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OBJECTIVE: Despite limited safety and efficacy data, inhaled corticosteroids (ICS) are prescribed to premature infants in the neonatal intensive care unit (NICU). We examined contemporary use and risk factors for ICS use in the NICU. STUDY DESIGN: Infants

Background: Budesonide and tixocortol pivalate as markers of contact allergy to corticosteroids have been questioned, as they are not able to detect a significant percentage of allergic patients. Objectives: To investigate the potential role of clobetasol propionate in enhancing corticosteroid sensitisation detection. Methods: Between January 2022 and December 2023, patients who attended centres involved in the Spanish Registry of Research in Contact Dermatitis and Cutaneous Allergy were tested with an extended baseline series that included budesonide, tixocortol pivalate, clobetasol propionate 0.1% in ethanol and 1% in petrolatum. Results: A total of 4338 patients were tested. Twenty‐four patients were allergic to budesonide (0.55%, 95% CI: 0.37–0.82); nine patients were allergic to tixocortol pivalate (0.21%, 95% CI: 0.11–0.39); and 23 patients were allergic to clobetasol (0.53%, 95% CI: 0.35–0.79). Only four of those patients allergic to clobetasol were detected by budesonide and one by tixocortol pivalate. No significant differences in the number of positive tests were found between clobetasol in petrolatum or ethanol. Conclusions: In Spain budesonide remains the main corticosteroid allergy marker whereas the role of tixocortol pivalate is questionable. The addition of clobetasol propionate to the Spanish baseline series would improve the ability to detect patients allergic to corticosteroids. [ABSTRACT FROM AUTHOR]

The terminal ileum is the most frequent site of Crohn's Disease (CD) that necessitates surgery. Of the postoperative complications (POCs) associated with ileocaecal resection for CD, intra-abdominal septic complications (IASCs) include anastomotic leak, abscesses, and entero-cutaneous fistula. We aimed to identify predictors of IASCs and severe POCs (Clavien-Dindo ≥3) after primary ileocaecal resection for CD. This is a retrospective single-centre cohort study including all consecutive primary ileocaecal resection for CD in a tertiary IBD centre between 2004 and 2021. A total of 853 patients underwent primary ileocaecal resection for CD. 307 (36.6 %) patients were receiving antibiotics, 253 (29.8 %), systemic steroids, and 178 (21.0 %) oral budesonide at surgery. At 90 days, 260 (30.8 %) patients developed POCs, 62 (7.3 %) severe POCs, and 56 (6.6 %) IASCs. At multivariate analysis, severe POCs were associated with lower preoperative albumin levels (OR1.58, 95 %CI 1.02–2.50, p = 0.040) and a history of cardiovascular diseases (OR2.36, 95 %CI 1.08–7.84, p = 0.030). IASCs were associated with lower preoperative albumin levels (OR1.81, 95 %CI 1.15–2.94, p = 0.011) and oral budesonide (OR2.07, 95 %CI 1.12–3.83, p = 0.021) with a dose-dependent effect. The independent association, dose-dependent effect, and biological plausibility of budesonide and IASCs suggest a robust causal effect. Oral budesonide should be carefully assessed before primary ileocaecal resection for CD. [ABSTRACT FROM AUTHOR]

Topical budesonide irrigations are frequently prescribed after endoscopic sinus surgery (ESS) to manage mucosal inflammation. However, this off‐label indication may conflict with health insurance formularies. We sought to quantify the relative frequency of postoperative budesonide prescriptions to determine if this could be considered common practice after ESS. We extracted and analyzed postoperative prescription data for patients undergoing ESS from 2016 to 2022 within our health care system. Overall, among 8157 ESS patients, 15.9% and 22.1% received topical budesonide prescriptions within 30 or 180 days postoperatively, respectively. On a year‐over‐year basis, budesonide prescription frequency increased significantly over time, culminating at 20.3% and 24.9% in 2022. Conversely, postoperative oral corticosteroid (OCS) prescriptions showed a decreasing frequency over the same time period (P <.001). Our results show topical budesonide irrigations are increasingly frequently prescribed after ESS and may offset postoperative OCS requirements. This argues for coverage of topical budesonide as a formulary medication after ESS. [ABSTRACT FROM AUTHOR]

Background and Aim Methods Results Conclusion Early treatment response of ulcerative colitis (UC) symptom resolution is desirable. This post hoc analysis evaluated efficacy outcomes, including endoscopic remission, by responder status and the influence of once‐daily (QD) versus twice‐daily (BID) budesonide foam dosing in patients with UC.Data were pooled from phase 2 and phase 3 clinical trials of budesonide rectal foam QD or BID or placebo for up to 12 weeks. Outcomes were evaluated by treatment and budesonide administration regimen and by responder group: early (rectal bleeding subscore [RBS] 0 from Week 2 through Week 6), delayed (RBS 0 at Week 6), and nonresponder (RBS > 0 at Week 6).The main analysis set included 55 (QD) and 120 (BID) budesonide‐treated patients and 116 placebo‐treated patients. At Week 6, the trend in early response rate was significant among treatment groups (BID, 45.3%; QD, 32.1%; placebo, 12.8%; P < 0.0001). Among BID recipients, trends for complete endoscopic remission rate (Mayo endoscopic score [MES] = 0) and endoscopic remission rate (MES = 0 or 1) were significant among responder status groups (early responder, 67.4% and 95.4%, respectively; delayed responder, 48.1% and 85.2%; nonresponder, 24.0% and 64.0%; P < 0.001 for both). Regardless of the administration regimen, most early responders achieved endoscopic remission at Week 6. Among responder status groups, early responders' cumulative non‐relapse period was greatest (P = 0.07).A BID budesonide administration regimen is preferred to increase the probability of early response and, following endoscopic remission, a better prognosis after stopping treatment. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the efficacy of triple inhaled therapy, a combination of inhaled glucocorticoids, long-acting muscarinic antagonists, and long-acting β2 agonists in managing acute exacerbations of chronic obstructive pulmonary disease (COPD). Methods: Medical data of 100 patients with acute exacerbation of COPD admitted to Shaoxing Second Hospital, Shaoxing, China between January 2020 to December 2022 was collected and retrospectively analyzed. The patients were randomized into control (n = 50) and study groups (n = 50). Control group received budesonide/formoterol inhalers while the study group received triple inhaled therapy (budesonide/glycopyrronium/formoterol inhalers). Arterial blood gas, pulmonary function, immune function, adverse effects, and efficacy were evaluated. Results: The study group exhibited significantly higher pH, partial pressure of arterial oxygen (PaO2), and lower partial pressure of carbon dioxide (PaCO2) compared to control group (p < 0.001). Furthermore, the study group showed significantly higher levels of pulmonary function and immune function indices compared to control group (p < 0.001). There was no significant difference in incidence of adverse reactions between the two groups (p > 0.05). The study group was associated with higher clinical efficacy compared to the control group (p < 0.05). Conclusion: Triple inhaled therapy significantly alleviates the clinical symptoms of patients with COPD and enhances pulmonary and immune functions. Future studies should cover a larger and more diverse group of participants for broader validity. [ABSTRACT FROM AUTHOR]

Objective: To explore the clinical value of Vitamin-D combined with budesonide/formoterol (BF) and theophylline sodium glycinate (TSG) sustained-release tablets in the treatment of patients with chronic obstructive pulmonary disease (COPD). Methods: Medical records of 114 patients with CODP, treated in Wenzhou Geriatric Hospital from October 2020 to February 2023, were retrospectively analyzed. Of them, 59 received treatment with Vitamin-D combined with BF and TSG sustained-release tablets (Group-A), and 55 patients received treatment with BF combined with TSG sustainedrelease tablets (Group-B). Lung function indicators, blood gas status, inflammatory factors, fractional exhaled nitric oxide (FeNO), and 25-hydroxyvitamin D [25(OH)D] levels before and after the treatment in both groups were collected. Results: After the treatment, lung function indicators, blood gas status, inflammatory factors, FeNO, and 25 (OH) D levels in both groups were significantly improved compared to pretreatment levels, and were significantly better in the Group-A compared to Group-B (P<0.05). Conclusions: The combination of Vitamin-D, BF, and TSG sustained-release tablets can effectively regulate the blood gas status of patients with COPD, improve lung function, regulate FeNO and 25 (OH) D, and effectively downregulate the levels of inflammatory factors, thus reducing the degree of inflammatory response. [ABSTRACT FROM AUTHOR]

Objective: To explore the clinical effect of various doses of Budesonide combined with Tiotropium bromide in the treatment of elderly patients with chronic obstructive pulmonary disease (COPD). Methods: Clinical data of elderly patients with COPD, admitted to Affiliated Hospital of Shaoxing University from April 2021 to February 2023, were retrospectively analyzed. Based on the dosage of Budesonide combined with Tiotropium bromide, patients were divided into Low-dose group (Budesonide = 1mg), Medium-dose group (Budesonide = 2mg), and High-dose group (Budesonide = 3mg). All groups were matched for age, gender, course of disease, and BMI. Patients treated with Tiotropium bromide alone were assigned to the Control group. The clinical effect, pulmonary function index level, symptom improvement, inflammatory factor index level and adverse reactions in all groups were analyzed and compared. Results: A total of 88 patients were included in this study with 22 patients in each group. The total efficacy of Medium-dose (90.91%) and High-dose group (90.91%) was significantly higher than that of Low-dose group (63.64%) and the Control group (59.09%) (P<0.05). After the treatment, levels of pulmonary function, symptom improvement and inflammatory factors in the High-dose and the Medium-dose groups were better than those in the Low-dose group and the Control group. Pulmonary function, symptom improvement and levels of inflammatory factors was significantly better in the Low-dose group compared to the Control group (P<0.05). Conclusions: Budesonide combined with tiotropium bromide is better than tiotropium bromide alone in the treatment of elderly patients with COPD. Compared with low (1mg) dosage, medium (2mg) and high (3mg) dosage of budesonide are more effective in improving lung function, alleviating symptoms, reducing inflammatory response,, and are not associated with increased rate of adverse reactions. [ABSTRACT FROM AUTHOR]

Purpose: Functional endoscopic sinus surgery (FESS) is a mainstay surgical intervention for chronic rhinosinusitis with nasal polyposis (CRSwNP). Nasal irrigation, particularly with normal saline, is a widely recommended postoperative care modality. This systematic review and meta-analysis aimed to assess the efficacy of various nasal irrigation solutions in postoperative FESS patients. Methods: A comprehensive search was conducted in multiple databases for randomized controlled trials investigating normal saline and various substances for nasal irrigation post-FESS. The systematic review followed PRISMA guidelines, and the meta-analysis used R software for data synthesis. Outcome measures included SNOT-22 and LKES scores. The Cochrane tool was employed to evaluate the potential for bias. Results: Results from 14 studies, focusing on six each for SNOT-22 and LKES, revealed a significant reduction in symptoms and endoscopic scores with various solutions compared to normal saline. The meta-analysis using the random-effects model indicated a negative standardized mean difference (SMD) of − 0.69(95% CI [− 1.64; 0.27], p = 0.157) for symptoms and endoscopic scores (SMD = − 0.48, 95% CI [− 1.32; 0.36], z = − 1.12, p = 0.264). Subgroup analyses highlighted budesonide's efficacy over normal saline, but substantial heterogeneity and potential publication bias were noted. Conclusion: Nasal irrigation with various solutions postoperative FESS patients demonstrated significant improvements in patient-reported symptoms and endoscopic scores compared to normal saline. Budesonide appeared particularly effective. However, high heterogeneity and potential publication bias warrant cautious interpretation. Standardized outcome measures and further research are needed to strengthen the evidence. [ABSTRACT FROM AUTHOR]

To assess the impact of budesonide-formoterol on pulmonary ventilation function and prognosis in patients with mild-to-moderate acute exacerbations of bronchial asthma. A retrospective analysis was conducted on clinical data from 232 patients with acute exacerbations of bronchial asthma. These patients were divided into 2 groups based on their treatment: a control group (n=104) receiving budesonide dry powder inhalation and an observation group (n=107) receiving budesonide-formoterol dry powder inhalation. Clinical efficacy and safety indicators were compared. The results showed that the total treatment effectiveness rate in the observation group was significantly higher than that in the control group. Following treatment, the observation group exhibited significantly higher scores in the Asthma Quality of Life Questionnaire (AQLQ), as well as improved levels of forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF), compared to the control group. Moreover, levels of tumor necrosis factor-alpha, interleukin-6, and C-reactive protein were significantly lower in the observation group. The incidence of adverse reactions between groups was comparable. Based on these findings, the application of budesonide-formoterol demonstrated significant effectiveness in patients with mild-to-moderate acute exacerbations of bronchial asthma. The combination therapy led to improved clinical outcomes, including enhanced pulmonary ventilation function and reduced inflammatory markers. Importantly, the safety profile of budesonideformoterol was comparable to that of budesonide monotherapy. These results highlight the potential benefits of using budesonide-formoterol as an alternative treatment option for patients experiencing acute exacerbations of mild-to-moderate bronchial asthma. [ABSTRACT FROM AUTHOR]

To improve the therapeutic activity of inhaled glucocorticoids and reduce potential side effects, we designed a formulation combining the advantages of nanoparticles, which have an enhanced uptake by alveolar cells, allow targeted delivery and sustained drug release, as well as limited drug systemic passage, with those of microparticles, which display good alveolar deposition. Herein, a polymer-drug conjugate, poly(malic acid)-budesonide (PMAB), was first synthesized with either 11, 20, 33, or 43 mol% budesonide (drug:polymer from 1:8 to 3:4), the drug creating hydrophobic domains. The obtained conjugates self-assemble into nanoconjugates in water, yielding excellent drug loading of up to 73 wt%, with 80–100 nm diameters. In vitro assays showed that budesonide could be steadily released from the nanoconjugates, and the anti-inflammatory activity was preserved, as evidenced by reduced cytokine production in LPS-activated RAW 264.7 macrophages. Nanoconjugates were then embedded into microparticles through spray-drying with L-leucine, forming nano-embedded microparticles (NEMs). NEMs were produced with an aerodynamic diameter close to 1 µm and a density below 0.1 g.cm−3, indicative of a high alveolar deposition. NEMs spray-dried with the less hydrophobic nanoconjugates, PMAB 1:4, were readily dissolved in simulated lung fluid and were chosen for in vivo experiments to study pharmacokinetics in healthy rats. As it was released in vivo from NEMs, sustained distribution of budesonide was obtained for 48 h in lung tissue, cells, and lining fluid. With high loading rates, modulable release kinetics, and low cytotoxicity, these nanoconjugates delivered by NEMs are promising for the more efficient treatment of pulmonary inflammatory diseases. [ABSTRACT FROM AUTHOR]

Background The anti-inflammatory effects of budesonide (BUN) and N-acetylcysteine (NAC) attenuate acute lung injury (ALI). The aim of this study was to investigate the effects of combination therapy consisting of BUN and NAC on ALI and the underlying mechanisms. Methods In vitro and in vivo models of ALI were generated by LPS induction. Western blotting was used to detect the expression levels of pyroptosis-related proteins and inflammation-related factors, and RT–qPCR was used to detect the expression of miR-381. Cell proliferation and apoptosis were detected by CCK-8 and flow cytometry, respectively. ELISA was used to detect the levels of inflammation-related factors. HE staining was used to detect lung injury. Results The results showed that LPS effectively induced pyroptosis in cells and promoted the expression of pyroptosis-related proteins (Caspase1, Gasdermin D and NLRP3) and inflammatory cytokines (TNF-α, IL-6 and IL-1β). The combination of BUN and NAC significantly alleviated LPS-induced pyroptosis and inflammation. In addition, the combination of BUN and NAC effectively promoted miR-381 expression. Transfection of miR-381 mimics effectively alleviated LPS-induced pyroptosis and inflammation, while transfection of miR-381 inhibitors had the opposite effect. miR-381 negatively regulates NLRP3 expression. Treatment with a miR-381 inhibitor or pc-NLRP3 reversed the effects of the combination of BUN and NAC. In a mouse model of ALI, the combination of BUN and NAC effectively improved lung injury, while treatment with a miR-381 inhibitor or pc-NLRP3 effectively reversed this effect. Conclusion Overall, this study revealed that BUN + NAC inhibits the activation of NLRP3 by regulating miR-381, thereby alleviating ALI caused by pyroptosis-mediated inflammation. [ABSTRACT FROM AUTHOR]

Background: Inhalational corticosteroids (ICS) were observed to increase the pneumonia risk in chronic obstructive pulmonary airway disorder (COPD). However, it is unknown whether any differences exist between the drugs within the ICS class. Aim: This study aimed to evaluate the risk of pneumonia associated with different ICS and identify factors that predict pneumonia in patients with moderate-to-severe COPD using a network meta-analysis. Method: Electronic databases (Medline, Cochrane CENTRAL and Google Scholar) were searched for trials comparing ICS in COPD patients. The outcomes were pneumonia and serious pneumonia. Odds ratios (OR) with 95% confidence interval (95% CI) were estimated. Meta-regression was used to identify the predictors. The strength of evidence was graded using the Grading of Recommendations, Assessment, Development, and Evaluations approach. Results: Sixty-six studies (103,347 participants) were included. Fluticasone (OR: 1.46; 95% CI: 1.26, 1.7), mometasone (OR: 2.2; 95% CI: 1.05, 4.6), and beclometasone (OR: 1.7; 95% CI: 1.1, 2.6) were observed with an increased pneumonia risk compared to placebo. Fluticasone (OR: 1.5; 95% CI: 1.3, 1.7) was observed with an increased risk of serious pneumonia. High doses (OR: 1.2; 95% CI: 1.03, 1.4), BMI ≥ 25 kg/m2 (OR: 1.6; 95% CI: 1.1, 2.2), and history of exacerbations in the preceding year predicted the pneumonia risk. Evidence strength was moderate. Conclusion: ICS class differences in pneumonia risk were observed in terms of pooled effect estimates but it is unlikely that any clinically relevant differences exist. Risk–benefit analysis supports ICS use in moderate-severe COPD. [ABSTRACT FROM AUTHOR]

Introduction: Non-responsive coeliac disease (NRCD), where symptoms and enteropathy persist despite a prolonged gluten-free diet (GFD), is common. Refractory coeliac disease (RCD), characterised by malabsorption and extensive enteropathy, is rare but serious. In both, treatment options are limited. Topical budesonide may help and an open capsule format promoting proximal small intestinal delivery may be advantageous. Aim: To describe the effect of budesonide and its presentation on mucosal healing, symptoms, and tolerability in NRCD and RCD. Methods: A retrospective cohort study of NRCD and RCD patients who received budesonide for enteropathy despite a strict GFD for over 12 months. Primary outcome was improvement in histology. Symptoms and adverse treatment effects were recorded. Results: 50 patients with NRCD (n = 14; 86% F), RCD type 1 (n = 30; 60% F), and RCD type 2 (n = 6 based on aberrant duodenal T cells; 33% F) were identified. Common RCD symptoms were diarrhoea (68%), fatigue (40%), and weight loss (34%). 16 received closed capsule budesonide (CCB) 9 mg OD and 35 open capsule budesonide (OCB) 3 mg 3 times a day. Complete and partial mucosal healing was significantly higher after OCB compared to CCB (p < 0.001, Mann–Whitney U test). Symptom improvement was also significantly higher after OCB compared to CCB (p = 0.002, Mann–Whitney U test). Side effects were mild and self-limiting and were reported in 25% of both cohorts. Conclusion: OCB was well tolerated and associated with improvements in enteropathy (83%) and symptoms (90%) in NRCD and RCD. Our findings support OCB as the preferred 1st-line therapy for NRCD and RCD type 1. [ABSTRACT FROM AUTHOR]

Acute respiratory distress syndrome (ARDS) is a life-threatening condition in which the lungs fail to provide sufficient oxygen to the body's vital organs. It is commonly associated with COVID-19 patients. Severe cases of COVID-19 can lead to lung damage and organ failure due to an immune response in the body. To mitigate these effects, corticosteroids, which are known for their anti-inflammatory properties, have been suggested as a potential treatment option. The primary focus of this study was to assess the impact of various corticosteroid administration methods on the outcomes of patients with COVID-19. Methods: The current study was conducted on COVID-19 patients divided into three groups. The first group was administered 6 mg of intravenous (IV) dexamethasone; the second group received 1 mg/kg of IV methylprednisolone (methylprednisolone); and the third group received budesonide respirable solution at a dosage of 1mg twice daily. The neubilizer used was a vibrating mesh nebulizer (VMN). All patients received standard care. We found that dexamethasone administered intravenously led to a significant reduction in C-reactive protein levels, surpassing the effectiveness of both IV methylprednisolone and inhaled budesonide. Oxygen saturation without mask change over time showed statistically significant differences (p = 0.004) in favor of the budesonide and dexamethasone groups for all days. Individuals who received methylprednisolone showed a significant decrease in mortality rate and an extended survival duration, with statistical significance observed at p = 0.024. The rest of the parameters, including ferritin, lymphocytes, total leukocyte count, platelets, hemoglobin, urea, serum potassium, serum sodium, serum creatinine, serum glutamic-pyruvic transaminase, serum glutamic-oxaloacetic transaminase, uric acid, albumin, globulin, erythrocyte sedimentation rate, international normalized ratio, oxygen saturation with flow, and oxygen flow, showed no statistically significant differences between the three drugs. In conclusion, treatment with IV methylprednisolone (1 mg/kg) resulted in a shorter hospital stay, decreased reliance on ventilation, and improved health outcomes for COVID-19 patients compared to using dexamethasone at a daily dosage of 6 mg or budesonide respirable solution at a dosage of 1mg twice daily. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the therapeutic effect of budesonide nasal irrigation and saline irrigation in patients undergoing surgery for chronic rhinosinusitis (CRS). Methods: One hundred patients scheduled for functional endoscopic sinus surgery (FESS) in Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, China were enrolled. The patients were divided into study and control groups comprising 50 cases each. The study group received postoperative budesonide irrigation while control group received normal saline irrigation after surgery. Post-operative symptoms, signs, and adverse reactions of the patients were compared. Results: Five weeks post-operation, the visual analogue scale (VAS) scores of nasal congestion, nasal discharge, nasal itching, sneezing, nasal pain, and the score of nasal endoscopy one week and 4-weeks after operation were significantly lower compared to control (p < 0.05). There was no significant difference in nasal bleeding when the packing was removed between the two groups (p > 0.05) after surgery. Within the first week after surgery, there was no significant difference in occurrence of nasal malodor (p > 0.05). Conclusion: Application of budesonide nasal irrigation alleviates post-operative symptoms, reduces inflammation and improves treatment outcomes. Further studies will be required to comprehensively investigate the dose effect of budesonide. [ABSTRACT FROM AUTHOR]

Background: Respiratory distress syndrome (RDS) is a leading cause of premature infant death. One of the most successful therapies for Bronchopulmonary dysplasia (BPD) is anti-inflammatory medication using corticosteroids. However, systemic corticosteroid administration is not suggested due to long-term side effects. We aim to study the effect of early intratracheal instillation of surfactant/budesonide with surfactant in preterm infants with severe Respiratory distress syndrome (RDS). Methods: This cross sectional study was carried out in the Pediatric Department, on 60 preterm infants weighing less than 1,500g who were admitted to the neonatal intensive care unit (NICU) of Zagazig University Hospital, during the period from November 2021 to November 2022. The treatment group (surfactant and budesonide) was given a mixture of 0.25 mg/kg (1 mL/kg) of budesonide and 100 mg/kg (4 mL/kg) of surfactant, and the control group (surfactant only) was given 100 mg/kg (4 mL/kg) of surfactant only. Results: There was no statistical significant difference between studied groups as regard Surfactant redoes, BPD, BPD moderate to severe, duration of non-invasive ventilation, duration of invasive ventilation, death, intraventricular hemorrhage (IVH), ROP and NEC. Among Surfactant-budesonide group; 16.7% Surfactant redoes, 26.7% BPD, 16.7% death, 6.7% IVH, 16.7% ROP, 0 % NEC and median duration of non-invasive ventilation is 3 days for surfactant-budesonide and control groups. Conclusions: Early intratracheal administration of budesonide and surfactant in preterm infants with sever RDS might decrease BPD and mortality without disturbing surfactant function. [ABSTRACT FROM AUTHOR]

The article describes two cases, highlighting the challenges and difficulties in management of non cirrhotic autoimmune hepatitis (AIH) patients.