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1.
BMC Anesthesiol ; 24(1): 164, 2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-38693477

RESUMEN

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).


Asunto(s)
Budesonida , Sulfato de Magnesio , Faringitis , Complicaciones Posoperatorias , Cuidados Preoperatorios , Zinc , Humanos , Faringitis/prevención & control , Faringitis/etiología , Budesonida/administración & dosificación , Budesonida/uso terapéutico , Método Doble Ciego , Femenino , Masculino , Estudios Prospectivos , Adulto , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/epidemiología , Cuidados Preoperatorios/métodos , Zinc/administración & dosificación , Persona de Mediana Edad , Sulfato de Magnesio/administración & dosificación , Intubación Intratraqueal , Magnesio/administración & dosificación , Incidencia , Procedimientos Quirúrgicos Electivos , Adulto Joven , Anestesia General/métodos
2.
BMC Pediatr ; 24(1): 262, 2024 Apr 20.
Artículo en Inglés | MEDLINE | ID: mdl-38643076

RESUMEN

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 .


Asunto(s)
Displasia Broncopulmonar , Surfactantes Pulmonares , Síndrome de Dificultad Respiratoria del Recién Nacido , Lactante , Recién Nacido , Humanos , Recien Nacido Prematuro , Budesonida/uso terapéutico , Tensoactivos/uso terapéutico , Displasia Broncopulmonar/tratamiento farmacológico , Irán , Método Simple Ciego , Respiración Artificial/métodos , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , Surfactantes Pulmonares/uso terapéutico , Lipoproteínas
3.
Curr Opin Allergy Clin Immunol ; 24(3): 122-128, 2024 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-38656287

RESUMEN

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.


Asunto(s)
Esofagitis Eosinofílica , Esofagitis Eosinofílica/diagnóstico , Esofagitis Eosinofílica/terapia , Esofagitis Eosinofílica/inmunología , Humanos , Budesonida/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Medicina de Precisión/métodos , Eosinófilos/inmunología , Calidad de Vida
4.
Am J Rhinol Allergy ; 38(3): 169-177, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38456692

RESUMEN

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.


Asunto(s)
Rinitis , Rinosinusitis , Sinusitis , Adulto , Humanos , Budesonida/uso terapéutico , Estudios Prospectivos , Rinitis/cirugía , Rinitis/tratamiento farmacológico , Sinusitis/cirugía , Sinusitis/tratamiento farmacológico , Solución Salina/uso terapéutico , Resultado del Tratamiento , Enfermedad Crónica
5.
Medicine (Baltimore) ; 103(10): e37309, 2024 Mar 08.
Artículo en Inglés | MEDLINE | ID: mdl-38457591

RESUMEN

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.


Asunto(s)
Budesonida , Enfermedad Pulmonar Obstructiva Crónica , Humanos , Budesonida/uso terapéutico , Ipratropio/uso terapéutico , Estudios Retrospectivos , Remodelación de las Vías Aéreas (Respiratorias) , Bromuros/uso terapéutico , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Broncodilatadores/uso terapéutico
6.
Arq Gastroenterol ; 61: e23114, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38451666

RESUMEN

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.


Asunto(s)
Colitis Microscópica , Enfermedades Inflamatorias del Intestino , Femenino , Humanos , Masculino , Anciano , Calidad de Vida , Colitis Microscópica/diagnóstico , Colitis Microscópica/tratamiento farmacológico , Budesonida/uso terapéutico , Respuesta Patológica Completa , Diarrea/tratamiento farmacológico , Diarrea/etiología
7.
JAMA ; 331(10): 866-877, 2024 03 12.
Artículo en Inglés | MEDLINE | ID: mdl-38470381

RESUMEN

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.


Asunto(s)
Glucocorticoides , Antagonistas de los Receptores Histamínicos , Rinitis Alérgica , Humanos , Budesonida/administración & dosificación , Budesonida/uso terapéutico , Cetirizina/uso terapéutico , Fluticasona/administración & dosificación , Fluticasona/uso terapéutico , Antagonistas de los Receptores Histamínicos H1/administración & dosificación , Antagonistas de los Receptores Histamínicos H1/uso terapéutico , Inmunoglobulina E/inmunología , Furoato de Mometasona/administración & dosificación , Furoato de Mometasona/uso terapéutico , Clorhidrato de Olopatadina/administración & dosificación , Clorhidrato de Olopatadina/uso terapéutico , Prurito/etiología , Rinitis Alérgica/complicaciones , Rinitis Alérgica/diagnóstico , Rinitis Alérgica/inmunología , Rinitis Alérgica/terapia , Rinorrea/etiología , Estornudo , Triamcinolona/administración & dosificación , Triamcinolona/uso terapéutico , Glucocorticoides/administración & dosificación , Glucocorticoides/uso terapéutico , Rinitis/tratamiento farmacológico , Antagonistas de los Receptores Histamínicos/administración & dosificación , Antagonistas de los Receptores Histamínicos/uso terapéutico , Administración Intranasal
8.
Minerva Med ; 115(2): 203-213, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38414250

RESUMEN

Allergic rhinitis (AR) and nonallergic rhinitis are prevalent diseases. In western countries, type 2 inflammation usually characterizes these medical conditions and mainly sustains nasal obstruction. Budesonide aqueous nasal spray (BANS) is an intranasal corticosteroid (INCS) that has been available since the early 1980s. BANS is indicated for treating allergic rhinitis, nonallergic rhinitis, and nasal polyps (both as treatment and prevention after surgery). Consolidated evidence confirms its efficacy in treating seasonal and perennial AR, and nonallergic rhinitis. In addition, BANS is safe with negligible local and systemic side effects. Recent guidelines for patients with AR recommend using INCS as the first line in many situations. In particular, patients may assess the perception of symptoms' severity using the Visual Analog Scale. 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 patients with type 2 inflammation of the nose.


Asunto(s)
Budesonida , Rociadores Nasales , Rinitis , Humanos , Budesonida/administración & dosificación , Budesonida/uso terapéutico , Rinitis/tratamiento farmacológico , Administración Intranasal , Rinitis Alérgica/tratamiento farmacológico
9.
J Allergy Clin Immunol Pract ; 12(4): 882-888, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38316182

RESUMEN

Prevention of asthma exacerbations and reduction of systemic corticosteroid burden remain unmet needs in asthma. US asthma guidelines recommend concomitant short-acting ß2-agonist (SABA) and inhaled corticosteroid (ICS) as an alternative reliever at step 2. The Food and Drug Administration approved a pressurized metered-dose inhaler containing albuterol and budesonide for as-needed treatment or prevention of bronchoconstriction and for reducing exacerbation risk in patients with asthma aged ≥18 years. This combination is approved for use as a reliever with or without maintenance therapy, but it is not indicated for maintenance therapy (or for single maintenance and reliever therapy). Intervening with as-needed SABA-ICS during the window of opportunity to reduce inflammation during loss of asthma control can reduce exacerbation risk, by exerting both genomic and nongenomic anti-inflammatory effects. We propose that the use of albuterol-budesonide rather than albuterol as a reliever to manage episodic symptoms driven by acute bronchoconstriction and airway inflammation can improve outcomes. This combination approach, shown to decrease asthma exacerbations and oral corticosteroid burden in patients with moderate-to-severe asthma, represents a paradigm shift for asthma treatment in the United States. Further safety and efficacy studies should provide evidence that this type of reliever should be standard of care.


Asunto(s)
Antiasmáticos , Asma , Humanos , Adolescente , Adulto , Budesonida/uso terapéutico , Albuterol/uso terapéutico , Etanolaminas/efectos adversos , Asma/tratamiento farmacológico , Asma/inducido químicamente , Corticoesteroides , Administración por Inhalación , Inflamación/tratamiento farmacológico , Fumarato de Formoterol/uso terapéutico , Broncodilatadores/uso terapéutico
10.
J Allergy Clin Immunol Pract ; 12(4): 889-893, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38346474

RESUMEN

Overuse of reliever as short-acting beta-agonist and associated underuse of controller as inhaled corticosteroid (ICS) administered via separate inhalers results in worse asthma outcomes. Such discordance can be obviated by combining both controller and reliever in the same inhaler. So-called anti-inflammatory reliever (AIR) therapy comprises the use of a single inhaler containing an ICS such as budesonide (BUD) in conjunction with a reliever as either albuterol (ALB) or formoterol (FORM), to be used on demand, with variable dosing driven by asthma symptoms in a flexible patient-centered regimen. Global guidelines now support the use of BUD-ALB as AIR therapy to reduce exacerbations, either on its own in mild asthma or in conjunction with fixed-dose maintenance ICS-long-acting beta-agonist in moderate to severe asthma. Using BUD-FORM on its own allows patients to seamlessly move in an intuitive flexible fashion between AIR and maintenance and reliever therapy, by stepping up and down the dosing escalator across a spectrum of asthma severities. Head-to-head clinical studies are indicated to compare BUD-FORM versus BUD-ALB as AIR in mild asthma, and also BUD-FORM as maintenance and reliever therapy versus BUD-ALB as AIR plus maintenance ICS-long-acting beta-agonist in moderate to severe asthma. Patients should be encouraged to make an informed decision in conjunction with their health care professional regarding the best therapeutic option tailored to their individual needs, which in turn is likely to result in long-term compliance and associated optimal asthma control.


Asunto(s)
Antiasmáticos , Asma , Humanos , Budesonida/uso terapéutico , Albuterol/uso terapéutico , Broncodilatadores/uso terapéutico , Antiasmáticos/uso terapéutico , Etanolaminas/uso terapéutico , Combinación de Medicamentos , Asma/tratamiento farmacológico , Combinación Budesonida y Fumarato de Formoterol/uso terapéutico , Fumarato de Formoterol/uso terapéutico , Corticoesteroides/uso terapéutico , Antiinflamatorios/uso terapéutico , Administración por Inhalación
11.
J Allergy Clin Immunol Pract ; 12(4): 870-879, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38237858

RESUMEN

The Global Initiative for Asthma (GINA) recommends that short-acting ß2-agonist (SABA) monotherapy should no longer be prescribed, and that as-needed combination inhaled corticosteroids (ICS)-formoterol is the preferred reliever therapy in adults and adolescents with mild asthma. These recommendations are based on the risks of SABA monotherapy, the evidence that ICS-formoterol reliever therapy markedly decreases the occurrence of severe asthma exacerbations compared with SABA reliever therapy alone, and because ICS-formoterol reliever therapy has a favorable risk/benefit profile compared with maintenance ICS plus SABA reliever therapy. Data supporting the use of combination ICS-albuterol reliever therapy in mild asthma are more limited, but there are studies that inform its use in this population. In this review, we compare, using a pros and cons format, the (1) long-term safety and efficacy of ICS-formoterol reliever therapy versus SABA reliever therapy alone, (2) long-term safety and efficacy of ICS-albuterol reliever therapy versus SABA reliever therapy alone, (3) immediate bronchodilator effects of ICS-formoterol versus SABA alone, and (4) clinical and regulatory factors that may inform reliever therapy prescription decisions. By presenting the evidence of these reliever inhaler options, we hope to inform the reader while also calling for necessary future effectiveness and implementation research.


Asunto(s)
Antiasmáticos , Asma , Adulto , Adolescente , Humanos , Antiasmáticos/uso terapéutico , Asma/tratamiento farmacológico , Asma/epidemiología , Broncodilatadores/uso terapéutico , Corticoesteroides/uso terapéutico , Fumarato de Formoterol/uso terapéutico , Albuterol/uso terapéutico , Administración por Inhalación , Budesonida/uso terapéutico , Etanolaminas/uso terapéutico
12.
J Allergy Clin Immunol Pract ; 12(2): 385-395.e4, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-38040117

RESUMEN

BACKGROUND: Digital health tools have been shown to help address challenges in asthma control, including inhaler technique, treatment adherence, and short-acting ß2-agonist overuse. The maintenance and reliever Digihaler System (DS) comprises 2 Digihaler inhalers (fluticasone propionate/salmeterol and albuterol) with an associated patient App and web-based Dashboard. Clinicians can review patients' inhaler use and Digihaler inhalation parameter data to support clinical decision-making. OBJECTIVE: CONNECT2 evaluated asthma control in participants using the DS versus standard-of-care (SoC) maintenance and reliever inhalers. METHODS: Participants (13 years or older) with uncontrolled asthma (Asthma Control Test [ACT] score <19) were randomized 4:3 (open-label) to the DS (n = 210) or SoC (n = 181) for 24 weeks. The primary endpoint was the proportion of patients achieving well-controlled asthma (ie, an ACT score ≥20 or increase from baseline of ≥3 units at week 24). RESULTS: There was an 88.7% probability that participants using the DS would have greater odds of achieving improvement in asthma control compared with SoC after 24 weeks. The mean odds ratio (95% credible interval) for DS versus SoC was 1.35 (0.846-2.038), indicating a 35% higher odds of improved asthma control with the DS. The DS group had more clinician-participant interactions versus SoC, mainly addressing a poor inhaler technique. DS participants' maintenance treatment adherence was good (month 1: 79.2%; month 6: 68.6%); reliever use decreased by 38.2% versus baseline. App and Dashboard usability was rated "good." CONCLUSION: The positive results in asthma control in this study after 24 weeks demonstrate the effectiveness of the DS in asthma management.


Asunto(s)
Antiasmáticos , Asma , Humanos , Budesonida/uso terapéutico , Fumarato de Formoterol/uso terapéutico , Etanolaminas/uso terapéutico , Antiasmáticos/uso terapéutico , Combinación de Medicamentos , Asma/tratamiento farmacológico , Albuterol/uso terapéutico , Administración por Inhalación , Broncodilatadores/uso terapéutico
13.
Ann Allergy Asthma Immunol ; 132(2): 229-239.e3, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37879568

RESUMEN

BACKGROUND: The management of mild asthma has lacked an over-the-counter (OTC) option aside from inhaled epinephrine, which is available in the United States. However, inhaled epinephrine use without an inhaled corticosteroid may increase the risk of asthma death. OBJECTIVE: To compare the cost-effectiveness of OTC as-needed budesonide-formoterol as a plausible alternative to inhaled epinephrine. METHODS: We developed a probabilistic Markov model to compare OTC as-needed budesonide-formoterol inhaler use vs inhaled epinephrine use in adults with mild asthma from a US societal perspective over a lifetime horizon, with a 3% annual discount rate (2022 US dollars). Inputs were derived from the SYmbicort Given as-needed in Mild Asthma (SYGMA) trials, published literature, and commercial costs. Outcomes were quality-adjusted life-years (QALY), costs, incremental net monetary benefit (INMB), severe asthma exacerbations, well-controlled asthma days, and asthma-related deaths. Microsimulation was used to evaluate underinsured Americans living with mild asthma (n = 5,250,000). RESULTS: Inhaled epinephrine was dominated (with lower QALYs gains at a higher cost) by both as-needed budesonide-formoterol (INMB, $15,541 at a willingness-to-pay of $100,000 per QALY) and the no-OTC inhaler option (INMB, $1023). Adults using as-needed budesonide-formoterol had 145 more well-controlled asthma days, 2.79 fewer severe exacerbations, and an absolute risk reduction of 0.23% for asthma-related death compared with inhaled epinephrine over a patient lifetime. As-needed budesonide-formoterol remained dominant in all sensitivity and scenario analyses, with a 100% probability of being cost-effective compared with inhaled epinephrine in probabilistic sensitivity analysis. CONCLUSION: If made available, OTC as-needed budesonide-formoterol for treating mild asthma in underinsured adults without HCP management improves asthma outcomes, prevents fatalities, and is cost-saving.


Asunto(s)
Asma , Combinación Budesonida y Fumarato de Formoterol , Adulto , Humanos , Combinación Budesonida y Fumarato de Formoterol/uso terapéutico , Broncodilatadores/uso terapéutico , Budesonida/uso terapéutico , Análisis Costo-Beneficio , Fumarato de Formoterol/uso terapéutico , Etanolaminas/uso terapéutico , Asma/tratamiento farmacológico , Epinefrina/uso terapéutico , Combinación de Medicamentos , Administración por Inhalación
14.
J Asthma ; 61(6): 574-583, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38153316

RESUMEN

OBJECTIVE: The aim of this pilot study was to assess the efficacy of doxofylline as an ICS-sparing agent in the treatment of Mexican children with asthma. METHODS: 10-week, open-label, crossover, pilot study, we examined the steroid-sparing effect of doxofylline in Mexican children with asthma. Patients aged 6-16 years treated with inhaled corticosteroids (ICS) for at least 8 wk before enrollment were divided randomly into two groups at the baseline visit. Group A (n = 31) received doxofylline (18 mg/kg/day) plus standard-dose budesonide (D + SDB) for the first 4-week period followed by doxofylline plus reduced-dose budesonide (D + RDB) for the second 4-week period. Group B (n = 30) received D + RDB followed by D + SDB. Clinical outcomes assessed included lung function (forced expiratory volume; in 1 s, FEV1), fractional exhaled nitric oxide (FeNO), asthma control, number of exacerbations and use of rescue medication (salbutamol). RESULTS: It was shown that combined use of doxofylline and ICS may allow children with asthma to reduce their daily dose of ICS while maintaining lung function and improving asthma control (p = 0.008). There were few asthma exacerbations and only one patient required treatment with systemic corticosteroids. Rescue medication use decreased significantly in patients receiving D + SDB during the first 4-week period. CONCLUSIONS: Our results suggest that doxofylline may be a steroid-sparing treatment in asthma, but longer-term, controlled studies are needed to confirm these observations.


Asunto(s)
Asma , Budesonida , Estudios Cruzados , Quimioterapia Combinada , Teofilina , Teofilina/análogos & derivados , Humanos , Niño , Asma/tratamiento farmacológico , Masculino , Femenino , Adolescente , México , Teofilina/uso terapéutico , Teofilina/administración & dosificación , Proyectos Piloto , Budesonida/administración & dosificación , Budesonida/uso terapéutico , Corticoesteroides/uso terapéutico , Corticoesteroides/administración & dosificación , Administración por Inhalación , Broncodilatadores/uso terapéutico , Broncodilatadores/administración & dosificación , Antiasmáticos/uso terapéutico , Antiasmáticos/administración & dosificación , Resultado del Tratamiento , Volumen Espiratorio Forzado/efectos de los fármacos
15.
Curr Opin Gastroenterol ; 40(1): 50-59, 2024 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-37874119

RESUMEN

PURPOSE OF REVIEW: Microscopic colitis is an inflammatory disease of the colon that presents as watery diarrhea with minimal to normal endoscopic changes on colonoscopy. It encompasses two common subtypes, lymphocytic colitis and collagenous colitis, which are both treated similarly.Immune checkpoint inhibitor colitis is among the most common immune-related adverse events. Endoscopic and histological findings range from normal colonic mucosa to inflammatory bowel like changes. This review article provides update in treatment and management of microscopic colitis and immune checkpoint inhibitor colitis (ICPi colitis). RECENT FINDINGS: Recent studies on microscopic colitis have focused on the successful use of immunomodulators such as biologics for treatment of budesonide refractory microscopic colitis cases. Microscopic colitis does not confer an added risk for colorectal cancer.With the increasing usage of immunotherapy agents, immune checkpoint inhibitor colitis is becoming more common. ICPi colitis can be successfully managed with steroids, with treatment stepped up to biologics for moderate to severe cases or for mild cases that do not respond to steroids. Immunotherapy agents can be carefully re-introduced in mild cases, after treatment of ICPi colitis. SUMMARY: Biologics can be used to treat budesonide refractory microscopic colitis. ICPi colitis can be managed with steroids and biologics in moderate to severe cases.


Asunto(s)
Productos Biológicos , Colitis Microscópica , Colitis , Humanos , Inhibidores de Puntos de Control Inmunológico/uso terapéutico , Colitis Microscópica/tratamiento farmacológico , Colitis Microscópica/patología , Colitis/inducido químicamente , Colitis/tratamiento farmacológico , Colitis/patología , Diarrea/tratamiento farmacológico , Diarrea/etiología , Colonoscopía , Budesonida/uso terapéutico , Productos Biológicos/uso terapéutico
17.
Ter Arkh ; 95(11): 985-990, 2023 Dec 22.
Artículo en Ruso | MEDLINE | ID: mdl-38158957

RESUMEN

Currently, there is an increase in the incidence of microscopic colitis. There are difficulties in diagnosing this disease due to the variability of histological signs, variability of morphological changes in the mucous membrane of the colon in different parts of the colon, and the combination in one patient of not only various forms of microscopic colitis, but also other intestinal diseases. The article describes the differential diagnosis, an example of its staging and successful treatment of various forms of microscopic colitis with budesonide (two clinical cases presented).


Asunto(s)
Colitis Microscópica , Humanos , Colitis Microscópica/diagnóstico , Colitis Microscópica/tratamiento farmacológico , Colitis Microscópica/epidemiología , Budesonida/uso terapéutico , Diagnóstico Diferencial
18.
Immun Inflamm Dis ; 11(11): e1068, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-38018572

RESUMEN

OBJECTIVE: Mycoplasma pneumoniae pneumonia (MPP) is a common respiratory tract infectious disease in children. The study aimed to elucidate the therapeutic efficacy of aerosolized budesonide and N-acetylcysteine combination therapy for MP infection in children. METHODS: One hundred and twenty children with MP infection were included and divided into the control group (received aerosol inhalation of budesonide) and the experimental group (aerosolized budesonide and N-acetylcysteine). After treatment, the disappearance time of clinical symptoms and efficacy were contrasted between the two groups. RESULTS: With the passage of treatment time, the children's cough score of the two groups were gradually reduced. The children in the experimental group got well from the cough faster than the control group, and the difference reached a significant level on the 5th and 7th days. The time required for fever, rale, and cough to disappear in the experimental group was shorter than those in the control group. As the treatment progressed, a gradual decrease in serum interleukin-6, tumor necrosis factor-α, and C-reactive protein values was detected in both groups, and the decrease was more significant in the experimental group. The total effective rate of the experimental group was 98.33%, which surpassed the control group (93.33%). CONCLUSION: Budesonide and N-acetylcysteine combination therapy in the treatment of MP infection in children has a significant effect, and can quickly relieve the clinical symptoms of children with good safety. It is worthy of widespread clinical use.


Asunto(s)
Neumonía por Mycoplasma , Niño , Humanos , Neumonía por Mycoplasma/tratamiento farmacológico , Neumonía por Mycoplasma/diagnóstico , Neumonía por Mycoplasma/patología , Budesonida/uso terapéutico , Acetilcisteína/uso terapéutico , Tos , Mycoplasma pneumoniae , Resultado del Tratamiento
19.
BMC Gastroenterol ; 23(1): 417, 2023 Nov 29.
Artículo en Inglés | MEDLINE | ID: mdl-38030966

RESUMEN

BACKGROUND: Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking integrin antibody, is effective in treating patients with moderately to severely active Crohn's disease (CD). In this study, we examined the real-world effectiveness and safety of induction therapy using VDZ alone or in combination with budesonide (VDZ + BUD) among patients with CD in Belgium, Israel, and Switzerland. METHODS: This retrospective chart review analysis included adult patients with moderately to severely active CD who started induction treatment with VDZ or VDZ + BUD (January 2015 through January 2019). The primary objective of this study was to assess the effectiveness in terms of clinical remission of VDZ alone or VDZ + BUD using patient-reported outcomes (PRO) of abdominal pain (AP) and/or loose stool frequency (LSF) (PRO-2) at weeks 0, 2, 6, 10, and 14. Regression models were used to assess differences and associations between the treatment groups. RESULTS: Overall, 123 patients were included (VDZ, n = 73; VDZ + BUD, n = 50). Clinical remission rates at week 14 were 71.4% (50/70) and 68.0% (34/50) with VDZ and VDZ + BUD, respectively. Mean percentage change in AP and LSF from baseline to week 14 was comparable between the groups. Median (95% confidence interval [CI]) time to clinical remission was 91 [70.0-98.0] and 95 [70.0-98.0] days, respectively. One patient in each group discontinued VDZ and 68.0% of patients in the VDZ + BUD group discontinued BUD before week 14. The rates of overall adverse events were similar between the groups (VDZ, 23.3%; VDZ + BUD, 26.0%). CONCLUSIONS: In this retrospective study, VDZ alone and VDZ + BUD showed similar high remission rates in patients with moderately to severely active CD. Prospective randomized studies are needed to conclude on the role of combining VDZ with BUD. TRIAL REGISTRATION: Not applicable.


Asunto(s)
Anticuerpos Monoclonales Humanizados , Enfermedad de Crohn , Adulto , Humanos , Anticuerpos Monoclonales Humanizados/efectos adversos , Budesonida/uso terapéutico , Enfermedad de Crohn/tratamiento farmacológico , Diarrea/inducido químicamente , Europa (Continente) , Fármacos Gastrointestinales/efectos adversos , Estudios Prospectivos , Inducción de Remisión , Estudios Retrospectivos , Resultado del Tratamiento , Quimioterapia Combinada/efectos adversos
20.
ORL J Otorhinolaryngol Relat Spec ; 85(6): 321-328, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37935139

RESUMEN

INTRODUCTION: Relevant studies have demonstrated that glucocorticoids and antihistamines, such as budesonide and azelastine, are effective in the treatment of vasomotor rhinitis, with their combined use being more effective than that of a single drug. The aim of this study was to assess the improvement in the symptoms of patients following the combined administration of these drugs. METHODS: We conducted a single-center randomized study on 42 patients. Participants were randomly treated with budesonide, levocabastine hydrochloride, or their combination for 2 weeks. The visual analog scale (VAS) score and levels of eosinophil cationic protein (ECP), histamine (HA), leukotriene B4 (LTB4), and vasoactive intestinal peptide (VIP) in nasal secretions were evaluated before and after treatment. RESULTS: The symptoms of patients were improved in all 3 treatment groups compared with those before treatment. Following combined treatment, the improvement in symptoms of nasal obstruction, runny nose, nasal itching, and sneezing was much greater than those in the groups treated with budesonide or levocabastine hydrochloride alone (p = 0.04, 0.004, 0.005, 0.004, respectively). The decreased levels of these inflammatory mediators were significantly different between the different treatment groups. CONCLUSIONS: Budesonide or levocabastine hydrochloride alone improved the nasal symptoms of patients with vasomotor rhinitis and reduced the levels of ECP, HA, LTB4, and VIP in nasal secretions. However, their combination improved the symptoms of patients more significantly than each drug alone.


Asunto(s)
Budesonida , Rinitis Vasomotora , Humanos , Budesonida/uso terapéutico , Rinitis Vasomotora/tratamiento farmacológico , Leucotrieno B4 , Administración Intranasal , Método Doble Ciego
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