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1.
J Investig Med High Impact Case Rep ; 12: 23247096241260964, 2024.
Article in English | MEDLINE | ID: mdl-38869105

ABSTRACT

Delayed-release (DR) budesonide received expedited approval from the US Food and Drug Administration (FDA) as a treatment for reducing proteinuria in individuals with primary IgA nephropathy (IgAN) who are at significant risk of disease progression. The approval was based on clinical trials primarily involving patients with an estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m2. However, the efficacy of DR budesonide in reducing kidney function decline, especially in patients with an eGFR less than 30 mL/min/1.73 m2 and proteinuria less than 1 g/d, remains unclear. We report the case of a 43-year-old man with a long-term history of hypertension and biopsy-proven IgAN who experienced a progressive increase in proteinuria and serum creatinine, along with a decline in eGFR to 28 mL/min/1.73 m2 despite maximal supportive management. Following therapy with DR budesonide, a decreasing trend in proteinuria and a stabilization of eGFR were observed in the recent measurements. While initial data suggested the effectiveness of DR budesonide primarily in patients with an eGFR over 30 mL/min/1.73 m2, our case demonstrates the potential of DR budesonide for use in scenarios beyond its currently approved indications. This underscores the need for additional research on patients with advanced stages of chronic kidney disease.


Subject(s)
Budesonide , Delayed-Action Preparations , Disease Progression , Glomerular Filtration Rate , Glomerulonephritis, IGA , Proteinuria , Renal Insufficiency, Chronic , Humans , Budesonide/administration & dosage , Budesonide/therapeutic use , Male , Glomerulonephritis, IGA/drug therapy , Glomerulonephritis, IGA/complications , Adult , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/drug therapy , Proteinuria/drug therapy , Glucocorticoids/administration & dosage , Glucocorticoids/therapeutic use
2.
ACS Appl Mater Interfaces ; 16(26): 33081-33092, 2024 Jul 03.
Article in English | MEDLINE | ID: mdl-38888094

ABSTRACT

Inflammatory bowel disease (IBD) is a chronic and recurrent inflammatory disease that affects the gastrointestinal tract. The major hurdles impeding IBD treatment are the low targeting efficiency and short retention time of drugs in IBD sites. Nanoparticles with specific shapes have demonstrated the ability to improve mucus retention and cellular uptake. Herein, mesoporous silica nanoparticles (MSNs) with various morphologies were used to deliver budesonide (BUD) for the treatment of IBD. The therapeutic efficacy is strongly dependent on their shapes. The system comprises different shapes of MSNs as carriers for budesonide (BUD), along with Eudragit S100 as the enteric release shell. The encapsulation of Eudragit S100 not only improved the stability of MSNs-BUD in the gastrointestinal tract but also conferred pH-responsive drug release properties. Then, MSNs efficiently deliver BUD to the colon site, and the special shape of MSNs plays a critical role in enhancing their permeability and retention in the mucus layer. Among them, dendritic MSNs (MSND) effectively reduced myeloperoxidase (MPO) activity and levels of inflammatory cytokines in the colon due to long retention time and rapid release in IBD sites, thereby enhancing the therapeutic efficacy against colitis. Given the special shapes of MSNs and pH-responsivity of Eudragit S100, BUD loaded in the voids of MSND (E@MSNs-BUD) could penetrate the mucous layer and be accurately delivered to the colon with minor side effects. This system is expected to complement current treatment strategies for the IBD.


Subject(s)
Budesonide , Drug Carriers , Inflammatory Bowel Diseases , Nanoparticles , Silicon Dioxide , Budesonide/chemistry , Budesonide/administration & dosage , Budesonide/therapeutic use , Budesonide/pharmacokinetics , Nanoparticles/chemistry , Nanoparticles/therapeutic use , Animals , Silicon Dioxide/chemistry , Inflammatory Bowel Diseases/drug therapy , Inflammatory Bowel Diseases/pathology , Drug Carriers/chemistry , Mice , Polymethacrylic Acids/chemistry , Drug Liberation , Humans , Anti-Inflammatory Agents/chemistry , Anti-Inflammatory Agents/therapeutic use , Anti-Inflammatory Agents/administration & dosage , Porosity , Hydrogen-Ion Concentration
3.
Ugeskr Laeger ; 186(22)2024 May 27.
Article in Danish | MEDLINE | ID: mdl-38847300

ABSTRACT

Acute pancreatitis (AP) is a sudden inflammation of the pancreas which often manifests as a mild disease but can be associated with high morbidity and mortality. Drug-induced AP is rare and most likely underdiagnosed. Vedolizumab is a human monoclonal antibody with gut-selective integrin antagonist effect, and it is used for treatment of inflammatory bowel disease (IBD). Budesonid is a glucocorticoid which is released in the colon and it is also used in IBD treatment. This is a case report where vedolizumab or budesonide caused acute pancreatitis in a young man with ulcerative colitis.


Subject(s)
Antibodies, Monoclonal, Humanized , Budesonide , Colitis, Ulcerative , Gastrointestinal Agents , Pancreatitis , Humans , Colitis, Ulcerative/drug therapy , Antibodies, Monoclonal, Humanized/adverse effects , Antibodies, Monoclonal, Humanized/therapeutic use , Male , Pancreatitis/chemically induced , Budesonide/adverse effects , Budesonide/therapeutic use , Gastrointestinal Agents/adverse effects , Gastrointestinal Agents/therapeutic use , Adult , Acute Disease , Anti-Inflammatory Agents/adverse effects , Anti-Inflammatory Agents/therapeutic use , Glucocorticoids/therapeutic use , Glucocorticoids/adverse effects
4.
Swiss Med Wkly ; 154: 3363, 2024 Jun 17.
Article in English | MEDLINE | ID: mdl-38885613

ABSTRACT

BACKGROUND: Benign tracheal stenosis is relatively rare but remains a significant chronic disease due to its drastic symptoms including dyspnoea and inspiratory stridor, and consequent negative effect on quality of life. Traditionally, the surgical approach by resection of the stenotic tracheal segment has been the therapy of choice. However, endoscopic techniques have arisen and may offer a safe and less invasive alternative. OBJECTIVES: The aim of the retrospective study was to evaluate procedure-related safety and outcome of endoscopic treatment of benign tracheal stenosis at a single centre. METHODS: The study included all patients at our institution who between 2013 and 2022 had received endoscopic treatment of benign tracheal stenosis by rigid tracheoscopy, radial incision by electric papillotomy needle and dilation (endoscopic tracheoplasty) followed by triamcinolone acetonide as a local submucosal injection and additionally, from 2020, budesonide inhalation. RESULTS: A total of 22 patients were treated in a total of 38 interventions, each resulting in immediate improvement of symptoms. There were no peri-interventional complications or mortality. Of the 38 interventions, 11 received no triamcinolone acetonide administration, resulting in a 54.5% recurrence rate after an average of 21.1 (±18.0) months, while 27 had local triamcinolone acetonide, with a 37% recurrence rate. Since 2020, we additionally initiated post-interventional budesonide inhalation as recurrence prophylaxis for newly admitted patients and patients with recurrences(n = 8), of whom only one (12.5%) has to date experienced a recurrence. CONCLUSION: Our results indicate that endoscopic tracheoplasty offers a safe and successful, minimally invasive alternative to open surgery for patients with benign tracheal stenosis. We recommend local administration of triamcinolone into the mucosa as an additional treatment to decrease the risk of recurrence. However, given the uncontrolled study design and low sample size, safety and effectiveness cannot be conclusively demonstrated. Nonetheless, our findings suggest promising avenues for further investigation. Further studies on the additional benefit of inhaled corticosteroids are warranted.


Subject(s)
Tracheal Stenosis , Humans , Tracheal Stenosis/surgery , Female , Male , Retrospective Studies , Middle Aged , Endoscopy/methods , Adult , Triamcinolone Acetonide/administration & dosage , Triamcinolone Acetonide/therapeutic use , Treatment Outcome , Dilatation/methods , Recurrence , Aged , Budesonide/administration & dosage , Budesonide/therapeutic use , Quality of Life , Glucocorticoids/administration & dosage , Glucocorticoids/therapeutic use
5.
J Exp Clin Cancer Res ; 43(1): 165, 2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38877560

ABSTRACT

BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) is the most lethal cancer with an aggressive metastatic phenotype and very poor clinical prognosis. Interestingly, a lower occurrence of PDAC has been described in individuals with severe and long-standing asthma. Here we explored the potential link between PDAC and the glucocorticoid (GC) budesonide, a first-line therapy to treat asthma. METHODS: We tested the effect of budesonide and the classical GCs on the morphology, proliferation, migration and invasiveness of patient-derived PDAC cells and pancreatic cancer cell lines, using 2D and 3D cultures in vitro. Furthermore, a xenograft model was used to investigate the effect of budesonide on PDAC tumor growth in vivo. Finally, we combined genome-wide transcriptome analysis with genetic and pharmacological approaches to explore the mechanisms underlying budesonide activities in the different environmental conditions. RESULTS: We found that in 2D culture settings, high micromolar concentrations of budesonide reduced the mesenchymal invasive/migrating features of PDAC cells, without affecting proliferation or survival. This activity was specific and independent of the Glucocorticoid Receptor (GR). Conversely, in a more physiological 3D environment, low nanomolar concentrations of budesonide strongly reduced PDAC cell proliferation in a GR-dependent manner. Accordingly, we found that budesonide reduced PDAC tumor growth in vivo. Mechanistically, we demonstrated that the 3D environment drives the cells towards a general metabolic reprogramming involving protein, lipid, and energy metabolism (e.g., increased glycolysis dependency). This metabolic change sensitizes PDAC cells to the anti-proliferative effect of budesonide, which instead induces opposite changes (e.g., increased mitochondrial oxidative phosphorylation). Finally, we provide evidence that budesonide inhibits PDAC growth, at least in part, through the tumor suppressor CDKN1C/p57Kip2. CONCLUSIONS: Collectively, our study reveals that the microenvironment influences the susceptibility of PDAC cells to GCs and provides unprecedented evidence for the anti-proliferative activity of budesonide on PDAC cells in 3D conditions, in vitro and in vivo. Our findings may explain, at least in part, the reason for the lower occurrence of pancreatic cancer in asthmatic patients and suggest a potential suitability of budesonide for clinical trials as a therapeutic approach to fight pancreatic cancer.


Subject(s)
Budesonide , Cell Proliferation , Energy Metabolism , Pancreatic Neoplasms , Humans , Budesonide/pharmacology , Budesonide/therapeutic use , Mice , Pancreatic Neoplasms/drug therapy , Pancreatic Neoplasms/metabolism , Pancreatic Neoplasms/pathology , Energy Metabolism/drug effects , Cell Proliferation/drug effects , Animals , Cell Line, Tumor , Carcinoma, Pancreatic Ductal/drug therapy , Carcinoma, Pancreatic Ductal/metabolism , Carcinoma, Pancreatic Ductal/pathology , Xenograft Model Antitumor Assays , Cell Movement/drug effects
7.
Ann Med ; 56(1): 2365989, 2024 Dec.
Article in English | MEDLINE | ID: mdl-38900021

ABSTRACT

BACKGROUND AND AIMS: Microscopic colitis has been increasingly recognized as a cause of chronic diarrhoea. We aimed to characterize the role of disease-related factors and treatments on the clinical outcomes of microscopic colitis. METHODS: We retrospectively reviewed the medical records of patients with microscopic colitis who were treated at the University of Chicago and Oregon Health & Science University between August 2010 and May 2016. Patient characteristics and treatments were evaluated as predictors of clinical outcomes using univariate and multivariate analyses. Clinical remission was defined as no symptoms associated with microscopic colitis based on physician assessment and histologic remission was defined as no evidence of histological inflammation of microscopic colitis. RESULTS: Seventy-two patients with microscopic colitis were included in the study (28 with lymphocytic colitis and 44 with collagenous colitis). Non-steroidal anti-inflammatory drugs, proton pump inhibitors and selective serotonin reuptake inhibitors were used in 23 (31.9%), 14 (19.4%) and 15 (20.8%), respectively, at the time of diagnosis. Among 46 patients with adequate follow-up data, 25 (54.3%) patients achieved clinical remission. Response to budesonide (p = .0002) and achieving histologic remission (p = .0008) were associated with clinical remission on univariate analysis. On multivariate analysis, budesonide response (p = .0052) was associated with clinical remission (odds ratio 25.00, 95% confidence interval 2.63-238.10). Among 22 patients who underwent a follow-up colonoscopy, five patients (22.7%) achieved histologic remission. All patients with histologic remission maintained clinical remission without medication, whereas only two patients (11.8%) were able to discontinue medical therapy when histologic inflammation was present (p = .0002). CONCLUSIONS: In the present cohort of patients with microscopic colitis, a favourable response to budesonide was significantly associated with long-term clinical remission, and all patients achieving histological remission were able to maintain clinical remission without further medical therapy. Larger studies are required to confirm these findings.


Subject(s)
Budesonide , Colitis, Microscopic , Humans , Male , Female , Middle Aged , Retrospective Studies , Aged , Colitis, Microscopic/drug therapy , Colitis, Microscopic/pathology , Colitis, Microscopic/diagnosis , Budesonide/therapeutic use , Treatment Outcome , Adult , Remission Induction , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Proton Pump Inhibitors/therapeutic use , Colitis, Lymphocytic/drug therapy , Colitis, Lymphocytic/pathology , Colitis, Collagenous/drug therapy , Colitis, Collagenous/pathology , Colitis, Collagenous/diagnosis , Colonoscopy
8.
Medicine (Baltimore) ; 103(24): e38332, 2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38875395

ABSTRACT

BACKGROUND: Budesonide, capable of reducing vascular permeability, suppressing mucus secretion, and alleviating edema and spasms, is widely used in China for combined infectious disease treatment. This study assesses budesonide's efficacy and safety as an adjunct to azithromycin in pediatric Mycoplasma pneumonia management in China, aiming to establish a strong theoretical foundation for its clinical application. METHODS: We conducted a comprehensive search for qualifying studies across 5 English databases and 4 Chinese databases, covering publications until October 31, 2023. Endpoint analyses were performed using standard software (Stata Corporation, College Station, TX). This study was conducted in compliance with the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. RESULTS: A total of 24 randomized controlled trials were involved in the current study, including 2034 patients. Our findings indicate that the combination of budesonide with azithromycin for the treatment of pediatric Mycoplasma pneumonia delivers superior therapeutic efficacy (Intravenous: odds ratio [OR], 0.156, P < .001; Sequential: OR, 0.163, P = .001; Oral: OR, 0.139, P < .001), improved pulmonary function (Forced expiratory volume in 1 second: weighted mean differences [WMD], -0.28, P = .001; Peak expiratory flow: WMD, -0.554, P = .002; Forced vital capacity: WMD, -0.321, P < .001), diminished lung inflammation (IL-6: WMD, 4.760, P = .002; c-reactive protein: WMD, 5.520, P < .001; TNF-α: WMD, 9.124, P < .001), reduced duration of fever, faster resolution of cough and rales, all without increasing the occurrence of adverse events. CONCLUSION: The combination of budesonide and azithromycin demonstrates enhanced therapeutic effectiveness, promotes improved pulmonary function, shortens the duration of symptoms, and effectively mitigates the overexpression of inflammatory factors like c-reactive protein, TNF-α, and IL-6, all without an associated increase in adverse reactions in pediatric mycoplasma pneumonia.


Subject(s)
Anti-Bacterial Agents , Azithromycin , Budesonide , Drug Therapy, Combination , Pneumonia, Mycoplasma , Humans , Azithromycin/administration & dosage , Azithromycin/therapeutic use , Pneumonia, Mycoplasma/drug therapy , Budesonide/administration & dosage , Budesonide/therapeutic use , Child , China , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Administration, Inhalation , Randomized Controlled Trials as Topic , Treatment Outcome , Child, Preschool , East Asian People
9.
J Pediatr Gastroenterol Nutr ; 79(1): 92-99, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38803200

ABSTRACT

OBJECTIVES: Oral viscous budesonide (OVB) is a common medication used to treat eosinophilic esophagitis (EoE). It is typically mixed with Splenda to produce a slurry, but other delivery vehicles have been used in clinical practice. We aimed to evaluate outcomes of pediatric EoE patients treated with OVB using different drug delivery vehicles. METHODS: We performed a retrospective chart review of pediatric EoE patients treated with OVB. The primary aim was to evaluate rates of histologic remission (defined by <15 eosinophils per high power field in both mid and distal esophagus) after 6-12 weeks of OVB treatment for each delivery vehicle. Secondary aims were to evaluate histologic response and endoscopic response and remission of different delivery vehicles, and to compare the efficacy of different treatment regimens. RESULTS: A total of 111 patients were included in the study. Median treatment duration was 3.4 months. Overall rate of histologic remission with OVB was 52.6%. There was no difference in rates of histologic remission (p = 0.313) or response (p = 0.195 and p = 0.681 in mid and distal esophagus, respectively) among the different vehicle types or treatment regimens. Similarly, there was no difference in endoscopic remission and response among the different vehicle types (p = 0.853 and p = 0.727) or treatment regimens (p = 0.244 and p = 0.157). Patients who achieve histologic remission were more likely to be non-Hispanic Caucasian. CONCLUSION: Our findings suggest there is no difference in histologic and endoscopic outcomes with various delivery vehicles or combination therapy with OVB in the treatment of EoE. More palatable and cost-effective vehicles can be used to treat EoE.


Subject(s)
Budesonide , Eosinophilic Esophagitis , Pharmaceutical Vehicles , Remission Induction , Humans , Eosinophilic Esophagitis/drug therapy , Eosinophilic Esophagitis/pathology , Budesonide/administration & dosage , Budesonide/therapeutic use , Retrospective Studies , Male , Female , Child , Child, Preschool , Remission Induction/methods , Treatment Outcome , Adolescent , Esophagus/pathology , Administration, Oral
10.
BMJ Paediatr Open ; 8(1)2024 May 23.
Article in English | MEDLINE | ID: mdl-38782481

ABSTRACT

OBJECTIVE: To develop evidence-based guidance for topical steroid use in paediatric eosinophilic oesophagitis (pEoE) in the UK for both induction and maintenance treatment. METHODS: A systematic literature review using Cochrane guidance was carried out by the British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) Eosinophilic Oesophagitis (EoE) Working Group (WG) and research leads to determine the evidence base for preparation, dosing and duration of use of swallowed topical steroid (STS) formulations in EoE. Seven themes relating to pEoE were reviewed by the WG, alongside the Cochrane review this formed the evidence base for consensus recommendations for pEoE in the UK. We provide an overview of practical considerations including treatment regimen and dosing. Oral viscous budesonide (OVB) and, if agreed by local regulatory committees, orodispersible budesonide (budesonide 1 mg tablets) were selected for ease of use and with most improvement in histology. A practical 'how to prepare and use' OVB appendix is included. Side effects identified included candidiasis and adrenal gland suppression. The use of oral systemic steroids in strictures is discussed briefly. RESULTS: 2638 citations were identified and 18 randomised controlled trials were included. Evidence exists for the use of STS for induction and maintenance therapy in EoE, especially regarding histological improvement. Using the Appraisal of Guidelines, Research and Evaluation criteria, dosing of steroids by age (0.5 mg two times per day <10 years and 1 mg two times per day ≥10 years) for induction of at least 3 months was suggested based on evidence and practical consideration. Once histological remission is achieved, maintenance dosing of steroids appears to reduce the frequency and severity of relapse, as such a maintenance weaning regimen is proposed. CONCLUSION: A practical, evidence-based flow chart and guidance recommendations with consensus from the EoE WG and education and research representatives of BSPGHAN were developed with detailed practical considerations for use in the UK.


Subject(s)
Budesonide , Eosinophilic Esophagitis , Humans , Eosinophilic Esophagitis/drug therapy , Child , Budesonide/administration & dosage , Budesonide/therapeutic use , Administration, Topical , Evidence-Based Medicine , Glucocorticoids/administration & dosage , Glucocorticoids/therapeutic use , United Kingdom , Administration, Oral
11.
BMC Anesthesiol ; 24(1): 164, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38693477

ABSTRACT

BACKGROUND: Post-operative sore throat (POST) has an incidence ranging from 21 to 80%. To prevent the development of POST, several pharmacological measures have been tried. Aim of this study was to compare the efficacy of preoperative zinc, magnesium and budesonide gargles in reducing the incidence and severity of POST in patients who underwent endotracheal intubation for elective surgeries. METHODS: We conducted a prospective, randomized, double-blind, controlled equivalence trial in 180 patients admitted for elective surgical procedures under general anaesthesia. Patients were randomised into three groups; group Z received 40 mg Zinc, group M received 250 mg Magnesium Sulphate and group B received 200 µg Budesonide in the form of 30 ml tasteless and colourless gargle solutions. Sore throat assessment and haemodynamic recording was done postoperatively at immediate recovery (0 h) and 2, 4, 6, 8, 12 and 24 h post-operatively. POST was graded on a four-point scale (0-3). RESULTS: POST score was comparable at all recorded time points i.e. 0,2,4,6,8,12 and 24 h. Maximum incidence was seen at 8 h in group B (33.3%) and the minimum incidence was at 24 h in group Z (10%) (p > 0.05). It was found that the incidence of POST was more in the surgeries lasting longer than 2 h in all groups. This difference was found to be statistically significant in Groups M and B. The incidence of POST was found to be comparable between laparoscopic and open procedures. CONCLUSION: Magnesium, zinc and budesonide have an equivocal effect in the prevention of POST at different time points. The incidence of sore throat increases significantly in surgeries lasting more than two hours if magnesium or budesonide have been used as premedicant. Duration of surgery is an independent predictor for POST. TRIAL REGISTRATION: CTRI/2021/05/033741 Date-24/05/2021(Clinical Trial Registry of India).


Subject(s)
Budesonide , Magnesium Sulfate , Pharyngitis , Postoperative Complications , Preoperative Care , Zinc , Humans , Pharyngitis/prevention & control , Pharyngitis/etiology , Budesonide/administration & dosage , Budesonide/therapeutic use , Double-Blind Method , Female , Male , Prospective Studies , Adult , Postoperative Complications/prevention & control , Postoperative Complications/epidemiology , Preoperative Care/methods , Zinc/administration & dosage , Middle Aged , Magnesium Sulfate/administration & dosage , Intubation, Intratracheal , Magnesium/administration & dosage , Incidence , Elective Surgical Procedures , Young Adult , Anesthesia, General/methods
12.
Respir Med Res ; 85: 101096, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38744231

ABSTRACT

BACKGROUND: This systematic review and meta-analysis aimed to evaluate the efficacy and safety of inhaled corticosteroids (budesonide, beclomethasone, or fluticasone propionate) in preventing bronchopulmonary dysplasia (BPD) for premature infants. METHOD: Electronic databases, including PubMed, EMBASE, Web of science, Scopus, and Cochrane library, were searched from databases inception to January 2022 for eligible randomized controlled trials. Clinical outcomes such as BPD, mortality, BPD or death, adverse events, and neurodevelopmental outcomes were assessed. RESULTS: Overall, budesonide was significantly associated with a reduction in BPD at 36 weeks' postmenstrual age (RR 0.48; 95 % CI [0.38, 0.62]) and patent ductus arteriosus (PDA) (RR 0.75; 95 % CI [0.63, 0.89]) compared with control treatments. Early longer duration inhalation of budesonide alone was associated with a lower risk of BPD at 36 weeks' postmenstrual age and PDA compared with controls. Early shorter duration intratracheal instillation of budesonide with surfactant as vehicle was associated with a lower risk of BPD at 36 weeks' postmenstrual age and all-cause mortality compared with surfactant. There was no statistically significant difference between budesonide and control groups regarding neurodevelopmental impairment. Beclomethasone and fluticasone propionate did not show any superior or inferior effect on clinical outcomes compared to control treatments. CONCLUSION: These findings suggest that budesonide, especially intratracheal instillation of budesonide using surfactant as a vehicle, is a safe and effective option in preventing BPD for preterm infants. More well-design large-scale trials with long-term follow-ups are necessary to verify the present findings.


Subject(s)
Beclomethasone , Bronchopulmonary Dysplasia , Budesonide , Fluticasone , Infant, Premature , Humans , Bronchopulmonary Dysplasia/prevention & control , Bronchopulmonary Dysplasia/epidemiology , Administration, Inhalation , Infant, Newborn , Budesonide/administration & dosage , Budesonide/therapeutic use , Beclomethasone/administration & dosage , Fluticasone/administration & dosage , Fluticasone/therapeutic use , Treatment Outcome , Adrenal Cortex Hormones/administration & dosage , Adrenal Cortex Hormones/adverse effects , Adrenal Cortex Hormones/therapeutic use , Randomized Controlled Trials as Topic , Ductus Arteriosus, Patent/drug therapy , Ductus Arteriosus, Patent/prevention & control , Female , Male , Pulmonary Surfactants/administration & dosage
13.
Curr Opin Allergy Clin Immunol ; 24(3): 122-128, 2024 06 01.
Article in English | MEDLINE | ID: mdl-38656287

ABSTRACT

PURPOSE OF REVIEW: Eosinophilic esophagitis is a chronic and commonly evolving condition leading to relevant and potentially irreversible burden in terms of tissue damage and related functional impairment, thus significantly impacting on quality of life. The aim of the present review is to summarize the recent advances in terms of diagnostic work-up and pharmacological and nonpharmacological management of the disease, under the broader perspective of type 2 inflammation. RECENT FINDINGS: Two major novelties have prompted an innovative approach to EoE. In terms of diagnosis, it has been proposed to dissect the disease heterogeneity in three endotypes, independent from tissue eosinophil number: EoEe1, characterized by normal appearing oesophagus; EoEe2, associated with type 2 inflammation and steroid-refractoriness; EoEe3, whose features include adult onset, a more fibro-stenotic aspect and loss of epithelial gene expression. Concerning treatment, two recently licensed drugs for EoE, oro-dispersible budesonide and dupilumab represent the first treatment options specifically developed for EoE and addressing EoE-related peculiar pathobiological features. SUMMARY: In the era of precision medicine, managing EoE according to a phenotype-driven approach might be helpful in defining the best treatment options in the different disease forms or stages. In addition, exploring the coexistence or the previous occurrence of other type 2 conditions may suggest the opportunity to specifically target type 2 inflammation through biologic therapy. The complex EoE pathobiology combining inflammatory and functional features, both at organ and systemic level, requires a multidimensional approach relying on the strict integration of gastroenterologists and allergist-immunologists.


Subject(s)
Eosinophilic Esophagitis , Eosinophilic Esophagitis/diagnosis , Eosinophilic Esophagitis/therapy , Eosinophilic Esophagitis/immunology , Humans , Budesonide/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Precision Medicine/methods , Eosinophils/immunology , Quality of Life
14.
BMC Pediatr ; 24(1): 262, 2024 Apr 20.
Article in English | MEDLINE | ID: mdl-38643076

ABSTRACT

BACKGROUND: Respiratory distress syndrome (RDS) is one of the most important and common disorders among premature infants. OBJECTIVE: This study aimed to compare the effect of the combination of surfactant and budesonide with surfactant alone on Bronchopulmonary dysplasia (BPD) and mortality rate among premature infants with RDS. METHOD: An outcome assessor-blind randomized clinical trial was conducted on 134 premature infants with RDS who were born in Ayatollah Mousavi Hospital, Zanjan, Iran in 2021. The covariate adaptive randomization method was utilized to allocate participants into two groups (surfactant alone and a combination of surfactant and budesonide). The primary outcomes were BPD and Mortality rate from admission to hospital discharge. The data in this study were analyzed using SPSS software version 18. RESULTS: Overall the comparison of mortality rate and BPD between the two groups did not show a significant difference(p > 0.05). The subgroup results showed that administering surfactant with budesonide to infants under 30 weeks of age significantly reduced the number of deaths compared to using surfactant alone (5 vs. 17). Similar positive effects were observed for the occurrence of Pulmonary Hemorrhage, the need for a second dose of surfactant, oxygen index, mean blood pressure and mean arterial pressure (MAP) in infants under 34 weeks of age compared to more than 34 weeks (p < 0.05). CONCLUSION: These findings suggest that the combination therapy of surfactant and budesonide may be beneficial, particularly in preterm infants with less than 34 weeks gestational age and 1500 birth weight. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and assess long-term outcomes. TRIAL REGISTRATION: The study was registered at the Iranian Registry of Clinical Trials website under the code IRCT20201222049802N1. https://en.irct.ir/user/trial/48117/view . REGISTRATION DATE: 28/02/2021. PUBLIC REPOSITORY: DATA SET: This research data set link is displayed on the Zanjan-Iran Medical Sciences website: https://repository.zums.ac.ir/cgi/users/login? target=https%3 A%2 F/repository.zums.ac.ir/id/eprint .


Subject(s)
Bronchopulmonary Dysplasia , Pulmonary Surfactants , Respiratory Distress Syndrome, Newborn , Infant , Infant, Newborn , Humans , Infant, Premature , Budesonide/therapeutic use , Surface-Active Agents/therapeutic use , Bronchopulmonary Dysplasia/drug therapy , Iran , Single-Blind Method , Respiration, Artificial/methods , Respiratory Distress Syndrome, Newborn/therapy , Pulmonary Surfactants/therapeutic use , Lipoproteins
15.
Gastroenterology ; 167(1): 132-147, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38556189

ABSTRACT

Nonresponsive celiac disease (CeD) is relatively common. It is generally attributed to persistent gluten exposure and resolves after correction of diet errors. However, other complications of CeD and disorders clinically mimicking CeD need to be excluded. Novel therapies are being evaluated to facilitate mucosal recovery, which might benefit patients with nonresponsive CeD. Refractory CeD (RCeD) is rare and is divided into 2 types. The etiology of type I RCeD is unclear. A switch to gluten-independent autoimmunity is suspected in some patients. In contrast, type II RCeD represents a low-grade intraepithelial lymphoma. Type I RCeD remains a diagnosis of exclusion, requiring ruling out gluten intake and other nonmalignant causes of villous atrophy. Diagnosis of type II RCeD relies on the demonstration of a clonal population of neoplastic intraepithelial lymphocytes with an atypical immunophenotype. Type I RCeD and type II RCeD generally respond to open-capsule budesonide, but the latter has a dismal prognosis due to severe malnutrition and frequent progression to enteropathy-associated T-cell lymphoma; more efficient therapy is needed.


Subject(s)
Celiac Disease , Celiac Disease/diagnosis , Celiac Disease/therapy , Celiac Disease/immunology , Celiac Disease/diet therapy , Humans , Diet, Gluten-Free , Intestinal Mucosa/pathology , Intestinal Mucosa/immunology , Intestinal Mucosa/drug effects , Glutens/immunology , Glutens/adverse effects , Treatment Outcome , Budesonide/therapeutic use
16.
Am J Rhinol Allergy ; 38(3): 169-177, 2024 May.
Article in English | MEDLINE | ID: mdl-38456692

ABSTRACT

BACKGROUND: Budesonide high-volume saline irrigations (HVSIs) are routinely used to treat chronic rhinosinusitis (CRS) due to improved sinonasal delivery and efficacy compared to intranasal corticosteroid sprays. The off-label use of budesonide is assumed to be safe, with several studies suggesting the systemically absorbed dose of budesonide HVSI is low. However, the actual budesonide dose retained in the sinonasal cavity following HVSI is unknown. The objective of this study was to quantify the retained dose of budesonide after HVSI. METHODS: Adult patients diagnosed with CRS who had undergone endoscopic sinus surgery (ESS) and were prescribed budesonide HVSI were enrolled into a prospective, observational cohort study. Patients performed budesonide HVSI (0.5 mg dose) under supervision in an outpatient clinic, and irrigation effluent was collected. High-performance liquid chromatography was employed to determine the dose of budesonide retained after HVSI. RESULTS: Twenty-four patients met inclusion criteria. The average corrected retained dose of budesonide across the cohort was 0.171 ± 0.087 mg (37.9% of administered budesonide). Increased time from ESS significantly impacted the measured retained dose, with those 3 months post-ESS retaining 27.4% of administered budesonide (P = .0004). CONCLUSION: The retained dose of budesonide in patients with CRS after HVSI was found to be significantly higher than previously estimated and decreased with time post-ESS. Given that budesonide HVSI is a cornerstone of care in CRS, defining the retained dose and the potential systemic implications is critical to understanding the safety of budesonide HVSI.


Subject(s)
Rhinitis , Rhinosinusitis , Sinusitis , Adult , Humans , Budesonide/therapeutic use , Prospective Studies , Rhinitis/surgery , Rhinitis/drug therapy , Sinusitis/surgery , Sinusitis/drug therapy , Saline Solution/therapeutic use , Treatment Outcome , Chronic Disease
17.
Medicine (Baltimore) ; 103(10): e37309, 2024 Mar 08.
Article in English | MEDLINE | ID: mdl-38457591

ABSTRACT

To explore the effect of probiotics combined with budesonide and ipratropium bromide in the treatment of chronic obstructive pulmonary disease (COPD) on lung function and gut microbiota. This was a retrospective study of prospectively collected clinical data of 118 patients with COPD admitted to our hospital between January 2020 and December 2022. According to the treatment records, 59 patients received budesonide and irpratropium bromide (control group), and 59 patients received probiotics combined with budesonide and irpratropium bromide (observation group). The lung function, inflammatory factor levels, airway remodeling, and gut microbiota before and after treatment were compared between the 2 groups. After treatment, FVC, MMEF, PEF, and FEV1 in the 2 groups were higher than before treatment, and the values in the observation group were higher than those in the control group (P < .05). After treatment, the serum levels of TNF-α, IL-6, and PCT in the 2 groups were lower than before treatment, and the levels in the observation group were lower than those in the control group (P < .05). After treatment, the levels of serum MMP-9, VEGF, basic fibroblast growth factor, and NGF in the 2 groups were lower than before treatment, and the levels in the observation group were lower than those in the control group (P < .05). After treatment, the levels of lactobacilli and bifidobacteria in the 2 groups increased compared to those before treatment, and the observation group had a higher level, while the levels of Enterobacteriaceae and Enterococcus were lower in the observation group than those before treatment (P < .05). Based on budesonide and irpratropium bromide, probiotic treatment of COPD is more conducive to reducing the degree of inflammatory reactions, inhibiting airway remodeling, regulating the level of gut microbiota, and promoting the recovery of lung function.


Subject(s)
Budesonide , Pulmonary Disease, Chronic Obstructive , Humans , Budesonide/therapeutic use , Ipratropium/therapeutic use , Retrospective Studies , Airway Remodeling , Bromides/therapeutic use , Pulmonary Disease, Chronic Obstructive/drug therapy , Bronchodilator Agents/therapeutic use
18.
Arq Gastroenterol ; 61: e23114, 2024.
Article in English | MEDLINE | ID: mdl-38451666

ABSTRACT

BACKGROUND: Microscopic colitis (MC) is a chronic inflammatory bowel disease causing non-bloody diarrhea, and several cases are undiagnosed as a hidden cause of chronic diarrhea. OBJECTIVE: We aimed to report the symptoms, delay diagnosis and the treatment of MC in a case series. METHODS: All patients were treated at a Gastroenterology reference office from May 2022 to June 2023. Personal history including preexisting disorders, use of medications and smoking habits were collected. The delay between the onset of symptoms and the correct diagnosis was informed. All patients consented to use budesonide MMX (Corament®) off label. RESULTS: During the study period, six Caucasoid patients were diagnosed with MC, five females and one male, between the ages of 65 and 74. All patients had comorbities and were taking multiple prescription drugs. Laboratory findings showed negative serology for celiac disease for all patients, normal levels of albumin and vitamin B12. The delay between the symptoms and the MC diagnosis varied from 2 months to 6 years. All patients had a previous diagnosis of irritable bowel syndrome. All patients were in complete clinical remission during the treatment and referred no side effects of the drug. CONCLUSION: Older females using high-risk medications are suggestive of MC. Preventing delay in the diagnosis of MC is crucial to improvement in patients´ quality of life. Budesonide MMX appears to be effective, safe and well-tolerated. BACKGROUND: • Microscopic Colitis is a chronic inflammatory bowel disease causing non-bloody diarrhea. BACKGROUND: • Several cases are undiagnosed and can be a hidden cause of chronic diarrhea. BACKGROUND: • Treatment with budesonide MMX (Corament®, off label) was effective and safe.


Subject(s)
Colitis, Microscopic , Inflammatory Bowel Diseases , Female , Humans , Male , Aged , Quality of Life , Colitis, Microscopic/diagnosis , Colitis, Microscopic/drug therapy , Budesonide/therapeutic use , Pathologic Complete Response , Diarrhea/drug therapy , Diarrhea/etiology
19.
JAMA ; 331(10): 866-877, 2024 03 12.
Article in English | MEDLINE | ID: mdl-38470381

ABSTRACT

Importance: Allergic rhinitis affects an estimated 15% of the US population (approximately 50 million individuals) and is associated with the presence of asthma, eczema, chronic or recurrent sinusitis, cough, and both tension and migraine headaches. Observations: Allergic rhinitis occurs when disruption of the epithelial barrier allows allergens to penetrate the mucosal epithelium of nasal passages, inducing a T-helper type 2 inflammatory response and production of allergen-specific IgE. Allergic rhinitis typically presents with symptoms of nasal congestion, rhinorrhea, postnasal drainage, sneezing, and itching of the eyes, nose, and throat. In an international study, the most common symptoms of allergic rhinitis were rhinorrhea (90.38%) and nasal congestion (94.23%). Patients with nonallergic rhinitis present primarily with nasal congestion and postnasal drainage frequently associated with sinus pressure, ear plugging, muffled sounds and pain, and eustachian tube dysfunction that is less responsive to nasal corticosteroids. Patients with seasonal allergic rhinitis typically have physical examination findings of edematous and pale turbinates. Patients with perennial allergic rhinitis typically have erythematous and inflamed turbinates with serous secretions that appear similar to other forms of chronic rhinitis at physical examination. Patients with nonallergic rhinitis have negative test results for specific IgE aeroallergens. Intermittent allergic rhinitis is defined as symptoms occurring less than 4 consecutive days/week or less than 4 consecutive weeks/year. Persistent allergic rhinitis is defined as symptoms occurring more often than 4 consecutive days/week and for more than 4 consecutive weeks/year. Patients with allergic rhinitis should avoid inciting allergens. In addition, first-line treatment for mild intermittent or mild persistent allergic rhinitis may include a second-generation H1 antihistamine (eg, cetirizine, fexofenadine, desloratadine, loratadine) or an intranasal antihistamine (eg, azelastine, olopatadine), whereas patients with persistent moderate to severe allergic rhinitis should be treated initially with an intranasal corticosteroid (eg, fluticasone, triamcinolone, budesonide, mometasone) either alone or in combination with an intranasal antihistamine. In contrast, first-line therapy for patients with nonallergic rhinitis consists of an intranasal antihistamine as monotherapy or in combination with an intranasal corticosteroid. Conclusions and Relevance: Allergic rhinitis is associated with symptoms of nasal congestion, sneezing, and itching of the eyes, nose, and throat. Patients with allergic rhinitis should be instructed to avoid inciting allergens. Therapies include second-generation H1 antihistamines (eg, cetirizine, fexofenadine, desloratadine, loratadine), intranasal antihistamines (eg, azelastine, olopatadine), and intranasal corticosteroids (eg, fluticasone, triamcinolone, budesonide, mometasone) and should be selected based on the severity and frequency of symptoms and patient preference.


Subject(s)
Glucocorticoids , Histamine Antagonists , Rhinitis, Allergic , Humans , Budesonide/administration & dosage , Budesonide/therapeutic use , Cetirizine/therapeutic use , Fluticasone/administration & dosage , Fluticasone/therapeutic use , Histamine H1 Antagonists/administration & dosage , Histamine H1 Antagonists/therapeutic use , Immunoglobulin E/immunology , Mometasone Furoate/administration & dosage , Mometasone Furoate/therapeutic use , Olopatadine Hydrochloride/administration & dosage , Olopatadine Hydrochloride/therapeutic use , Pruritus/etiology , Rhinitis, Allergic/complications , Rhinitis, Allergic/diagnosis , Rhinitis, Allergic/immunology , Rhinitis, Allergic/therapy , Rhinorrhea/etiology , Sneezing , Triamcinolone/administration & dosage , Triamcinolone/therapeutic use , Glucocorticoids/administration & dosage , Glucocorticoids/therapeutic use , Rhinitis/drug therapy , Histamine Antagonists/administration & dosage , Histamine Antagonists/therapeutic use , Administration, Intranasal
20.
Minerva Pediatr (Torino) ; 76(4): 526-536, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38407014

ABSTRACT

Allergic rhinitis (AR) is a prevalent disease in childhood and adolescence. A type 2 inflammation characterizes AR and, mainly, sustains nasal obstruction. Budesonide aqueous nasal spray (BANS) is an intranasal corticosteroid (INCS) available since the early 1980s. BANS is indicated for treating allergic rhinitis. There is evidence about its efficacy in treating children and adolescents with seasonal and perennial AR. In addition, BANS is safe with negligible local and systemic side effects. Recent guidelines for patients with AR recommend the use of INCS as first line in many situations. In particular, AR patients (and their parents) may assess the perception of symptoms' severity using the Visual Analog Scale (VAS). A score ≥5/10 means uncontrolled symptoms and requires adequate treatment. BANS could appropriately be used in patients with uncontrolled symptoms and/or moderate/severe nasal obstruction. In conclusion, BANS represents a valuable option in managing children and adolescents with AR.


Subject(s)
Administration, Intranasal , Budesonide , Rhinitis, Allergic , Humans , Budesonide/therapeutic use , Child , Adolescent , Rhinitis, Allergic/drug therapy , Glucocorticoids/therapeutic use , Nasal Sprays , Practice Guidelines as Topic , Severity of Illness Index , Nasal Obstruction/drug therapy , Rhinitis, Allergic, Perennial/drug therapy
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