，并经研究者判断为过去曾感染梅毒但已治愈的参与者除外）；
(18) 随机前规定的洗脱期内接受了以下任何一种治疗者：
3个月内（或5个半衰期，以时间较长者为准）接受过生物疗法，包括但不限于度普利尤单抗、司普奇拜单抗等；
4周内（或5个半衰期，以时间较长者为准）接受过已知或可能影响特应性皮炎的系统治疗，包括但不限于JAK1/2/3抑制剂、系统性皮质类固醇或促肾上腺皮质激素类似物、环孢菌素、甲氨蝶呤、硫唑嘌呤或其他系统性免疫抑制或免疫调节剂（如霉酚酸酯或他克莫司）；
4周内接受过紫外光治疗或长时间暴露于自然或人工紫外线辐射源（如阳光或日光浴），和/或有意在研究期间接受此类暴露者；
4周内接受过长效抗凝药物（如华法林、氯吡格雷等）或需要持续使用抗凝药物治疗者（≤100mg/天的阿司匹林除外）；
2周内接受过已知或可能影响特应性皮炎的外用药物治疗，包括外用糖皮质激素（TCS）、钙调磷酸酶抑制剂（TCI）、磷酸二酯酶4（PDE4）抑制剂等；
2周内接受过用于治疗特应性皮炎的口服中草药或中成药（以下中药需洗脱4周：含明确免疫抑制/强免疫调节成分的中药或中成药，包括但不限于：雷公藤及其制剂、复方甘草酸苷等；组方复杂且成分不清、或无法明确主要有效/活性成分及其停用时间的中药治疗；研究者判断可能对疾病严重程度或免疫状态产生持续影响，干扰疗效评估或增加风险者）；
(19) 既往暴露于TYK2抑制剂治疗者，或既往接受过系统性JAK1/2/3抑制剂治疗且疗效不佳或因安全性原因停药的参与者；
(20) 筛选前3个月内有酗酒史和/或药物滥用史；
(21) 存在任何可能影响药物吸收的情况者，包括但不限于：吸收不良综合征、乳糜泻、胃切除术、肠切除术（阑尾切除术除外）；
(22) 首次给药前4周或5个半衰期（以时间较长者为准）内使用过或在研究期间不能避免使用CYP3A强诱导剂或抑制剂的药物（见附录7）者；
(23）首次给药前7天内食用了圣·约翰草（贯叶连翘）制品、葡萄柚，或拒绝在整个研究期间（包括随访期）避免食用此类物质者；
(24) 筛选前3个月内献血或失血≥ 400mL或计划在研究期间献血者；
(25) 已知或怀疑对试验药物中任何一种成分过敏者，或任何其他显著的药物过敏（如过敏性休克或肝毒性）；
(26) 妊娠或哺乳期女性；
(27) 首次给药前3个月或5个半衰期内（以时间较长者为准）使用其他临床试验药物或目前正在参加其他临床研究者；
(28) 研究者认为不适宜参加本临床研究的其他情况。Exclusion criteria：
Exclusion criteria:
Participants who meet any of the following exclusion criteria must be excluded:
(1) Suffering from other skin diseases (such as systemic erythroderma, psoriasis, lupus erythematosus, Netherton syndrome, etc.) that may confuse the diagnosis of AD or affect the evaluation of treatment efficacy, skin infections, or pigmentation, scars, fetal spots, tattoos, etc. at the affected area, which may affect the evaluation of skin lesions according to the researcher's judgment;
(2) Have a history of severe herpes zoster or severe herpes simplex (including but not limited to disseminated herpes zoster, generalized herpes zoster, central nervous system herpes zoster, ocular herpes zoster, recurrent herpes zoster (occurring twice or more within 2 years), or a current history of herpes simplex or herpes zoster infection;
(3) History of bacterial, fungal, or viral infections requiring hospitalization or intravenous anti infective treatment within 3 months prior to the first administration;
(4) History of bacterial, fungal, or viral infections requiring oral anti infective treatment within 4 weeks prior to the first administration;
(5) Within 7 days before the first administration, there is an active infection or acute disease state (such as fever, nausea, vomiting, or diarrhea);
(6) In screening or baseline, the presence of chronic or recurrent infectious diseases, including but not limited to chronic kidney infection, recurrent urinary tract infection, chronic chest infection, fungal infection (except for superficial nail fungal infection) or infectious skin wounds or ulcers, may increase the safety risk of participants as assessed by the investigator;
(7) Meet any of the following tuberculosis screening criteria:
Present or past medical history of active tuberculosis infection;
During the screening period, the researcher judged that there were signs or symptoms of active tuberculosis;
Chest CT indicates current or previous active tuberculosis infection;
The results of the interferon gamma release test show evidence of latent tuberculosis infection, defined as: positive interferon gamma release test during screening or uncertain results from two consecutive interferon gamma release tests, and no clinical symptoms. Unless there is a record indicating that the participant has completed sufficient treatment for latent tuberculosis infection, or started preventive treatment at least 4 weeks before the first dose, and agrees to complete subsequent preventive treatment courses, the entire course of preventive measures does not need to be completed before the first dose.
Note:
1)The use of rifampicin or rifampicin for tuberculosis prevention is not allowed.
2)If the tuberculosis test result is uncertain, a retest can be conducted once.
(8) Those who have received attenuated live vaccine within 4 weeks before the first administration, or plan to receive attenuated live vaccine at any time during the treatment period or within 8 weeks after the completion of the study;
(9) Patients with significant or unstable digestive/hepatobiliary, renal/urinary, cardiovascular, respiratory, endocrine, hematological, immune, or central nervous system diseases within 6 months prior to the first administration, who, according to the researcher's judgment, do not meet the clinical research conditions, such as but not limited to pancreatitis, unstable angina, myocardial infarction, symptomatic congestive heart failure (New York Heart Association Class III or IV), arrhythmia requiring treatment, poorly controlled hypertension (systolic blood pressure >= 160mmHg, diastolic blood pressure >= 100mmHg), pulmonary hypertension, respiratory failure, stroke (including transient ischemic attack), cirrhosis, venous thromboembolism, etc;
(10) Suffering from malignant tumors (excluding skin squamous cell carcinoma in situ, basal cell carcinoma, and cervical cancer in situ that have been thoroughly treated and show no signs of recurrence) or lymphoproliferative diseases within 5 years before the first administration;
(11) Currently suffering from other autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc.);
(12) Individuals with or suspected of having a history of congenital or acquired immunodeficiency, or conditions that researchers believe may impair the immune status of participants (such as a history of splenectomy, primary immunodeficiency);
(13) Individuals with mental illness or medical history (such as depression) that affects medication adherence or is clinically judged by researchers to be at risk of suicide;
(14) Participants who have undergone or plan to undergo organ transplantation surgery and require immunosuppressants (such as liver and kidney transplantation);
(15) Any significant clinical and laboratory abnormalities during screening that researchers believe may affect the safety of participants, including but not limited to:
Blood routine: White blood cell count<3.0 × 10^9/L, neutrophil count<1.5 × 10^9/L, lymphocyte count<0.5 × 10^9/L; platelet count<100.0 × 10^9/L, hemoglobin<100g/L;
Renal function: Estimated glomerular filtration rate (eGFR)<60mL/min/1.73m^2;
Liver function: Alanine transaminase (ALT) or aspartate transaminase (AST) >= 2 × ULN (upper limit of normal); Total bilirubin >= 1.5 × ULN;
Any other laboratory test results that are abnormal and clinically significant, as assessed by the researcher, may pose an unacceptable risk to the participants if they participate in the study;
(16) When screening or baseline, if vital signs, physical examination, 12 lead electrocardiogram, and chest CT (CT scan results within 1 month are acceptable) are abnormal and clinically significant, and the researcher evaluates that participating in the study may pose an unacceptable risk to the participants;
(17) During the screening visit, any of the following infected individuals were identified:
Hepatitis B: HBsAg positive; Or the core antibody (HBcAb) is positive, and the copy number of hepatitis B virus deoxyribonucleic acid (HBV-DNA) is positive (defined as exceeding the upper limit of the normal range of the research center's detection value);
Hepatitis C (HCV) antibody positive and HCV-RNA copy number positive (defined as exceeding the upper limit of the normal range of detection values in the research center);
Positive for Human Immunodeficiency Virus Antibody (HIV Ab);
Positive syphilis specific antibody test (excluding participants who tested negative for syphilis non-specific antibody RPR or TRUST and were diagnosed by the researcher as having previously been infected with syphilis but have been cured);
18. Individuals who received any of the following treatments within the designated elution period prior to randomization:
Received biological therapy within 3 months (or 5 half lives, whichever is longer), including but not limited to Dupilumab, Sprucubizumab, etc;
Within 4 weeks (or 5 half lives, whichever is longer), have received systemic treatments known or likely to affect atopic dermatitis, including but not limited to JAK1/2/3 inhibitors, systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulatory agents (such as mycophenolate mofetil or tacrolimus);
Individuals who have received UV treatment within 4 weeks or have been exposed to natural or artificial UV radiation sources (such as sunlight or sunbathing) for a prolonged period of time, and/or who intend to receive such exposure during the study period;
Those who have received long-acting anticoagulants (such as warfarin, clopidogrel, etc.) within 4 weeks or require continuous use of anticoagulants (excluding aspirin <= 100mg/day);
Within 2 weeks, have received external medication treatment known or likely to affect atopic dermatitis, including topical corticosteroids (TCS), calcineurin inhibitors (TCI), phosphodiesterase 4 (PDE4) inhibitors, etc;
Have received oral Chinese herbal medicine or traditional Chinese patent medicines and simple preparations for the treatment of atopic dermatitis within 2 weeks (the following Chinese medicines need to be eluted for 4 weeks: Chinese herbal medicine or traditional Chinese patent medicines and simple preparations containing clear immunosuppressive/strong immunomodulatory ingredients, including but not limited to: tripterygium wilfordii and its preparations, compound glycyrrhizin, etc.; Chinese herbal medicine treatment with complex formula and unclear ingredients, or the main effective/active ingredients and their stopping time cannot be clear; the researcher judges those who may have a continuous impact on disease severity or immune status, interfere with efficacy evaluation, or increase the risk);
(19) Participants who have been previously exposed to TYK2 inhibitor therapy, or who have previously received systemic JAK1/2/3 inhibitor therapy with poor efficacy or have discontinued medication for safety reasons;
(20) History of alcohol and/or drug abuse within the past 3 months prior to screening;
(21) Individuals with any conditions that may affect drug absorption, including but not limited to: malabsorption syndrome, celiac disease, gastrectomy, and intestinal resection (excluding appendectomy);
(22) Those who have used CYP3A strong inducers or inhibitors within 4 weeks or 5 half lives (whichever is longer) before the first administration, or who cannot avoid using CYP3A strong inducers or inhibitors during the study period (see Appendix 7);
(23) Those who consumed St. John's wort (Forsythia suspensa) products or grapefruit within 7 days prior to the first administration, or refused to avoid such substances throughout the entire study period (including follow-up);
(24) Select individuals who have donated blood or lost ≥ 400mL of blood within the previous 3 months or plan to donate blood during the study period;
(25) Individuals who are known or suspected to be allergic to any component of the investigational drug, or to any other significant drug allergy (such as anaphylactic shock or hepatotoxicity);
(26) Pregnant or lactating women;
(27) Those who use other clinical trial drugs or are currently participating in other clinical studies within 3 months or 5 half lives before the first administration (whichever is longer);
(28) Other circumstances that the researcher deems unsuitable for participation in this clinical study.研究实施时间：
Study execute time：
从
From
2025-12-29 00:00:00至
To
2026-12-31 00:00:00
征募观察对象时间：
Recruiting time：
从
From
2026-03-06 00:00:00
至
To
2026-12-31 00:00:00干预措施：
Interventions：
组别：
50mg QD组
样本量：
40
Group：
50mg QD group
Sample size：
干预措施：
空腹口服给药，每日服药一次，持续服药 12 周。
干预措施代码：
Intervention：
Take the medication on an empty stomach, once a day, for a duration of 12 weeks.
Intervention code：
组别：
100mg QD 组
样本量：
40
Group：
100mg QD group
Sample size：
干预措施：
空腹口服给药，每日服药一次，持续服药 12 周。
干预措施代码：
Intervention：
Take the medication on an empty stomach, once a day, for a duration of 12 weeks.
Intervention code：
组别：
200mg QD组
样本量：
40
Group：
200mg QD group
Sample size：
干预措施：
空腹口服给药，每日服药一次，持续服药 12 周。
干预措施代码：
Intervention：
Take the medication on an empty stomach, once a day, for a duration of 12 weeks.
Intervention code：
组别：
安慰剂组
样本量：
40
Group：
Placebo
Sample size：
干预措施：
空腹口服给药，每日服药一次，持续服药 12 周。
干预措施代码：
Intervention：
Take the medication on an empty stomach, once a day, for a duration of 12 weeks.
Intervention code：研究实施地点：
Countries of recruitment and research settings：
国家：
中国
省(直辖市)：
北京
市(区县)：
Country：
China
Province：
Beijing
City：
单位(医院)：
中日友好医院
单位级别：
三甲
Institution
hospital：
China-Japan Friendship Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
广东
市(区县)：
Country：
China
Province：
Guangdong
City：
单位(医院)：
南方医科大学皮肤病医院
单位级别：
三甲
Institution
hospital：
Southern Medical University Dermatology Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
上海
市(区县)：
Country：
China
Province：
Shanghai
City：
单位(医院)：
上海市皮肤病医院
单位级别：
三甲
Institution
hospital：
Shanghai Skin Disease Hospita
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
湖北
市(区县)：
Country：
China
Province：
Hubei
City：
单位(医院)：
武汉市第一医院
单位级别：
三甲
Institution
hospital：
Wuhan First Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
浙江
市(区县)：
Country：
China
Province：
Zhejiang
City：
单位(医院)：
杭州市第一人民医院
单位级别：
三甲
Institution
hospital：
Hangzhou First People's Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
浙江
市(区县)：
Country：
China
Province：
Zhejiang
City：
单位(医院)：
浙江省人民医院
单位级别：
三甲
Institution
hospital：
Zhejiang Provincial People's Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
四川
市(区县)：
Country：
China
Province：
Sichuan
City：
单位(医院)：
四川省人民医院
单位级别：
三甲
Institution
hospital：
Sichuan Provincial People's Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
河北
市(区县)：
Country：
China
Province：
Hebei
City：
单位(医院)：
河北医科大学第二医院
单位级别：
三甲
Institution
hospital：
The Second Hospital of Hebei Medical University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
广东
市(区县)：
Country：
China
Province：
Guangdong
City：
单位(医院)：
北京大学深圳医院
单位级别：
三甲
Institution
hospital：
Peking University Shenzhen Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
宁夏回族自治区
市(区县)：
Country：
China
Province：
Ningxia Hui Autonomous Region
City：
单位(医院)：
宁夏医科大学总医院
单位级别：
三甲
Institution
hospital：
General Hospital of Ningxia Medical University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
海南
市(区县)：
Country：
China
Province：
Hainan
City：
单位(医院)：
海南省第五人民医院
单位级别：
三甲
Institution
hospital：
Hainan Provincial Fifth People's Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
江苏
市(区县)：
Country：
China
Province：
Jiangsu
City：
单位(医院)：
江苏大学附属医院
单位级别：
三甲
Institution
hospital：
Affiliated Hospital of Jiangsu University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
河南
市(区县)：
Country：
China
Province：
Henan
City：
单位(医院)：
郑州市中心医院
单位级别：
三甲
Institution
hospital：
Zhengzhou Central Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
浙江
市(区县)：
Country：
China
Province：
Zhejiang
City：
单位(医院)：
杭州市第三人民医院
单位级别：
三甲
Institution
hospital：
Hangzhou Third People's Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
天津
市(区县)：
Country：
China
Province：
Tianjin
City：
单位(医院)：
天津医科大学总医院
单位级别：
三甲
Institution
hospital：
General Hospital of Tianjin Medical University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
北京
市(区县)：
Country：
China
Province：
Beijing
City：
单位(医院)：
首都医科大学附属北京同仁医院
单位级别：
三甲
Institution
hospital：
Beijing Tongren Hospital, Capital Medical University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
山东
市(区县)：
Country：
China
Province：
Shandong
City：
单位(医院)：
山东大学齐鲁医院
单位级别：
三甲
Institution
hospital：
Qilu Hospital of Shandong University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
四川
市(区县)：
Country：
China
Province：
Sichuan
City：
单位(医院)：
四川大学华西医院
单位级别：
三甲
Institution
hospital：
West China Hospital, Sichuan University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
辽宁
市(区县)：
Country：
China
Province：
Liaoning
City：
单位(医院)：
沈阳市中西医结合医院
单位级别：
三甲
Institution
hospital：
Shenyang Integrated Traditional Chinese and Western Medicine Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
辽宁
市(区县)：
Country：
China
Province：
Liaoning
City：
单位(医院)：
沈阳医学院附属中心医院
单位级别：
三甲
Institution
hospital：
Central Hospital Affiliated to Shenyang Medical College
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
福建
市(区县)：
Country：
China
Province：
Fujian
City：
单位(医院)：
福建医科大学附属第一医院
单位级别：
三甲
Institution
hospital：
The First Affiliated Hospital of Fujian Medical University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
陕西
市(区县)：
Country：
China
Province：
Shaanxi
City：
单位(医院)：
陕西省人民医院
单位级别：
三甲
Institution
hospital：
Shaanxi Provincial People's Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
山东
市(区县)：
Country：
China
Province：
Shandong
City：
单位(医院)：
滨州医学院附属医院
单位级别：
三甲
Institution
hospital：
Affiliated Hospital of Binzhou Medical University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
河北
市(区县)：
Country：
China
Province：
Hebei
City：
单位(医院)：
华北理工大学附属医院
单位级别：
三甲
Institution
hospital：
Affiliated Hospital of North China University of Science and Technology
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
江苏
市(区县)：
Country：
China
Province：
Jiangsu
City：
单位(医院)：
苏州市立医院
单位级别：
三甲
Institution
hospital：
Suzhou Municipal Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
湖北
市(区县)：
Country：
China
Province：
Hubei
City：
单位(医院)：
十堰市人民医院
单位级别：
三甲
Institution
hospital：
Shiyan People's Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
上海
市(区县)：
Country：
China
Province：
Shanghai
City：
单位(医院)：
上海中医药大学附属岳阳中西医结合医院
单位级别：
三甲
Institution
hospital：
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
北京
市(区县)：
Country：
China
Province：
Beijing
City：
单位(医院)：
北京怀柔医院
单位级别：
三甲
Institution
hospital：
Beijing Huairou Hospital
Level of the institution：
Tertiary A测量指标：
Outcomes：
指标中文名：
湿疹面积和严重程度指数较基线改善至少75%（EASI 75）的参与者比例
指标类型：
主要指标
Outcome：
Proportion of participants with at least 75% improvement from baseline in the Eczema Area and Severity Index (EASI 75)
Type：
Primary indicator
测量时间点：
第12周
测量方法：
Measure time point of outcome：
Week 12
Measure method：
指标中文名：
湿疹面积和严重程度指数较基线改善至少75%（EASI 75）的参与者比例
指标类型：
次要指标
Outcome：
The proportion of participants whose eczema area and severity index improved by at least 75% compared to baseline (EASI 75)
Type：
Secondary indicator
测量时间点：
第2、4、8周
测量方法：
Measure time point of outcome：
At weeks 2, 4, and 8
Measure method：
指标中文名：
达到EASI 50/90的参与者比例
指标类型：
次要指标
Outcome：
Proportion of participants reaching EASI 50/90
Type：
Secondary indicator
测量时间点：
第2、4、8、12周
测量方法：
Measure time point of outcome：
At weeks 2, 4, 8, and 12
Measure method：
指标中文名：
达到IGA 0或1分且较基线改善≥2分的参与者比例
指标类型：
次要指标
Outcome：
The proportion of participants who achieved IGA score of 0 or 1 and improved by >= 2 points from baseline
Type：
Secondary indicator
测量时间点：
第2、4、8、12周
测量方法：
Measure time point of outcome：
At weeks 2, 4, 8, and 12
Measure method：
指标中文名：
达到IGA 0分或1分的参与者比例
指标类型：
次要指标
Outcome：
The proportion of participants who achieved 0 or 1 IGA score
Type：
Secondary indicator
测量时间点：
第2、4、8、12周
测量方法：
Measure time point of outcome：
At weeks 2, 4, 8, and 12
Measure method：
指标中文名：
Itch NRS评分较基线改善≥4分的参与者比例
指标类型：
次要指标
Outcome：
The proportion of participants whose Itch NRS scores improved by >= 4 points from baseline
Type：
Secondary indicator
测量时间点：
第2、4、8、12周
测量方法：
Measure time point of outcome：
At weeks 2, 4, 8, and 12
Measure method：
指标中文名：
EASI评分较基线的百分比变化
指标类型：
次要指标
Outcome：
Percentage change in EASI score compared to baseline
Type：
Secondary indicator
测量时间点：
第2、4、8、12周
测量方法：
Measure time point of outcome：
At weeks 2, 4, 8, and 12
Measure method：
指标中文名：
SCORAD评分较基线的百分比变化
指标类型：
次要指标
Outcome：
Percentage change in SCORAD score compared to baseline
Type：
Secondary indicator
测量时间点：
第2、4、8、12周
测量方法：
Measure time point of outcome：
At weeks 2, 4, 8, and 12
Measure method：
指标中文名：
Itch NRS评分较基线的变化
指标类型：
次要指标
Outcome：
Changes in Itch NRS score compared to baseline
Type：
Secondary indicator
测量时间点：
第2、4、8、12周
测量方法：
Measure time point of outcome：
At weeks 2, 4, 8, and 12
Measure method：
指标中文名：
受累体表面积（BSA）较基线的百分比变化
指标类型：
次要指标
Outcome：
Percentage changes in affected body surface area (BSA) compared to baseline
Type：
Secondary indicator
测量时间点：
第2、4、8、12周
测量方法：
Measure time point of outcome：
At weeks 2, 4, 8, and 12
Measure method：
指标中文名：
皮肤病学生活质量指数（DLQI）评分较基线的变化
指标类型：
次要指标
Outcome：
Changes in Dermatology Quality of Life Index (DLQI) scores from baseline
Type：
Secondary indicator
测量时间点：
第2、4、8、12周
测量方法：
Measure time point of outcome：
At weeks 2, 4, 8, and 12
Measure method：
指标中文名：
不良事件、实验室检查、生命体征、心电图检查、体格检查等
指标类型：
附加指标
Outcome：
Adverse events, laboratory tests, vital signs, electrocardiogram examination, physical examination, etc
Type：
Additional indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
评价CMS-D001及其主要代谢产物（如适用）在中重度特应性皮炎参与者中的PK特征
指标类型：
附加指标
Outcome：
Evaluate the PK characteristics of CMS-D001 and its major metabolites (if applicable) in participants with moderate to severe atopic dermatitis
Type：
Additional indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
群体药代动力学（PopPK）分析
指标类型：
附加指标
Outcome：
Population pharmacokinetic (PopPK) analysis
Type：
Additional indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
暴露-效应分析：CMS-D001及其主要代谢产物（如适用）的暴露与疗效和不良事件之间的关系
指标类型：
附加指标
Outcome：
Exposure effect analysis: The relationship between exposure to CMS-D001 and its major metabolites (if applicable) and efficacy and adverse events
Type：
Additional indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
评价血清胸腺活化调节趋化因子（TARC）和免疫球蛋白E（IgE）等生物标志物水平及其较基线变化随时间的变化
指标类型：
附加指标
Outcome：
Evaluate the levels of biomarkers such as serum thymic activation regulatory chemokine (TARC) and immunoglobulin E (IgE) and their changes over time compared to baseline
Type：
Additional indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：采集人体标本：
Collecting sample(s)
from participants：
标本中文名：
血液
组织：
无
Sample Name：
Blood
Tissue：
None
人体标本去向
使用后销毁
说明
无
Fate of sample：
Destruction after use
Note：
None征募研究对象情况：
Recruiting status：
尚未开始
Not yet
recruiting
年龄范围：
Participant age：
最小
Min age
18
岁
years
最大
Max age
75
岁
years性别：
男女均可
Gender：
Both随机方法（请说明由何人用什么方法产生随机序列）：
本研究采用分层区组随机化方法，参与者的基线IGA评分（3分或4分）将作为随机分层因子，在每层内参与者将按照1:1:1:1比例随机分配至CMS-D001 50mg QD剂量组、100mg QD剂量组、200mg QD剂量组和安慰剂组。随机化将采用网络应答系统（IWRS）进行，该系统按照随机化编号自动随机分配治疗组。经过合适包装的研究药物，可一次或分若干次提供给研究中心。对符合纳入条件的参与者，将根据参与者的随机号，匹配对应的药物编号，分配药物。已完成随机的参与者，如果终止治疗或退出研究，无论其是否使用试验用药品、因任何原因终止治疗或退出研究，其随机号都不能分配给其他参与者再次使用。Randomization Procedure (please state who
generates the
random number sequence and by what method)：
This study used a stratified block randomization method, where participants' baseline IGA scores (3 or 4 points) were used as random stratification factors. Within each layer, participants were randomly assigned to CMS-D001 50mg QD dose group, 100mg QD dose group, 200mg QD dose group, and placebo group in a 1:1:1:1 ratio. Randomization will be conducted using an Internet of Response System (IWRS), which automatically assigns treatment groups based on randomization numbers. The research drug, packaged appropriately, can be provided to the research center in one or several portions. For participants who meet the inclusion criteria, corresponding drug numbers will be matched based on their random numbers and drugs will be assigned. Participants who have completed randomization and terminate treatment or withdraw from the study, regardless of whether they use the investigational drug or terminate treatment or withdraw from the study for any reason, their randomization number cannot be assigned to other participants for reuse.是否公开试验完成后的统计结果:
Calculated Results after the Study Completed public access:
不公开/Private盲法：
盲法可确保研究评估不受具体治疗分配的影响。本研究采用双盲设计，即研究治疗过程中参与者、研究者均不清楚随机分组治疗分配情况。Blinding：
Blinding ensures that the research evaluation is not affected by specific treatment allocation. This study uses a double-blind design, meaning that neither the participants nor the researchers are aware of the random group treatment allocation during the treatment process.是否共享原始数据：
IPD sharing
否No共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：
无The way of sharing IPD”(include metadata and
protocol,
If use web-based public database, please provide
the
url)：
None数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case
Record Form, CRF)，二为电子采集和管理系统(Electronic Data
Capture, EDC)，如ResMan即为一种基于互联网的EDC：
电子采集和管理系统Data collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture：
Electronic Data Capture, EDC数据与安全监察委员会：
Data and Safety Monitoring Committee：
无/No注册人：
Name of Registration：
2026-02-25 09:33:15
临床2期
2026-02-25
Strategic Initiatives and Refined Business Model Produced Financial and Operating Efficiencies
Established
Long-Term License and Supply Agreement to Commercialize VAZKEPA® Across Europe and
Sustained U.S. Market Leadership for VASCEPA® Franchise
Total of 45 Publications (Abstracts, Posters, Manuscripts) Furthering the Expansion of the VASCEPA
®
/VAZKEPA® (icosapent ethyl) Body of Knowledge
Supported in 2025
DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular disease worldwide, today announced financial results for the fourth quarter and full year ended December 31, 2025.
“Our performance in the fourth quarter and full year of 2025 confirmed both the initial impact and long-term potential of our strategic initiatives and re-imagined operating model,” said Aaron Berg, President and Chief Executive Officer of Amarin. “We have entered 2026 from an improved position of market, operational, and financial strength. We have maintained our U.S. leading market share for VASCEPA and are actively expanding our presence in Europe for VAZKEPA via our long-term partnership agreement with Recordati S.p.A., strengthening our now fully partnered international commercial strategy. We are a leaner organization, having made great progress in reducing costs and narrowing our losses, while continuing to invest in expanding an already formidable body of scientific knowledge that supports our global VASCEPA/VAZKEPA franchise and its proven ability to reduce cardiovascular risk. While work remains, we are encouraged by our progress and continue to examine strategic actions to maximize future shareholder value and options regarding management of capital.”
Q4 2025 Financial Highlights
($ in millions)
Q4 2025
Q4 2024
% Change
Total Net Revenue
$49.2
$62.3
(21)%
Operating Expenses
$29.5
$43.0
(31)%
Operating Loss
Operating Margin % *
$(6.3)
(13)%
$(52.5)
(84)%
(88)%
NM
Net Loss
Net Margin
$(1.2)
(2)%
$(48.6)
(78)%
(97)%
NM
Cash
$302.6
$294.2
* Operating margin is calculated as operating loss divided by total net revenue.
NM – Not Meaningful
Peter Fishman, Amarin’s Chief Financial Officer, said, “Our fourth quarter performance reflects our early success in optimizing the Company’s operations and creating what we believe is a more efficient platform for long-term growth. We realized $31 million of the expected $70 million in cost savings from our restructuring initiatives and have incurred nearly all of the $37 - $40 million in restructuring costs. Our cash position improved sequentially and year over year, ending 2025 with total cash and investments of $303 million and no debt. As a direct result of our continued revenue generation and new financial operating profile, our return to positive cash flow in the fourth quarter was ahead of schedule and has positioned us to generate positive cash flow for the full year ahead. We are well positioned to deliver on our operational and strategic priorities in 2026.”
Q4 2025 Financial Performance
Comparisons to Q4 2024, unless otherwise stated
Revenues
($ in millions)
Q4 2025
Q4 2024
% Change
Product Revenue, net:
U.S.
Europe
Rest-of-World (ROW)
$41.1
$2.3
$3.1
$44.2
$4.0
$11.9
(7)%
(42)%
(74)%
Total Product Revenue, net
$46.5
$60.1
(23)%
Licensing & Royalties
$2.7
$2.2
20%
Total Net Revenue
$49.2
$62.3
(21)%
NM - Not Meaningful
Total Net Revenue:
Decreased $13.1 million, or 21%, due primarily to a decline in ROW sales that reflected a $7.8 million stocking order in last year’s fourth quarter in preparation for a market launch, a decline in net selling price in the U.S., and the effects of the transition of our European sales activities to Recordati that included both supply shipments and direct sales in the 2025 fourth quarter. European sales in the fourth quarter of 2024 included direct sales only; once the transition to a fully partnered sales model is complete, European sales will consist only of supply shipments to Recordati. Royalties increased by $0.5 million due to higher in-market sales generated by our global partners.
Operating Expenses
Comparisons to Q4 2024, unless otherwise stated
($ in millions)
Q4 2025
Q4 2024
% Change
COGS
$26.1
$71.9
SG&A
$20.1
$37.0
R&D
$5.4
$6.0
Restructuring
$4.1
--
NM
Total Operating Expenses *
$29.5
$43.0
* Total operating expenses reflect the sum of SG&A, R&D, and Restructuring expenses.
NM - Not Meaningful
Total Operating Expenses:
Decreased $13.5 million, or 31%, primarily due to the impact of the June 2025 Global Restructuring Plan that produced declines in Selling, General, and Administrative expenses (SG&A). Excluding the restructuring charge of $4.1 million (
see discussion below
), Q4 2025 total operating expenses were $25.4 million, representing a decline of 41%.
COGS:
Decreased $45.8 million, or 64%. COGS in Q4 2024 included a one-time inventory restructuring charge of $36.5 million related to the Company’s efforts to amend supplier agreements to align with then current and expected future demand and a one-time inventory write off. Excluding these one-time charges, Q4 2025 COGS decreased $2.8 million, or 10%, primarily due to lower net product sales.
SG&A:
Decreased $16.9 million, or 46%, primarily due to a reduction in costs pursuant to the Global Restructuring Plan and other cost optimization initiatives.
R&D:
Consistent with the prior year period.
Restructuring:
The Company recognized $4.1 million in Q4 2025 related to the continued implementation of the Global Restructuring Plan associated with the execution of the Recordati Licensing Agreement announced in June 2025. This resulted in the elimination of commercial roles in the Company’s Europe operations, among other operating expense savings across the Company’s global operations. The Company incurred $36.2 million of restructuring charges in full year 2025 and continues to expect total restructuring charges to range from $37 to $40 million, with the remaining charges expected to be realized in early 2026.
Additional Q4 2025 Financial Information
Comparisons to Q4 2024, unless otherwise stated
Operating Loss:
Narrowed to $6.3 million from an operating loss of $52.5 million, an improvement of $46.2 million, or 88%. Operating loss in Q4 2025 included restructuring costs of $4.1 million compared to $36.5 million in Q4 2024.
Net Loss:
Improved to $(1.2) million, or $(0.00) per share, from a net loss of $(48.6) million, or $(0.12) per share.
Cash:
Reported aggregate cash and investments of $302.6 million, as of December 31, 2025, compared to $294.2 million as of December 31, 2024, reflecting a year-over-year increase of $8.4 million, and compared to $286.6 million as of September 30, 2025, reflecting a sequential increase of $16.0 million.
Debt:
Remained debt free as of December 31, 2025.
Fourth Quarter and Full Year 2025 Earnings Conference Call and Webcast Information
Amarin will host a conference call on February 25, 2026, at 8:00 a.m. ET to discuss this information. The conference call can be accessed on the investor relations section of the Company's website at or via telephone by dialing 888-506-0062 within the United States, 973-528-0011 from outside the United States, and referencing conference ID 675507. A replay of the webcast will be made available until August 25,2026. To listen to a replay of the call, dial 877-481-4010 from within the United States and 919-882-2331 from outside of the United States, and reference conference ID 53567. A replay of the call will also be available through the Company's website shortly after the call.
About Amarin
Amarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering close to 100 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD.
About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty-five million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria.
United States Indications and Limitation of Use
VASCEPA is indicated:
As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.
As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.
FULL U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION
CAN BE FOUND AT
WWW.VASCEPA.COM
Europe
For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit:
Globally, prescribing information varies; refer to the individual country product label for complete information.
Use of Non-GAAP Adjusted Financial Information
Included in this press release are non-GAAP adjusted financial information as defined by U.S. Securities and Exchange Commission Regulation G. The GAAP financial measure is most directly comparable to each non-GAAP adjusted financial measure used or discussed, and a reconciliation of the differences between each non-GAAP adjusted financial measure and the comparable GAAP financial measure, is included in this press release after the condensed consolidated financial statements.
Non-GAAP adjusted net (loss) income was derived by taking GAAP net loss and adjusting it for non-cash stock-based compensation expense, restructuring expense and other one-time expenses. Management uses these non-GAAP adjusted financial measures for internal reporting and forecasting purposes, when publicly providing its business outlook, to evaluate the company’s performance and to evaluate and compensate the company’s executives. The company has provided these non-GAAP financial measures in addition to GAAP financial results because it believes that these non-GAAP adjusted financial measures provide investors with a better understanding of the company’s historical results from its core business operations.
While management believes that these non-GAAP adjusted financial measures provide useful supplemental information to investors regarding the underlying performance of the company’s business operations, investors are reminded to consider these non-GAAP measures in addition to, and not as a substitute for, financial performance measures prepared in accordance with GAAP. Non-GAAP measures have limitations in that they do not reflect all the amounts associated with the company’s results of operations as determined in accordance with GAAP. In addition, it should be noted that these non-GAAP financial measures may be different from non-GAAP measures used by other companies, and management may utilize other measures to illustrate performance in the future.
Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s key achievements in 2025 and the potential impact and outlook for achievements in 2026 and beyond; Amarin’s 2026 financial outlook and cash position; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; expectations regarding potential strategic collaboration and licensing agreements with third parties, including our ability to attract additional collaborators, as well as our plans and strategies for entering into potential strategic collaboration and licensing agreements and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin.
All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission. Amarin’s annual report on Form 10-K for the fiscal year ended 2025 will also be accessible there later this week. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Investors and others should note that Amarin communicates with its investors and the public using the company website (
), the investor relations website (
), including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts.
Amarin Contact Information
Media Inquiries:
Tegan Berry
Amarin Corporation plc
PR@amarincorp.com
Investor Inquiries:
Devin Sullivan & Conor Rodriguez
The Equity Group on Behalf of Amarin
devin.sullivan.ext@amarincorp.com
or
conor.rodriguez.ext@amarincorp.com
Investor.relations@amarincorp.com
-Tables to Follow-
CONSOLIDATED BALANCE SHEET DATA
(U.S. GAAP)
Unaudited *
December 31, 2025
December 31, 2024
(in thousands)
ASSETS
Current Assets:
Cash and cash equivalents
$
134,660
$
121,038
Restricted cash
201
300
Short-term investments
167,929
173,182
Accounts receivable, net
126,832
122,279
Inventory
195,910
166,048
Prepaid and other current assets
24,350
12,552
Total current assets
649,882
595,399
Property, plant and equipment, net
12
16
Long-term inventory
—
64,740
Operating lease right-of-use asset
6,461
7,592
Other long-term assets
1,055
1,213
Intangible asset, net
13,365
16,389
TOTAL ASSETS
$
670,775
$
685,349
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
$
45,355
$
40,366
Accrued expenses and other current liabilities
149,104
139,583
Total current liabilities
194,459
179,949
Long-Term Liabilities:
Long-term operating lease liability
6,080
7,723
Other long-term liabilities
10,955
11,501
Total liabilities
211,494
199,173
Stockholders’ Equity:
Common stock
310,184
305,298
Additional paid-in capital
1,923,801
1,914,750
Treasury stock
(67,360
)
(65,326
)
Accumulated deficit
(1,707,344
)
(1,668,546
)
Total stockholders’ equity
459,281
486,176
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
670,775
$
685,349
* Unaudited as a standalone schedule; copied from consolidated financial statements
CONSOLIDATED STATEMENTS OF OPERATIONS DATA
(U.S. GAAP)
Unaudited *
Three Months Ended December 31,
Year Ended December 31,
(in thousands, except per share amounts)
(in thousands, except per share amounts)
2025
2024
2025
2024
Product revenue, net
$
46,543
$
60,068
$
182,753
$
204,590
Licensing and royalty revenue
2,676
2,238
30,893
24,024
Total revenue, net
49,219
62,306
213,646
228,614
Less: Cost of goods sold
26,050
35,399
92,778
110,758
Less: Cost of goods sold - restructuring inventory
—
36,474
—
36,474
Gross margin
23,169
(9,567
)
120,868
81,382
Operating expenses:
Selling, general and administrative
(1)
20,059
36,970
115,003
152,310
Research and development
(1)
5,371
5,985
19,806
20,869
Restructuring
4,064
—
36,229
—
Total operating expenses
29,494
42,955
171,038
173,179
Operating loss
(6,325
)
(52,522
)
(50,170
)
(91,797
)
Interest income
2,570
3,371
10,853
13,403
Interest expense
(1
)
(3
)
(7
)
(7
)
Other income (expense), net
2,904
(753
)
3,276
1,201
Loss from operations before taxes
(852
)
(49,907
)
(36,048
)
(77,200
)
(Provision for) benefit from income taxes
(372
)
1,289
(2,750
)
(4,983
)
Net loss
$
(1,224
)
$
(48,618
)
$
(38,798
)
$
(82,183
)
Loss per share:
Basic
$
(0.00
)
$
(0.12
)
$
(0.09
)
$
(0.20
)
Diluted
$
(0.00
)
$
(0.12
)
$
(0.09
)
$
(0.20
)
Weighted average shares outstanding:
Basic
416,000
411,293
414,984
410,937
Diluted
416,000
411,293
414,984
410,937
* Unaudited as a standalone schedule; copied from consolidated financial statements
(1) Excluding non-cash stock-based compensation, selling, general and administrative expenses were $105,759 and $138,144 for the years ended December 31, 2025 and 2024, respectively, and research and development expenses were $17,345 and $17,330, respectively, for the same periods.
RECONCILIATION OF NON-GAAP NET (LOSS) INCOME
Unaudited
Three months ended December 31,
Year Ended December 31,
(in thousands, except per share amounts)
(in thousands, except per share amounts)
2025
2024
2025
2024
Net (loss) income for EPS - GAAP
$
(1,224
)
$
(48,618
)
$
(38,798
)
$
(82,183
)
Stock-based compensation expense
1,559
3,400
11,705
17,705
Restructuring expense
4,064
—
36,229
—
Restructuring Inventory
—
36,474
—
36,474
ADS Ratio Change Fees
—
—
2,015
—
Licensing Agreement Fees
—
—
5,038
—
Adjusted net (loss) income for EPS - non-GAAP
$
4,399
$
(8,744
)
$
16,189
$
(28,004
)
Basic and diluted
(Loss) earnings per share:
Basic - non-GAAP
$
0.01
$
(0.02
)
$
0.04
$
(0.07
)
Diluted - non-GAAP
$
0.01
$
(0.02
)
$
0.04
$
(0.07
)
Weighted average shares:
Basic
416,000
411,293
414,984
410,937
Diluted
433,019
411,293
427,104
410,937
上市批准财报引进/卖出AHA会议
2026-02-24
·国际循环
点击蓝字
关注我们
点上方蓝字“国际循环”关注我们，
然后点右上角“…”菜单，选择“设为星标”
作者：张岩岩 郑博 霍勇
北京大学第一医院心内科
时间迈入2026年，回望过去一年，冠心病领域的临床研究画卷依然精彩纷呈，成果丰硕。围绕冠心病诊疗开展的研究不仅内容丰富、视角多元，更在多个关键领域取得了突破性进展。尤其在腔内影像与功能学指导的精准介入、多支血管病变的干预时机、药物球囊的拓展应用、抗血小板治疗的个体化策略，以及降脂药物的新靶点研发等方面，共同勾勒出冠心病管理的新格局，推动临床实践不断迈向更精准、更高效、更安全的诊疗时代。接下来，本文将对这些关键领域的临床研究进展进行系统盘点和梳理。
❤
1.腔内影像学与功能学
腔内影像及功能学检查已成为经皮冠状动脉介入治疗（percutaneous coronary intervention，PCI）过程中重要的组成部分，相较单纯造影，其可精确评估病变性质、狭窄或缺血程度，还能够指导策略选择、优化支架置入，最终更优地改善预后。尤其是对于高危或复杂病变（如左主干病变、真性分叉病变、长病变等）的介入指导，其在术前、术中、术后全程均发挥着精准诊疗的关键作用。近年来，随着越来越多临床研究证据的支持，国内外众多指南均已将其列为I类推荐，提示冠脉介入已正式全面进入“精准”时代。
在过去的2025年也有多项关于腔内影像学与功能学指导PCI的研究成果发表，并分析了其在不同人群、不同病变类型中的应用价值。CALIPSO研究[1]比较了基于光学相干断层扫描（optical coherence tomography，OCT）与基于血管造影的PCI策略在处理中重度钙化病变时的临床效果。研究结果显示，OCT组在PCI术后获得的最小支架面积显著优于血管造影组（6.5 mm2 vs.5.0 mm2，P<0.001），成功达到了试验设定的主要终点。进一步分析表明，相较于血管造影指导的PCI，OCT指导下的PCI不仅实现了更大程度的平均支架膨胀，同时降低了支架贴壁不良发生，且未引发额外的手术安全性问题。这些研究发现，不仅证实了既往在非钙化及复杂病变研究中的相关结果，也与同年发表的ECLIPSE试验中腔内影像亚组数据[2]，以及ILUMIEN IV试验中钙化病变亚组分析结果[3]相一致。此外值得关注的是，该研究PCI术前的OCT分析对术者制定斑块预处理策略产生了显著影响。在OCT指导组中，血管内碎石术（intravascular lithotripsy，IVL）作为一线预处理方案的应用频率显著高于造影指导组【主要以非顺应性球囊（non-compliant balloon，NCB）预扩张作为一线选择】，这一差异也充分反映出OCT在指导临床决策中的重要价值。一项关于RENOVATE-COMPLEX-PCI试验的二次分析进一步探索了腔内影像指导PCI在合并高出血风险（high bleeding risk，HBR）的复杂冠心病患者中的应用价值[4]，研究结果显示，相较非HBR患者，HBR患者具有更高的死亡或靶血管相关心梗风险；与单纯造影指导相比，腔内影像指导PCI在两个人群中均可显著降低靶血管失败发生率（P交互=0.796）。
在功能学评估方面，2025 ACC会议上来自浙江大学医学院附属第二医院王建安院士公布了FLAVOUR Ⅱ研究结果[5]，这项大规模RCT研究证实，对于冠状动脉狭窄至少50%的患者，血管造影衍生的血流储备分数（AngioFFR）指导的PCI，其临床效果不劣于传统血管内超声（intravascular unltrasound，IVUS）指导。在前期的FLAVOUR研究中，已发现针对冠状动脉狭窄程度在40%~70%之间的患者，应用基于导丝的FFR指导PCI与IVUS指导PCI在临床结局上没有显著差异；而且FFR指导的PCI能够减少21%的支架植入，这对于减少医疗资源消耗和患者经济负担具有重要意义。此次FLAVOUR Ⅱ研究在关注狭窄程度更重（50%~90%）的患者同时，聚焦基于造影的功能学评价技术，探索AngioFFR这一简便、无创的新型指标在指导冠脉介入中的应用价值。中位随访12个月，AngioFFR组和IVUS组中在主要不良心血管事件（major adverse cardiovascular event，MACE）终点（死亡+心肌梗死+血运重建）方面无显著差异（6.3% vs. 6.0%；P非劣效性=0.022，HR 1.04，95% CI：0.71~1.51）。亚组分析也显示，在不同年龄、性别、疾病类型等亚组中，两组主要终点结果同样相似。此外，研究还发现AngioFFR指导下的综合PCI策略，包括血运重建决策和支架植入优化，均非劣于IVUS指导，且PCI率更低，支架植入和双联抗血小板治疗使用更少。这一重磅成果不仅为临床医生提供了一种更为简便、无创的PCI决策和优化工具，也为未来心血管介入治疗指南的更新提供了有力的证据支持。当然，腔内影像学与功能学两项技术，仍有其各自的优势与不足，联合这两项技术，优势互补，可能会达到更优获益。目前FLAVOUR Ⅲ研究正在进行中，旨在探索联合使用AngioFFR和IVUS是否优于单独应用FFR的治疗策略，实现“解剖-功能”双重评估与全方位精准诊疗。
❤
2.STEMI合并多支血管病变的血运重建策略
目前关于ST段抬高型心肌梗死（ST-segment elevation myocardial infarction，STEMI）合并多支病变的血运重建策略仍是临床上一项尚存争议的话题。在过去的一年，完全血运重建 vs.仅治疗罪犯血管，亦或是即刻完全血运重建 vs.延迟完全血运重建的策略选择一直是研究者们关注和探索的焦点。
DANAMI-3-PRIMULTI研究既往结果显示，在中位27个月的随访期内，相较仅处理罪犯血管病变，FFR指导的完全血运重建可显著降低未来心血管事件风险，主要受益于再次血运重建的减少。2025年，该研究10年随访结果[6]公布，进一步证明完全血运重建组的主要复合终点事件风险显著低于仅处理罪犯血管组（HR 0.76，95%CI：0.60~0.94，P=0.014）；再次血运重建事件在完全血运重建组显著减少，但在死亡率、复发性心肌梗死发生率方面两组无显著差异。关于完全血运重建的时机，OPTION-STEMI和iMODERN两项研究进行了相关探讨。OPTION-STEMI试验[7]将994名患者随机分至FFR指导的即刻完全血运重建组或分期（在本次住院期间）完全血运重建组。结果显示，在1年全因死亡、非致死性心梗或任何计划外血运重建的复合终点方面，即刻完全血运重建策略并不优于分期完全血运重建。此外，即刻血运重建组还观察到心源性休克风险增加的趋势。iMODERN试验[8]比较了基于瞬时无波形比值（instantaneous wave-free ratio，iFR）指导的即刻非罪犯病变介入治疗，与随机化后6周内行心脏负荷磁共振成像指导的延迟PCI的疗效预后。结果显示，即刻iFR指导的血运重建策略在3年全因死亡、复发性心肌梗死或因心力衰竭住院的复合终点方面，并未显示出优效性。由此可以总结，对于合并多支病变的STEMI患者，行完全血运重建是合理的，但即刻处理非罪犯血管的策略并未带来显著获益，甚至还可能有害（易导致血流动力学不稳定）。上述研究结果进一步有力支持了当前指南的推荐：将完全血运重建推迟至急性事件后6周内进行，而即刻非罪犯血管干预仅限于经过选择的（如血流动力学稳定、存在明确高危特征）患者。这提醒临床医生，在急诊PCI时，应克制一站式解决所有问题的冲动。优先稳定罪犯血管，让心肌和患者从急性打击中恢复，再进行基于功能学评估的、理性的分期处理，可能是更安全有效的策略。
❤
3. 药物涂层球囊（drug-coated balloon，DCB）
由南京市第一医院陈绍良教授牵头的DCB-BIF研究[9]证实，针对简单分叉病变的边支治疗，DCB优于NCB。该研究共纳入784例接受主支血管支架植入术后边支直径狭窄≥70%的真性冠状动脉分叉病变患者，1:1随机分配接受DCB或NCB介入治疗，主要终点是1年MACE风险，包括心源性死亡、靶血管心梗或临床驱动的靶病变血运重建。研究结果显示，术后1年MACE：DCB组7.2%（28例），NCB组12.5%（49例）（HR 0.56，95%CI：0.35~0.88，P=0.013），这主要与DCB组的心梗减少有关。与此同时，在2025 TCT会议上，来自日本的Takayuki Ishihara教授也公布了OCVC-BIF研究结果，进一步为DCB治疗分叉病变边支提供了高质量的研究证据。该研究主要探讨在主支植入支架并完成主/边支对吻球囊扩张后，对边支是否进一步行DCB辅助扩张这一科学问题。研究结果显示，DCB组在术后9个月时由血管造影显示的边支再狭窄率显著低于对照组（8.1% vs. 18.3%，P=0.012），DCB组的再狭窄风险显著降低64%（HR 0.36，95%CI：0.16～0.79）；进一步的定量分析表明，DCB组边支的狭窄程度更轻，最小管腔直径更大。在临床结局方面，术后1年时，DCB组的靶病变血运重建率和MACE发生率也显示出更低的趋势。
除了分叉血管病变，2025年还有众多研究深入探索或进一步验证了DCB在其他类型病变【如慢性完全闭塞（chronic total occlusion，CTO）、小血管病变、支架内再狭窄、大血管原位病变等】介入治疗中的应用价值[10-12]，同时也有研究比较了雷帕霉素涂层球囊和紫杉醇涂层球囊间的优劣（SIBLINT-ISR、SPACIOUS试验）[13,14]。ERCTO注册研究[10]发现，在CTO PCI中，接受DCB治疗的CTO患者心包填塞发生率显著更低。倾向评分匹配后，使用DCB可减少药物洗脱支架的长度（44.2±36.9 mm vs. 58.1±35.9 mm；P<0.001）；造影剂用量也更少（202.4±109.8 ml vs. 211.6±123 ml；P=0.005）。
也是在去年，中华医学会心血管病学分会发布了《经皮冠状动脉介入治疗指南（2025）》，新版指南对DCB的临床应用给予了更高的推荐和支持。在未来的冠心病介入治疗中，DCB将会扮演更加重要的角色，根据病变类型进行个性化诊疗，实现优效的“介入无植入”新格局。
❤
4. 抗血小板治疗
抗血小板治疗始终是冠心病患者药物治疗中的基石，目前关于不同抗血小板方案和策略选择的研究未曾停歇，在过去的一年中，仍有多项重磅研究成果发表。在2025 ACC会议上公布的SMART-CHOICE 3研究[15]表明，在PCI术后完成标准双联抗血小板治疗（dual antiplatelet therapy，DAPT）的高缺血风险患者中，与阿司匹林单药治疗相比，维持氯吡格雷单药长期治疗可显著降低全因死亡、心肌梗死或卒中的复合终点风险（4.4% vs. 6.6%；HR=0.71，95%CI：0.54～0.93，P=0.013），且未增加出血风险（3.0% vs. 3.0%）。此外，氯吡格雷组在减少上消化道出血等特定出血事件方面表现优于阿司匹林组。虽然当前国内外指南仍将阿司匹林作为PCI后长期维持抗血小板治疗的Ⅰ类推荐，但随着HOST-EXAM、OPT-BIRISK、SMART-CHOICE 3等大规模RCT结果的公布，越来越多的证据支持氯吡格雷可替代阿司匹林作为长期维持抗血小板治疗的方案选择，但由于上述研究最长随访结果仅5年，且均局限于东亚人群，故还需更多包含多种族人群、长随访的研究进一步证实此策略的长期疗效和安全性。
2025 ESC年会上公布了TARGET-FIRST研究[16]结果，该研究纳入急性心肌梗死发生后7天内成功接受完全血运重建（均置入支架），并完成1个月DAPT且未发生缺血和大出血事件的患者，按照1:1比例随机分至P2Y12受体抑制剂单药治疗组（single antiplatelet therapy，SAPT）或继续DAPT组。研究的主要终点为11个月内的净不良临床事件（net adverse clinical event，NACE），包括全因死亡、心肌梗死、支架内血栓、卒中或BARC定义的3型或5型出血。研究结果显示，SAPT组和DAPT组分别有2.1%和2.2%患者发生了主要结局事件，非劣效性假设成立（P=0.02）。进而对两组BARC定义的2型、3型或5型出血发生情况进行了比较，结果显示与DAPT组相比，SAPT组出血发生率显著降低（2.6% vs. 5.6%；HR 0.46，95%CI：0.29~0.75，P=0.002）。与此同时，大会上还公布了NEO-MINDSET研究[17]结果，纳入成功接受PCI的急性冠脉综合征（acute coronary syndrome，ACS）患者，在入院后4天内（中位时间2天）以1:1的比例随机分为仅接受强效P2Y12受体抑制剂（替格瑞洛或普拉格雷，停用阿司匹林）治疗组或DAPT组（阿司匹林+替格瑞洛或普拉格雷）。随访12个月，强效P2Y12受体抑制剂单药治疗组的缺血事件发生率为7.0%，DAPT组为5.5%，组间差异为1.47%，未达到非劣效性检验（P=0.11）。在出血事件方面，单药治疗组和DAPT组的BARC2型、3型或5型出血发生率分别为2.0%和4.9%，组间差别为-2.97%。此外，需要注意的是，强效P2Y12受体抑制剂单药治疗组中有12例患者发生了支架内血栓，而DAPT组仅为4例，提示针对ACS患者PCI术后的抗血小板治疗策略，仍应保持相当疗程的DAPT，过早停用阿司匹林相对有风险。除此之外，来自空军军医大学西京医院陶凌教授开展了REC-CAGEFREE II研究[18]，旨在评估在仅接受DCB治疗的ACS患者中逐步DAPT降阶策略（对比标准12个月DAPT）对缺血和出血事件的综合影响。该研究将患者按1:1随机分配至以下两组：逐步降阶DAPT组：阿司匹林+替格瑞洛（1个月）→替格瑞洛单药（5个月）→阿司匹林单药（6个月）；标准DAPT组：阿司匹林+替格瑞洛（12个月）。主要终点方面，逐步降阶组与标准组NACE发生率分别为8.9%和8.6%（非劣效性P=0.013）。出血事件方面，BARC 3或5型出血在逐步降阶组仅0.4%，显著低于标准组的1.6%（P=0.008）。缺血事件方面，全因死亡、卒中、心肌梗死和血运重建发生率两组无显著差异（8.6% vs.7.6%，P=0.396）。
在2025年，美国心脏病学会公布了最新的ACS管理指南[19]，其中降阶抗血小板治疗方案推荐如下：阿司匹林联合替格瑞洛1~3个月后，替格瑞洛单药治疗至PCI后1年（Ⅰ，A）；阿司匹林联合替格瑞洛或普拉格雷1个月后，阿司匹林联合氯吡格雷至PCI后1年（Ⅱb，B）；高出血风险患者DAPT 1个月后，阿司匹林或P2Y12抑制剂单药治疗11个月（Ⅱb，B）。与2023年ESC ACS管理指南相比，美国指南更积极推荐抗血小板降阶治疗，DAPT后P2Y12抑制剂单药治疗的推荐等级提升为Ⅰ类，并将降阶前的DAPT疗程缩短至1~3个月。不过，目前研究结论尚不完全一致，仍应根据不同人群特征、临床情况或缺血和出血风险等因素进行综合评估和合理个体化选择。
❤
5.降脂治疗
降脂治疗也是预防和改善动脉粥样硬化性心血管疾病（atherosclerotic cardiovascular disease，ASCVD）预后的核心关键。2025年，血脂领域研究聚焦新靶点/新技术药物研发、残余风险防控、治疗策略转型等多个方面，全面推动“精准降脂、精准防治”的新理念。
关于新型口服PCSK9抑制剂AZD0780的PURSUIT Ⅱ期临床试验结果于2025年发表[20]，研究显示，在他汀治疗基础上，AZD0780（每日一次口服）能显著、剂量依赖性地降低低密度脂蛋白胆固醇（low density lipoprotein cholesterol，LDL-C），12周时最高剂量组（30 mg）可使LDL-C较基线降低约50.7%，使84.2%的患者LDL-C达标。其疗效与注射型PCSK9抑制剂相当，且不良事件率与安慰剂组无显著差异。
VESALIUS-CV研究[21]首次创新性探究了PCSK9抑制剂在一级预防中的作用。研究显示，在伴有动脉粥样硬化或糖尿病，但既往无心梗或卒中史的高危患者中，使用PCSK9抑制剂依洛尤单抗治疗（中位随访4.6年）相较于安慰剂，可显著降低19%~25%的MACE风险。研究期间，依洛尤单抗将患者的LDL-C中位值从入组时的2.98 mmol/L大幅降低了约55%，稳定维持在1.17 mmol/L的低水平；而安慰剂组则始终保持在2.82 mmol/L的高位，进一步验证胆固醇水平的显著降低是临床明显获益的根本原因。该项研究改变了以往PCSK9抑制剂主要用于二级预防的局面，将其获益人群扩大到了规模更庞大的高危一级预防领域。此防控前移，深刻体现出“更积极、更早期、更高效”的降脂新理念。
2025 ESC会议上，Ⅲ期Essence-TIMI 73b研究[22]结果公布，研究显示在确诊ASCVD的中重度高甘油三酯血症或因2型糖尿病且年龄≥55岁所致ASCVD风险升高的患者中，靶向APOC3的反义寡核苷酸（ASO）药物Olezarsen可显著降低甘油三酯水平58.4%~60.6%，安全性良好。同年的AHA大会，关于Olezarsen治疗重度高甘油三酯血症的关键Ⅲ期研究（CORE/CORE2）[23]也发布，提示Olezarsen平均降低甘油三酯达72%，急性胰腺炎风险显著降低85%，整体耐受性良好。该药已于2025年9月被欧盟正式批准用于家族性乳糜微粒血症综合征（familial chylomicronemia syndrome，FCS）成人患者，这也是全球首个获批用于FCS的APOC3靶向ASO药物，为这类罕见遗传病患者提供了新的治疗选择。
此外，另一个靶向APOC3的siRNA药物Plozasiran，在2025年美国脂质学会年会上公布了其SHASTA-2研究结果，证实Plozasiran在重度高甘油三酯血症患者中每3个月皮下注射可显著降低甘油三酯达57%、使90.6%患者甘油三酯降至500 mg/dl以下，安全性良好。基于前期的PALISADE Ⅲ期与SUMMIT Ⅱ期等研究项目的支持性数据，2025年11月，美国食品药品监督管理局（FDA）正式批准Plozasiran用于降低FCS成人患者的甘油三酯水平，成为全球首个获批用于FCS的靶向APOC3的siRNA药物。也就在近日，Plozasiran也获得了我国国家药品监督管理局（NMPA）批准，在饮食控制基础上，用于降低FCS成人患者的甘油三酯水平，填补了国内FCS靶向治疗领域空白，改变了FCS长期以来国内“无药可医”的临床困境。
在2025年，还有多部关于血脂管理的临床指南和共识发布或更新，如欧洲《2019 ESC/EAS血脂异常管理指南：2025重点更新》[24]、美国《2025 AACE成人血脂异常药物管理指南》[25]、中国《2025全面管理血脂相关心血管风险专家共识》等，聚焦更精细的危险分层、更全面的剩留风险管理、更积极的治疗目标和启动时机，旨在推动血脂领域迈向“多靶点、多通路、个体化、终身管理”的新时代。
郑博
北京大学第一医院心内科主任医师、博士研究生导师，北京大学第一医院心血管病研究所副所长。长期从事冠心病介入诊疗工作，擅长应用冠脉腔内影像和功能学技术指导复杂冠脉介入手术，现为国家卫生健康委冠心病介入培训导师、中国医师协会和中国县域医院院长联盟冠心病介入培训导师。学术任职包括美国心脏协会专家会员（FACC）、欧洲心脏学会专家会员（FESC）、亚太介入心血管病学学会专家会员（FAPSIC）、第十届中华医学会心血管病分会青年委员、中华医学会心血管病分会冠脉腔内影像和生理学学组委员、中国医疗保健国际交流促进会心血管健康医学分会常务委员兼秘书长、中国医师协会冠脉介入专业委员会委员、北京医师协会心血管医师分会常务理事、北京医学会血栓与止血分会第二届青年委员会委员、北京整合医学学会心血管代谢分会委员，中国介入心脏病学杂志青年编委，主持十四五国家重点研发计划子课题1项，在JACC Cardiovascular Imaging、European Heart Journal-Cardiovascular Imaging、Pharmacological Reserach等国际期刊及核心期刊发表论文80余篇，其中第一作者/通讯作者SCI文章24篇，参编学术专著6部，获得4项国家发明专利，研究成果被中国经皮冠状动脉介入治疗指南（2016）及2025 ACC/AHA/ACEP/NAEMSP/SCAI急性冠状动脉综合征患者管理指南引用。
张岩岩
北京大学第一医院心血管内科临床型博士在读。目前主要从事心血管疾病基础和临床诊疗相关研究工作。在读期间，获得北京大学优秀科研奖、优秀医学生等荣誉。目前以第一或共同第一作者身份发表SCI数篇。
参考文献
（上下滑动可查看）
[1] Amabile N, Rangé G, Landolff Q, et al. OCT vs Angiography for Guidance of Percutaneous Coronary Intervention of Calcified Lesions: The CALIPSO Randomized Clinical Trial. JAMA Cardiol. 2025;10(7):666-675.
[2] Stone GW, Genereux P, Maehara A, et al. Intravascular Imaging vs Angiography Guidance for PCI of Severely Calcified Lesions: The ECLIPSE Trial. JACC Cardiovasc Interv. 2025;18(19):2338-2351.
[3] Ali ZA, Shin D, Vijayvergiya R, et al. Optical coherence tomography- vs angiography-guided coronary stent implantation in calcified lesions: the ILUMIEN IV trial. Eur Heart J. 2025;46(32):3201-3210.
[4] Jo J, Lee SY, Kwon W, et al. Intravascular Imaging-Guided Versus Angiography-Guided Complex PCI in Patients With High Bleeding Risk: A Secondary Analysis of the RENOVATE-COMPLEX PCI Trial. Circ Cardiovasc Interv. 2025;18(3):e014952.
[5] Hu X, Zhang J, Yang S, et al. Angiography-derived fractional flow reserve versus intravascular ultrasound to guide percutaneous coronary intervention in patients with coronary artery disease (FLAVOUR II): a multicentre, randomised, non-inferiority trial. Lancet. 2025;405(10488):1491-1504.
[6] Marquard JM, Beske RP, Kelbæk H, et al. 10-Year Outcome of Complete or Infarct Artery-Only Revascularization in STEMI With Multivessel Disease: The DANAMI-3-PRIMULTI Study. J Am Coll Cardiol. 2025;86(2):119-129.
[7] Kim MC, Ahn JH, Hyun DY, et al. Immediate versus staged complete revascularisation during index admission in patients with ST-segment elevation myocardial infarction and multivessel disease (OPTION-STEMI): a multicentre, non-inferiority, open-label, randomised trial. Lancet. 2025;406(10507):1032-1043.[8] Nijveldt R, Maeng M, Beijnink CWH, et al. Immediate or Deferred Nonculprit-Lesion PCI in Myocardial Infarction. N Engl J Med. 2025.[9] Gao X, Tian N, Kan J, et al. Drug-Coated Balloon Angioplasty of the Side Branch During Provisional Stenting: The Multicenter Randomized DCB-BIF Trial. J Am Coll Cardiol. 2025;85(1):1-15.[10] Ciardetti N, Mattesini A, Werner GS, et al. Drug-Coated Balloons in the European Registry of Chronic Total Occlusion: The ERCTO Registry. JACC Cardiovasc Interv. 2025;18(18):2209-2221.[11] Fezzi S, Giacoppo D, Fahrni G, et al. Individual patient data meta-analysis of paclitaxel-coated balloons vs. drug-eluting stents for small-vessel coronary artery disease: the ANDROMEDA study. Eur Heart J. 2025;46(17):1586-1599.[12] Caminiti R, Vizzari G, Ielasi A, et al. Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients. Clin Res Cardiol. 2025;114(8):978-990.[13] Liu H, Li Y, Fu G, et al. Sirolimus- vs Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis: The SIBLINT-ISR Randomized Trial. JACC Cardiovasc Interv. 2025;18(8):963-971.[14] Zhou Y, Hu Y, Zhao X, et al. Sirolimus-coated versus paclitaxel-coated balloons for bifurcated coronary lesions in the side branch: the SPACIOUS trial. EuroIntervention. 2025;21(6):e307-e317.[15] Choi KH, Park YH, Lee JY, et al. Efficacy and safety of clopidogrel versus aspirin monotherapy in patients at high risk of subsequent cardiovascular event after percutaneous coronary intervention (SMART-CHOICE 3): a randomised, open-label, multicentre trial. Lancet. 2025;405(10486):1252-1263.[16] Tarantini G, Honton B, Paradies V, et al. Early Discontinuation of Aspirin after PCI in Low-Risk Acute Myocardial Infarction. N Engl J Med. 2025;393(21):2083-2094.[17] Guimarães PO, Franken M, Tavares CAM, et al. Early Withdrawal of Aspirin after PCI in Acute Coronary Syndromes. N Engl J Med. 2025;393(21):2095-2106.[18] Gao C, Zhu B, Ouyang F, et al. Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial. Bmj. 2025;388:e082945.[19] Rao SV, O'Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025;151(13):e771-e862.[20] Koren MJ, Vega RB, Agrawal N, et al. An Oral PCSK9 Inhibitor for Treatment of Hypercholesterolemia: The PURSUIT Randomized Trial. J Am Coll Cardiol. 2025;85(21):1996-2007.[21] Bohula EA, Marston NA, Bhatia AK, et al. Evolocumab in Patients without a Previous Myocardial Infarction or Stroke. N Engl J Med. 2026;394(2):117-127.[22] Bergmark BA, Marston NA, Prohaska TA, et al. Targeting APOC3 with Olezarsen in Moderate Hypertriglyceridemia. N Engl J Med. 2025;393(13):1279-1291.[23] Marston NA, Bergmark BA, Alexander VJ, et al. Olezarsen for Managing Severe Hypertriglyceridemia and Pancreatitis Risk. N Engl J Med. 2025.[24] Mach F, Koskinas KC, Roeters van Lennep JE, et al. 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2025;46(42):4359-4378.[25] Patel SB, Wyne KL, Afreen S, et al. American Association of Clinical Endocrinology Clinical Practice Guideline on Pharmacologic Management of Adults With Dyslipidemia. Endocr Pract. 2025;31(2):236-262.
声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。
（来源：《国际循环》编辑部）
版
权
声
明
凡原创文章版权属《国际循环》所有。欢迎个人转发分享。其他任何媒体、网站如需转载或引用本网版权所有之内容须在醒目位置处注明“转自《国际循环》”
临床研究
100 项与 硫酸氢氯吡格雷 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 动脉粥样硬化 | 澳大利亚 | 2001-07-06 | |
| 缺血 | 澳大利亚 | 2001-07-06 | |
| 稳定型心绞痛 | 中国 | 2000-01-01 | |
| 脑血管疾病 | 中国 | 2000-01-01 | |
| 心肌缺血 | 中国 | 2000-01-01 | |
| 非ST段抬高型心肌梗死 | 中国 | 2000-01-01 | |
| 非 ST 段抬高急性冠脉综合征 | 欧盟 | 1998-07-15 | |
| 非 ST 段抬高急性冠脉综合征 | 冰岛 | 1998-07-15 | |
| 非 ST 段抬高急性冠脉综合征 | 列支敦士登 | 1998-07-15 | |
| 非 ST 段抬高急性冠脉综合征 | 挪威 | 1998-07-15 | |
| 非q波心肌梗死 | 欧盟 | 1998-07-15 | |
| 非q波心肌梗死 | 冰岛 | 1998-07-15 | |
| 非q波心肌梗死 | 列支敦士登 | 1998-07-15 | |
| 非q波心肌梗死 | 挪威 | 1998-07-15 | |
| ST段抬高心肌梗死 | 欧盟 | 1998-07-15 | |
| ST段抬高心肌梗死 | 冰岛 | 1998-07-15 | |
| ST段抬高心肌梗死 | 列支敦士登 | 1998-07-15 | |
| ST段抬高心肌梗死 | 挪威 | 1998-07-15 | |
| 急性冠状动脉综合征 | 欧盟 | 1998-07-14 | |
| 急性冠状动脉综合征 | 冰岛 | 1998-07-14 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 血管疾病 | 临床3期 | 德国 | 2011-08-08 | |
| 陈旧性心肌梗死 | 临床3期 | 日本 | 2008-12-01 | |
| 先天性心脏缺损 | 临床3期 | 美国 | 2006-11-01 | |
| 先天性心脏缺损 | 临床3期 | 中国 | 2006-11-01 | |
| 先天性心脏缺损 | 临床3期 | 阿根廷 | 2006-11-01 | |
| 先天性心脏缺损 | 临床3期 | 比利时 | 2006-11-01 | |
| 先天性心脏缺损 | 临床3期 | 巴西 | 2006-11-01 | |
| 先天性心脏缺损 | 临床3期 | 加拿大 | 2006-11-01 | |
| 先天性心脏缺损 | 临床3期 | 丹麦 | 2006-11-01 | |
| 先天性心脏缺损 | 临床3期 | 埃及 | 2006-11-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
N/A | 急性缺血性卒中 CYP2C19 Loss-of-Function Alleles | 317 | 顧簾蓋鹹鑰淵糧選鏇壓(衊廠顧鏇窪鑰願遞鹹襯) = 淵顧衊餘鏇積壓選壓範 繭鏇獵淵獵蓋簾構艱鑰 (製選簾鏇製鏇淵廠鬱糧 ) 更多 | 积极 | 2026-02-04 | ||
N/A | 912 | 夢鏇窪積鬱憲構鹽構網(繭糧網鏇鹹糧鬱顧範簾): P-Value = 0.214 更多 | 积极 | 2026-02-04 | |||
Single antiplatelet therapy (SAPT) (aspirin or clopidogrel alone) | |||||||
临床3期 | 5,919 | Ticagrelor-aspirin | 繭鹽蓋簾鹹窪鑰觸遞鏇(鹹構繭遞淵夢憲簾艱構) = The risk of bleeding associated with ticagrelor-aspirin did not differ across Lp-PLA2 activity levels. 窪網鹹膚簾窪夢選糧繭 (觸積範窪選繭鏇糧獵遞 ) 更多 | 不佳 | 2026-01-13 | ||
临床4期 | 200 | 膚糧窪壓製鬱衊繭網艱(膚範積窪製選簾襯積廠) = 壓襯艱積衊選鑰顧製齋 築製餘窪築繭製夢窪獵 (窪顧鑰蓋醖遞膚廠獵餘 ) 更多 | 积极 | 2026-01-01 | |||
Warfarin | 願膚醖選窪蓋衊醖膚繭(簾選顧鹽齋襯製構鹽積) = 積壓夢觸願顧餘鑰鬱鑰 鹹積鹽繭獵餘淵膚簾壓 (憲廠選糧窪衊壓積艱顧 ) 更多 | ||||||
临床3期 | 5,651 | Aspirin-Ticagrelor | 繭繭壓積餘選鏇鹽網憲(願顧觸築齋鏇築窪醖觸) = 壓顧蓋鏇鹽遞憲蓋艱網 鏇餘廠壓選築淵廠糧選 (壓鏇簾積鬱窪艱簾網廠 ) 更多 | 积极 | 2025-12-18 | ||
繭繭壓積餘選鏇鹽網憲(願顧觸築齋鏇築窪醖觸) = 憲夢遞顧遞範鏇鏇顧鹹 鏇餘廠壓選築淵廠糧選 (壓鏇簾積鬱窪艱簾網廠 ) 更多 | |||||||
临床4期 | 2,201 | 膚鬱鹽夢壓壓顧鏇築願(獵網積鹽蓋憲範構築網) = 糧淵艱構憲廠夢壓製簾 襯蓋夢築網鏇構鹹蓋壓 (廠製構淵艱艱鏇製繭醖 ) 更多 | 不佳 | 2025-12-01 | |||
膚鬱鹽夢壓壓顧鏇築願(獵網積鹽蓋憲範構築網) = 齋選艱顧簾艱選鹹壓憲 襯蓋夢築網鏇構鹹蓋壓 (廠製構淵艱艱鏇製繭醖 ) 更多 | |||||||
临床3期 | 短暂性脑缺血发作 CYP2C19 loss-of-function alleles | 1,379 | Ticagrelor-aspirin | 衊範襯憲膚積獵糧廠蓋(憲鏇衊積鬱餘網齋膚鏇) = 繭獵範鹽齋廠醖製糧遞 鏇製積襯築餘繭範膚選 (艱遞窪襯鹹獵積廠鏇憲 ) | 积极 | 2025-12-01 | |
衊範襯憲膚積獵糧廠蓋(憲鏇衊積鬱餘網齋膚鏇) = 鹽積範獵鏇遞鹽積膚憲 鏇製積襯築餘繭範膚選 (艱遞窪襯鹹獵積廠鏇憲 ) | |||||||
N/A | 63 | (Atomoxetine) | 網鏇夢廠構憲簾構築鹹(簾鑰鹹齋選鑰鏇選觸窪) = 壓築範顧簾鹹憲觸鏇遞 製糧窪壓遞選夢鬱獵鹹 (築製獵顧積鏇遞餘醖鏇, 繭膚齋簾積製觸壓膚網 ~ 蓋齋齋獵遞範膚鹽廠獵) 更多 | - | 2025-11-14 | ||
Placebo (Placebo (Matching Atomoxetine)) | 網鏇夢廠構憲簾構築鹹(簾鑰鹹齋選鑰鏇選觸窪) = 廠積遞遞淵積鬱積製淵 製糧窪壓遞選夢鬱獵鹹 (築製獵顧積鏇遞餘醖鏇, 壓衊鑰膚鑰遞淵觸淵鹹 ~ 鏇鹹壓齋構襯窪艱廠艱) 更多 | ||||||
临床2期 | 376 | Aspirin, clopidogrel, and high-intensity statins | 夢艱網壓觸襯積鏇夢範(簾顧網夢積鹹膚簾鬱膚) = 鏇窪築獵遞製淵壓襯糧 艱範顧壓廠壓糧構顧繭 (範齋網獵膚膚鬱鑰鹹醖 ) 更多 | 积极 | 2025-11-01 | ||
Single antiplatelet therapy and moderate- or low-intensity statins | 夢艱網壓觸襯積鏇夢範(簾顧網夢積鹹膚簾鬱膚) = 糧憲鹹蓋觸鹽襯繭繭願 艱範顧壓廠壓糧構顧繭 (範齋網獵膚膚鬱鑰鹹醖 ) 更多 | ||||||
N/A | 28,982 | 顧鏇觸選鬱醖夢繭廠製(廠觸顧顧齋齋窪鬱積壓) = 夢醖衊窪構憲膚製顧鏇 選網淵遞鏇蓋衊夢壓餘 (鏇鏇壓簾齋齋鑰鏇鹽範 ) 更多 | 积极 | 2025-09-19 | |||
顧鏇觸選鬱醖夢繭廠製(廠觸顧顧齋齋窪鬱積壓) = 壓糧鹽襯簾壓鹹願廠網 選網淵遞鏇蓋衊夢壓餘 (鏇鏇壓簾齋齋鑰鏇鹽範 ) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用