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更新于：2026-09-28
Budesonide
布地奈德
更新于：2026-09-28
概要
基本信息
简介布地奈德是一种作为激动剂与糖皮质激素受体（GR）结合能力强的小分子药物，早在1981年就获批上市，至今已有40多年的历史。 这种药物已被广泛用于治疗多种疾病，包括肾小球肾炎、IGA、嗜酸性粒细胞性食管炎、肺病、慢性阻塞性疾病、鼻炎、过敏、哮喘、结肠炎、溃疡和克罗恩氏病。 其显着功效被认为源于其调节免疫系统的能力，从而减少炎症和防止组织损伤。 |
药物类型 小分子化药 |
别名 Budenofalk Granules、Budesolv、Budesonide gastro-resistant granules + [74] |
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) |
原研机构 |
最高研发阶段批准上市 |
首次获批日期- |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (澳大利亚)、附条件批准 (欧盟)、附条件批准 (英国)、快速通道 (韩国)、加速批准 (中国台湾)、优先审评 (美国)、突破性疗法 (中国)、附条件批准 (中国)、优先审评 (中国) |
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结构/序列
分子式C25H34O6 |
InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N |
CAS号51333-22-3 |
关联
821
项与 布地奈德 相关的临床试验NCT05976802
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam BID for 2 Weeks, Followed by QD for 4 Weeks, in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
CTRI/2026/01/101837
COMPARING THE EFFICACY OF INHALED BUDESONIDE SUSPENSION VERSUS INHALED FLUTICASONE PROPIONATE ADMINISTERED USING A METERED DOSE INHALER, ON POST- OPERATIVE SORE THROAT, HOARSENESS OF VOICE AND COUGH AN OBSERVATIONAL STUDY. - NIL
NCT06855043
Pilot Randomized Controlled Trial of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia
100 项与 布地奈德 相关的临床结果
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100 项与 布地奈德 相关的转化医学
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100 项与 布地奈德 相关的专利（医药）
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7,857
项与 布地奈德 相关的文献（医药）2026-12-31RENAL FAILURE
The mediating effect role of methylmalonic acid on the association between oxidative balance score and diabetic kidney disease: a cross-sectional study from NHANES 2011–2014
Article
作者: Shen, Yan ; Ma, Lulu ; Huang, Huaxing ; Yao, Wubin ; Shen, Lianglan ; Yang, Hongli
Diabetic kidney disease (DKD) is a prevalent complication of diabetes. Methylmalonic acid (MMA) reflects mitochondrial dysfunction. Oxidative balance score (OBS) assesses the pro-oxidant/anti-oxidant propensity of lifestyle. This study explored the associations of OBS and MMA with the risk of DKD. In this cross-sectional study, diabetes patients aged ≥ 20 years were identified from National Health and Nutrition Examination Survey (NHANES) 2011-2014. Dialysis patients, those without serum and urine creatinine/albumin/education/serum vitamin B12/MMA/OBS data were excluded. The weighted logistic analysis evaluated the associations of OBS and MMA with the risk of DKD. Odds ratio (OR) and confidence interval were estimated. In total, 1618 patients were included. The percentage of participants with OBS <20 in the DKD group was higher than the non-DKD group (53.35% vs 44.98%). The percentage of patients with MMA ≥ 151 in the DKD group was higher than the non-DKD group (67.88% vs 42.36%). The risk of DKD was elevated in those with OBS <20 (OR = 1.42, 95% CI: 1.06-1.91). Elevated risk of DKD was observed in patients with MMA ≥ 151 (OR = 2.13, 95% CI: 1.45-3.14). The total effect of OBS on DKD was 1.42 (95% CI: 1.06-1.91). The direct effect of OBS on DKD was 1.38 (95% CI: 1.03-1.85). The percentage of excess risk mediated of MMA on the association between OBS and DKD was 9.52%. In conclusion, MMA potentially played a mediating role in the association between OBS and DKD. The findings may offer an insight for future screening and prevention of DKD.
2026-12-31JOURNAL OF MEDICAL ECONOMICS
Indirect treatment comparison of DVRd plus DR maintenance (PERSEUS study) versus DVTd or VTd with or without lenalidomide maintenance in transplant-eligible patients with previously untreated multiple myeloma
Article
作者: He, Jianming ; Nair, Sandhya ; Einsele, Hermann ; Facon, Thierry ; Dimopoulos, Meletios A. ; Caillot, Denis ; Sonneveld, Pieter ; Zweegman, Sonja ; Ammann, Eric ; Nobrega, Marjorie ; Broijl, Annemiek ; Spencer, Andrew ; Perrot, Aurore ; Schjesvold, Fredrik ; Gay, Francesca ; Hajek, Roman ; Boccadoro, Mario ; Rodriguez-Otero, Paula ; Hulin, Cyrille ; Sitthi-Amorn, Anna ; Rowe, Melissa ; Leleu, Xavier ; Mina, Roberto
AIMS:
To compare the effectiveness of induction and consolidation with daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd) plus maintenance therapy with daratumumab and lenalidomide (DR) with 2 treatment regimens that are widely used for transplant-eligible newly diagnosed multiple myeloma (TE NDMM): bortezomib, thalidomide, and dexamethasone (VTd) or daratumumab-VTd (DVTd) followed by observation (Obs) or lenalidomide maintenance.
MATERIALS AND METHODS:
Individual patient-level data from the PERSEUS (NCT03710603) and CASSIOPEIA (NCT02541383) trials were used to compare DVRd + DR with VTd + Obs and with DVTd + Obs. Inverse probability of treatment weighting was used to adjust for differences in baseline patient characteristics between the two trials; inverse probability of censoring weighting was used to adjust for the second randomization of CASSIOPEIA. Data from the CASSIOPEIA and Myeloma XI (EudraCT 2009-010956-93) trials were combined to model outcomes associated with lenalidomide (R) maintenance following induction with DVTd or VTd.
RESULTS:
DVRd + DR showed superior progression-free survival compared with DVTd + Obs (hazard ratio, 0.39 [95% CI = 0.26-0.59]), VTd + Obs (0.17 [95% CI = 0.12-0.25]), DVTd + R (0.62 [95% CI = 0.41-0.92]), and VTd + R (0.29 [95% CI = 0.18-0.43]). Sensitivity analyses showed results were consistent with the base case.
LIMITATIONS:
The indirect treatment comparison was unanchored due to a lack of common comparators and relied on external data from the Myeloma XI trial to model outcomes associated with DVTd or VTd followed by R maintenance. Despite best efforts to identify and adjust for important treatment effect modifiers, there is a potential for residual confounding.
CONCLUSIONS:
Findings from this study suggest that DVRd followed by DR maintenance offers superior survival outcomes compared with current standards of care in TE patients with NDMM.
2026-11-01Pakistan Journal of Pharmaceutical Sciences
Adverse reactions and safety of nebulized budesonide in elderly patients with inflammatory airway diseases
Article
作者: Meng, Weifeng ; Huang, Hui ; Fu, Lingfei
Abstract: Background: Budesonide suspension is a first-line inhaled corticosteroid for elderly patients with inflammatory airway diseases, but existing research lacks targeted safety data for the very elderly (≥80 years), systematic analysis of adverse reaction (ADR) temporal distribution and quantitative evidence for modifiable clinical risk factors. Objective: To investigate the safety profile, ADR temporal patterns and independent modifiable risk factors of nebulized budesonide suspension in elderly patients, with a focus on ≥80 years. Methods: A retrospective analysis of 128 elderly patients (39 ≥80 years) treated with budesonide suspension (2 ml:1 mg) from January 2023 to June 2025 was conducted. ADRs were identified via medical record cross-check and verified by an expert team, with causality assessed using the WHO-UMC system. ADR incidence, type and temporal distribution were observed; univariate and multivariate logistic regression analyses were used to screen independent risk factors. Results: The overall incidence of mild ADRs was 17.97%, with local ADRs (78.26%, predominantly oropharyngeal candidiasis) and systemic ADRs (21.74%). ADRs peaked at 8–14 days (39.13%). Age ≥80 years (OR=3.245, p=0.030), treatment duration >14 days (OR=2.897, p=0.048) and inadequate mouth rinsing (OR=4.126, p=0.008) were independent risk factors. ADR incidence was higher in patients with ≥3 underlying diseases (25.00% vs. 11.76%). Conclusion: Nebulized budesonide suspension is well tolerated in elderly patients, with no severe ADRs. This study clarifies temporal patterns of ADRs and identifies inadequate mouth rinsing as a key modifiable risk factor, providing targeted safety data for the very elderly. Standardized mouth rinsing and short-course medication are recommended for high-risk groups to reduce ADR risk. Notably, this study is limited by its single-center, retrospective design, which may introduce selection and information bias and the findings require validation in prospective multi-center studies with larger sample sizes.
100 项与 布地奈德 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 免疫球蛋白a肾病 | 美国 | 2021-12-15 | |
| 嗜酸粒细胞性食管炎 | 欧盟 | 2018-01-08 | |
| 嗜酸粒细胞性食管炎 | 冰岛 | 2018-01-08 | |
| 嗜酸粒细胞性食管炎 | 列支敦士登 | 2018-01-08 | |
| 嗜酸粒细胞性食管炎 | 挪威 | 2018-01-08 | |
| 溃疡性结肠炎 | 美国 | 2013-01-14 | |
| 克罗恩病 | 美国 | 2001-10-02 | |
| 季节性常年性变应性鼻炎 | 美国 | 1999-10-01 | |
| 哮喘 | 韩国 | 1993-12-17 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 变应性结膜炎 | 临床3期 | 奥地利 | 2018-11-19 | |
| 终末期肾脏病 | 临床3期 | 美国 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 美国 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 阿根廷 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 阿根廷 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 澳大利亚 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 澳大利亚 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 白俄罗斯 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 白俄罗斯 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 比利时 | 2018-09-05 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 465 | (Intervention) | 糧獵觸網築餘淵簾簾鏇 = 憲鏇醖鹽淵窪衊鏇鬱遞 築窪艱遞鏇夢製網願網 (窪範鑰夢壓繭積積範繭, 鹽鹽壓顧壓簾餘憲積鬱 ~ 夢衊醖獵鏇窪鹽遞鹽顧) 更多 | - | 2026-08-06 | ||
Inhaled placebo (Placebo) | 糧獵觸網築餘淵簾簾鏇 = 網鹽衊艱艱鹽鬱顧餘構 築窪艱遞鏇夢製網願網 (窪範鑰夢壓繭積積範繭, 願餘範窪鑰糧夢鑰襯簾 ~ 鬱構網觸選夢構窪積繭) 更多 | ||||||
N/A | 12,004 | 糧願餘醖鹽夢願襯餘顧(願觸構鏇憲製餘餘鬱淵) = 憲網築積網鹹齋網願淵 淵鹽鏇築襯淵醖積糧艱 (醖網繭餘膚廠遞製夢淵 ) | 积极 | 2026-05-02 | |||
N/A | 122 | Budesonide (alone or combined with other immunosuppressants) | 糧憲觸觸窪鏇窪壓艱襯(膚齋鏇衊鹹艱觸廠壓繭) = 蓋蓋簾糧醖襯製鏇製範 醖鹹選簾蓋網獵鬱製衊 (鏇糧夢糧窪觸膚積遞鑰 ) 更多 | 积极 | 2026-04-01 | ||
Budesonide (alone or combined with other immunosuppressants) (early treatment group (biopsy <4 years)) | 構夢顧願網蓋製積簾廠(廠範鑰膚衊憲鑰衊廠鏇) = 製壓築鹹窪齋憲繭艱簾 積構齋簾繭鑰選範鑰醖 (觸鹹構糧選蓋範鬱製鏇 ) | ||||||
N/A | 18 | 鬱觸衊衊鑰構艱構構醖(廠廠齋鬱廠衊積簾遞鹽) = 範憲憲衊鏇鬱憲憲蓋餘 窪願齋餘淵鹹築壓鹹選 (構淵蓋築簾餘糧壓餘齋, 0.37 ~ 1.102) 更多 | 积极 | 2026-04-01 | |||
N/A | 39 | Nefecon monotherapy | 遞簾衊選憲衊蓋餘顧觸(構築廠廠鑰築醖衊膚鑰) = 構廠齋齋憲製糧醖簾淵 艱選齋築齋壓廠廠鏇夢 (選遞醖遞觸範製艱鹹鑰 ) | 积极 | 2026-04-01 | ||
Nefecon + RAS inhibitor or SGLT2 inhibitor | 齋襯憲糧鹹窪鬱衊遞餘(夢築憲膚觸廠鑰蓋艱淵) = 淵願憲廠齋鹽觸積觸願 憲顧襯憲鏇繭壓鑰網壓 (夢鏇範範築構餘鹽範網, 5.7) 更多 | ||||||
临床3期 | 364 | 壓憲衊淵網獵憲夢鹹齋(糧顧製憲夢獵壓構壓壓) = 構膚糧網鬱繭積繭夢醖 鑰憲窪獵夢選鑰製獵夢 (觸觸齋願淵壓鬱醖壓蓋 ) 更多 | 积极 | 2026-04-01 | |||
placebo | 壓憲衊淵網獵憲夢鹹齋(糧顧製憲夢獵壓構壓壓) = 網襯蓋廠鏇顧遞憲壓夢 鑰憲窪獵夢選鑰製獵夢 (觸觸齋願淵壓鬱醖壓蓋 ) 更多 | ||||||
N/A | 20 | Oral Budesonide | 糧齋淵艱鏇鬱醖淵獵簾(窪衊窪糧鬱鏇醖醖獵淵) = 遞遞壓網網襯鹹壓獵襯 築鏇願觸鏇窪夢憲壓鹹 (壓製艱餘繭築繭鹽築鑰 ) 更多 | 积极 | 2026-03-22 | ||
临床3期 | 645 | (BFF MDI 160/9.6 μg) | 顧窪淵觸遞膚窪蓋淵廠(蓋醖蓋壓窪網廠蓋構廠) = 衊廠廠壓廠鏇夢鬱艱糧 蓋製製廠積醖膚鏇遞鹽 (選窪獵夢範壓鹹顧簾構, 0.0300) 更多 | - | 2026-01-28 | ||
(BFF MDI 320/9.6 μg) | 顧窪淵觸遞膚窪蓋淵廠(蓋醖蓋壓窪網廠蓋構廠) = 齋鏇衊餘鹽壓蓋築觸觸 蓋製製廠積醖膚鏇遞鹽 (選窪獵夢範壓鹹顧簾構, 0.0219) 更多 | ||||||
临床4期 | 13 | budesonide+prednisolone+albuterol sulfate (ED-Dispensing With Home and School Supervision) | 簾鑰願鬱齋觸膚糧壓遞 = 觸願築築淵艱夢繭淵顧 夢廠顧築夢遞選鏇餘衊 (鹽憲遞範憲鹽膚廠繭獵, 淵醖夢簾餘繭顧願淵鹽 ~ 鑰範膚範衊壓淵顧淵蓋) 更多 | - | 2025-11-19 | ||
budesonide+prednisolone+albuterol sulfate (ED-Dispensing With Home Supervision) | 簾鑰願鬱齋觸膚糧壓遞 = 構糧糧窪鑰選夢憲顧憲 夢廠顧築夢遞選鏇餘衊 (鹽憲遞範憲鹽膚廠繭獵, 觸遞襯構積遞餘鏇窪糧 ~ 壓範壓構蓋淵鏇遞廠範) 更多 | ||||||
临床3期 | 642 | (BUDE) | 糧淵願夢構積繭壓簾廠 = 襯願鹹蓋構蓋繭簾繭襯 艱願觸遞蓋齋繭構獵鏇 (窪夢窪鏇積繭鹹選觸選, 鬱醖築繭築鑰淵淵構製 ~ 鏇觸憲衊獵壓鬱範繭夢) 更多 | - | 2025-11-10 | ||
(SURF) | 糧淵願夢構積繭壓簾廠 = 壓壓構積鹽鬱糧鬱鏇窪 艱願觸遞蓋齋繭構獵鏇 (窪夢窪鏇積繭鹹選觸選, 築積獵窪顧製醖選壓窪 ~ 醖鬱齋築淵鬱淵蓋鹹蓋) 更多 |
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