This is an open-label, randomized feasibility trial in which patients admitted to Oregon Health & Science University (OHSU) after a pregnancy complicated by preeclampsia who are considering a progestin-only pill contraception postpartum will be randomized to norethindrone or drospirenone for 6 weeks following hospital discharge.

开始日期2026-07-01

申办/合作机构

Oregon Health & Science University

CTIS2026-525727-24-00

/ Not yet recruiting临床3期

Prospective, multicentre, open-label, single arm trial on contraceptive efficacy, safety and tolerability of LPRI-CF113 (Drospirenone 4 mg + 2.8 mg) during 13 cycles.

开始日期2026-06-30

申办/合作机构-

NCT07340190

/ Recruiting临床1期

A Phase 1b, Open Label, 2-Part Study to Evaluate the Effect of Pelabresib (DAK539/CPI-0610) on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Patients With Advanced Malignancies

This drug-drug interaction (DDI) study aims to evaluate the impact of pelabresib at steady-state plasma concentrations on the pharmacokinetic (PK) profile of A) a single dose of repaglinide and a single dose of midazolam, and B) a single dose of combined drospirenone and ethinyl estradiol. The study will be conducted in adult participants with advanced malignancies for whom no standard or curative treatment options are available.

开始日期2026-06-12

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

100 项与屈螺酮相关的临床结果

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100 项与屈螺酮相关的转化医学

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100 项与屈螺酮相关的专利（医药）

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项与屈螺酮相关的文献（医药）

2026-12-31·GYNECOLOGICAL ENDOCRINOLOGY

Continuous estetrol/drospirenone regimen for the treatment of endometriosis-related pain: preliminary results

Article

作者: Bifulco, Giuseppe ; Dell'Aquila, Michela ; Della Corte, Luigi ; Di Carlo, Costantino ; Kafetzis, Dimitrios ; Giampaolino, Pierluigi

PURPOSE:

Endometriosis is a chronic inflammatory condition that causes significant physical and psychological distress. This study aimed to evaluate the therapeutic efficacy and safety of a combined oral contraceptive containing estetrol (E4, 14 mg) and drospirenone (DRSP, 3 mg) in managing endometriosis-related pain.

MATERIALS AND METHODS:

A retrospective cohort study was carried out at the Endometriosis Center, Federico II University Hospital, Naples, from January 2024 to November 2024. Forty patients with diagnosis of endometriosis and significant pain symptoms (VAS > 6) were included and received E4/DRSP under a continuous regimen for 6 months. Chronic pelvic pain, dyspareunia, dysmenorrhea, and patient quality of life were assessed at baseline, after 3 and 6 months. In the group of patients with endometrioma, reduction in size was evaluated.

RESULTS:

E4/DRSP significantly reduced chronic pelvic pain and dyspareunia. Dysmenorrhea was resolved entirely due to amenorrhea induction. Endometriomas decreased in size by 30% on average after 6 months. Adverse effects were mild and occurred in 13/40 of patients (32.5%).

CONCLUSION:

E4/DRSP demonstrated efficacy and tolerability for managing endometriosis-related pain, offering a promising option for long-term treatment. Further research is needed to confirm its impact on lesion regression and disease progression.

2026-07-01·AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY

Venous thromboembolism with combined oral contraceptives based on estrogen and progestin content: a disproportionality analysis of the United States Food and Drug Administration Adverse Event Reporting System database

Article

作者: Beaudart, Charlotte ; Locquet, Médéa ; Dogne, Jean-Michel ; Didembourg, Marie ; Creinin, Mitchell D ; Douxfils, Jonathan ; Raskin, Lucie

BACKGROUND:

Disproportionality analyses using pharmacovigilance databases permit comparisons between products for rare outcomes, such as venous thromboembolism with combined oral contraceptives.

OBJECTIVE:

To compare the proportionality reporting rate of venous thromboembolic adverse events in the Food and Drug Administration Adverse Reporting System database between 2 body-identical estrogen combined oral contraceptives available in the United States, 17β-estradiol valerate/dienogest and estetrol/drospirenone, and combined oral contraceptives containing ethinyl estradiol.

STUDY DESIGN:

We extracted individual case safety reports and adverse events from the Food and Drug Administration Adverse Reporting System database from its inception to October 2024. We performed a proportionality reporting rate analysis of venous thromboembolic events associated with various combined oral contraceptives as compared to reference standards of ethinyl estradiol/levonorgestrel combined oral contraceptives and the entire therapeutic class. Secondarily, we assessed the proportionality reporting rate with drospirenone-only pills and norethindrone-only pills.

RESULTS:

Compared to ethinyl estradiol/levonorgestrel, we found lower proportionality reporting rates with estetrol/drospirenone (0.54; 95% confidence interval, 0.30-0.99) and 17β-estradiol valerate/dienogest (0.79 [5]; 95% confidence interval, 0.65-0.97), which were similar to the proportionality reporting rates for drospirenone-only pills (0.64; 95% confidence interval, 0.55-0.74) and norethindrone-only pills (0.69; 95% confidence interval, 0.60-0.79). Ethinyl estradiol/drospirenone had the highest proportionality reporting rate at 5.18 (95% confidence interval, 4.95-5.42). Using the entire therapeutic class as reference, we similarly found lower proportionality reporting rates with estetrol/drospirenone (0.17; 95% confidence interval, 0.09-0.31) and 17β-estradiol valerate/dienogest (0.25; 95% confidence interval, 0.21-0.30), both of which were similar to the proportionality reporting rate observed for drospirenone-only pills (0.20; 95% confidence interval, 0.17-0.23) and norethindrone-only pills (0.21; 95% confidence interval, 0.19-0.24); the highest proportionality reporting rate, for ethinyl estradiol/drospirenone, was 4.52 (95% confidence interval, 4.41-4.63).

CONCLUSION:

Combined oral contraceptives containing body-identical estrogens, estetrol, and 17β-estradiol have lower proportions of venous thromboembolism reports than ethinyl estradiol-based pills and are similar to progestin-only pills. These findings suggest a potentially safer thrombotic profile of body-identical estrogen-based combined oral contraceptives.

2026-07-01·CONTRACEPTION

Safety and effectiveness of contraception among women with chronic kidney disease: A systematic review

Review

作者: Folger, Suzanne ; Curtis, Kathryn M ; Whiteman, Maura K ; Kortsmit, Katherine ; Tepper, Naomi K ; Burgner, Anna ; Nguyen, Antoinette T

OBJECTIVES:

To systematically review evidence on the safety and effectiveness of contraceptive use among women with chronic kidney disease (CKD).

STUDY DESIGN:

We searched for articles in multiple databases from database inception through December 12, 2022, that assessed safety and effectiveness of contraceptive use among women with CKD; all study designs were included. We extracted data from included articles; for studies that were not case series or case reports, we assessed risk of bias and determined certainty of evidence for each outcome.

RESULTS:

Eight articles, including 5 case reports, met inclusion criteria. All articles assessed safety outcomes associated with contraceptive use among women with CKD; none examined contraceptive effectiveness. Risk of bias for three studies (not including case reports) ranged from moderate to high and varied by outcome. One prospective cohort study observed no increased risk of hypertension or end stage renal disease among oral contraceptive (type unknown) users compared with non-users, while a non-randomized trial observed no changes in blood pressure over 21 days among 5 peritoneal dialysis patients using combined oral contraceptives. Another non-randomized trial examined hyperkalemia risk among drospirenone progestin-only pill users; hyperkalemia did not develop in participants with normal, mild, or moderate renal impairment. Four case reports described adverse events among intrauterine device (IUD) users, and one case report described decreased bleeding with levonorgestrel IUD use.

CONCLUSION:

Despite several theoretical concerns (e.g., worsening kidney disease, worsening hypertension, and thrombosis) about the safety of contraception among women with CKD, data are limited, and the certainty of existing evidence is very low.

IMPLICATIONS:

Health care providers can use the information in this review when counseling women with CKD about contraceptive decision-making. More research is needed to better understand the safety and effectiveness of the full range of available contraceptive methods among women with CKD.

项与屈螺酮相关的新闻（医药）

2026-07-08

·FiercePharma

Foreign drugmaker caught faking doctors’ petition to evade China’s price cut scheme

Amid an ongoing expansion of China’s volume-based procurement (VBP) scheme to lower drug costs, the Chinese government has singled out a fraud case involving a foreign originator drug in a warning to the industry. In an attempt to influence whether a drug gets selected for price bidding, a foreign drug innovator faked doctors’ signatures in a petition, China’s National Healthcare Security Administration (NHSA) said in a post (Chinese) on Tuesday. Among the 78 signatures from 31 hospitals, over 80% were found to be doctored. Some signatures were forged by sales representatives, some used misappropriated images from other sources, and some pointed to individuals that do not exist, according to the agency. As for the few signatures that the experts themselves indeed wrote, the doctors were mostly tricked into signing the document under the guise of survey questionnaires or post-sales follow-up, the agency said. The drug has since been included in the latest VBP batch of 65 drug varieties, which together represent a total market value of nearly 60 billion Chinese yuan ($8.8 billion), according to the NHSA. The VBP, now in its 12th round, is a government-led drug-buying program targeting off-patent medicines. Under the program, generics and the originators offer price cuts to secure procurement contracts with hospitals. The government unveiled the latest list on June 23 and is now in the bidding process. In a statement to local news outlet The Paper , Novartis confirmed it was not the unnamed drugmaker flagged in the NHSA alert. The Swiss pharma’s blockbuster heart failure treatment Entresto (sacubitril/valsartan) is one of the biggest products in this VBP round. According to local reports, Entresto and its generics generated more than 6 billion yuan of end-market sales ($880 million) at public hospitals in China last year, with the Novartis originator accounting for more than 90%. The VBP program now threatens to split up that huge market by rewarding significant shares to companies that offer lower prices. In what’s slated to be an über-competitive bidding process, more than 30 Entresto generics competitors are vying for a place under VBP, according to local drug intelligence database DXY Insight. As part of the largest patent expiry in Novartis’ history, Entresto lost its U.S. market exclusivity last year and has seen major sales declines since. Some uncertainties remain for VBP’s potential impact on Entresto. The Novartis drug is among eight products that carry an asterisk, which indicates ongoing patent disputes. A few days before the revelation of the latest VBP list last month, China’s National Intellectual Property Administration doled out a five-year patent-term extension to Entresto to make up for time lost during its drug regulatory review process, effectively pushing back the expiration of its core patent to November 2031. In a new rule introduced into VBP this time, generic rivals to those asterisked drugs must submit a declaration of non-infringement or be removed from procurement platforms. Takeda’s angiotensin II receptor blocker Edarbi (azilsartan medoxomil) and acid blocker Takecab (vonoprazan fumarate), Eli Lilly’s JAK inhibitor Olumiant, Daiichi Sankyo’s factor Xa inhibitor edoxaban and AstraZeneca’s Xigduo XR (dapagliflozin and metformin extended release) are also included in VBP despite ongoing patent disagreements. Takeda, Bayer and Eisai have also denied they were the company in the NHSA’s announcement, according to The Paper. Bayer’s drospirenone/ethinyl estradiol oral contraceptive, known commercially as Yaz or Yasmin, and its imaging contrast agent Ultravist (iopromide) are included for VBP bidding against generics. Eisai has anti-vertigo medication Merislon (betahistine) and anti-seizure med Fycompa (perampanel) on the list. In addition to the companies above, the 65-item roster includes brand-name products from almost all major pharmas, including Astellas, Fresenius Kabi, GSK, Johnson & Johnson, Pfizer, Merck & Co., Merck KGaA, Otsuka, Sanofi and Servier. Among the smaller firms involved are Cheplapharm, Dr. Falk Pharma and Grünenthal from Germany; Japan’s Maruishi Pharmaceutical, Sumitomo Pharma, LTL Pharma and Minophagen Pharmaceutical; as well as the Wellcome Foundation and Tillotts Pharma in Switzerland.

2026-06-06

·新药杂货铺

痛经（原发性痛经）创新中药穴位贴敷治疗药物研发立项医学报告

最近闲来无事，做了一项医学立项调研——非命题作文，以飨读者。痛经（原发性痛经）创新中药穴位贴敷治疗药物研发立项医学报告目录一、执行摘要二、疾病概述三、流行病学 3.1 全球流行病学 3.2 中国流行病学 3.3 疾病负担四、目前治疗手段 4.1 药物治疗 4.2 非药物治疗 4.3 手术治疗 4.4 治疗指南推荐五、未满足的临床需求六、疾病信号通路 6.1 核心发病机制 6.2 信号通路图 6.3 潜在治疗靶点七、中医药治疗理论 7.1 中医病因病机 7.2 辨证分型与治则 7.3 穴位贴敷治疗的理论基础 7.4 穴位与用药规律 7.5 临床循证证据八、临床试验特点 8.1 主要研究设计 8.2 核心评价指标 8.3 关键方案参数九、研发策略建议十、参考文献一、执行摘要痛经（Dysmenorrhea）是女性月经期最常见的妇科症状之一，全球育龄女性患病率高达50%-91%，其中重度痛经约15%-29%。中国育龄女性总体患病率约56%-60%，15-25岁青少年群体高达79%。该疾病导致显著的缺课/缺勤、生活质量下降及心理健康损害，被WHO列为重要公共卫生问题。目前治疗以NSAIDs和激素避孕药为主，但约18%患者NSAIDs无效，且存在胃肠道不良反应和长期用药依从性问题。中医药穴位贴敷疗法凭借"内病外治"理论，通过穴位刺激与透皮给药双重机制起效，具有副作用小、操作简便、远期疗效优于单纯西药的显著优势，尤其适合实证（寒凝、气滞、血瘀）型痛经。临床研究证实其总有效率可达90%以上，PGF₂α/PGE₂比值显著下降，多项RCT支持其安全有效。本项目拟开发一种创新中药穴位贴敷新药，锁定寒凝血瘀型原发性痛经适应症，目标填补目前市场缺乏标准化、高质量中药外用制剂的空白，具有良好的临床价值和市场前景。二、疾病概述2.1 定义与分类痛经是指在行经前后或月经期出现下腹部痉挛性疼痛、坠胀，伴有腰酸或其他不适，严重者可影响生活和工作质量。根据病因分为：（1）原发性痛经（Primary Dysmenorrhea, PD）：无盆腔器质性病变，多见于初潮后1-2年的青春期女性，占痛经总数的70%以上。主要与月经期子宫内膜前列腺素（尤其是PGF₂α）过度分泌有关。（2）继发性痛经（Secondary Dysmenorrhea）：由盆腔器质性疾病引起，如子宫内膜异位症（占65%以上）、子宫腺肌病、盆腔炎性疾病等。多见于30岁以上经产妇。 ICD-10编码：原发性痛经 N94.4；继发性痛经 N94.5。2.2 临床表现 • 下腹部痉挛性疼痛，可放射至腰骶部及大腿内侧 • 常伴恶心、呕吐、腹泻、头痛、乏力等全身症状 • 原发性痛经多始于月经来潮前数小时或来潮时，持续48-72小时 • 疼痛VAS评分常达4-8分，重度者可>8分三、流行病学3.1 全球流行病学根据2024年发表的一项覆盖70个国家、纳入约20万例样本的系统评价与Meta分析，全球育龄女性痛经患病率为50%-91%（汇总患病率约71%），其中重度痛经约15%-29%。患病率因地域、年龄、人群差异而不同：地区/人群患病率重度痛经比例数据来源全球（70国荟萃） 71%（50%-91%） 15%-29% Pain, 2024 WHO GBD 2024（15-19岁） 67.8% 23% GBD 2024 北欧/西欧 55%-72% 10%-20% Cochrane Review 中东 65%-85% 20%-30% BMC Womens Health 日本 46%-54% 15% J Obstet Gynaecol Res 美国 45%-90% 14%-25% ACOG 3.2 中国流行病学中国育龄女性痛经患病率因调查方法和人群不同而有所差异，综合多项研究数据总结如下：研究/来源人群样本量患病率说明全国月经生理常数协作组（1980）全国妇女 71,746 33.2% 重度13.6% 中国妇幼健康研究（2024） 15-49岁育龄女性 23,000+ 总体60.2%；15-25岁79.4% 中重度36.8% 中国妇产科临床杂志（2023）全国女性 — 56.2% 原发性占70%以上北京协和医院（2025）初中女生多中心 52.3% — 北京协和医院（2025）高中女生多中心 74.6% — 湖南横断面（2020）女大学生 4,606 41.7% — 中华妇幼临床医学杂志 13-25岁青春期 — 68.3% — 关键流行病学特征：① 青少年患病率显著高于整体育龄女性，呈年轻化趋势；② 学业压力与痛经严重度存在显著正相关；③ 初潮年龄<12岁者顽固性痛经风险比达2.31；④ 家族聚集性明显，母亲有痛经史者风险增加OR=2.55（95%CI: 2.24-2.92）。3.3 就诊率与疾病负担指标数据来源青少年主动就医率 28.6%（中国）vs 45%（欧美）协和2025 年均缺课天数 6.4天/人教育部2025 高三模拟考缺考率 17.8% 教育部2025 痛经组PHQ-9抑郁评分较对照组高7.2分协和2025 青少年贫血率（月失血>80ml） 18.7%（Hb<110g/L）协和2025 内异症诊断平均延迟 6.4年 ACOG 美国年经济损失约20亿美元 JPR 2024 荷兰人均年生产力损失 1.3天（缺勤）+8.9天（生产性减损） BMJ Open 3.4 继发性痛经——子宫内膜异位症指标数据育龄女性内异症患病率 10%-15% 以痛经为首发症状比例 72% 内异症中痛经发生率 87.6% 中国患者估计数 289万（GBD 2021）；另估3000万-4500万年龄标准化患病率 416.65/10万子宫腺肌病患者痛经发生率 91.3%，VAS平均7.2分未及时干预不孕率 40%-50% 四、目前治疗手段4.1 药物治疗（一线）（1）非甾体抗炎药（NSAIDs）——一线基石通过抑制COX-1/COX-2酶，阻断花生四烯酸转化为前列腺素，减少PGF₂α和PGE₂生成。需在月经来潮前1-2天或来潮即刻开始用药，持续2-3天。药物剂量特点布洛芬（Ibuprofen） 400-600mg q4-6h 或 800mg q8h（最大2,400mg/日）首选，安全性最佳萘普生（Naproxen）首剂500mg，后250mg q6-8h 半衰期长，适合持续镇痛甲芬那酸（Mefenamic acid）首剂500mg，后250mg q6h 兼具PG合成抑制和受体拮抗双氯芬酸（Diclofenac） 50mg tid 胃肠道不良反应较大塞来昔布（Celecoxib） 200mg bid COX-2选择性，胃肠道安全性更优局限性：约18%患者NSAID治疗无效；仅阻断新的PG合成，对已生成的PG无效；长期使用可致胃肠道溃疡、肾功能损害；不适用于备孕或有胃肠疾病患者。（2）激素避孕药——同等一线通过抑制排卵、减少子宫内膜增生、降低经期PG释放发挥镇痛作用。类别代表药物/方式特点复方口服避孕药（COCs）炔雌醇+孕激素复合制剂雌激素<35μg与>35μg症状缓解相似左炔诺孕酮宫内节育系统（LNG-IUS）曼月乐 60%→29%痛经减少（36个月）依托孕烯植入剂（Nexplanon）皮下植入约68%痛经减少（6个月）醋酸甲羟孕酮注射剂（Depo-Provera）肌注，每3月一次约58%减少，注意骨质流失风险纯孕激素口服药炔诺酮0.35mg/屈螺酮4mg 适用于雌激素禁忌者禁忌症：高血压、卒中/DVT/PE病史、缺血性心脏病、凝血障碍、乳腺癌、肝病、偏头痛伴先兆、吸烟+年龄>35岁。局限性：不适合备孕女性；依从性差；系统吸收副作用（体重增加、情绪波动等）。4.2 二线药物及非药物治疗（1）对乙酰氨基酚：325-650mg q4-6h，中枢镇痛，外周抗炎作用弱，疗效弱于NSAIDs。（2）GnRH类似物（Relugolix/Elagolix）：适用于难治性痛经和子宫内膜异位症，但长期使用可致骨质流失、潮热等低雌激素症状。（3）物理疗法：局部热敷（一级证据）、规律运动（8-12周显著降低疼痛）、TENS（证据中等）。（4）替代医学：针灸（证据中等）、膳食补充剂（姜、茴香、维生素E/B1/镁/锌、鱼油，证据有限）。（5）手术疗法（难治性）：子宫内膜消融术、骶前神经切除术、腹腔镜子宫骶神经消融术（LUNA）。4.3 治疗指南推荐总结（2024） • 一线：NSAIDs（布洛芬首选）± 激素避孕药 • 启动治疗前应至少规律用药3个月经周期再评估疗效 • 鼓励NSAIDs+激素+非药物多模式联合治疗 • 重度痛经是慢性疼痛综合征发生的危险因素，早期充分治疗可预防中枢敏化五、未满足的临床需求尽管痛经患病率极高，但当前临床管理仍存在多重"未被满足的需求"，为创新药物研发提供了重要机遇：5.1 药物治疗缺口 ① NSAIDs抵抗：约18%患者对NSAIDs不敏感，且仅阻断新PG合成而对已生成的PG无效。 ② 激素治疗限制：备孕女性、有雌激素禁忌症（卒中/VTE/偏头痛等）者无法使用激素类药物。 ③ 长期用药安全性担忧：NSAIDs的胃肠道/肾毒性、激素药的系统性副作用影响依从性。 ④ 缺少高质量的外用制剂：目前市场缺乏经皮、局部、标准化的中药外用制剂治疗痛经。5.2 诊疗体系缺口 ① 高患病-低就诊：中国青少年就诊率仅28.6%，远低于欧美，多数女性靠"忍"度过。 ② 疼痛常态化误解：社会文化将痛经视为"正常现象"，导致就医意识薄弱。 ③ 诊断延迟：内异症从症状到确诊平均延误6.4年，错过最佳干预窗口。 ④ 缺乏个体化治疗方案：临床以"试错法"为主，缺少基于生物标志物或中医辨证的精准方案。5.3 未满足需求→创新药物机会未满足需求创新机会本项目优势 NSAIDs抵抗/不耐受非COX通路的外用镇痛药物穴位贴敷透皮吸收，不依赖PG合成通路激素禁忌症人群非激素类药物纯中药组分，无激素依赖长期用药安全性局部外用，避免系统暴露经皮局部给药，肝肾代谢负担低依从性差简便易用的剂型贴敷8h/日，月经期使用2-3天缺少中药外用标准制剂标准化、高质量中药新药固定处方、标准化提取物、GMP生产缺少多靶点综合干预同时兼顾疼痛与伴随症状穴位+药物双重作用，调节PG平衡+炎症因子+内分泌六、疾病信号通路6.1 核心发病机制原发性痛经的核心病理机制为月经期子宫内膜前列腺素（Prostaglandins, PGs）过度释放。黄体期末孕酮撤退启动级联反应，导致COX-2表达上调、PGF₂α/PGE₂失衡，引发子宫平滑肌痉挛性收缩和螺旋小动脉缺血，最终产生疼痛。6.2 信号通路图以下为原发性痛经的关键分子信号通路（NF-κB/COX-2/PG核心轴）： ═══════════════════════════════════════════════════════════════════════════ 原发性痛经（Primary Dysmenorrhea）核心分子信号通路 ═══════════════════════════════════════════════════════════════════════════ 黄体期末孕酮急剧撤退（Progesterone Withdrawal） │ ▼ ┌──────────────────────┐ │ NF-κB 激活 │ │ （核转录因子-κB） │ └──────────┬───────────┘ │ ┌──────────────┼──────────────┐ │ │ │ ▼ ▼ ▼ COX-2 上调 NLRP3 炎症小体促炎细胞因子 (诱导型环氧合酶) 激活 IL-1β, IL-6, │ Caspase-1 TNF-α, IL-18 │ │ │ ▼ ▼ │ 花生四烯酸 → PGF₂α IL-1β成熟体 ←──┘ & PGE₂ │ │ │ └──────┬───────┘ │ │ ▼ ▼ ┌─────────────────────────────────────────┐ │ PGF₂α ↑↑↑ → 子宫平滑肌强烈收缩 │ │ PGE₂ ↑ → 痛觉敏化 │ │ PGF₂α/PGE₂ 比值失衡 │ └──────────────────┬──────────────────────┘ │ ▼ ┌─────────────────────────────────────────┐ │ 子宫螺旋小动脉收缩 → 子宫内膜缺血 │ │ → 无氧代谢产物堆积 → 氧化应激 │ │ → MDA↑, ROS↑, SOD↓, GSH-Px↓ │ └──────────────────┬──────────────────────┘ │ ▼ ┌─────────────────────────────────────────┐ │ ★ 疼痛 ★ │ │ 下腹部痉挛性疼痛 + 腰骶部放射 │ │ 恶心/呕吐/腹泻（PGF₂α全身效应） │ └─────────────────────────────────────────┘ ─ ─ ─ ─ ─ ─ ─ ─ ─ 辅助通路 ─ ─ ─ ─ ─ ─ ─ ─ ─ ① 催产素（Oxytocin）→ 刺激PGF₂α产生和COX-2表达 ② 血管加压素（AVP）→ V1a受体 → 子宫血管收缩 ③ 白三烯（Leukotrienes）→ 增强子宫收缩和炎症 ④ SP1/Hsp90ab1 → COX-2 转录调控（新发现通路） ⑤ 中枢敏化（Central Sensitization）→ 慢性疼痛转化 ═══════════════════════════════════════════════════════════════════════════6.3 潜在治疗靶点总结治疗靶点作用机制代表性干预 COX-1/COX-2 抑制PG合成 NSAIDs（布洛芬、萘普生） COX-2选择性选择性抑制诱导型COX-2 塞来昔布、天然产物（姜黄素） NF-κB通路抑制COX-2和炎症因子转录植物提取物（紫菀、芍药花粉） NLRP3炎症小体减少IL-1β/IL-18成熟 MCC950（实验阶段） Hsp90/SP1/COX-2轴抑制COX-2转录调控 DHEA（脱氢表雄酮）催产素信号抑制排卵/OT释放口服避孕药 PGF₂α受体（FP受体）直接拮抗子宫收缩 FP受体拮抗剂（在研）中枢敏化通路调控CNS痛觉处理 CBT、正念（实验阶段）多靶点综合（TCM）平衡PG+抗炎+调节免疫穴位贴敷（本项目）七、中医药治疗理论7.1 中医病因病机原发性痛经在中医学中称"痛经"或"经行腹痛"，《金匮要略·妇人杂病脉症并治》最早记载。病机总纲为"不通则痛"与"不荣则痛"：（1）不通则痛（实证，占80%以上）：气滞血瘀、寒凝血瘀、湿热瘀结，阻碍气血运行。（2）不荣则痛（虚证）：气血虚弱、肝肾不足，胞宫失于濡养。经典文献核心观点《金匮要略》血瘀为发病主要病因；"经水不利，少腹满痛" 《诸病源候论》经期气血不足，寒邪侵入，寒凝血瘀《妇人大全良方》寒气客于血室，血凝不行《傅青主女科》涉及肝、肾、脾三脏；"经欲行而肝不应，则拂其气而痛生" 《医宗金鉴》经前痛为气血凝滞，经后痛为气血虚弱病位：冲任、胞宫；以气血变化为中心，气滞、血瘀、寒湿为主要病理因素。现代医家发展：夏桂成强调肾虚血瘀，郭志强重脾肾阳虚，付宏伟倡"恶血归肝"理论。7.2 辨证分型与治则证型核心病机治法代表方寒凝血瘀型/寒湿凝滞证寒邪客于冲任，血为寒凝温经散寒，化瘀止痛温经汤（《金匮要略》）、少腹逐瘀汤气滞血瘀型肝郁气滞，瘀阻胞宫理气活血，祛瘀止痛血府逐瘀汤、膈下逐瘀汤湿热瘀结证湿热内蕴，与血搏结清热利湿，化瘀止痛清热调血汤气血两虚证气虚血弱，胞宫失养益气养血，调经止痛圣愈汤、八珍汤肝肾不足证肝肾亏损，精血不足补益肝肾，养血止痛调肝汤治疗总则："急则治其标，缓则治其本"，辨病与辨证相结合。7.3 穴位贴敷治疗的理论基础穴位贴敷疗法是中医"内病外治"理论的典型应用，源远流长： ① 经络传导效应：通过穴位刺激，激发经络之气，调脏腑、平衡阴阳。"经脉者，所以决生死，处百病，调虚实，不可不通。"——《灵枢经》 ② 透皮吸收效应：药物有效成分经皮吸收，直达病所，避免肝脏首过效应和胃肠道降解。 ③ 穴位-药物协同：药物对穴位的刺激+穴位对药物的放大，二者相互影响、叠加效应。 ④ 缓释长效：贴敷8-12小时，药物持续释放，维持平稳血药浓度。优势：刺激性小、操作简便、副作用少、患者依从性高，尤其适合青少年人群。7.4 核心用药与选穴规律（数据挖掘）基于多项数据挖掘研究，穴位贴敷治疗痛经的核心规律如下：高频用药（前5位）：排名药物性味归经功效使用频次占比 1 延胡索（Corydalis yanhusuo）辛、苦，温；归肝、脾经活血、行气、止痛 72% 2 肉桂（Cinnamomum cassia）辛、甘，大热；归肾、脾、心、肝经补火助阳，散寒止痛，温通经脉 65% 3 细辛（Asarum sieboldii）辛，温；归心、肺、肾经祛风散寒，通窍止痛，温肺化饮 58% 4 当归（Angelica sinensis）甘、辛，温；归肝、心、脾经补血活血，调经止痛 55% 5 川芎（Ligusticum chuanxiong）辛，温；归肝、胆、心包经活血行气，祛风止痛 52% 核心穴位（前5位）：排名穴位归经定位使用频次占比 1 关元（CV4）任脉脐下3寸 85% 2 神阙（CV8）任脉脐中 80% 3 中极（CV3）任脉脐下4寸 72% 4 三阴交（SP6）足太阴脾经内踝尖上3寸 68% 5 子宫（EX-CA1）经外奇穴脐下4寸，旁开3寸 62% 核心配伍处方：神阙 + 关元 + 三阴交 + 子宫 + 气海 + 中极。选穴以任脉穴为主（"阴脉之海"，起于胞中），体现"腧穴所在，主治所在"的近治规律。7.5 临床循证证据研究类型干预/对照主要结果来源 Meta分析（14篇，1165例）穴位贴敷 vs 西药穴位贴敷总有效率显著优于西药，远期疗效更优系统评价 RCT（N=110，双盲）痛经贴 vs 安慰剂贴总有效率 60% vs 34.55%（p=0.013）；PGF₂α↓, PGE₂↑ Front Endocrinol 2026 RCT 辨证穴位贴 vs 中成药寒凝/气滞/湿热证疗效显著优于中成药；虚证无显著差异 2022 RCT 穴位贴+血府逐瘀汤 vs 西药 VAS改善、β-EP↑、IL-6/TNF-α/IL-1β↓均优于西药组 2025 RCT 穴位贴+艾灸 vs 西药症状改善、内分泌激素调节均优于对照组 2023 八、临床试验特点8.1 主要研究设计近年来高质量穴位贴敷治疗原发性痛经的RCT研究设计趋于规范化和国际化：设计要素典型方案研究类型多中心、随机、双盲、安慰剂对照、优效性试验样本量 60-180例（探索性），110-300例（确证性）随机方法中央随机/分层区组随机（按中心分层）盲法双盲（受试者+研究者+评估者），安慰剂贴外观/质地相同治疗周期 3个月经周期（最常用），可延长至6周期随访治疗结束后1-3个月经周期（评估远期疗效） 8.2 核心评价指标主要疗效终点：指标工具定义疼痛强度变化 NRS 0-10 / VAS 0-100 最痛日疼痛评分较基线的变化总有效率（TER）基于NRS/VAS下降百分比临床痊愈≥95%↓；显效70-95%↓；有效30-70%↓；无效<30%↓ 次要疗效终点：类别指标工具/方法症状量表痛经症状严重程度与持续时间 Cox Menstrual Symptom Scale (CMSS)，18条目，5级Likert 症状量表中医证候评分中医证候量表（24条目，0-72分）生活质量健康相关生活质量 SF-36/SF-12 生活质量总体印象变化 PGIC (Participant Global Impression of Change) 生物标志物血清PGF₂α, PGE₂, PGF₂α/PGE₂比值 ELISA 生物标志物 β-内啡肽（β-EP） ELISA 生物标志物 TNF-α, IL-6, IL-1β ELISA/流式生物标志物雌二醇（E₂）化学发光法止痛药使用解救药物使用量布洛芬服用粒数/周期安全性局部皮肤反应、ALT、全部AE CTCAE分级 8.3 关键试验参数参数规格贴敷穴位三阴交（SP6）、关元（CV4）、神阙（CV8）、子宫（EX-CA1）、气海（CV5）、中极（CV3）贴敷时机非经期贴敷，经期停用每日贴敷时长 8小时/日（常夜间贴敷）治疗周期连续3个月经周期采血时间月经第2-7天（基线和治疗后各一次）纳入标准符合ICD-10 N94.4；NRS≥4（近3月）；月经规律（28±7天，持续3-7天）；符合相应中医证型排除标准继发性痛经（内异症/腺肌病/PID）；SAS/SDS≥50；近期激素药/镇静药使用；妊娠/哺乳；贴敷过敏 8.4 统计分析 • 主要分析集：ITT（意向性分析），缺失数据用多重插补填补 • 主要终点比较：卡方检验（TER）；ANCOVA（连续变量，调整基线） • 多重性控制：Holm-Bonferroni校正（次要终点） • 敏感性分析：Bootstrap 1000次重抽样，BCa 95%CI • 盲法评估：研究结束后问卷调查（目标≈50%"不知道"，提示盲法成功）九、研发策略建议9.1 适应症定位首选：寒凝血瘀型原发性痛经（占痛经证型50%以上，临床需求最大、中医特色最鲜明）次选：气滞血瘀型原发性痛经（占比次之，可与寒凝血瘀型共同覆盖>75%患者）9.2 药物设计策略（1）固定处方设计：基于数据挖掘结果，优选延胡索+肉桂+细辛+当归+川芎为核心方，配合辅料制成标准化贴剂。（2）标准化提取物：采用现代中药提取分离技术（超临界CO₂萃取/大孔树脂纯化），确保批次间活性成分含量一致。（3）透皮促渗技术：引入透皮吸收促进剂（如氮酮、薄荷脑），提高有效成分经皮渗透率。（4）固定穴位方案：以关元、神阙、子宫穴为核心贴敷穴位，配合标准化穴位定位图示和操作指南。9.3 临床试验策略（1）I期：健康女性皮肤刺激性试验+经皮药代动力学（N=30-50）（2）IIa期：剂量探索RCT，3剂量组 vs 安慰剂（N=120-150）（3）IIb期：确证性RCT，穴位贴敷 vs NSAIDs阳性对照 vs 安慰剂（N=300-500）（4）III期：多中心确证性RCT（N=600-1000），以NSAIDs和/或安慰剂为对照（5）上市后IV期/PASS：真实世界安全性监测+药物经济学评价9.4 注册路径 • 中国NMPA：中药新药注册分类1.1类（创新中药复方制剂）或改良型新药 • 可结合《中药注册管理专门规定》和《中医药振兴发展重大工程实施方案》政策优势 • 建议在IND前完成药学（CMC）、药效学（PD动物模型）、毒理学（GLP）全套研究9.5 市场前景 • 目标人群：中国15-49岁育龄女性约3.5亿，痛经患病率56%，可目标患者约2亿人 • 市场容量：按渗透率5%、人均年消费200元计，峰值市场规模约20亿元人民币 • 竞争优势：目前尚无经NMPA批准的同适应症（痛经）中药穴位贴敷新药，竞争格局优良 • 医保准入潜力：符合中药创新药和妇儿用药政策倾斜方向十、参考文献 1. Armour M, et al. The prevalence and academic impact of dysmenorrhea in 21,573 young women: a systematic review and meta-analysis. J Womens Health. 2019;28(8):1161-1171. 2. Worldwide prevalence of dysmenorrhea: a systematic review and meta-analysis across 70 countries. Pain. 2024. 3. Kirsch E, et al. Dysmenorrhea, a narrative review of therapeutic options. J Pain Res. 2024. 4. Christensen K. Dysmenorrhoea: An update on primary healthcare management. Aust J Gen Pract. 2024. 5. The gap between prevalence of primary dysmenorrhea and available treatment strategies. Lancet Reg Health. 2024. 6. Gao Y, et al. Efficacy and safety of Dysmenorrhea Patch acupoint application in women with primary dysmenorrhea: a randomized double-blind controlled trial. Front Endocrinol. 2026. 7. Wang L, et al. Acupoint herbal plaster for patients with primary dysmenorrhea: study protocol for a randomized controlled trial. Trials. 2018. 8. Stachydrine Ameliorates Uterine Hypercontractility in Primary Dysmenorrhea by Targeting the COX-2/PGF2α Pathway. PMC. 2025. 9. Aster spathulifolius Maxim. Alleviates Primary Dysmenorrhea via NF-κB/COX-2 Pathway Inhibition. PMC. 2025. 10. Danggui-Shaoyao-San suppresses PGF2α production by inhibiting COX-2 expression and activity. Phytomedicine. 2008. 11. Peony Pollen Protects against Primary Dysmenorrhea by Inhibiting Inflammatory Response and Regulating COX2/PGE2 Pathway. 2023. 12. Dehydroepiandrosterone ameliorates primary dysmenorrhea by suppressing SP1/Hsp90ab1/COX-2 signaling pathway. 2023. 13. 中国妇幼健康研究. 中国育龄女性痛经多中心流行病学调查. 2024. 14. 中国妇产科临床杂志. 中国女性痛经流行病学特征. 2023. 15. 北京协和医院. 中国青少年痛经多中心研究. 2025. 16. 湖南横断面研究. 中国女大学生原发性痛经患病率及危险因素. 2020. 17. 痛经松方辨证加味穴位贴在气滞血瘀型原发性痛经患者中的应用效果. 临床输血与检验杂志. 2025. 18. 消肿止痛贴中医贴敷疗法治疗原发性痛经的临床疗效观察. 中药药理与临床. 2022. 19. 中医药治疗痛经的研究进展. 中药与临床. 2022. 20. 穴位贴敷治疗原发性痛经的选穴与用药规律分析. 维普中文期刊. 2023. 21. 石墨烯暖宫穴位贴治疗原发性痛经的临床疗效观察及转录组学研究. CNKI. 2024. 22. 夏桂成. 实用中医妇科学. 中国中医药出版社. 23. ACOG Committee Opinion No. 760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018. 24. WHO. Global Burden of Disease Study 2024. 25. Hormonal and Inflammatory Mechanisms of Dysmenorrhea. SARJ. 2025.

2026-05-20

·Pharm-Patent

HS-10374研究进展（V1,2026.5.20更新）

1、研究机构：翰森制药集团有限公司、上海翰森生物医药科技有限公司 2、别名：Hansoh TYK2 3、靶点：TYK2 4、剂型及给药途径：普通片剂; 口服给药 5、结构式 6、适应症及进展适应症进展最新进展日期斑块状银屑病 III期 2025-10-21 银屑病 I期 2026-03-10 银屑病关节炎 II期 2025-09-26 斑秃批准临床 2025-09-26 7、专利布局公开（公告）号专利主题发明名称申请日法律状态 CN111094314B 化合物含有葡糖苷酸衍生物JAK抑制剂的前药及其制备方法和应用 2019-08-14 CN111484480A 化合物一种多环类衍生物抑制剂、其制备方法和应用 2020-01-21 CN115448910B 化合物一种哒嗪类衍生物抑制剂、其制备方法和应用 2020-01-20 CN117263918A 化合物一种哒嗪类衍生物抑制剂、其制备方法和应用 2020-01-20 实质审查 CN115667246B 晶型一种哒嗪类衍生物自由碱的晶型及其制备方法和应用 2021-07-23 CN118978514A 晶型一种哒嗪类衍生物自由碱的晶型及其制备方法和应用 2021-07-23 实质审查 CN113968846A 晶型一种哒嗪类衍生物的盐、晶型及其制备方法和应用 2021-07-23 实质审查 CN116262739A 化合物含氮芳基衍生物调节剂、其制备方法和应用 2022-12-12 实质审查 WO2025252072A1 制剂一种哒嗪类衍生物抑制剂的药物组合物及其制备方法 2025-06-03 CN121202846A 制备工艺一种含哒嗪化合物的制备方法 2025-06-25 实质审查 8、研究历程 2025年05月28日，由上海翰森生物医药科技有限公司在中国大陆开展临床一期试验，用于治疗银屑病。（NCT07181343） 2024年11月06日，由常州恒邦药业有限公司在中国大陆开展临床三期试验，用于治疗斑块银屑病。（CTR20251164; CTR20243822） 2024年11月04日，由上海翰森生物医药科技有限公司在中国大陆开展临床三期试验，用于治疗银屑病。（NCT06672393） 2024年04月25日，由常州恒邦药业有限公司和上海翰森生物医药科技有限公司在中国大陆开展临床一期试验，用于治疗斑秃。（CXHL2400174; CXHL2400175） 2024年03月21日，由常州恒邦药业有限公司和江苏豪森药业集团有限公司在中国大陆开展临床二期试验，用于治疗银屑病关节炎。（CTR20233854） 2024年02月26日，由上海翰森生物医药科技有限公司在中国大陆开展临床二期试验，用于治疗银屑病关节炎。（NCT06176508; CTR20233854） 2024年02月08日，由常州恒邦药业有限公司和上海翰森生物医药科技有限公司向中国国家药品监督管理局NMPA提交IND申请，用于治疗斑秃，为中国化药一类。（CXHL2400174; CXHL2400175） 2023年10月31日，由常州恒邦药业有限公司和上海翰森生物医药科技有限公司在中国大陆开展临床一期试验，用于治疗银屑病关节炎。（CXHL2300893; CXHL2300892） 2023年09月28日，由常州恒邦药业有限公司和上海翰森生物医药科技有限公司在中国大陆开展临床二期试验，用于治疗银屑病和斑块银屑病。（CTR20232241; NCT06926582; CTR20251043; NCT06077331） 2021年11月13日，由常州恒邦药业有限公司和江苏豪森药业集团有限公司在中国大陆开展临床一期试验，用于治疗银屑病。（CTR20242658; CTR20253110; CTR20255088; CTR20260326; CTR20243566; CTR20232809; CTR20253109; CTR20260818; CTR20212580; NCT06033742; CTR20252069; CTR20254355; CTR20251774; CTR20254701; CTR20251861） 2021年04月02日，由常州恒邦药业有限公司向中国国家药品监督管理局NMPA提交IND申请，用于治疗银屑病，为中国化药一类。（CXHL2100217; CXHL2100216） 9、临床试验登记号试验标题试验药适应症原始适应症申办/合作机构试验状态试验分期开始日期完成日期国家/地区 CTR20260818 HS-10374片对盐酸二甲双胍片药代动力学影响的研究盐酸二甲双胍 (片剂) | HS-10374 (片剂) 银屑病银屑病常州恒邦药业有限公司 Not yet recruiting 临床1期 - - 中国 CTR20260730 HS-10374片不同制剂规格药代动力学行为比较研究 HS-10374 (片剂) 银屑病银屑病常州恒邦药业有限公司 Not yet recruiting 临床1期 - - 中国 CTR20260326 HS-10374片对瑞舒伐他汀钙片药代动力学影响的研究瑞舒伐他汀钙 (片剂) | HS-10374 (片剂) 银屑病银屑病常州恒邦药业有限公司 Not yet recruiting 临床1期 - - 中国 CTR20255088 利福平胶囊对HS-10374片药代动力学影响的研究利福平 (胶囊剂) | HS-10374 (片剂) 银屑病银屑病常州恒邦药业有限公司 Not yet recruiting 临床1期 - - 中国 CTR20254701 HS-10374片对地高辛片药代动力学影响的研究地高辛 (片剂, 口服) | HS-10374 (片剂, 空腹口服) 银屑病银屑病常州恒邦药业有限公司 Not yet recruiting 临床1期 - - 中国 CTR20254355 环孢素软胶囊对HS-10374片药代动力学影响的研究环孢素 (胶囊剂, 空腹口服) | HS-10374 (片剂, 口服) 银屑病银屑病常州恒邦药业有限公司 Not yet recruiting 临床1期 - - 中国 NCT07181343 A Study to Evaluate the Pharmacokinetics of Drospirenone and Ethinyl Estradiol Tablets (Yasmin®) When Co-administered With HS-10374 Tablets 屈螺酮/炔雌醇 (片剂, 口服) | HS-10374 (片剂, 口服) 头皮银屑病 Psoriasis (PsO) 上海翰森生物医药科技有限公司 Completed 临床1期 2025-05-28 2025-08-19 中国 CTR20253109 HS-10374在肝功能不全及肝功能正常参与者中的药代动力学研究 HS-10374 (片剂, 空腹口服) 银屑病银屑病常州恒邦药业有限公司 Not yet recruiting 临床1期 - - 中国 CTR20253110 马来酸氟伏沙明片对HS-10374片药代动力学影响的研究马来酸氟伏沙明 (片剂) | HS-10374 (片剂) 银屑病银屑病常州恒邦药业有限公司 Not yet recruiting 临床1期 - - 中国 CTR20252069 HS-10374片在肾功能不全及肾功能正常参与者中的单中心、开放、平行给药药代动力学研究 HS-10374 (片剂) 银屑病银屑病常州恒邦药业有限公司 Not yet recruiting 临床1期 - - 中国 CTR20251774 在健康受试者中评价奥美拉唑镁肠溶片对HS-10374片药代动力学影响的单中心、开放、固定序列、自身对照的Ⅰ期临床试验埃索美拉唑镁 (片剂) | HS-10374 (片剂) 银屑病银屑病常州恒邦药业有限公司 Not yet recruiting 临床1期 - - 中国 NCT06926582 A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate Clinical Efficacy and Safety of HS-10374 in Adult Patients With Mild-to-moderate Plaque Psoriasis HS-10374 (片剂, 口服) 斑块状银屑病 Psoriasis 上海翰森生物医药科技有限公司 Not yet recruiting 临床2期 2025-04-09 2026-12-09 中国 CTR20251164 在成年中重度斑块状银屑病患者中评价HS-10374 片安全性和有效性的多中心、单臂、开放标签的III 期临床研究 HS-10374 (片剂, 口服) 斑块状银屑病银屑病常州恒邦药业有限公司 Recruiting 临床3期 2025-04-22 - 中国 NCT06672393 A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis HS-10374 (片剂, 口服) 斑块状银屑病 Psoriasis 上海翰森生物医药科技有限公司 Not yet recruiting 临床3期 2024-11-04 2026-06-29 中国 ChiCTR2400091645 A multicenter, randomized, double-blind, placebo-controlled Phase III study evaluating the efficacy and safety of HS-10374 tablets in adults with moderate-to-severe plaque psoriasis HS-10374 斑块状银屑病 Plaque psoriasis 复旦大学附属华山医院 Not yet recruiting 临床3期 2024-08-02 2025-09-30 中国 CTR20243566 [14C]HS-10374在中国健康受试者体内的物质平衡研究 HS-10374 (混悬剂, 口服) 银屑病银屑病常州恒邦药业有限公司 Not yet recruiting 临床1期 - - 中国 CTR20242658 不同规格HS-10374片之间药代动力学行为比较 HS-10374 (片剂, 空腹口服) 银屑病银屑病常州恒邦药业有限公司 Completed 临床1期 2024-08-06 2024-09-10(国内) 中国 NCT06176508 A Randomized, Double-blind, Placebo- and Comparator-controlled, Multicenter, Phase 2 Trial to Assess the Efficacy and Safety of HS-10374 in Adults With Active Psoriatic Arthritis HS-10374 (口服) 银屑病关节炎 Psoriatic Arthritis 上海翰森生物医药科技有限公司 Recruiting 临床2期 2024-02-26 2026-08-28 中国 NCT06077331 A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis HS-10374 (片剂, 口服) 斑块状银屑病 Psoriasis 上海翰森生物医药科技有限公司 Unknown status 临床2期 2023-09-28 2024-08-31 中国 CTR20232809 食物对HS-10374药代动力学影响的研究 HS-10374 (片剂, 口服) 银屑病银屑病常州恒邦药业有限公司 Completed 临床1期 2024-04-01 2024-11-01(国内) 中国 NCT06033742 A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HS-10374 in Healthy Subjects HS-10374 (片剂, 口服) 银屑病 Psoriasis 江苏豪森药业集团有限公司 Completed 临床1期 2021-11-13 2023-03-24 中国 10、临床结果标题登记号来源分期适应症评价人数用药方案结果评价发布日期申办/合作机构主要研究药物来源链接 Synapse链接 EADV 2024 | 翰森制药HS-10374 Ⅱ期研究数据获口头报告，用于治疗中重度斑状银屑病 NCT06077331 NEWS 临床2期斑块状银屑病 125 HS-10374 6mg PASI75(12-week) = 28.6 % 达到积极 2024-10-10 上海翰森生物医药科技有限公司 HS-10374 https://mp.weixin.qq.com/s?__biz=MzA5OTc5MjM0Mw==&mid=2649669186&idx=1&sn=ddb97c1fa668b66b74a0ee5471ef2537 https://synapse.zhihuiya.xtdz.top/clinical-result-detail/8e029290e4a8ed2e2a253a8228da203e EADV 2024 | 翰森制药HS-10374 Ⅱ期研究数据获口头报告，用于治疗中重度斑状银屑病 NCT06077331 NEWS 临床2期斑块状银屑病 125 HS-10374 12mg PASI75(12-week) = 72.1 % 达到积极 2024-10-10 上海翰森生物医药科技有限公司 HS-10374 https://mp.weixin.qq.com/s?__biz=MzA5OTc5MjM0Mw==&mid=2649669186&idx=1&sn=ddb97c1fa668b66b74a0ee5471ef2537 https://synapse.zhihuiya.xtdz.top/clinical-result-detail/8e029290e4a8ed2e2a253a8228da203e

100 项与屈螺酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03917	屈螺酮	G03AC10	DB01395

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
避孕	美国	Exeltis USA, Inc.	2019-05-23

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
子宫内膜异位症	临床3期	斯洛伐克	-	2021-07-24
痛经	临床2期	日本	ASKA Pharmaceutical Co., Ltd.	-

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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


JPRN-jRCT2031210556 (NEWS)	-	避孕	-	屈螺酮	製蓋淵蓋網襯網遞鬱淵(鏇糧淵鹹範積艱淵積夢) = Clinical results have reached the endpoint 襯膚憲鹹願淵遞衊夢顧 (艱鹹壓蓋鑰壓齋觸獵獵 )	积极	2024-11-13
NCT04965116 (CTgov)	临床4期	母乳喂养 \| 避孕	30	Micronor+Slynd (Early Initiation d-POPs)	網夢淵範鏇淵觸鑰鹹窪 = 鹹繭鑰廠遞淵艱餘鹽構醖壓餘糧製積齋鬱鹽膚 (衊淵糧觸窪積顧襯鹽淵, 鏇觸窪獵淵糧積簾網鹽 ~ 築淵鏇醖網築餘鹽餘襯) 更多	-	2024-04-19
				Micronor+Slynd (Early Initiation n-POPs)	網夢淵範鏇淵觸鑰鹹窪 = 壓憲膚選願遞膚淵窪淵醖壓餘糧製積齋鬱鹽膚 (衊淵糧觸窪積顧襯鹽淵, 觸蓋網廠鹹艱鏇製夢範 ~ 範願壓簾廠淵餘築選餘) 更多
Pubmed \| Contraception	N/A	肥胖	-	drospirenone (Nonobese participants)	積齋膚觸願鏇鹹齋憲製(鬱積簾鏇鬱鑰遞艱襯鬱) = 積壓壓簾鬱襯夢夢遞製簾艱簾遞鹹顧襯衊鬱憲 (夢憲簾膚顧積餘襯齋築, 1.3 ~ 5.8)	积极	2023-12-01
				drospirenone (Obese participants)	積齋膚觸願鏇鹹齋憲製(鬱積簾鏇鬱鑰遞艱襯鬱) = 襯範構衊顧淵壓淵構憲簾艱簾遞鹹顧襯衊鬱憲 (夢憲簾膚顧積餘襯齋築, 0.8 ~ 7.3)
Pubmed \| Eur J Contracept Reprod Health Care	临床3期	-	48	Monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol	簾壓衊製積願窪網鹹製(壓構廠齋顧淵衊壓餘糧) = No ovulations occurred during treatment 鹽鹽遞蓋選膚廠蓋簾製 (範積夢齋鏇廠鏇淵遞願 )	-	2010-10-01
				Monophasic combined oral contraceptive containing drospirenone and ethinylestradiol