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更新于：2025-07-20

Methylprednisolone

甲泼尼龙

更新于：2025-07-20

概要

基本信息

简介甲泼尼龙是一种小分子药物，通过调节NMDA受体和糖皮质激素受体的活性来发挥作用。它可作为NMDA受体调节剂和糖皮质激素受体激动剂。甲泼尼龙被用于治疗多发性硬化症、水肿、过敏反应和炎症等病症。这种药物由Pharmacia & Upjohn公司研制，并于1957年10月24日获得首次批准。甲泼尼龙可通过口服、注射和局部涂抹等方式给药，但需要在医生的指导下进行，以确保其安全性和疗效。由于甲泼尼龙具有免疫抑制和抗炎作用，因此它被广泛应用于许多疾病的治疗，包括关节炎、哮喘、皮肤炎症和类风湿性疾病等。虽然甲泼尼龙的使用会带来一些副作用，但在医生的指导下正确使用它，可以显著改善患者的生活质量。

药物类型

小分子化药

别名

(6α,11β)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione、1-dehydro-6α-methylhydrocortisone、6α-methyl-11β,17α,21-triol-1,4-pregnadiene-3,20-dione

+ [10]

靶点

作用方式

激动剂

作用机制

GR激动剂(糖皮质激素受体激动剂)

治疗领域

肿瘤免疫系统疾病神经系统疾病+ [7]

在研适应症

多发性硬化症过敏胶原蛋白疾病+ [15]

非在研适应症

急性移植物抗宿主病难治性慢性淋巴细胞白血病肠梗阻+ [8]

原研机构

Pfizer Inc.

在研机构

Pfizer Inc.

Bristol Myers Squibb Co.

Celgene Corp.

+ [3]

非在研机构

Mallinckrodt Plc

Novartis Pharmaceuticals Corp.

2-BBB Medicines BV

权益机构

Sanofi

Fidia Farmaceutici SpA

最高研发阶段批准上市

首次获批日期

美国 (1957-10-24),

过敏胶原蛋白疾病水肿+ [9]

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C22H30O5

InChIKeyVHRSUDSXCMQTMA-PJHHCJLFSA-N

CAS号83-43-2

关联

858

项与甲泼尼龙相关的临床试验

NCT07072585

/ Not yet recruiting临床2/3期IIT

A Phase 2/3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)

This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.

开始日期2025-09-30

申办/合作机构

The Children's Oncology Group Foundation, Inc.

NCT06489626

/ Not yet recruiting临床4期IIT

The Effect of a Methylprednisolone Taper on Outcomes Following Total Knee Arthroplasty

Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. This study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. A taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.

开始日期2025-08-01

申办/合作机构

University of Pittsburgh

NCT06892197

/ Not yet recruiting临床4期IIT

Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)

The goal of this cluster randomized controlled trial is to determine the optimal treatment for community aquired pneumonia (CAP). The study compares the effects and side effects of hydrocortisone and prednisolone in patients above 18 years old diagnosed with severe CAP. The main question is whether there is a difference in all cause mortality within thirty days.
Participants will be randomized to receive treatment with either hydrocortisone or prednisolone.

开始日期2025-08-01

申办/合作机构-

100 项与甲泼尼龙相关的临床结果

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100 项与甲泼尼龙相关的转化医学

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100 项与甲泼尼龙相关的专利（医药）

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28,569

项与甲泼尼龙相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Successful treatment of etanercept- and adalimumab-resistant pyoderma gangrenosum with spesolimab, moderate-dose corticosteroids, and minocycline

Article

作者: Zhang, Hanlin ; Wu, Chao ; Jin, Hongzhong

PURPOSE:

Pyoderma gangrenosum (PG) is a rare, neutrophilic dermatosis characterized by rapidly developing, painful ulcers. This study explores the potential of spesolimab, an anti-IL-36R antibody, as a therapeutic option for refractory PG.

MATERIALS AND METHODS:

We report a case of a 48-year-old male with refractory PG who failed to respond to etanercept and adalimumab. Upon admission, the patient presented with extensive, painful ulcerations on the trunk and extremities. He was started on oral methylprednisolone (32 mg/day) and minocycline (50 mg twice daily). After a week, minimal improvement was observed. After reviewing the screening results and discussing treatment options, the patient received two doses of spesolimab (900 mg intravenously) administered two weeks apart.

RESULTS:

Marked clinical improvement was observed after spesolimab initiation. Complete ulcer healing was achieved within six weeks of starting spesolimab, with no adverse effects reported.

CONCLUSIONS:

This case demonstrates the potential efficacy of spesolimab for treating refractory PG, particularly in patients unresponsive to TNF-α inhibitors. Despite the added complexity of the patient's underlying HBV infection and elevated M-protein, no HBV reactivation or other hematologic complications occurred. Further studies are needed to validate its role in managing PG and other neutrophilic dermatoses.

2025-12-01·BIOMATERIALS

Hydrogen activates ACOD1-itaconate pathway to ameliorate steroid-associated osteonecrosis

Article

作者: Xu, Shunxiang ; Sun, Wei ; Cheng, Liming ; Zhang, Shi'an ; Zheng, Lizhen ; Zhang, Yuantao ; Xu, Jiankun ; Qin, Ling ; Chen, Ziyi ; Yao, Hao ; Zhang, Haozhi ; Li, Ye ; Tian, Qinyu ; Wen, Zhenkang ; Tong, Wenxue ; Shao, Hongwei ; An, Yuanming

Steroid-associated osteonecrosis (SAON) remains a challenging clinical condition as there are few effective preventive measures. This study investigates the effects of hydrogen (H₂) administrated via saturated hydrogen-rich water (HRW) in mice received high dose of glucocorticoids (for inducing SAON model). Here we find that HRW treatment significantly reduces osteocyte apoptosis, improves deteriorated trabecular architecture, increases osteoblast numbers and the bone formation, while decreases osteoclast numbers and the bone resorption. Additionally, HRW-treated mice exhibit improved serum lipid profiles, including decreased levels of low-density lipoprotein (LDL), triglycerides (TG), and total cholesterol (T-CHO), as well as reduced lipid accumulation. HRW treatment also enhances blood perfusion and increases formation of type H vessels in SAON mice. We further demonstrate that HRW shifts the polarization of macrophages from M1 to M2 phenotype and suppresses inflammatory marker TNF-α. RNA sequencing data and subsequent validation reveal that HRW upregulates ACOD1 mRNA and protein levels in bone tissues. The protective effects of HRW are mimicked by supplementation with the itaconate derivative dimethyl itaconate in a dose-dependent manner, highlighting the importance of the ACOD1-itaconate pathway in the prevention of SAON by HRW. These findings indicate that HRW ameliorates SAON by modulating the ACOD1-itaconate pathway, presenting a novel avenue for the cost-effective prevention of osteonecrosis.

2025-12-01·IMMUNOLOGIC RESEARCH

Protective role of ABCC drug subfamily resistance transporters (ABCC1-7) in intestinal inflammation

Article

作者: Miguel-Cruz, Erika ; Yamamoto-Furusho, Jesus K ; Barreto-Zuñiga, Rafel ; Furuzawa-Carballeda, Janette ; Fonseca-Camarillo, Gabriela ; Martínez-Benítez, Braulio

The ABCC subfamily contains thirteen members. Nine of these transporters are called multidrug resistance proteins (MRPs). The MRPs have been associated with developing ulcerative colitis (UC). This study aimed to evaluate the ABCC expression in UC patients and its role in a dextran sulfate sodium (DSS)-induced colitis mice model under 5-aminosalicylates or methylprednisolone treatment and compared with control without inflammation. DSS-induced colitis mice were treated with 5-aminosalicylates (50 mg/kg 24 h) or methylprednisolone (2 mg/kg 24 h). Human rectal biopsies were obtained from UC patients. The abcc-relative mRNA levels and protein expression were determined by RT-PCR and immunohistochemistry. abcc4, abcc5, and abcc6 mRNA levels were significantly increased in DSS-induced colitis compared to the other groups. The 5-aminosalicylate treatment dramatically increased the abcc2 and abcc3 mRNA levels vs. control. Methylprednisolone treatment increased abcc1 vs. DSS-induced colitis and colitis treated with 5-aminosalicylate. Immunohistochemical analysis revealed down-regulation of ABCC1/ABCC2/ABCC5/ABCC7 in mice colitis vs. control. Treatment with 5-aminosalicylate restored ABCC5 levels, while methylprednisolone restored ABCC2/ABCC5/ABCC7 in colitis mice at similar control levels. Relative mRNA levels of mrp1-5 were increased in active UC patients vs. control. ABCC2/ABCC4/ABCC7 were conspicuously expressed in the mucosa of 5-aminosalicylate and/or methylprednisolone-treated UC patients, while ABCC2/ABCC4/ABCC5/ABCC7 in submucosa, ABCC1/ABCC5/ABCC7 in muscular, and ABCC1/ABCC4/ABCC5/ABCC7 in serosa were expressed vs. controls. This is the first report about the differential up-regulation of the ABCC subfamily gene and protein expression in DSS-induced colitis under aminosalicylates or methylprednisolone treatment.

133

项与甲泼尼龙相关的新闻（医药）

2025-07-08

·梅斯医学

伏欣奇拜单抗III期研究亮相国际顶刊《The Innovation》：半年内降低87%痛风急性复发风险！长效抗炎重塑治疗格局

临床上有相当一部分痛风患者因存在禁忌症、药物不耐受或疗效不佳，无法从标准治疗方案（非甾体类抗炎药/秋水仙碱/糖皮质激素）中获益，进而导致痛风频繁发作，全身多脏器损伤，严重干扰患者日常生活，也给社会带来了沉重负担。值得欣慰的是，国内首款痛风治疗1类创新药——伏欣奇拜单抗（金蓓欣）已于近日上市，为这些痛风反复发作的患者带来了福音，接下来，我们将为您深入解读该药物上市前III期临床研究的重要发现及其临床意义。1痛风急性发作的疾病负担与治疗现状在我国，痛风的患病率约为3.2%，且呈年轻化趋势[1]。痛风的急性发作不仅带来难以忍受的剧痛，更会引发关节及其周围组织的炎性损伤与功能障碍，严重影响患者生活质量。更值得警惕的是，临床上约有40%的患者遭受“频发型”痛风的困扰（每年发作次数≥2次），每一次痛风复发都可能加剧关节的不可逆损害，更可能累及心脏、肾脏等多个重要器官[2, 3]。研究表明，痛风会显著提升多种疾病的风险：心血管疾病风险整体升高87%（缺血性心脏病风险增加90%，中风风险增加81%），慢性肾脏病的发生风险更是增加4.61倍[4]。这提示，反复发作所引发的持续炎症，会显著增加心血管与肾脏负担，造成更深远且被低估的健康隐患。痛风治疗目标是快速止痛、长效抗炎、安全耐受。一线治疗药物有非甾体类抗炎药（NSAIDs）和秋水仙碱，当存在治疗禁忌或治疗效果不佳时，亦可考虑短期应用糖皮质激素抗炎治疗。然而，有相当一部分患者因存在禁忌症、药物不耐受或疗效不佳，无法从标准治疗方案中获益，使得患者无法长期用药，或用药后短时间仍频繁经历痛风的发作。预计到2030年，我国痛风药物市场规模将达108亿元，因此临床亟需机制更明确、安全性更高，且具备长期抗炎与降低发作频率的创新治疗方案。解密痛风，IL-1β成为治疗关键点尿酸盐结晶会激活NLRP3炎症小体，促进IL-1β的成熟及分泌，最终导致痛风炎症反应的发生及发展，因此IL-1β是痛风治疗的关键靶点[5]。国外也有多个指南推荐IL-1抑制剂用于标准治疗失败的患者[6-9]，但在伏欣奇拜单抗获批上市前，国内长期无获批该适应症的IL-1抑制剂。伏欣奇拜单抗（Firsekibart；曾用名金纳单抗；研发代号Gensci048）是我国首款且唯一获批用于治疗痛风急性发作的1类创新药。伏欣奇拜单抗为抗白介素-1β 全人源单克隆抗体，对IL-1β具有高亲和力，能精准、强力阻断其下游炎症信号通路，从而在源头上有效遏制炎症风暴[10]。此外，与IgG1相比，作为全人源IgG4/λ型单抗，伏欣奇拜单抗可降低抗体依赖性细胞介导的细胞毒性（ADCC）和补体依赖性细胞毒性效应（CDC），可能具有更好的安全性[11, 12]。而在临床效果方面，前期研究（Ib/II期研究[NCT05328531]）的结果表明，伏欣奇拜单抗在治疗痛风急性发作方面具有良好的疗效和安全性，可实现长期控制、快速止痛、安全耐受。基于这些积极结果，伏欣奇拜单抗开展了本次III期临床试验，并于国际顶刊《The Innovation》（IF：25.7）上发表研究成果：《Firsekibart versus compound betamethasone in acute gout patients unsuitable for standard therapy: A randomized phase III trial》[13]。研究目的本研究旨在评估对于NSAIDs/秋水仙碱存在禁忌、不耐受或疗效不佳且频繁出现痛风急性发作的患者，伏欣奇拜单抗与复方倍他米松比较的疗效和安全性。2III期研究设计：严谨设计验证卓越疗效本研究是一项多中心、随机化、双盲、双模拟、阳性对照的III期临床试验（NCT05983445），于2023年1月至2024年6月在中国的51家中心开展。研究包括双盲治疗阶段和开放标签治疗阶段，双盲阶段从第0周持续至第24周，而开放标签阶段则延续至第48周。现为大家带来24周结果的解读。伏欣奇拜单抗III期研究设计核心设计亮点精确直击临床痛点最大限度减少偏倚双主要终点：直击抗炎防复发精确直击临床痛点本研究的的核心目标为直击临床痛点——解决现有治疗无法覆盖的迫切需求。为此，研究制定了“确诊痛风+1年内≥2次痛风急性发作+NSAIDs/秋水仙碱禁忌、不耐受或缺乏疗效”的纳入标准。同时，研究人群符合真实临床实践患者特征，允许患者使用降尿酸治疗，以明确伏欣奇拜单抗在降尿酸治疗基础上的急性期疼痛控制和额外预防获益。伏欣奇拜单抗III期研究纳排标准最大限度减少偏倚研究采用了随机、双盲、双模拟、阳性对照的设计方法，最大限度确保研究结果的科学性与可靠性。随机：使用分层区组随机法（分层因素：50≤疼痛VAS评分<70；70≤疼痛VAS评分≤100），区组宽度为6，随机化过程通过交互式网络应答系统（IWRS）实现。有效保障了治疗组间基线特征的均衡可比。双盲与双模拟：伏欣奇拜单抗组患者接受伏欣奇拜单抗+复方倍他米松模拟剂；对照组患者则接受伏欣奇拜单抗模拟剂+复方倍他米松注射液。研究中研究者和患者均无法辨别实际接受的是哪一种治疗方案，从而有效消除安慰剂效应和主观判断对疗效评估的影响。阳性对照：选择临床广泛用于痛风急性发作治疗的复方倍他米松作为对照。与安慰剂对照相比，阳性对照设计使研究结果更具临床实用性，且阳性对照设计确保所有患者都能接受试验药物或标准治疗药物，更符合伦理学要求。双主要终点：直击抗炎防复发快速抗炎应答评估：治疗后72h靶关节的疼痛VAS评分较基线的变化（非劣效检验）复发预防评估：治疗后至首次急性痛风复发的时间（治疗12周内）（优效检验）这一“双终点、双达标”的设计策略，参考了美国风湿病学会（American College of Rheumatology; ACR）于2020年发布的《痛风管理指南》和中华医学会内分泌学分会于2019 年发布的《中国高尿酸血症与痛风诊疗指南》[6, 14]，旨在同时证明伏欣奇拜单抗在长效抗炎和缓解疼痛方面的疗效，需要两个主要终点同时达到统计假设。3伏欣奇拜组单抗III期研究结果惊艳！未来可期！研究共纳入311例患者进入全分析集（FAS；伏欣奇拜单抗组，N=156；复方倍他米松组，N=155）。基线特征在各治疗组间总体均衡。在FAS中，患者平均年龄为44.9岁，绝大部分为男性（98.7%）。痛风病史的中位数为84.0个月。研究对象特征与中国临床真实世界患者特征相符，确保了研究结果的外推性。基线表快速抗炎，镇痛效果与激素相当两组72小时疼痛VAS评分较基线变化分别为：伏欣奇拜单抗组：-57.09mm（95% CI -60.08, -54.10）复方倍他米松组：-53.77mm（95% CI -56.77, -50.77）组间差异：-3.32mm（95% CI -7.56, 0.91），95% CI上限<10mm（预设非劣效界值）。结果证实伏欣奇拜单抗缓解疼痛效果与强效激素相当。主要终点1：治疗后72h靶关节的疼痛VAS评分较基线的变化同时，研究展现了伏欣奇拜单抗的快速止痛效果。开始治疗仅6小时后，伏欣奇拜单抗组疼痛评分已较基线下降近20mm，疼痛首次降低至≤基线值50%所需的中位时间（24.5小时）与复方倍他米松组（24.3小时）相近。给药24小时后，出现疼痛难以忍受或受试者痛风急性复发但不能予以再次给药时，根据研究者判断可进行补救治疗，补救药物可选择口服醋酸泼尼松（≤30mg/d）或甲泼尼龙（≤24mg/d）。结果显示，24周内，伏欣奇拜单抗组中有17例（10.9%）患者使用了补救治疗，远低于复方倍他米松组的75例（48.4%），且伏欣奇拜单抗组中位激素使用量更少（30mg vs 127.5mg）。预防复发结果惊艳！12周内复发风险显著降低90%12周内首次急性发作的中位复发时间（95% CI）伏欣奇拜单抗组：未达到（95% CI 无法预估[NE], NE）复方倍他米松组：45.0天（95% CI 28.00, 63.00）伏欣奇拜单抗与复方倍他米松组比较的风险比（HR）：0.10（95% CI 0.06, 0.17），这意味着伏欣奇拜单抗组患者12周内的首次复发风险相比复方倍他米松组显著降低了90%！伏欣奇拜单抗组中至少有一次复发的患者比例为10.7%，远低于复方倍他米松组的65.2%。主要终点2：治疗后至首次急性痛风复发的时间（治疗12周内）此外，进一步的亚组分析显示，无论患者基线时VAS评分（50~70mm，70~100mm），BMI（＜28kg/m²，≥28 kg/m²），体重（＜75kg，≥75kg）联合降尿酸治疗情况（是，否），伏欣奇拜单抗组均能有效降低预防痛风复发，亚组分析结果与总体人群结果一致。值得注意的是，无论基线时是否合并降尿酸治疗，伏欣奇拜单抗两个亚组12周内中位复发时间均未达到,而复方倍他米松的中位复发时间分别为28天及51.5天，12周内的首次复发风险比（HR）分别为0.11 (95% CI: 0.05, 0.25)及0.09 (95% CI: 0.04, 0.18)，因此，无论基线是否合并降尿酸治疗，伏欣奇拜单抗均能有效降低痛风复发。长期随访疗效一致，24周内降低复发风险高达87%！在24周时，伏欣奇拜单抗组仍保持优势，从基线至首次中位复发时间仍未达到，与复方倍他米松组相比，其HR为0.13（95% CI 0.08, 0.21），复发风险显著降低87%。此外，伏欣奇拜单抗组中至少有一次复发的患者比例为14.7%，远低于复方倍他米松组的66.5%。这一长效抗炎效果可能与其半衰期较长有关（25.5~30.8天），为患者提供了持久的复发防御屏障。治疗后至首次急性痛风复发的时间（治疗24周内）安全性良好：未发现严重不良事件本研究使用CTCAE分级（5.0版）对AE 的严重程度进行分类，伏欣奇拜单抗大多数不良事件为1~2级，无需药物干预。伏欣奇拜单抗组中最常见的不良反应为高甘油三酯血症，高胆固醇血症及高脂血症，但未见不良转归，可能与基线时多数患者血脂水平异常相关。伏欣奇拜组未发现与药物相关严重不良事件，也未出现抗药物抗体（ADA）相关不良事件。研究中共出现3例导致停药的不良事件以及3例药物相关严重不良事件，均发生在复方倍他米松组。安全性总结炎症控制与生活质量改善：快速起效、深度缓解、持久稳定从治疗开始到研究第4周的不同时间点，伏欣奇拜单抗组均展现出明显的抗炎效果，从给药后第8天起，伏欣奇拜单抗组的超敏C反应蛋白（hsCRP）较基线的中位下降值均显著大于复方倍他米松组。在第4周时，两组中位下降值分别达到7.66 mg/L和3.20 mg/L。同时，根据SF-36健康量表评估，伏欣奇拜单在改善患者心理及生理评分方面，在数值上的提升更明显。这些结果提示伏欣奇拜单抗具有快速、持续的炎症控制优势，为长期预防痛风急性发作提供了有利保障。hsCRP较基线的变化小结伏欣奇拜单抗是中国首款且唯一获批急性痛风性关节炎适应症的1类创新药；研究同时达到预设的双终点：兼具“长期控制、快速强效、安全放心”多重优势，展现明确的临床获益；试验设计严谨，采用双盲、双模拟、双终点、阳性对照设计，纳入人群符合中国痛风患者特征；伏欣奇拜单抗III期研究针对无法使用或不耐受NSAIDs/秋水仙碱，或疗效不佳的痛风急性发作的患者人群，为现有痛风药物无法满足的临床需求提供了新的治疗选择；伏欣奇拜单抗总体耐受性良好，未发现严重药物相关不良事件。基于本次研究结果，金赛药业自主研发的1类创新药——伏欣奇拜单抗已于2025年6月30日上市。获批适应症为对NSAIDs和/或秋水仙碱禁忌、不耐受或缺乏疗效的，以及不适合反复使用类固醇激素的成年痛风性关节炎急性发作患者。作为中国首款获批用于痛风急性发作的IL-1β抑制剂，伏欣奇拜单抗兼具长期控制、快速强效、安全放心的多重优势，有望开启痛风治疗新格局！声明部分：声明1. 本材料旨在传递前沿信息和满足医疗卫生专业人士的医学信息需要，无意向您做任何产品的推广，不作为临床用药指导。2. 若您想了解具体疾病诊疗信息，请遵从医疗卫生专业人士的意见与指导。*“中国首款且唯一”的适用情况：截至注射用伏欣奇拜单抗获批当日，根据中国国家药品监督管理局相关信息显示，尚无其他IL-1β单抗产品获批急性痛风性关节炎适应症。作者介绍通讯作者：邹和建教授复旦大学附属华山医院复旦大学附属华山医院风湿免疫科学术带头人、教授复旦大学风湿免疫过敏性疾病研究中心主任国际硬皮病临床与研究协作网（InSCAR）副主席中华预防医学会风湿病预防专委会主任委员中华医学会风湿病学分会第7、8届委员会副主任委员中国医师协会风湿免疫科医师分会第1、2届委员会副会长第一作者：薛愉教授复旦大学附属华山医院复旦大学附属华山医院风湿科主任医师上海市医学会风湿病专科分会委员兼秘书中华医学会风湿病专科分会委员中国中西医结合学会风湿类疾病专业委员会青年副主任委员中国医师协会风湿免疫专科分会青年委员上海市医学会职业病与环境医学专科分会委员兼秘书中华预防医学会中毒与急救专业青年分会青年委员参考文献：1. J Transl Int Med, 2022. 10(2): p. 134-145.2. 2021中国高尿酸及痛风趋势白皮书.3. Ther Adv Musculoskelet Dis, 2024. 16: p. 1759720x241240837.4. The Lancet Regional Health - Western Pacific, 2025. 58: p. 101572.5. Nat Rev Dis Primers, 2019. 5(1): p. 69.6. Arthritis Care Res (Hoboken), 2020. 72(6): p. 744-760.7. Ann Rheum Dis, 2017. 76(1): p. 29-42.8. Rheumatology (Oxford), 2017. 56(7): p. e1-e20.9. Am Fam Physician, 2020. 102(9): p. 533-538.10. 长春金赛药业有限责任公司, 抗IL-1β单克隆抗体及其应用:CN201710276999.6. 2020.11. Front Oncol, 2024. 14: p. 1395784.12. Clin Pharmacokinet, 2012. 51(6): p. e1-18.13. The Innovation, 2025: p. 101015.14. Zhonghua Nei Ke Za Zhi, 2020. 59(6): p. 421-426.

临床3期

2025-07-06

·国际糖尿病idiabetes

肾例明鉴丨咳嗽咯血也可能是肾病？男子咳嗽咯血，想不到是这种危重凶险肾病惹的祸

点击“蓝字”关注我们编者按：肺出血-肾炎综合征（GS）系临床少见的自身免疫性疾病，可能系病毒感染和/或吸入某些化学物质引起原发性肺损害，由于肺泡毛细血管基膜和肾小球基底膜存在交叉反应抗原，故可引起继发性肾损害。临床上对肺出血-肾炎综合征患者的病情进行诊断的难度较大，而且患者的病情发展迅速，其预后较差，常因窒息、呼吸衰竭或肾功能衰竭而死亡。若能及时诊治该病，对其进行及时有效的治疗，可有效地改善其预后[1]。一、临床资料男性，23岁。主诉：肉眼血尿20天，咯血10天。现病史：20天前受凉后发热，体温38℃，伴咳嗽，咳少量白痰。2天后出现持续全程肉眼血尿，伴尿中泡沫增多。双下肢对称可凹性水肿，进行性加重，尿量不少。当地医院查尿蛋白（+++），红细胞满视野，血白蛋白23g/L，血肌酐143μmol/L。B超示双肾体积增大、皮质增厚，外院给予泼尼松40mg/d无好转。10天前患者出现咳嗽，痰中带鲜血，3~4次/天，10~20ml/d，未予处理。5天前患者自觉尿量减少，约500ml/d。3天前至我院查血红蛋白84g/L、血肌酐593μmol/L，血钾6.01mmol/L，同时出现少尿，急诊给予甲泼尼龙500mg冲击1次，血液透析1次，收入病房。既往史：体健。入院查体：体温36.6℃，脉搏85次/分，血压130/70mmHg，呼吸24次/分。双肺呼吸音粗，双下肺可闻及较多细湿啰音。心脏和腹部查体未见异常。双膝关节以下轻度可凹性水肿。辅助检查：血WBC 8.27x109/L，PLT 238x109/L，Hb 81.0g/L。ESR 26mm/h。尿RBC满视野，为变形红细胞，尿蛋白定量4.67g/d。血SCr 634.0μmol/L，BUN 26.3mmol/L，ALB 24.3g/L，肝功能正常。RF阴性，CRP阳性，ANCA阴性，ANA、抗dsDNA、ENA阴性，抗GBM抗体阳性（百分结合率98%）。动脉血气分析：pH 7.352，PO2 69mmHg，PCO3 38mmHg，SaO2 93%。胸片：两肺满布粟粒状模糊影，以两肺中下叶为著，部分融合成团片状，肺野透过度差。初步诊断：抗肾小球基底膜病；急进性肾炎（I型）；急性肾衰竭；高钾血症；肺出血；间质性肺疾病。二、诊断思路和临床诊治经过患者血肌酐短期内迅速升高，出现少尿，B超提示双肾体积增大、皮质增厚，符合急性肾衰竭。根据患者出现血尿、大量蛋白尿、水肿及快速进展的肾功能损害，提示为肾小球疾病所致，符合急进性肾炎综合征。患者在出现急性肾衰竭的同时有肺出血，提示为多系统受累的疾病所致。进一步查ANCA、ANA、抗dsDNA、ENA均阴性，可以除外ANCA相关性小血管炎、系统性红斑狼疮。临床表现及辅助检查亦不支持抗磷脂综合征、血栓性微血管病、心衰、结核等疾病。同时查血清抗GBM抗体阳性，因此诊断为抗肾小球基底膜病，累及肾脏及肺，目前呈急性肾衰竭合并肺出血。患者入院后立即给予血浆置换治疗，每日1次，每次3000ml。患者入院第2天出现大咯血，予以机械通气辅助呼吸。入院第6天进行肾穿刺活检以明确肾脏病理诊断。免疫荧光：IgG（+++），C3（+++）沿毛细血管壁线条样沉积（图1）；光镜：19个肾小球，毛细血管壁严重破坏，GBM断裂，100%新月体形成，16个细胞性新月体，3个细胞纤维性新月体。肾小管多灶状萎缩，肾间质弥漫水肿伴多灶状淋巴、单核细胞浸润，少量中性粒细胞浸润，小动脉无明显病变。电镜：肾小球细胞性新月体形成，基底膜皱缩，未见电子致密物。肾小管上皮细胞微绒毛脱落。肾间质淋巴和单核细胞浸润。符合I型新月体性肾小球肾炎。图1. 免疫荧光患者共进行12次血浆置换治疗，直至血清抗GBM抗体转阴。同时继续甲泼尼龙500mg/d，共3天，环磷酰胺50mg每日2次口服。10天后咯血停止，但肾功能未恢复，进入终末期肾脏病（ESRD），依赖透析。最终诊断：抗肾小球基底膜病；急进性肾炎（I型）；急性肾衰竭（CKD 5期）；肺出血；间质性肺疾病。三、讨论本病例提供了一个典型的抗肾小球基底膜（glomerular basement membrane，GBM）病的范例，表现为肺出血-肾炎综合征（GS），同时抗GBM抗体阳性，又称Good-pasture病。该病多病情凶险，起病急、进展快、预后差。肺受累可引起大咯血而危及生命。肾脏受累多为急进性肾炎I型，表现为血尿、蛋白尿，肾功能进行性下降，较早出现少尿和无尿，短期内不可逆地进展至终末期肾衰竭。GS的发病率估计为每年每百万人中发生一例，该病通常认为白人较黑人多发。该病在20岁~30岁以及60岁~70岁两个年龄段组高发。目前国内尚无对该病发病率的报道。关于GS的发病机制，目前认为GS是一种自身免疫病，以产生直接作用于肾小球基底膜的抗体为特征，尽管基底膜是普遍存在的，但只有肺泡和肾小球基底膜在临床上被认为是易受到影响的。肾小球基底膜的α3胶原蛋白链在结构上更容易与循环系统中的抗体接触。尽管关于GS的准确病因目前尚未可知，已有文献报道特殊的行为和环境因素被认为会导致人们更高的发病率，如下列发病诱因：与HLA-DR15基因型相关；吸烟；感染等[2,3]。GS患者最初的症状可能包括疲劳、乏力、嗜睡、恶心呕吐、食欲不振以及面色苍白等。如果疾病发展影响到肺脏，可能出现咯血。有时影响到肺部的症状可能致命，如果发生大量的肺部出血将导致呼吸衰竭。如果疾病进展至肾脏，可能会出现血尿、蛋白尿、手足肿胀、高血压以及肋下背痛。其他肾脏疾病临床表现包括水肿以及尿毒症。体格检查可发现GS患者如下表现：呼吸急促，肺底湿啰音、发绀，肝脾肿大，高血压、皮疹以及水肿。首先对于高血压、流血、异常的心肺听诊以及既往医疗史的检查十分必要。典型的胸片会显示不均匀的肺实变，肺门周围呈对称性并且好发于双侧肺底，实变通常会在2~3 d内消退，并逐渐发展为间质化表现，如患者肺出血的反复发作。抗GBM病的确诊依靠在血清中检出抗CBM抗体，或肾脏免疫病理学检查见到IgG和（或）C，沿肾小球毛细血管袢呈线样沉积。国内在开展抗GBM抗体血清学检测之前，诊断一直依靠肾活检免疫病理学检查，因此不能做到早期诊断。更为重要的是，并非所有患者的免疫病理均表现为典型的IgG、C3沿肾小球毛细血管袢呈线条样沉积，仅有60%的患者有此表现。因此，对于有肺出血和尿检异常或肾功能损害的患者，不应等待肾活检结果，应提倡早期对抗GBM 抗体进行血清学检测。应用人可溶性GBM蛋白为抗原的ELISA法是国内外通用和公认的抗GBM抗体的血清学检测方法。该法敏感性（95%）和特异性（99%）高，简便易行，结果客观。抗GBM病病情进展急骤，预后差，因此，根据典型的临床表现和可靠的血清学检测结果就可以进行诊断并立即开始治疗。及时创造条件尽早行肾活检，对于判断病情及估计预后有重要意义[4,5]。影响肺脏以及肾脏的原因对于鉴别诊断非常重要。需鉴别诊断的疾病包括韦格纳肉芽肿病、系统性红斑狼疮、显微镜下多发性血管炎、其他类型的系统性脉管炎。GS对于韦格纳肉芽肿病的鉴别尤其重要。有些GS患者可能测得ANCAs的升高，而ANCAs升高主要见于韦格纳肉芽肿病的患者。肺肾综合征是IgA介导的较为不常见的一种疾病。直至今日，仍无研究表明对于抗GBM病有何种最佳治疗方案。早期的诊断是正确治疗的必要因素。基于对GS认为是自身免疫性疾病的假说，治疗通常具有免疫抑制性。大剂量的糖皮质激素以及环磷酰胺是目前的标准治疗方法。除此之外，特别是对有大量肺内出血的患者，血浆置换十分重要。亦有研究认为生物制剂对于治疗自免性肾病，在未来有望成为更加安全并且有效的选择[2]。抗GBM病总体预后较差。确诊时SCr>600μmol/L或依赖透析、肾小球新月体比例100%提示预后不良。但如合并肺出血，仍应予以积极治疗。血浆置换是明确能够改善预后的治疗方法。其疗效与患者的临床表现、开始治疗的早晚和治疗是否充分密切相关。充分的血浆置换，置换量应为每天50ml/kg（最多4L），共14天或置换至血清抗GBM抗体转阴。在疗效上，血浆置换虽然不一定能去除基本病因，但是确是一种见效快而有效的辅助治疗措施。血浆置换与免疫抑制剂联用可使肺出血停止，肾功能改善，死亡率由原来的75%降至25%。该病人确诊时SCr>600μmol/L，肾小球新月体比例100%，虽然经过积极的血浆置换和免疫抑制治疗，仍然进入ESRD。参考文献：[1] Reggiani F, L'Imperio V, Calatroni M, Pagni F, Sinico RA. Goodpasture syndrome and anti-glomerular basement membrane disease. Clin Exp Rheumatol. 2023 Apr;41(4):964-974. [2] Marques C, Plaisier E, Cacoub P, Cadranel J, Saadoun D. Mise au point sur la maladie des anticorps anti-membrane basale glomérulaire ou syndrome de Goodpasture [Review on anti-glomerular basement membrane disease or Goodpasture's syndrome]. Rev Med Interne. 2020 Jan;41(1):14-20. French. [3] Greco A, Rizzo MI, De Virgilio A, Gallo A, Fusconi M, Pagliuca G, Martellucci S, Turchetta R, Longo L, De Vincentiis M. Goodpasture's syndrome: a clinical update. Autoimmun Rev. 2015 Mar;14(3):246-53. [4] Hellmark T, Segelmark M. Diagnosis and classification of Goodpasture's disease (anti-GBM). J Autoimmun. 2014 Feb-Mar;48-49:108-12. [5] Fouka E, Drakopanagiotakis F, Steiropoulos P. Pathogenesis of Pulmonary Manifestations in ANCA-Associated Vasculitis and Goodpasture Syndrome. Int J Mol Sci. 2024 May 12;25(10):5278. 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。该等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。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《肾医线》编辑部）

临床研究

2025-06-12

·PRNewswire

4 Emerging Graft versus Host Disease Therapies That Could Change the Treatment Landscape | DelveInsight

Key companies, such as CSL Behring, Equillium, Biocon, and medac, are advancing their assets through late-stage graft versus host disease clinical trials, driving innovation in the graft versus host disease market and creating significant growth opportunities. LAS VEGAS, June 12, 2025 /PRNewswire/ -- Graft versus host disease (GvHD) is an immune-driven disorder caused by a complex interplay between the donor's and recipient's adaptive immune systems. It typically manifests in two main forms: acute (aGvHD) and chronic (cGvHD). As per DelveInsight's analysis, approximately 60,000 allogeneic transplants and around 55,000 GvHD cases occurred in the 7MM in 2024. These numbers are projected to grow at a notable CAGR over the forecast period from 2025 to 2034. Corticosteroids like prednisone and methylprednisolone are the primary first-line treatments, often combined with other immunosuppressants. Mild GcHD is managed with topical steroids, while systemic cases require stronger immunosuppressive therapy. Several treatments for GvHD have received FDA approval in the US, including ORENCIA (abatacept), JAKAFI/JAKAVI (ruxolitinib), IMBRUVICA (ibrutinib), and REZUROCK (belumosudil), among others. In the upcoming GvHD treatment market landscape, there are a plethora of companies investigating agents in various stages of development. To know more about the graft versus host disease clinical trials market, visit @ Graft versus Host Disease Market DelveInsight estimates that the market size for GvHD is expected to grow from USD 1.4 billion in 2024 with a significant CAGR of 8.2% by 2034. This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies. The current pipeline for graft versus host disease includes a range of drugs with diverse mechanisms of action (MoA). CSL964 (Alpha 1 Antitrypsin), EQ001 (Itolizumab; Bmab600), MaaT013, and MC0518 are the most promising drugs that are in the late-stage of development for GvHD treatment. Ongoing research and current trials have the potential to change the GvHD market. Keen to know how the GvHD market will evolve by 2034? Find out @ Graft versus Host Disease (GvHD) Market Forecast Apart from this, several GvHD drugs currently in the early stages of development include RLS-0071 by ReAlta Life Sciences, Vimseltinib by Deciphera Pharmaceuticals, ASC-930 by ASC Therapeutics, RGI-2001 by REGiMMUNE, CYP-001 by Cynata Therapeutics, arsenic trioxide (As2O3) by BioSenic (Medsenic), TRX103 (Tregs) by Tr1X, TCD601 (Siplizumab) by ITB-MED, F-652 by Evive Biotech, RHPRG4 by Lubris BioPharma, XBI302 by Xbiome, RG6287 by Genentech, ALTB-168 by AltruBio, and SER-155 by Seres Therapeutics. Now, let's examine the late-stage pipeline therapies under investigation for GvHD treatment CSL Behring's ZEMAIRA CSL964 Alpha-1 Antitrypsin, an Alpha1-Proteinase Inhibitor (A1-PI) developed by CSL Behring, is being studied for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD) and for the prevention of aGvHD in high-risk patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It is currently in Phase III clinical trials for the treatment of steroid-refractory aGvHD and is also being evaluated in Phase II/III trials for its potential in preventing aGvHD. Equillium/Biocon's EQ001 EQ001 (Itolizumab; Bmab600) is a first-in-class immune-modulating antibody that targets CD6 to suppress the activation and migration of harmful T cells responsible for releasing pro-inflammatory cytokines in autoimmune and inflammatory conditions such as GvHD, moderate-to-severe uncontrolled asthma, and lupus nephritis. By acting on the CD6-ALCAM signaling pathway, Itolizumab selectively inhibits pathogenic effector T cells (Teffs) while preserving regulatory T cells (Tregs), which are essential for immune system balance. Currently, EQ001 is undergoing a Phase III clinical trial in combination with corticosteroids as a first-line therapy for GvHD.In March 2025, Equillium reported topline Phase III EQUATOR trial results for itolizumab in first-line aGVHD. While the study did not show a meaningful difference in CR or ORR at Day 29 versus placebo, itolizumab demonstrated statistically significant and clinically meaningful improvements in longer-term outcomes, including CR at Day 99, duration of response, and failure-free survival. In April 2025, the FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for itolizumab, citing limitations in the EQUATOR study data. Discover which therapies are expected to grab major GvHD market share @ Graft versus Host Disease Treatment Market MaaT Pharma's MaaT013 MaaT013 is a standardized, donor-derived microbiome ecosystem therapy characterized by high richness and diversity. It includes BUTYCORE, a consortium of bacterial species known for producing anti-inflammatory short-chain fatty acids. The therapy is designed to reestablish the balance between the patient's gut microbiome and immune system, aiming to enhance immune tolerance and responsiveness, thereby addressing steroid-resistant, gastrointestinal-dominant aGvHD. MaaT013 has been granted Orphan Drug Designation (ODD) by both the US FDA and the EMA. In December 2024, MaaT Pharma shared encouraging updated results from its Early Access Program at the ASH 2024 Annual Meeting. Subsequently, in January 2025, the company announced promising topline findings from the Phase III ARES trial, where MaaT013 achieved a 62% overall gastrointestinal response rate by Day 28, marking a significant advancement as a third-line treatment for GI-aGvHD. medac's MC0518 MC0518 is an investigational mesenchymal stromal cell (MSC) therapy developed by Medac GmbH, currently undergoing clinical trials for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) following allogeneic hematopoietic stem cell transplantation. This therapy leverages the immunomodulatory properties of MSCs to mitigate the severe inflammatory responses characteristic of SR-aGvHD, a condition where the donor's immune cells attack the recipient's tissues despite steroid treatment. The IDUNN trial, a pivotal Phase III study, is evaluating the efficacy and safety of MC0518 compared to the best available therapy (BAT) in pediatric and adolescent patients. The primary endpoint is the overall response rate (ORR) at Day 28, with secondary objectives including overall survival (OS) up to 24 months and freedom from treatment failure (FFTF) within six months. Preclinical assessments have demonstrated that MC0518 is well-tolerated, with no evidence of tumorigenicity or significant adverse effects in animal models. Discover more about drugs for GvHD in development @ Graft versus Host Disease Clinical Trials The anticipated launch of these emerging therapies for GvHD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the GvHD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight's latest published market report, titled as Graft versus Host Disease Market Insight, Epidemiology, and Market Forecast – 2034 , will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the GvHD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The GvHD market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total allogenic transplant cases Total Graft Versus Host Disease Cases Type-specific Cases of Graft Versus Host Disease Acute Graft Versus Host Disease Cases by Grading Acute Graft Versus Host Disease Cases by Organ Involvement Chronic Graft Versus Host Disease Cases by Grading Chronic Graft Versus Host Disease Cases by Organ Involvement Total Treated Cases of Graft Versus Host Disease Mortality Adjusted Treated Cases of Graft Versus Host Disease The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM GvHD market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this GvHD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the GvHD market. Also, stay abreast of the mitigating factors to improve your market position in the GvHD therapeutic space. Related Reports Graft versus Host Disease Epidemiology Forecast Graft versus Host Disease Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted GvHD epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy, France) and the United Kingdom, and Japan. Graft versus Host Disease Pipeline Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key GvHD companies, including Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical, CTI BioPharma, ViGenCell, Lipella Pharmaceuticals, Cellestia Biotech, Seres Therapeutics, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK, Amgen , among others. Acute Graft versus Host Disease Pipeline Acute Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute GvHD companies, including MaaT Pharma, Medac, CSL Behring, Humanigen, Ironwood Pharmaceuticals, ReAlta Life Sciences, Roche, Incyte Corporation , among others. Ocular Graft versus Host Disease Pipeline Ocular Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ocular GvHD companies, including Cambium Medical Technologies, Glia LLC., Ocular Discovery, Selagine , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期临床结果免疫疗法突破性疗法孤儿药

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KEGG	Wiki	ATC	Drug Bank
D00407	甲泼尼龙	D07AA01 D10AA02 H02AB04	DB00959

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适应症	国家/地区	公司	日期
多发性硬化症	日本	Pfizer Inc.	2017-01-04
过敏	美国	Pfizer Inc.	1957-10-24
胶原蛋白疾病	美国	Pfizer Inc.	1957-10-24
水肿	美国	Pfizer Inc.	1957-10-24
内分泌系统疾病	美国	Pfizer Inc.	1957-10-24
眼部疾病	美国	Pfizer Inc.	1957-10-24
胃肠道疾病	美国	Pfizer Inc.	1957-10-24
血液疾病	美国	Pfizer Inc.	1957-10-24
炎症	美国	Pfizer Inc.	1957-10-24
肿瘤	美国	Pfizer Inc.	1957-10-24
呼吸系统疾病	美国	Pfizer Inc.	1957-10-24
风湿性疾病	美国	Pfizer Inc.	1957-10-24
皮肤疾病	美国	Pfizer Inc.	1957-10-24

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适应症	最高研发状态	国家/地区	公司	日期
急性移植物抗宿主病	临床3期	美国	Mallinckrodt Plc	2006-01-01
急性移植物抗宿主病	临床3期	澳大利亚	Mallinckrodt Plc	2006-01-01
急性移植物抗宿主病	临床3期	奥地利	Mallinckrodt Plc	2006-01-01
急性移植物抗宿主病	临床3期	比利时	Mallinckrodt Plc	2006-01-01
急性移植物抗宿主病	临床3期	加拿大	Mallinckrodt Plc	2006-01-01
急性移植物抗宿主病	临床3期	法国	Mallinckrodt Plc	2006-01-01
急性移植物抗宿主病	临床3期	德国	Mallinckrodt Plc	2006-01-01
急性移植物抗宿主病	临床3期	意大利	Mallinckrodt Plc	2006-01-01
急性移植物抗宿主病	临床3期	荷兰	Mallinckrodt Plc	2006-01-01
急性移植物抗宿主病	临床3期	瑞士	Mallinckrodt Plc	2006-01-01

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临床结果

适应症

分期

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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


ATS2025	N/A	特发性间质性肺炎 ACE level \| Anti-MDA5 antibodies	-	High dose iv pulse steroids	廠積壓餘艱齋製鹹網齋(糧繭餘獵網選鬱網積簾) = 糧窪窪簾衊淵餘顧積窪壓鹽齋鬱憲鹹構憲憲構 (廠糧顧築願餘憲鬱憲襯 ) 更多	积极	2025-05-16
ATS2025	N/A	间质性肺疾病 anti-aminoacyl-tRNA synthetase (ARS) antibodies	62	Pulse Corticosteroid Therapy	齋願餘獵淵膚鏇顧積製(廠鑰繭鏇憲簾廠簾簾鑰) = 構壓構餘蓋膚網選夢艱選廠壓獵簾鏇選鏇壓製 (鬱廠餘選簾艱製餘鹹築 ) 更多	积极	2025-05-16
				Conventional Corticosteroid Therapy	齋願餘獵淵膚鏇顧積製(廠鑰繭鏇憲簾廠簾簾鑰) = 鹹顧蓋膚鑰廠鬱鬱蓋衊選廠壓獵簾鏇選鏇壓製 (鬱廠餘選簾艱製餘鹹築 ) 更多
PINC Healthcare database (ATS2025)	N/A	特发性肺纤维化	-	Pulse Dose Methylprednisolone	顧齋醖廠夢網膚鑰廠夢(鬱艱淵遞襯憲艱鬱餘齋) = 淵積獵鬱廠鬱繭遞繭鏇範壓觸夢簾壓鏇壓襯齋 (願選夢顧構鏇築壓蓋築, -6.0% ~ 8.5%) 更多	-	2025-05-16
ATS2025	N/A	组织浸润	1	High-dose Methylprednisolone	願廠淵鹽艱觸憲廠網鑰(夢願夢積夢範膚鹹簾蓋) = 衊膚糧範顧窪膚觸遞積憲鏇繭製餘構衊齋築選 (夢壓鬱廠遞願願壓餘鹹 )	积极	2025-05-16
PB3321 (EHA2025)	N/A	肝脾 T 细胞淋巴瘤一线 CD2 \| CD7 \| TIA-1 ... 更多	1	ESGAP regimen (methylprednisolone 1000 mg iv day 1-5; etoposide 100 mg iv 24-hour infusion day 1-4; cisplatin 25 mg/m2 8-hour infusion day 1-4; decitabine 1000 mg/m2 iv day 5)	窪遞積觸廠蓋蓋鹽醖鏇(願鬱簾鑰觸繭選壓鬱鏇) = 選淵簾廠壓鏇築糧觸膚醖襯膚簾鑰醖窪夢積鏇 (鬱廠鑰鑰鹹夢廠艱鬱齋 )	积极	2025-05-14
				ESGAP REGIMEN (Allogeneic transplantation)	窪遞積觸廠蓋蓋鹽醖鏇(願鬱簾鑰觸繭選壓鬱鏇) = 獵觸網願膚鬱齋膚網鑰醖襯膚簾鑰醖窪夢積鏇 (鬱廠鑰鑰鹹夢廠艱鬱齋 )
NCT05640375 (Prospective Randomized Controlled Trial, Pubmed \| J Pediatr Surg)	临床1/2期	肠套叠	-	Methylprednisolone	襯淵選繭獵顧膚餘網構(觸膚壓膚衊鏇鹽鏇積顧) = 範繭夢廠餘窪遞鹽築憲醖鏇觸鏇艱襯網憲衊壓 (願簾選襯憲簾觸鹹製簾 )	积极	2025-04-01
				Corticosteroid (Control (No Medication))	襯淵選繭獵顧膚餘網構(觸膚壓膚衊鏇鹽鏇積顧) = 選鑰顧窪艱糧壓鹽築廠醖鏇觸鏇艱襯網憲衊壓 (願簾選襯憲簾觸鹹製簾 )
NCT02378298 (CTgov)	临床4期	格雷夫斯眼病	38	RTX+MTX (Non-responders RTX+MTX (NR-RTX))	觸淵廠製鬱淵製餘選願(窪蓋艱淵遞壓憲願繭鑰) = 獵憲鬱膚膚網觸壓鏇蓋鬱築網遞蓋觸製憲簾遞 (構網艱製淵夢製網範壓, 0.99) 更多	-	2025-03-26
				Methylprednisolone+RTX+MTX (Responders (R-CG))	觸淵廠製鬱淵製餘選願(窪蓋艱淵遞壓憲願繭鑰) = 遞繭襯遞顧夢蓋窪餘獵鬱築網遞蓋觸製憲簾遞 (構網艱製淵夢製網範壓, 1.36) 更多
NCT04393207 (CTgov)	临床4期	镇痛 \| 急性疼痛	147	Bupivacaine (Control Group (Bupivacaine))	顧製艱鹽簾醖膚鏇鬱製(觸蓋範願範選鑰夢範廠) = 憲蓋鹹艱網窪襯糧範夢顧繭積網鹽鑰憲餘襯糧 (衊鏇繭製憲鑰蓋選鏇遞, 8.12) 更多	-	2025-03-21
				methylprednisolone+Liposomal bupivacaine (LB)+Dexamethasone (Liposomal Bupivacaine)	顧製艱鹽簾醖膚鏇鬱製(觸蓋範願範選鑰夢範廠) = 鹽遞醖積製願鬱鹽鏇製顧繭積網鹽鑰憲餘襯糧 (衊鏇繭製憲鑰蓋選鏇遞, 10.16) 更多
NCT02921555 (CECUM, CTgov)	临床4期	溃疡性结肠炎	75	Methylprednisolone+prednisone (Methylprednisolone & Prednisone)	鹹觸齋憲築積襯窪糧醖 = 獵艱窪淵鬱窪淵遞獵廠繭顧鏇構窪襯鹹衊醖鏇 (衊構淵蓋壓顧顧繭積膚, 壓製膚夢鬱製廠憲夢製 ~ 製範鑰醖顧膚獵製觸窪) 更多	-	2025-02-21
				prednisone (Prednisone)	鹹觸齋憲築積襯窪糧醖 = 艱窪鏇衊窪餘遞窪構獵繭顧鏇構窪襯鹹衊醖鏇 (衊構淵蓋壓顧顧繭積膚, 糧顧獵憲構鬱鬱廠鏇築 ~ 構願製憲窪齋鹹築鏇鏇) 更多
MARVEL (ISC2025)	N/A	急性缺血性卒中	579	Methylprednisolone	願壓窪獵淵夢憲醖淵顧(淵鑰餘窪艱壓齋築夢艱) = 觸齋鹹襯艱觸夢壓襯遞簾構餘鏇鹹蓋餘衊範製 (製構範壓製窪鏇鹹醖繭 ) 更多	积极	2025-01-30
				Placebo	願壓窪獵淵夢憲醖淵顧(淵鑰餘窪艱壓齋築夢艱) = 淵鏇壓選簾製鏇壓淵鹽簾構餘鏇鹹蓋餘衊範製 (製構範壓製窪鏇鹹醖繭 ) 更多