Efficacy Of Budesonide Research Articles

Exogenous Surfactant as a Pulmonary Delivery Vehicle for Budesonide In Vivo.

BackgroundLung inflammation is associated with many respiratory conditions. Consequently, anti-inflammatory medications, like glucocorticoids, have become mainstay intrapulmonary therapeutics. However, their effectiveness for treating inflammation occurring in the alveolar regions of the lung is limited by suboptimal delivery. To improve the pulmonary distribution of glucocorticoids, such as budesonide to distal regions of the lung, exogenous surfactant has been proposed as an ideal delivery vehicle for such therapies. It was therefore hypothesized that fortifying an exogenous surfactant (BLES) with budesonide would enhance efficacy for treating pulmonary inflammation in vivo.MethodsAn intratracheal instillation of heat-killed bacteria was used to elicit an inflammatory response in the lungs of male and female rats. Thirty minutes after this initial instillation, either budesonide or BLES combined with budesonide was administered intratracheally. To evaluate the efficacy of surfactant delivery, various markers of inflammation were measured in the bronchoalveolar lavage and lung tissue.ResultsAlthough budesonide exhibited anti-inflammatory effects when administered alone, delivery with BLES enhanced those effects by lowering the lavage neutrophil counts and myeloperoxidase activity in lung tissue. Combining budesonide with BLES was also shown to reduce several other pro-inflammatory mediators. These results were shown across both sexes, with no observed sex differences.ConclusionBased on these findings, it was concluded that exogenous surfactant can enhance the delivery and efficacy of budesonide in vivo.

Dilation Modifies Association Between Symptoms and Esophageal Eosinophilia in Adult Patients With Eosinophilic Esophagitis.

We investigated whether dilation modifies the association between symptoms and esophageal eosinophilia (peak esophageal eosinophils/high-power field [eos/hpf]) in patients with eosinophilic esophagitis enrolled into a randomized trial comparing the efficacy of budesonide and fluticasone. Baseline Dysphagia Symptom Questionnaire and Eosinophilic Esophagitis Activity Index were available in 102 and 73 patients, respectively, of whom 56 and 39 underwent dilation at screening endoscopy before symptom assessment. The pair-wise relationship between Dysphagia Symptom Questionnaire, Eosinophilic Esophagitis Activity Index, and eos/hpf was analyzed with nonparametric correlations. In nondilated patients, the association between baseline eos/hpf and symptoms was moderate and significant, although it was abolished in dilated patients. Dilation modifies association between symptoms and eos/hpf (clinicaltrials.gov NCT02019758).

A placebo-controlled randomised trial of budesonide for PBC following an insufficient response to UDCA

In patients with primary biliary cholangitis (PBC), the efficacy of budesonide, a synthetic corticosteroid displaying high first-pass metabolism, is unresolved. In a placebo-controlled, double-blind trial, we evaluated the added-value of budesonide in those with PBC and ongoing risk of progressive disease despite ursodeoxycholic acid (UDCA) treatment. We evaluated 62 patients with PBC who had histologically confirmed hepatic inflammatory activity, according to the Ishak score, and an alkaline phosphatase (ALP) >1.5× upper limit of normal (ULN), after at least 6 months of UDCA therapy. Participants were randomly assigned 2:1 to receive budesonide (9 mg/day) or placebo once daily, for 36 months, with UDCA treatment (12-16 mg/kg body weight/day) maintained. Primary efficacy was defined as improvement of liver histology with respect to inflammation and no progression of fibrosis. Secondary outcomes included changes in biochemical markers of liver injury. Recruitment challenges resulted in a study that was underpowered for the primary efficacy analysis. Comparing patients with paired biopsies only (n= 43), the primary histologic endpoint was not met (p >0.05). The proportion of patients with ALP <1.67×ULN, a ≥15% decrease in ALP and normal bilirubin was higher in the budesonide group than in the placebo group at 12, 24, and 36 months (p <0.05, each). In contrast to placebo, budesonide reduced mean ALP and 35% of budesonide-treated patients achieved normalisation of ALP (placebo 9%; p= 0.023). Serious adverse events occurred in 10 patients receiving budesonide and 7 patients receiving placebo. Budesonide add-on therapy was not associated with improved liver histology in patients with PBC and insufficient response to UDCA; however, improvements in biochemical markers of disease activity were demonstrated in secondary analyses. Around one-third of patients with primary biliary cholangitis (PBC) needs additional medical therapy alongside ursodeoxycholic acid (UDCA) treatment. In this clinical trial, the addition of the corticosteroid budesonide did not improve liver histology; there were however relevant improvements in liver blood tests. CLINICALTRIALS. NCT00746486.

Intranasal administration of budesonide-loaded nanocapsule microagglomerates as an innovative strategy for asthma treatment.

The co-existence with rhinitis limits the control of asthma. Compared with oral H1 receptor antagonists, intranasal corticosteroids have been demonstrated to provide greater relief of all symptoms of rhinitis and are recommended as first-line treatment for allergic rhinitis. Intrinsic limitations of nasal delivery, such as the presence of the protective mucous layer, the relentless mucociliary clearance, and the consequent reduced residence time of the formulation in the nasal cavity, limit budesonide efficacy to the treatment of local nasal symptoms. To overcome these limitations and to enable the treatment of asthma via nasal administration, we developed a budesonide-loaded lipid-core nanocapsule (BudNC) microagglomerate powder by spray-drying using a one-step innovative approach. BudNC was obtained, as a white powder, using L-leucine as adjuvant with 75 ± 6% yield. The powder showed a bimodal size distribution curve by laser diffraction with a principal peak just above 3μm and a second one around 0.45μm and a drug content determined by HPLC of 8.7mg of budesonide per gram. In vivo after nasal administration, BudNC showed an improved efficacy in terms of reduction of immune cell influx; production of eotaxin-1, the main inflammatory chemokine; and arrest of airways remodeling when compared with a commercial budesonide product in both short- and long-term asthma models. In addition, data showed that the results in the long-term asthma model were more compelling than the results obtained in the short-term model. Graphical abstract.

Histologic and Clinical Effects of Different Topical Corticosteroids for Eosinophilic Esophagitis: Lessons from an Updated Meta-Analysis of Placebo-Controlled Randomized Trials

Background: Topical corticosteroids (TS) have become standard therapy for eosinophilic esophagitis (EoE). However, a variety of drug formulations have been used for which results of histological and clinical responses may be different. We aimed at determining the short-term histologic efficacy of TS for EoE based on randomized placebo-controlled trials and to review clinical response. Methods: We searched MEDLINE, ISI Web of Science, and clinicaltrials.gov for randomized controlled trials (RCTs) on TS versus placebo for active EoE published until June 2019. Treatment effects were calculated as risk ratios (RRs) comparing histologic remission between groups. Results: Nine RCTs (6 budesonide and 3 fluticasone) involving a total of 483 participants were included. A substantial overall effect of TS on acute histologic remission (RR 12.5, 95% confidence interval 6.0–25.9) was found despite varying definitions of histologic response. Indirect comparisons between drug and formulation types showed a trend for a better histologic efficacy of budesonide (RR 13.5 vs. 10.4 fluticasone) and for the orodispersible tablet (RR 46.2 vs. 11.5 suspension, and 10.4 nebulized formula/spray), but only based on small patient numbers. Scores used for clinical response assessment were different between studies, and short-term clinical results were less impressive: significant differences favoring TS were found in 4/9 RCTs (4/6 budesonide, 0/3 fluticasone). Conclusions: TS are effective for short-term induction of histological remission in EoE with less impressive clinical response rates. The mode of drug delivery to the esophagus may be a relevant factor for the degree of histologic remission. Further trials should use uniform assessment criteria and long-term patient-centered outcomes.

Budesonide versus systemic corticosteroids in IgA Nephropathy: A retrospective, propensity-matched comparison.

IgA Nephropathy (IgAN) is characterized by mesangial deposition of dominant, polymeric, galactose-deficient IgA1 molecules of gut-associated lymphoid tissue origin. We sought to evaluate the efficacy of targeting the mucosal immune system dysregulation underlying IgAN pathogenesis with a pH-modified formulation of budesonide with a maximum release of active compound in the distal ileum and proximal colon.We did a retrospective study evaluating the efficacy of budesonide (Budenofalk) in the treatment of IgAN. From a retrospective cohort of 143 patients with IgAN followed in our department we identified 21 patients that received treatment with budesonide. These patients received budesonide at a dose of 9 mg/d in the first 12 months, followed by a dose reduction to 3 mg/d for the subsequent period. Only patients that received a 24-month treatment with budesonide were included in the analysis (n = 18). We matched the budesonide-treated cohort to 18 patients with IgAN treated with systemic steroids from the same retrospective cohort. Efficacy was measured as change in proteinuria, hematuria and estimated glomerular filtration rate over a 24-month period.Treatment with budesonide was associated with a 24-month renal function decline of -0.22 (95%CI, -8.2 to 7.8) ml/min/1.73m2, compared to -5.89 (95%CI, -12.2 to 0.4) ml/min/1.73m2 in the corticosteroid treatment group (p = 0.44, for between group difference). The median reduction in proteinuria at 24-month was 45% (interquartile range [IQR]: -79%; -22%) in the budesonide group and 11% (IQR: -39%; 43%) in the corticosteroid group, respectively (P = .009, for between group difference). The median reduction in hematuria at 24-month was 72% (IQR: -90%; -45%) in the budesonide group and 73% (IQR: -85%; 18%) in the corticosteroid group, respectively (P = .22, for between group difference). Treatment with budesonide was well tolerated with minimal side effects.Budesonide (Budenofalk) was effective in the treatment of patients with IgAN at high-risk of progression in terms of reducing proteinuria, hematuria and preserving renal function over 24 months of therapy.

Efficacy\xa0and safety of inhaled budesonide on prevention of acute mountain sickness during emergent ascent: a meta-analysis of randomized controlled trials

BackgroundAcute Mountain Sickness (AMS) is a pathophysiologic process that occurs in non-acclimated susceptible individuals rapidly ascending to high-altitude. Barometric pressure falls at high altitude and it translates to a decreased partial pressure of alveolar oxygen (PAO2) and arterial oxygen (PaO2). A gradual staged ascent with sufficient acclimatization can prevent AMS but emergent circumstances requiring exposure to rapid atmospheric pressure changes – such as for climbers, disaster or rescue team procedures, and military operations – establishes a need for effective prophylactic medications. This systematic review and meta-analysis aim to analyze the incidence of AMS during emergent ascent of non-acclimatized individuals receiving inhaled budesonide compared to placebo.MethodsThis current meta-analysis was conducted according to the guidance of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. We searched PubMed, Google Scholar and Embase for relevant studies. The efficacy of budesonide in reducing incidence of AMS was evaluated by calculating the pooled ORs and 95% CIs. The efficacy of budesonide in maintaining hemoglobin-oxygen saturation was evaluated by calculating standard mean difference (SMD) and 95% confidence intervals.ResultsWe found that at high altitude, inhaled budesonide was effective in reducing the incidence of mild AMS [OR: 0.37; 95% CI, 0.14 to 0.9, p = 0.042] but was ineffective in reducing the incidence of severe AMS [OR: 0.46; 95% CI, 0.14 to 1.41, p = 0.17]. Inhaled budesonide was also effective in maintaining SpO2 (SMD: 0.47; 95% CI, 0.09 to 0.84, p = 0.014) at high altitude. However, it was not effective in maintaining or improving pulmonary function at high altitude. Systematic-review found no adverse effects of budesoide in the dose used for prophylaxis of AMS.ConclusionsOur systematic review showed that prophylactic inhaled budesonide is effective in preventing mild AMS during emergency ascent but not effective in preventing severe AMS. Though statistically significant, authors recommend caution in interpretation of data and questions for further well designed randomized studies to evaluate the role of budesonide in prophylaxis of AMS during an emergent ascent.

Role of Budesonide for the Treatment of Rejection in Pediatric Liver Transplantation.

Corticosteroids are an integral part of liver transplant (LT) immunosuppression regimens but are often accompanied by many adverse effects. Budesonide is an oral corticosteroid with extensive (80%-90%) hepatic first-pass metabolism and minimal systemic absorption. The aim of this study was to examine the safety and efficacy of budesonide for management of acute cellular rejection (ACR) in pediatric LT recipients. A retrospective descriptive analysis was performed for all pediatric patients who underwent LT at our center and were prescribed oral budesonide for the treatment of ACR. Alanine aminotransferase (ALT) values and documented adverse effects were reviewed. Twenty-nine patients were prescribed budesonide for the treatment of ACR; 65.5% with biopsy-proven acute rejection and 34.5% with presumed ACR. There was a significant decrease in ALT noted from the time of rejection when compared to values 1 month (P = 0.0011), 3 months (P = 0.0003), and 6 months (P = 0.0001) after treatment with budesonide. There was no difference noted between patient baseline ALT levels before rejection when compared to 1, 3, and 6 months posttreatment values suggesting resolution of rejection. Three patients required conversion from budesonide to systemic steroids. There were no discontinuations of budesonide secondary to adverse effects. Oral budesonide may be a promising alternative to systemic corticosteroids for the management of mild/moderate ACR and for empiric treatment of ACR in select pediatric LT recipients. Data from this study may provide the foundation for larger, prospective, multicenter trials to assess the effectiveness of budesonide in the treatment of ACR.

Nebulized step-down budesonide vs. fluticasone in infantile asthma: A retrospective cohort study.

The United States Food and Drug Administration has approved budesonide in infantile asthma but nebulization of infants under budesonide has the risk of relapse of asthma. The objective of the present study was to compare the effectiveness and safety of fluticasone step-down treatment with budesonide step-down treatment in infantile asthma. The data of 778 infants with confirmed asthma were included in the analysis. Infants who had received nebulized 500 µg budesonide twice daily for 6 weeks followed by 250 µg budesonide twice daily for 6 weeks were included in the BS group (n=389), while infants who had received nebulized 250 µg fluticasone twice daily for 6 weeks followed by 125 µg fluticasone twice daily for 6 weeks were included in the FC group (n=389). The data of lung function tests and a safety study were collected and analyzed. Budesonide treatment achieved a reduced specific airway resistance (sRaw; 1.28±0.11 vs. 1.21±0.10 kPa/sec; P<0.0001, q=13.45) and improved forced expiratory volume in 1 sec (FEV1; 0.977±0.068 vs. 0.997±0.085 l/sec; P<0.0001, q=5.54). In addition, fluticasone treatment achieved a reduced sRaw (1.27±0.1 vs. 1.23±0.11 kPa/sec, P<0.0001, q=7.39) and improved FEV1 (0.971±0.069 vs. 0.992±0.085 l/sec; P=0.0003, q=5.46). Of note, the efficacy of budesonide to reduce sRaw (P=0.008, q=3.69) and improve FEV1 (P<0.0001, q=6.93) was greater than that of fluticasone. The budesonide treatment group had more post-treatment symptom-free days than the fluticasone treatment group (165.56±23.15 vs. 112.21±9.45 days; P<0.0001). The step-down approach of budesonide nebulization may better support the functional and clinical outcomes with an increased number of post-treatment symptom-free days compared with fluticasone in infantile asthma (level of evidence, 3).

Efficacy and Safety of Budesonide in the Treatment of Eosinophilic Esophagitis: Updated Systematic Review and Meta-Analysis of Randomized and Non-Randomized Studies.

Background and ObjectiveEosinophilic esophagitis (EE) is an immune/antigen-driven inflammation that causes esophageal dysfunction. Budesonide has shown promising effect in the management of EE in multiple studies, and we therefore conducted this systematic review/meta-analysis to assess budesonide efficacy and safety in order to provide more updated and robust evidence.MethodsIn April 2018, we conducted a systematic electronic search through four databases: PubMed, Scopus, Web of Science (ISI), and Cochrane Central. All original studies reporting the efficacy of budesonide in the treatment of EE were included in our meta-analysis. The Cochrane Collaboration tool was employed to assess the risk of bias among included randomized controlled trials, while the Newcastle–Ottawa Scale was used for non-randomized studies.ResultsA total of 12 studies including 555 participants were included in our review. Budesonide showed marked efficacy at the level of histological response compared to placebo [risk ratio (RR) (95% confidence interval (CI)) 11.93 (4.82–29.50); p > 0.001]. Analysis of randomized and non-randomized studies revealed considerable reduction in eosinophil count, with a mean difference (MD) (95% CI) of − 69.41 (− 105.31 to − 33.51; p < 0.001) and 46.85 (33.93–59.77; p < 0.001), respectively. Similarly, there was a marked improvement in the clinical symptoms via the analysis of randomized and non-randomized studies, with an RR (95% CI) of 1.72 (1.22–2.41; p = 0.002) and MD (95% CI) of 2.45 (0.76–4.15; p = 0.005), respectively.ConclusionBudesonide showed significant effect at all treatment endpoints. However, since budesonide carries a risk of candidiasis and our inferences are based only on a small number of included studies, more research is warranted to clarify these results.Electronic supplementary materialThe online version of this article (10.1007/s40268-018-0253-9) contains supplementary material, which is available to authorized users.

The Combination Therapy of Dietary Galacto-Oligosaccharides With Budesonide Reduces Pulmonary Th2 Driving Mediators and Mast Cell Degranulation in a Murine Model of House Dust Mite Induced Asthma.

Background: Dietary non-digestible galacto-oligosaccharides (GOS) suppress allergic responses in mice sensitized and challenged with house dust mite (HDM). Budesonide is the standard therapy for allergic asthma in humans but is not always completely effective.Aim: To compare the efficacy of budesonide or different doses of GOS alone or with a combination therapy of budesonide and GOS on HDM-allergic responses in mice.Methods:BALB/c mice were sensitized and challenged with HDM, while fed a control diet or a diet supplemented with 1 or 2.5 w/w% GOS, and either or not oropharyngeally instilled with budesonide. Systemic and local inflammatory markers, such as mucosal mast cell protease-1 (mMCP-1) in serum, pulmonary CCL17, CCL22, and IL-33 concentrations and inflammatory cell influx in the bronchoalveolar lavage fluid (BALF) were determined.Results: Budesonide or GOS alone suppressed the number of eosinophils in the BALF of HDM allergic mice whereas budesonide either or not combined with GOS lowered both eosinophil and lymphocyte numbers in the BALF of HDM-allergic mice. Both 1 w/w% and 2.5 w/w% GOS and/or budesonide suppressed serum mMCP-1 concentrations. However, budesonide nor GOS alone was capable of reducing Th2 driving chemokines CCL17, CCL22 and IL-33 protein levels in supernatants of lung homogenates of HDM allergic mice, whereas the combination therapy did. Moreover, IL-13 concentrations were only significantly suppressed in mice treated with budesonide while fed GOS. A similar tendency was observed for the frequency of GATA3+CD4+ Th2 and CD4+RORγt+ Th17 cells in the lungs of the allergic mice.Conclusion: Dietary intervention using GOS may be a novel way to further improve the efficacy of anti-inflammatory drug therapy in allergic asthma by lowering Th2 driving mediators and mast cell degranulation.

Systemic and inhaled glucocorticosteroids in acute obstructive laryngotracheitis

Acute laryngotracheitis (croup) is an acute condition that most commonly affects children of the first 6 years. Croup is caused by viral infection of the upper airway, predominantly by parainfluenza virus. Croup is characterized by the signs of subglottic stenosis, which determines croup severity. Corticosteroids are the mainstay of croup treatment due to a strong anti-inflammatory effect. Typically, duration of corticosteroid treatment in croup does not exce ed several days. Even short-course systemic corticosteroids are associated with a number of adverse effects: nausea, vomiting, behavioral changes and sleep disturbance, etc. According to Russian clinical guidelines for croup management inhaled corticosteroid budesonide is the first line therapy. Budesonide efficacy in croup has been proved in numerous clinical trials. Based on similar effectiveness of inhaled and systemic corticosteroids in croup patients, budesonide is the preferred treatment option, because it helps to minimize the risk of adverse effects.

The comparison the efficacy of budesonide by nebulizer, metered dose inhaler and dry powder inhaler in chronic stable bronchial asthma

Background: The study has been performed to evaluate the efficacy of budesonide delivery by different form of devices like nebulizer, metered dose inhaler and dry powder inhaler to adult patients of chronic stable bronchial asthma. The changes in pulmonary function test parameters have been consider for evaluation.Methods: This prospective study was undertaken to assess the relative efficiency of budesonide administered from devices like nebulizer, metered dose inhaler and dry powder inhaler in adult patients of chronic stable bronchial asthma. Fifty subjects where administered budesonide (1mg) via nebulizer, budesonide (400 microgram) by metered dose inhaler and dry powder inhaler consecutively each week for four weeks under direct supervision. To analyze the effect of budesonide delivered through different devices pulmonary function test was carried out on the subject before and one hour after administration of the drug on each visit.Results: No significant difference in Peak expiratory flow rate (P=0.77), forced expiratory volume in one second (P=0.851), forced vital capacity (P=0.178) and forced expiratory volume in one second and forced vital capacity ratio (P=0.298) was seen after giving budesonide by different devices.Conclusions: Budesonide delivered by different devices (nebulizer, metered dose inhaler, and dry powder inhaler) have similar effect on lung function in patients of chronic stable bronchial asthma. In the daily clinical practice, the correct choice of an inhaler device should be related with the patient's characteristics. They may be used interchangeably depending on availability, cost and compliance of the patients.

The Effectiveness and Tolerability of Budesonide in Treatment of Autoimmune Hepatitis : A Systematic Review

Background: Budesonide was effective in treating and keeping short-term remission with a fewer steroid-specific side effects in contrast to prednisone. Contradicting outcomes were detailed on the efficiency of budesonide in the management of Autoimmune Hepatitis. This review aiming at evaluating the use of budesonide for the treatment of autoimmune hepatitis. Methods: An electronic search was conducted in MEDLINE and EMBASE using these keywords steroids, autoimmune, liver, effectiveness, and side effects. The search was limited to clinical setting which resulted in 24 clinical studies. Results: The total number of AIH patients included in this review were 386 of which 304 females (78.7%), the sample size ranged from 9 patients to 207 and the mean age ranged from 13 years in to 54. Concerning the efficacy of Budesonide, it ranged from 15% to 78% as the end points were different among the included studies. Regarding the tolerability and side effects like Moon faces or cushingoid features, acne, heartburn, hirsutism, alopecia, osteoporosis, diabetes mellitus and easy bruising. Side effects reported in X studies and the incidence ranged from 28% to 56%. Conclusion: Budesonide could be a promising treatment option especially in patients prone to corticosteroid side effects like elderly individuals and postmenopausal women with high risk for osteoporosis or children with risk for impaired growth.

Comparison of Nebulized Budesonide and Intravenous Dexamethasone Efficacy on Tracheal Tube Cuff Leak in Intubated Patients admitted to Intensive Care Unit.

Background:Tracheal intubation is a common action in intensive care unit (ICU); however, it may cause laryngeal edema or laryngotracheal injury which leads to edema. The cuff-leak test is usually done to define the upper airway patency. Considering the point that laryngeal edema would be treated by anti-inflammatory agents, our aim was to evaluate the impact of nebulized budesonide on ICU patients’ relief and comparison between nebulized budesonide efficacy and intravenous (IV) dexamethasone.Materials and Methods:In our clinical trial, 270 intubated patients from ICU were randomly selected and divided into three groups (each group was included 90 patients) as follows: IV dexamethasone, nebulized budesonide, and placebo group. All the patients were monitored at 0, 12, 24, 36, and 48 h of starting follow-up. Hemodynamic parameters and cuff-leak ratio were measured and data were analyzed using SPSS (ver. 20).Results:Our findings revealed that dexamethasone and budesonide treatment approaches were beneficial for an increase of cuff-leak volume (P < 0.001). Furthermore, the superiority of mentioned methods in patients’ relief was significant compared with placebo group (P < 0.001). Moreover, hemodynamic parameters were not altered and were within the normal range in both dexamethasone and budesonide groups (P > 0.05).Conclusion:Our findings demonstrated that the use of budesonide and dexamethasone is beneficial in intubated ICU patients, and the above-mentioned approaches can reduce the complications of tracheal intubation. Furthermore, budesonide could be a trustworthy substitute treatment strategy instead of IV dexamethasone.

Meta-analysis of nursing and clinical efficacy of budesonide on children with bronchial asthma

Objective To explore the nursing and clinical efficacy of budesonide inhalation on children with bronchial asthma. Methods The computer retrieval on China CNKI, Wanfang database and VIP database was conducted for the randomized controlled trials in terms of budesonide inhalation and routine nursing to observe the curative effect of bronchial asthma on children, and the studies meeting the inclusion criteria were evaluated, and Meta analysis was performed by RevMan 5.2 statistical software.The effect of Budesonide aerosol inhalation to alleviate the symptoms of bronchial asthma on children was evaluated from the aspects of curative effect, the change of time for clinical symptoms and signs and vital capacity. Results A total of 11 studies (1 174 cases) were included in this study.Meta analysis showed that there were statistical significances in terms of differences of curative effect, the change of time for clinical symptoms and signs and vital capacity of the two groups. Conclusion Compared with the conventional nursing, budesonide inhalation was shown high effect on the clinical nursing for children with bronchial asthma, which can not only significantly increase the therapeutic effect, reduce the cough, asthma and wheezing disappearance time, but also increase the vital capacity of children with bronchial asthma. Key words: Budesonide; Inhalation; Children; Bronchial asthma; Meta-analysis

Comparing the efficacy of Budesonide and Montelukast in children with asthma: a prospective interventional open label controlled clinical study

Background: Bronchial asthma is a chronic inflammatory airway disease and is more prevalent in children. Inhaled corticosteroids (Budesonide) and leukotriene receptor antagonist (Montelukast) are the drugs of choice for asthma in children. The present study was aimed to compare the efficacy of these drugs in childhood asthma at tertiary care center.Methods: This is a prospective interventional open label controlled clinical study carried out from January 2012 to December 2014. Children recently diagnosed with mild persistent asthma that attended Asthma clinic or admitted in ward of department of paediatrics LTMMC and Hospital, Sion, Mumbai was participated in the study. A total of 70 patients were selected for the study and are categorized into two groups consisting of 35 in each group. Group A patients were given metered dose inhaler (MDI) Budesonide 200 mcg 1 puff twice a day (with MDI spacer and mask for children &lt;5 years and without mask for children &gt;5 years. Group B patients were given Montelukast 4 mg (&lt;5 years) and 5 mg (&gt;5 years) tablet as once a daily in the evening for 1 year. Primary and secondary outcome measures were calculated and analysed.Results: No significant difference on the basis of age and gender was observed among both groups. The complaints of cough, wheeze and breathlessness, lesser emergency department visits, nebulization and lesser number of systemic steroids (days/year) was significantly lesser in patients of group A (p&lt;0.05) compared to group B. Group A subjects had lesser number of acute exacerbations, required lesser number of systemic steroids courses and the frequency of hospitalization. Statistically significant (p&lt;0.05) difference was observed in episode free days in a year among both groups.Conclusions: The findings of the study prove that Budesonide had better efficacy over Montelukast in control of asthma.

Observation of curative effect of budesonide combined with terbutaline aerosol inhalation in the treatment of acute asthma

Objective To investigate the efficacy of budesonide combined with terbutaline atomization inhalation in the treatment of acute asthma attacks, and to provide reference for clinical treatment. Methods 118 patients with acute asthma attack were selected and randomly divided into observation group and control group, 59 cases in each group.The control group was treated with budesonide inhalation, the observation group was treated with budesonide combined with terbutaline aerosol inhalation The clinical efficacy of the two groups, clinical symptoms and signs of the disappearance time were compared, the pulmonary function test results and the occurrence of adverse reactions were compared. Results In the observation group, the total effective rate was 72.88%, which was significantly higher than 52.54% of the control group (χ2=5.218, P<0.05). The disappear time of shortness breath, cough, pulmonary rales in the observation group were (4.01±1.42)d, (6.58±1.51)d, (7.02±227)d, which were significantly shorter than (5.71±1.59)d, (8.52±1.97)d, (8.69±2.61)d in the control group (t=4.557, 4.421, 4.659, all P<0.05). After treatment, the FEV1, FVC and peak expiratory flow (PEF) of the observation group were (2.35±0.67)L, (2.76±0.62)L, (2.91±0.49)L, which were significantly higher than(2.09±0.57)L, (2.31±0.51)L, (2.48±0.59)L of the control group (t=3.625, 3.641, 3.887, all P<0.05). The two groups had no serious adverse reactions. Conclusion Budesonide combined with terbutaline atomization inhalation can relieve the clinical symptoms of patients with acute asthma, improve lung function, improve the clinical treatment effect and has good security. Key words: Asthma; Budesonide; Terbutaline

Collagenous colitis: Requirement for high-dose budesonide as maintenance treatment

BackgroundControlled studies show high efficacy of budesonide in inducing short-term clinical remission in collagenous colitis (CC), but relapses are common after its withdrawal. AimTo evaluate the need for high-dose budesonide (≥6mg/d) to maintain clinical remission in CC. MethodsAnalysis of a multicentre retrospective cohort of 75 patients with CC (62.3±1.5years; 85% women) treated with budesonide in a clinical practice setting between 2013 and 2015. Frequency of budesonide (9mg/d) refractoriness and safety, and the need for high-dose budesonide to maintain clinical remission, were evaluated. Drugs used as budesonide-sparing, including azathioprine and mercaptopurine, were recorded. Logistic regression analysis was performed to evaluate the risk factors associated with the need for high-dose budesonide (≥6mg/d) to maintain clinical remission. ResultsBudesonide induced clinical remission in 92% of patients, with good tolerance. Fourteen of 68 patients (21%; 95% CI, 13–32%) needed high-dose budesonide to maintain remission. Only intake of NSAIDs at diagnosis (OR, 8.6; 95% CI, 1.6–44) was associated with the need for high-dose budesonide in the multivariate analysis. Treatmentwith thiopurines was effective in 5 out of 6 patients (83%; 95% CI, 44–97%), allowing for withdrawal from or a dose decrease of budesonide. ConclusionsOne fifth of CC patients, especially those with NSAID intake at diagnosis, require high-dose budesonide (≥6mg/d) to maintain clinical remission. In this setting, thiopurines might be effective as budesonide-sparing drugs.

Efficacy and Limitations of Budesonide as a Second-Line Treatment for Patients With Autoimmune Hepatitis

Many patients with autoimmune hepatitis (AIH) develop steroid-specific side effects or require doses of steroids that are unacceptable for long-term treatment. We investigated the efficacy of budesonide as an alternative steroid for patients previously treated with prednisolone who developed side effects or were unable to reduce their dose of prednisolone below acceptable levels. We also report the effects of more than 12 months of budesonide treatment in a large cohort of patients with AIH. We performed a retrospective analysis of data from 60 patients (51 female) with AIH who were treated initially with prednisolone (mean time, 47 mo) but then switched to budesonide, managed at a single center in Germany from 2001 through June 2016. Patients were evaluated after 6 months, 12 months, 24 months, 36 months, and at the last follow-up evaluation; response to treatment with budesonide was assessed based on normal serum levels of aminotransferases and IgG (biochemical response). Thirty patients were switched to budesonide therapy because of prednisolone-induced side effects and 30 patients switched because of prednisolone dependency. Overall, a biochemical response was detected in 55% of patients after 6 months of budesonide treatment, in 70% after 12 months, and in 67% after 24 months. At the last follow-up evaluation (mean time, 63 mo) 23patients (38%) still were receiving budesonide treatment. Fifteen patients (25%) had switched back to prednisolone therapy because of insufficient response to budesonide or its side effects. Fifteen patients with osteopenia at the beginning of budesonide treatment were followed up and evaluated by dual-energy X-ray absorptiometry. After a median of 24 months of budesonide treatment, bone mineral density had improved in 6 patients, remained stable in 8 patients, and worsened in 1 patient. We performed a retrospective analysis of patients with AIH that confirmed the therapeutic value of budesonide beyond 12 months of treatment in patients who are intolerant to or dependent on prednisolone. Although budesonide-induced side effects appear to be mild in real life, effectiveness was limited in a considerable proportion of patients; close monitoring is advised.