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budesonide (Xavin / Pulairmax / Aerosial)

✓ Approved

Teva Pharmaceutical Industries Ltd. · NR3C1 · 小分子

什么是 budesonide?

budesonide 是一种小分子,由Teva Pharmaceutical Industries Ltd.研发。该药已获批,用于治疗相关适应症,给药途径:Inhaled。

药物档案

商品名Xavin, Pulairmax, Aerosial
公司Teva Pharmaceutical Industries Ltd.
药物类别小分子
分子靶点NR3C1
给药途径Inhaled
状态Approved

作用机制

分子靶点

budesonide 作用于 1 个分子靶点:

NR3C1nuclear receptor subfamily 3 group C member 1 (GR, GCCR)
需要更深入的分析?Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

budesonide 针对 1 个适应症,涉及 1 个治疗领域。

治疗领域疾病/病症分期
Respiratory, thoracic and mediastinal disordersAsthma✓ Approved

相关研究文献

PubMedThe Journal of asthma : official journal of the Association for the Care of Asthma2026-06-13

Inhaled Corticosteroids Monotherapy in Childhood Asthma: Any Differential Response Rate between Activated and Prodrugs?

Majumder Poly P, Smyrnova Anna A, Ducharme Francine M FM

The efficacy of inhaled corticosteroids (ICS) as prodrugs (inactive at delivery) has been compared to activated ICS, in mean changes in lung function and symptoms, with limited evidence on achieving control. We aimed to compare the real-life success rate of two broad ICS types (prodrug and activated) to prevent poor asthma control and exacerbations in children with asthma. We conducted a retrospective cohort study of children aged 1-17 years, initiating a new maintenance ICS monotherapy at low or medium doses. Initiation referred to a new ICS (after ≥2-month washout) or a switch to another ICS type (prodrug or activated). Co-primary outcomes included: unsatisfactory asthma control, measured by the Pharmacoepidemiologic Pediatric Asthma Control Index, and occurrence of ≥1 severe exacerbation, in following 6 months. A propensity score (PS) weight-adjusted binary logistic regression compared outcomes between ICS types, reporting odds ratios [95% confidence intervals]. Of 213 participants (56% male, median age: 6.9 years), 194 were incident users and 19, switchers. Most (N = 148) children were prescribed an activated ICS (97.3% fluticasone propionate, 2.7% budesonide) and 65, an ICS prodrug (100% ciclesonide), 61% using low-dose ICS. The PS-adjusted odds of unsatisfactory asthma control were significantly higher in the prodrug than activated ICS groups (adjOR: 2.35 [95% CI: 1.46-3.81]), with no significant group difference in severe exacerbations (adjOR: 0.92 [95% CI: 0.49-1.72]). Compared to activated ICS, children initiating a prodrug were two-fold more likely to display unsatisfactory control, with no significant difference nor equivalence in likelihood of severe exacerbations.

PMID 42286870
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PubMedInternal medicine (Tokyo, Japan)2026-06-11

Azathioprine-Induced Acute Sialadenitis and Pancreatitis in a Patient With Ulcerative Colitis.

Namikawa Mio M, Okabe Makoto M, Wakasugi Kenji K, Fuyuno Takashi T et al.

A 38-year-old woman with a five-year history of ulcerative colitis (UC) treated with 5-aminosalicylic acid presented with an acute flare of UC. The patient was treated with azathioprine (AZA) as maintenance therapy following budesonide rectal foam and developed AZA-induced sialadenitis and pancreatitis. To the best of our knowledge, this is the first reported case of concomitant azathioprine-induced sialadenitis and pancreatitis, highlighting the possibility of a shared immunologically mediated hypersensitivity mechanism. This case highlights the impact of idiosyncratic hypersensitivity reactions in thiopurine toxicity and provides clinically relevant insights into the safe application of AZA for inflammatory bowel disease management.

PMID 42270390
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PubMedJournal of investigative medicine high impact case reports2026-06-09

Azathioprine-Induced Pancreatitis in a Patient With Autoimmune Hepatitis: A Case Report.

Oikeh Oikigbeme O, Rathnam Aparna Abhirami AA, Cabrales Jazmin Mexia JM, Abdelghffar Mohamed M

A 67-year-old woman with biopsy-proven autoimmune hepatitis (AIH) developed acute pancreatitis shortly after starting azathioprine (AZA) and budesonide. She presented with abdominal pain, fever, and elevated lipase levels. Imaging confirmed acute interstitial edematous pancreatitis, and common etiologies-including gallstones, alcohol use, and hypertriglyceridemia-were ruled out. AZA was identified as the likely cause and was discontinued, resulting in full clinical recovery with supportive care. The patient was subsequently transitioned to mycophenolate mofetil (MMF) for continued immunosuppression. This case highlights the importance of early recognition of azathioprine-induced pancreatitis (AIP), particularly within the first few weeks of therapy. It also demonstrates the utility of MMF as a viable second-line agent in AZA-intolerant patients with AIH.

PMID 42259501
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PubMedMedicine2026-06-09

Adverse event mining for Breztri and Trelegy Ellipta based on the three international pharmacovigilance databases.

Wang Junyu J, Chen Kexu K, Yun Lu L, Xu Dexiang D

This study aimed to identify adverse drug reaction (ADR) risk signals associated with budesonide/glycopyrrolate/formoterol (Breztri) and fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) to support clinical decision-making and risk management. ADR reports related to Breztri and Trelegy Ellipta from the FDA Adverse Event Reporting System (FAERS) database, Japanese Adverse Drug Event Report (JADER) database and Canada Vigilance Adverse Reaction database (Q3 2004 to Q2 2024) were analyzed. After deduplication, reports were categorized using Medical Dictionary for Regulatory Activities (MedDRA) to obtain System Organ Class (SOC) and preferred terms (PTs). Disproportionality analysis was conducted using reporting odds ratio (ROR) and proportional reporting ratio methods. Analysis of 394 Breztri and 18,866 Trelegy Ellipta FAERS reports (predominantly consumer-submitted, U.S.-originated) identified 47 signals across 11 SOCs for Breztri (e.g., "Drug delivery system issue" ROR = 411.16, "Intentional device misuse" ROR = 410.69) and 160 signals across 15 SOCs for Trelegy (e.g., "Chronic eosinophilic rhinosinusitis" ROR = 187.65, "Foreign body in mouth" ROR = 107.67), revealing unlabeled risks like administration errors and packaging confusion. JADER data reinforced respiratory risks (Breztri: Chronic obstructive pulmonary disease (COPD) ROR = 516.8; Trelegy: gastrointestinal fungal infection ROR = 413.11) and device-independent safety signals (e.g., Trelegy urinary retention ROR = 28.81), while CVARD highlighted region-specific concerns including Trelegy-associated vasculitis (pulmonary vasculitis n = 29) and Breztri hypertension (ROR = 7.82). Cross-database convergence confirmed core anticholinergic/cardiopulmonary risks, yet divergent signals, FAERS' device errors, JADER's infection prominence, and CVARD's immunological events, underscore geographic heterogeneity in adverse reaction profiles, necessitating tailored risk management strategies for inhaler therapies. Inhalation device-related ADRs were observed, with Breztri showing higher incidence than Trelegy Ellipta, likely due to its more complex device usage. These findings highlight the need for enhanced patient education by healthcare providers to ensure proper device use in COPD treatment. Although core respiratory and anticholinergic risks are globally relevant, infection profiles, device complications, and rare immunological events exhibit significant geographic heterogeneity, necessitating tailored risk mitigation strategies aligned with regional pharmacovigilance patterns.

PMID 42260824
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PubMedIndian journal of pediatrics2026-06-08

Randomised Controlled Trial Comparing Single Maintenance and Reliever Therapy (SMART) with Inhaled Budesonide-Formoterol Combination, Versus Conventional Budesonide and Additional As-Needed Levo-Salbutamol, in Children with Persistent Bronchial Asthma: Author's Reply.

Mathew Joseph L JL

PMID 42258037
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PubMedThe Lancet. Child & adolescent health2026-06-05

Respiratory trajectories of infants born before 26 weeks of gestation from birth to discharge: an exploratory analysis of a randomised controlled trial.

Martinez Tugba Alarcon TA, Francis Kate L KL, Kamlin Omar O, Shalish Wissam W et al.

To survive, infants born before 26 weeks' gestation require respiratory assistance immediately after birth. However, the respiratory trajectories of these most preterm infants are not well delineated. We aimed to describe the early respiratory trajectories of infants born before 26 weeks' gestation who received surfactant during their initial neonatal intensive care admission. This study was a post-hoc exploratory analysis of PLUSS, a randomised controlled trial comparing intratracheal budesonide mixed with surfactant versus surfactant alone. Infants were recruited from 21 neonatal intensive care units in Australia, New Zealand, Canada, and Singapore. Infants born before 28 weeks' gestation and aged less than 48 h were eligible if (1) they were mechanically ventilated, or (2) they were receiving non-invasive respiratory support and there was a clinical decision to treat with surfactant. For this analysis, only infants born before 26 weeks' gestation were included, and treatment and control groups were combined. We aimed to describe early respiratory trajectories, including the levels of respiratory support and oxygen administered during the first 14 days, and respiratory outcomes at 28 postnatal days and 36 weeks' and 40 weeks' postmenstrual age. The main in-hospital respiratory outcomes were the timing and success of the first extubation, the durations of respiratory support, including oxygen requirements, and outcomes at hospital discharge, such as duration of hospital stay and discharge home on oxygen. PLUSS is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000322336), and follow-up is ongoing. Between Jan 4, 2018, and March 27, 2023, 1062 infants were recruited to the PLUSS trial, of whom 601 were born before 26 weeks' gestation. 131 (97%) of 135 infants born at 22-23 weeks' gestation were intubated at birth, compared with 163 (74%) of 220 infants born at 24 weeks and 157 (64%) of 246 infants born at 25 weeks. The median postnatal age at first extubation ranged from 15 days (IQR 8-26) in infants born at 22-23 weeks' gestation to 6 days (2-18) in those born at 24 weeks and 3 days (1-10) in those born at 25 weeks. 54 (66%) of 82 infants born at 22-23 weeks' gestation required reintubation, compared with 80 (51%) of 158 infants born at 24 weeks and 72 (38%) of 189 infants born at 25 weeks. The median duration of mechanical ventilation in infants who survived to 36 weeks' postmenstrual age was 36 days (IQR 23-49) in those born at 22-23 weeks' gestation, 26 days (14-39) in those born at 24 weeks, and 12 days (3-27) in those born at 25 weeks. At 40 weeks' postmenstrual age, nine (11%) of 83 surviving infants born at 22-23 weeks' gestation were discharged home, and 63 (85%) of 74 infants still in the hospital were receiving oxygen or respiratory support. By contrast, 36 (23%) of 160 surviving infants born at 24 weeks and 61 (30%) of 204 born at 25 weeks were discharged home, and 97 (78%) of 124 in-hospital infants born at 24 weeks and 79 (55%) of 143 in-hospital infants born at 25 weeks required oxygen or respiratory support. The most preterm infants born at the margins of viability require intensive and prolonged respiratory support. Knowledge of the respiratory trajectories in surfactant-treated infants born before 26 weeks' gestation could assist clinicians in family consultations while also guiding future randomised controlled trials. National Health and Medical Research Council, Australia; Chiesi Farmaceutici.

PMID 42242271
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