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1.
Rev Fac Cien Med Univ Nac Cordoba ; 76(4): 222-226, 2019 11 27.
Artigo em Espanhol | MEDLINE | ID: mdl-31833745

RESUMO

Introduction: Asthma is related to caries but the risk factors are not completely determined. Therefore, the objective of the study was to determine the risk of dental caries in pediatric asthmatic patients in inhalation treatment with salbutamol and budesonide who went to the National Hospital Arzobispo Loayza. Methods: Case-control study that consisted of 184 pediatric patients, between 5 and 12 years old, who attended the pneumology and pediatric dentistry service of the National Hospital Arzobispo Loayza during the years 2016-2017. The group of cases (n = 92) was composed of patients with moderate asthma medicated with inhaled salbutamol and budesonide, while the control group (n = 92) was composed of healthy patients. The risk of dental caries was evaluated with the dietary record, oral hygiene index and number of carious lesions. Results: The risk according to the type of cariogenic diet was moderate in both groups (p = 0.768). The oral hygiene index in the control group was regular in 63% (n = 58) and in the case group, bad in 60.9% (n = 56); p=0.001. The number of carious lesions in the control group was moderate in 50% (n = 46) and in the case group, high in 47.8% (n = 44); p = 0.001. Therefore, the risk of dental caries in the case group was high in 50% (n = 46) and in the control group it was moderate in 72.8% (n = 67); p = 0.001. Conclusion: The risk of dental caries in asthmatic patients on inhaled therapy with salbutamol and budesonide is significantly higher than that of healthy patients.


Assuntos
Albuterol/efeitos adversos , Antiasmáticos/efeitos adversos , Asma/tratamento farmacológico , Budesonida/efeitos adversos , Cárie Dentária/induzido quimicamente , Administração por Inalação , Albuterol/administração & dosagem , Antiasmáticos/administração & dosagem , Budesonida/administração & dosagem , Estudos de Casos e Controles , Criança , Pré-Escolar , Cárie Dentária/epidemiologia , Feminino , Humanos , Incidência , Masculino , Higiene Bucal , Peru/epidemiologia , Projetos Piloto , Fatores de Risco
2.
Arq Gastroenterol ; 56(4): 390-393, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31721973

RESUMO

BACKGROUND: Drug-induced liver injury is still misunderstood in Brazil due to diagnostic difficulties or lack of reporting incidents. OBJECTIVE: To assess the frequency of adverse events related to the use of medicines in a primary healthcare unit, in a city locate southwestern of the state of Bahia, Brazil. METHODS: Prospective study conducted at the Primary Center for Specialized Health (CEMEA), February at August of 2013 in Vitoria da Conquista, Bahia, Brazil. Interviews were conducted with patients over 18 years old, and their clinical and laboratorial data were collected. The CIOMS scale was used to validate the cases. RESULTS: A total of 149 patients, mainly Afro-Brazilian women, received follow-up. Among these patients, three cases of hepatotoxicity were identified, and the medicines associated to drug-induced liver injuries were: nimesulide, budesonide and valacyclovir. CONCLUSION: Drug-induced liver injury is rare in primary healthcare units. It also allowed estimating the incidence of hepatotoxicity induced by allopathic medicines which are standardized by public healthcare authorities.


Assuntos
Budesonida/efeitos adversos , Doença Hepática Induzida por Substâncias e Drogas/epidemiologia , Monitoramento de Medicamentos/métodos , Sulfonamidas/efeitos adversos , Valaciclovir/efeitos adversos , Adulto , Brasil/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Atenção Primária à Saúde , Estudos Prospectivos
5.
Croat Med J ; 60(4): 345-351, 2019 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-31483120

RESUMO

AIM: To compare the early biochemical response and rate of adverse effects in patients who received prednisolone (PRED)/azathioprine (AZA) and those who received budesonide (BUD)/AZA as the first-line treatment for autoimmune hepatitis. METHODS: The study involved 25 patients receiving PRED 30 mg/day + AZA 50 mg/day and 25 patients receiving BUD 9 mg/day + AZA 50 mg/day from February 2015 to February 2018. Biochemical and hemogram data at baseline and after 6 months of treatment, and adverse effects observed in the follow-up, were compared. RESULTS: There was no difference between the groups in biochemical response (17 patients receiving PRED/AZA and 18 receiving BUD/AZA) and the rate of adverse effects (9 patients receiving PRED/AZA and 5 receiving BUD/AZA). The total number of adverse effects in the BUD/AZA group was lower (15 vs 7) and the treatment was discontinued in 2 (8%) patients in PRED/AZA group, while no treatment discontinuation was observed in BUD/AZA group. CONCLUSIONS: This study showed no differences in biochemical response between the groups. Lower, although not significantly, rate of adverse effects and lower total number of adverse effects indicate that BUD/AZA may potentially be used as the first-line treatment of choice, especially in patients with obesity, diabetes, resistant hypertension, glaucoma, or osteoporosis.


Assuntos
Budesonida/uso terapêutico , Hepatite Autoimune/tratamento farmacológico , Imunossupressores/uso terapêutico , Adulto , Idoso , Azatioprina/uso terapêutico , Budesonida/efeitos adversos , Quimioterapia Combinada , Feminino , Humanos , Imunossupressores/efeitos adversos , Masculino , Pessoa de Meia-Idade , Prednisolona/uso terapêutico , Indução de Remissão , Estudos Retrospectivos , Fatores Socioeconômicos
6.
Int J Chron Obstruct Pulmon Dis ; 14: 1195-1207, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31213797

RESUMO

Purpose: Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms and is a leading cause of disability in China. Acute exacerbations of COPD (AECOPD) are a leading cause of hospitalizations, and account for a substantial proportion of medical expenditure. Corticosteroids are commonly used to manage AECOPD in hospitalized patients, so our objective was to analyze the total medical expenditure associated with nebulized budesonide (nBUD) vs. systemic corticosteroids (SCS) in this population. Patients and methods: A post-hoc analysis was carried out in 1,577 and 973 patients diagnosed with COPD who had received "any" nBUD or SCS regimen for AECOPD during hospitalization, respectively. Regimens included monotherapy, sequential therapy, and sequential-combination therapy. Comparative total medical expenditure was analyzed using a generalized linear model controlling for age, gender, comorbidities, smoking history, and respiratory failure or pneumonia on admission. Results: The total medical expenditure per capita with any nBUD or SCS regimen was CN¥11,814 (US$1,922) and CN¥12,153 (US$1,977), respectively. Any nBUD regimen was associated with a significant saving of 5.1% in expenditure compared with any SCS regimen (P=0.0341). Comorbidities, Type II respiratory failure, or pneumonia were patient factors associated with higher total medical expenditure (P<0.0001). In a subgroup analysis of the patients who received monotherapy, total medical expenditure was CN¥10,900 (US$1,773) for nBUD and CN¥11,581 (US$1,884) for SCS; nBUD was associated with a significant saving of 8.7% in expenditure compared with SCS (P=0.0013). Similarly, in patients with respiratory failure, treatment with any nBUD regimen was associated with a 10.6% saving in expenditure over any SCS regimen (P=0.0239); however, the same comparison was not significant in patients without respiratory failure (3.4%; P=0.2299). Conclusion: AECOPD is a leading cause of hospitalization in China, which places substantial burden on the healthcare system. This post-hoc analysis suggests that nBUD regimens are associated with lower medical expenditure than SCS regimens in hospitalized patients with AECOPD, and may reduce the financial burden of COPD. However, prospective studies evaluating the effectiveness of nBUD therapies are warranted.


Assuntos
Corticosteroides/economia , Budesonida/administração & dosagem , Budesonida/economia , Custos de Medicamentos , Glucocorticoides/administração & dosagem , Glucocorticoides/economia , Gastos em Saúde , Custos Hospitalares , Hospitalização/economia , Pulmão/efeitos dos fármacos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/economia , Administração por Inalação , Corticosteroides/administração & dosagem , Corticosteroides/efeitos adversos , Aerossóis , Idoso , Budesonida/efeitos adversos , China , Progressão da Doença , Feminino , Glucocorticoides/efeitos adversos , Humanos , Pacientes Internados , Pulmão/fisiopatologia , Masculino , Nebulizadores e Vaporizadores , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Estudos Retrospectivos , Resultado do Tratamento
7.
Cochrane Database Syst Rev ; 5: CD001176, 2019 05 28.
Artigo em Inglês | MEDLINE | ID: mdl-31136680

RESUMO

BACKGROUND: Pouchitis occurs in approximately 50% of patients following ileal pouch-anal anastomosis (IPAA) for chronic ulcerative colitis (UC). OBJECTIVES: The primary objective was to determine the efficacy and safety of medical therapies for prevention or treatment of acute or chronic pouchitis. SEARCH METHODS: We searched MEDLINE, Embase and CENTRAL from inception to 25 July 2018. We also searched references, trials registers, and conference proceedings. SELECTION CRITERIA: Randomized controlled trials of prevention or treatment of acute or chronic pouchitis in adults who underwent IPAA for UC were considered for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently screened studies for eligibility, extracted data and assessed the risk of bias. The certainty of the evidence was evaluated using GRADE. The primary outcome was clinical improvement or remission in participants with acute or chronic pouchitis, or the proportion of participants with no episodes of pouchitis after IPAA. Adverse events (AEs) was a secondary outcome. We calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for each dichotomous outcome. MAIN RESULTS: Fifteen studies (547 participants) were included. Four studies assessed treatment of acute pouchitis. Five studies assessed treatment of chronic pouchitis. Six studies assessed prevention of pouchitis. Three studies were low risk of bias. Three studies were high risk of bias and the other studies were unclear.Acute pouchitis: All ciprofloxacin participants (7/7) achieved remission at two weeks compared to 33% (3/9) of metronidazole participants (RR 2.68, 95% CI 1.13 to 6.35, very low certainty evidence). No ciprofloxacin participants (0/7) had an AE compared to 33% (3/9) of metronidazole participants (RR 0.18, 95% CI 0.01 to 2.98; very low certainty evidence). AEs included vomiting, dysgeusia or transient peripheral neuropathy. Forty-three per cent (6/14) of metronidazole participants achieved remission at 6 weeks compared to 50% (6/12) of budesonide enema participants (RR 0.86, 95% CI 0.37 to 1.96, very low certainty evidence). Fifty per cent (7/14) of metronidazole participants improved clinically at 6 weeks compared to 58% (7/12) of budesonide enema participants (RR 0.86, 95% CI 0.42 to 1.74, very low certainty evidence). Fifty-seven per cent (8/14) of metronidazole participants had an AE compared to 25% (3/12) of budesonide enema participants (RR 2.29, 95% CI 0.78 to 6.73, very low certainty evidence). AEs included anorexia, nausea, headache, asthenia, metallic taste, vomiting, paraesthesia, and depression. Twenty-five per cent (2/8) of rifaximin participants achieved remission at 4 weeks compared to 0% (0/10) of placebo participants (RR 6.11, 95% CI 0.33 to 111.71, very low certainty evidence). Thirty-eight per cent (3/8) of rifaximin participants improved clinically at 4 weeks compared to 30% (3/10) of placebo participants (RR 1.25, 95% CI 0.34 to 4.60, very low certainty evidence). Seventy-five per cent (6/8) of rifaximin participants had an AE compared to 50% (5/10) of placebo participants (RR 1.50, 95% CI 0.72 to 3.14, very low certainty evidence). AEs included diarrhea, flatulence, nausea, proctalgia, vomiting, thirst, candida, upper respiratory tract infection, increased hepatic enzyme, and cluster headache. Ten per cent (1/10) of Lactobacillus GG participants improved clinically at 12 weeks compared to 0% (0/10) of placebo participants (RR 3.00, 95% CI 0.14 to 65.90, very low certainty evidence).Chronic pouchitis: Eighty-five per cent (34/40) of De Simone Formulation participants maintained remission at 9 to 12 months compared to 3% (1/36) of placebo participants (RR 20.24, 95% CI 4.28 to 95.81, 2 studies; low certainty evidence). Two per cent (1/40) of De Simone Formulation participants had an AE compared to 0% (0/36) of placebo participants (RR 2.43, 95% CI 0.11 to 55.89; low certainty evidence). AEs included abdominal cramps, vomiting and diarrhea. Fifty per cent (3/6) of adalimumab patients achieved clinical improvement at 4 weeks compared to 43% (3/7) of placebo participants (RR, 1.17, 95% CI 0.36 to 3.76, low certainty evidence). Sixty per cent (6/10) of glutamine participants maintained remission at 3 weeks compared to 33% (3/9) of butyrate participants (RR 1.80, 95% CI 0.63 to 5.16, very low certainty evidence). Forty-five per cent (9/20) of patients treated with bismuth carbomer foam enema improved clinically at 3 weeks compared to 45% (9/20) of placebo participants (RR 1.00, 95% CI 0.50 to 1.98, very low certainty evidence). Twenty-five per cent (5/20) of participants in the bismuth carbomer foam enema group had an AE compared to 35% (7/20) of placebo participants (RR 0.71, 95% CI 0.27 to 1.88, very low certainty evidence). Adverse events included diarrhea, worsening symptoms, cramping, sinusitis, and abdominal pain. PREVENTION: At 12 months, 90% (18/20) of De Simone Formulation participants had no episodes of acute pouchitis compared to 60% (12/20) of placebo participants (RR 1.50, 95% CI 1.02 to 2.21, low certainty evidence). Another study found 100% (16/16) of De Simone Formulation participants had no episodes of acute pouchitis at 12 months compared to 92% (11/12) of the no treatment control group (RR 1.10, 95% 0.89 to 1.36, very low certainty evidence). Eighty-six per cent (6/7) of Bifidobacterium longum participants had no episodes of acute pouchitis at 6 months compared to 60% (3/5) of placebo participants (RR 1.43, 95% CI 0.66 to 3.11, very low certainty evidence). Eleven per cent (1/9) of Clostridium butyricum MIYAIRI participants had no episodes of acute pouchitis at 24 months compared to 50% (4/8) of placebo participants (RR 0.22, 95% CI 0.03 to 1.60, very low certainty evidence). Forty-six per cent (43/94) of allopurinol participants had no episodes of pouchitis at 24 months compared to 43% (39/90) of placebo participants (RR 1.06, 95% CI 0.76 to 1.46; low certainty evidence). Eighty-one per cent (21/26) of tinidazole participants had no episodes of pouchitis over 12 months compared to 58% (7/12) of placebo participants (RR 1.38, 95% CI 0.83 to 2.31, very low certainty evidence). AUTHORS' CONCLUSIONS: The effects of antibiotics, probiotics and other interventions for treating and preventing pouchitis are uncertain. Well designed, adequately powered studies are needed to determine the optimal therapy for the treatment and prevention of pouchitis.


Assuntos
Anastomose Cirúrgica/efeitos adversos , Colite Ulcerativa/cirurgia , Pouchite/tratamento farmacológico , Antibacterianos/efeitos adversos , Antibacterianos/uso terapêutico , Budesonida/efeitos adversos , Budesonida/uso terapêutico , Ciprofloxacino/efeitos adversos , Ciprofloxacino/uso terapêutico , Enema , Fármacos Gastrointestinais/efeitos adversos , Fármacos Gastrointestinais/uso terapêutico , Humanos , Metronidazol/efeitos adversos , Metronidazol/uso terapêutico , Complicações Pós-Operatórias/tratamento farmacológico , Complicações Pós-Operatórias/prevenção & controle , Pouchite/etiologia , Pouchite/prevenção & controle , Probióticos , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão
8.
Regul Toxicol Pharmacol ; 106: 251-261, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31047944

RESUMO

Home healthcare is a growing area of employment. Assessment of occupational health risks to home health care workers (HHCWs) is important because in many cases the unique characteristics of the home environment do not facilitate the level of exposure control afforded to caregivers in hospitals and other fixed patient care sites. This assessment is focused on health risks to HHCWs from exposure to pharmaceutical drugs used to treat asthma and other respiratory diseases, which are commonly administered to patients in aerosolized form via nebulizers. We developed risk-based exposure limits for workers in the form of occupational exposure limits (OEL) values for exposure to nebulized forms of the three most common drugs administered by this method: albuterol, ipratropium, and budesonide. The derived OEL for albuterol was 2 µg/day, for ipratropium was 30 µg/day, and for budesonide was 11 µg/day. These OELs were derived based on human effect data and adjusted for pharmacokinetic variability and areas of uncertainty relevant to the underlying data (human and non-human) available for each drug. The resulting OEL values provide an input to the occupational risk assessment process to allow for comparisons to HHCW exposure that will guide risk management and exposure control decisions.


Assuntos
Budesonida/análise , Pessoal de Saúde , Ipratrópio/análise , Exposição Ocupacional/análise , Saúde do Trabalhador , Budesonida/efeitos adversos , Budesonida/farmacocinética , Humanos , Ipratrópio/efeitos adversos , Ipratrópio/farmacocinética , Exposição Ocupacional/efeitos adversos , Medição de Risco
9.
N Engl J Med ; 380(21): 2020-2030, 2019 05 23.
Artigo em Inglês | MEDLINE | ID: mdl-31112386

RESUMO

BACKGROUND: In double-blind, placebo-controlled trials, budesonide-formoterol used on an as-needed basis resulted in a lower risk of severe exacerbation of asthma than as-needed use of a short-acting ß2-agonist (SABA); the risk was similar to that of budesonide maintenance therapy plus as-needed SABA. The availability of data from clinical trials designed to better reflect clinical practice would be beneficial. METHODS: We conducted a 52-week, randomized, open-label, parallel-group, controlled trial involving adults with mild asthma. Patients were randomly assigned to one of three treatment groups: albuterol (100 µg, two inhalations from a pressurized metered-dose inhaler as needed for asthma symptoms) (albuterol group); budesonide (200 µg, one inhalation through a Turbuhaler twice daily) plus as-needed albuterol (budesonide maintenance group); or budesonide-formoterol (200 µg of budesonide and 6 µg of formoterol, one inhalation through a Turbuhaler as needed) (budesonide-formoterol group). Electronic monitoring of inhalers was used to measure medication use. The primary outcome was the annualized rate of asthma exacerbations. RESULTS: The analysis included 668 of 675 patients who underwent randomization. The annualized exacerbation rate in the budesonide-formoterol group was lower than that in the albuterol group (absolute rate, 0.195 vs. 0.400; relative rate, 0.49; 95% confidence interval [CI], 0.33 to 0.72; P<0.001) and did not differ significantly from the rate in the budesonide maintenance group (absolute rate, 0.195 in the budesonide-formoterol group vs. 0.175 in the budesonide maintenance group; relative rate, 1.12; 95% CI, 0.70 to 1.79; P = 0.65). The number of severe exacerbations was lower in the budesonide-formoterol group than in both the albuterol group (9 vs. 23; relative risk, 0.40; 95% CI, 0.18 to 0.86) and the budesonide maintenance group (9 vs. 21; relative risk, 0.44; 95% CI, 0.20 to 0.96). The mean (±SD) dose of inhaled budesonide was 107±109 µg per day in the budesonide-formoterol group and 222±113 µg per day in the budesonide maintenance group. The incidence and type of adverse events reported were consistent with those in previous trials and with reports in clinical use. CONCLUSIONS: In an open-label trial involving adults with mild asthma, budesonide-formoterol used as needed was superior to albuterol used as needed for the prevention of asthma exacerbations. (Funded by AstraZeneca and the Health Research Council of New Zealand; Novel START Australian New Zealand Clinical Trials Registry number, ACTRN12615000999538.).


Assuntos
Albuterol/administração & dosagem , Asma/tratamento farmacológico , Broncodilatadores/administração & dosagem , Budesonida/administração & dosagem , Fumarato de Formoterol/administração & dosagem , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Adulto , Idoso , Albuterol/efeitos adversos , Broncodilatadores/efeitos adversos , Budesonida/efeitos adversos , Quimioterapia Combinada , Feminino , Fumarato de Formoterol/efeitos adversos , Humanos , Masculino , Inaladores Dosimetrados , Pessoa de Meia-Idade
10.
J Coll Physicians Surg Pak ; 29(4): 345-348, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30925958

RESUMO

OBJECTIVE: To determine the effects of combined treatment of montelukast and budesonide on young children with cough variant asthma, and their serum inflammatory factors of serum hypersensitive c-reactive protein (hs-CRP), tumour necrosis factor-α (TNF-α), interleukin-6 (IL-6) and pulmonary function. STUDY DESIGN: An experimental study. PLACE AND DURATION OF STUDY: The Second Affiliated Hospital of Xi'an Jiaotong University, China, from January 2016 to January 2017. METHODOLOGY: A total of 112 children with cough variant asthma were randomly divided into observation group and control group with 56 cases in each group. All children were treated with antibiotics and resolving phlegm. The control group were given budesonide, while the observation group was treated additionally with montelukast. After the course, improvement time of clinical symptoms of cough, asthma, etc., changes in levels of serum inflammatory factors of hs-CRP, TNF-α and IL-6, and pulmonary function indexes of forced vital capacity (FVC), forced expiratory volume at the end of the first 1s (FEV1), peak expiratory flow (PEF), and observe concurrence of untoward effects in the two groups of sick children were compared. RESULTS: After treatment, extinction time for cough and for asthma of the observation group was less than those in the control group (all p<0.001). Levels of serum hs-CRP, TNF-α, IL-6 in the observation group were all lower than those of the control group (all p<0.001). Pulmonary function indices of FVC, FEV1 and PEF of the two groups of sick children were all higher than those of the control group (all p<0.001). During the treatment, there was no difference in the comparison of untoward effect rate of the two groups (p=0.696). After follow-up observation on the two groups of sick children for 1 year, the recurrence rate of the observation group was lower than that of the control group (p=0.026). CONCLUSION: Curative effects on young children with cough variant asthma of montelukast combined with budesonide are significant. The therapy may improve clinical symptoms and pulmonary function and reduce serum inflammatory factor level of sick children, with high application value and worthy of application and promotion.


Assuntos
Acetatos/administração & dosagem , Antiasmáticos/administração & dosagem , Anti-Inflamatórios/administração & dosagem , Asma/tratamento farmacológico , Budesonida/administração & dosagem , Tosse/tratamento farmacológico , Pulmão/fisiopatologia , Quinolinas/administração & dosagem , Antiasmáticos/efeitos adversos , Anti-Inflamatórios/efeitos adversos , Budesonida/efeitos adversos , Proteína C-Reativa/efeitos dos fármacos , Proteína C-Reativa/metabolismo , Criança , Pré-Escolar , Tosse/complicações , Feminino , Humanos , Interleucina-6/sangue , Pulmão/efeitos dos fármacos , Pulmão/metabolismo , Masculino , Testes de Função Respiratória , Resultado do Tratamento , Fator de Necrose Tumoral alfa/sangue , Fator de Necrose Tumoral alfa/efeitos dos fármacos
11.
Dig Dis Sci ; 64(6): 1571-1578, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30659470

RESUMO

BACKGROUND: A new prepared oral viscous budesonide (PVB) has been effective in inducing clinical and histological remission in pediatric eosinophilic esophagitis (EoE). AIMS: To evaluate the efficacy of a 12-week maintenance therapy on clinical, endoscopic, and histological remission using half of the dose used in the induction therapy. METHODS: We prospectively enrolled pediatric patients with active EoE. After 12 weeks of induction therapy with PVB (< 150 cm: 2 mg/day; ≥ 150 cm: 4 mg/day) patients received a maintenance dose of half of the dose used in the induction therapy (1 mg or 2 mg) for another 12 weeks. A 12-week follow-up was then performed in all patients after the end of therapy. Endoscopy was performed at weeks 0, 12, 24, and 36. Symptoms, endoscopy, and histology scores were also calculated. Serum cortisol was evaluated during the treatment period. RESULTS: We enrolled 20 children (15 males; median age 10 years; range 4-17). After the 12-week induction therapy 18 patients (90%) were in remission, with a significant decrease in the median peak of eosinophil count/HPF as well as a marked reduction in clinical, endoscopic, and histological scores (p < 0.01). At the end of the maintenance therapy (week 24), 17 patients (85%) were still in remission, while there were only 9 at week 36 (45%). No significant changes in cortisol levels were observed during the study period. CONCLUSIONS: The 12-week maintenance treatment with the half the dose of PVB was effective in sustaining remission at week 24; however, no reduction in the rate of relapse after suspension of treatment occurred.


Assuntos
Budesonida/administração & dosagem , Esofagite Eosinofílica/tratamento farmacológico , Glucocorticoides/administração & dosagem , Administração Oral , Adolescente , Idade de Início , Budesonida/efeitos adversos , Criança , Pré-Escolar , Esquema de Medicação , Composição de Medicamentos , Esofagite Eosinofílica/imunologia , Esofagite Eosinofílica/patologia , Feminino , Glucocorticoides/efeitos adversos , Humanos , Quimioterapia de Manutenção , Masculino , Soluções Farmacêuticas , Projetos Piloto , Estudos Prospectivos , Recidiva , Indução de Remissão , Roma , Fatores de Tempo , Resultado do Tratamento , Viscosidade
12.
Clin Gastroenterol Hepatol ; 17(1): 98-106.e4, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-29702300

RESUMO

BACKGROUND & AIMS: Although proctitis is the most limited form of ulcerative colitis, it causes unpleasant symptoms. Topical mesalamine, the standard treatment, is not always effective. We conducted a randomized phase 2 trial to determine the efficacy and safety of 2 doses of a budesonide suppository vs mesalamine suppositories vs combined budesonide and mesalamine suppositories for proctitis. METHODS: We performed a prospective, double-blind, double-dummy, multicenter trial in 337 patients with active proctitis to compare the efficacies of 4 different suppository treatments. Patients were randomly assigned to groups given 2 mg budesonide suppositories (2 mg BUS; n = 89 patients), 4 mg BUS (n = 79), 1 g mesalamine suppositories (1 g MES; n = 81), or the combination of 2 mg BUS and 1 g MES (n = 88). The study was performed from November 2013 through July 2015 at 36 study sites in Europe and Russia. The primary end point was the time to resolution of clinical symptoms, defined as the first of 3 consecutive days with a score of 0 for rectal bleeding and stool frequency. RESULTS: The mean time to resolution of symptoms in the 4 mg BUS (29.8 days) and combination of 2 mg BUS and 1 g MES (29.3 days) groups resembled that of the standard 1 g MES treatment (29.2 days), but was significantly longer in the 2 mg BUS group (35.5 days). Furthermore, proportions of patients with deep, clinical, and endoscopic remission, as well as mucosal healing, were similar among the 1 g MES, 4 mg BUS, and combination therapy groups, but significantly lower in the group that received 2 mg BUS. No safety signals were observed, and the patients' treatment acceptance was high (67%-85% of patients). CONCLUSIONS: In a multicenter randomized trial, we found that the efficacy and safety of 4 mg BUS in treatment of active proctitis did not differ significantly from those of 1 g MES. Budesonide suppositories offer an alternative therapy to mesalamine for topical treatment of proctitis. Clinicaltrialsregister.eu no: 2012-003362-41.


Assuntos
Anti-Inflamatórios/administração & dosagem , Budesonida/administração & dosagem , Colite Ulcerativa/tratamento farmacológico , Proctite/tratamento farmacológico , Supositórios/administração & dosagem , Adolescente , Adulto , Idoso , Anti-Inflamatórios/efeitos adversos , Budesonida/efeitos adversos , Método Duplo-Cego , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/métodos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Europa (Continente) , Feminino , Humanos , Masculino , Mesalamina/administração & dosagem , Mesalamina/efeitos adversos , Pessoa de Meia-Idade , Estudos Prospectivos , Federação Russa , Supositórios/efeitos adversos , Resultado do Tratamento , Adulto Jovem
13.
Drugs R D ; 18(4): 259-269, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30387081

RESUMO

BACKGROUND AND OBJECTIVE: Eosinophilic 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. METHODS: In 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. RESULTS: A 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. CONCLUSION: Budesonide 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.


Assuntos
Budesonida/uso terapêutico , Esofagite Eosinofílica/tratamento farmacológico , Budesonida/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
Respir Care ; 63(10): 1302-1310, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30237276

RESUMO

BACKGROUND: COPD guidelines report that systemic corticosteroids are preferred over inhaled corticosteroids in the treatment of exacerbations, but the inhaled route is considered to be an option. OBJECTIVES: To conduct a systematic review and meta-analysis regarding the efficacy and safety of inhaled corticosteroids for COPD exacerbations. The second objective was to provide pharmacologic and clinical perspectives of inhaled corticosteroids for COPD exacerbations. METHODS: The primary outcome was a change in FEV1 baseline versus the last measured value. Secondary outcomes were a change in (PaO2 ) and (PaCO2 ) baselines versus the last measured values; FEV1, PaO2 , and PaCO2 at 24 or 72 h; and hyperglycemia. RESULTS: Each of the 9 studies included in the meta-analysis was conducted in subjects who were hospitalized and not critically ill. Our meta-analysis indicated that high-dose nebulized budesonide 4-8 mg/d was noninferior to systemic corticosteroids on the change in FEV1 between baseline and the last measured value (mean difference of 0.05, 95% CI -0.01 to 0.12, P = .13) and PaCO2 (mean difference of -1.14, 95% CI -2.56 to 0.27, P = .11) but of inferior efficacy for PaO2 changes (mean difference of -1.46, 95% -2.75 to -0.16, P = .03). Hyperglycemia was less frequent with high-dose nebulized budesonide (risk ratio, 0.13; 95% CI 0.03-0.46; P = .002). CONCLUSIONS: Based on our meta-analysis with a change in FEV1 as the primary end point, high-dose nebulized budesonide was an acceptable alternative to systemic corticosteroids in hospitalized subjects with COPD exacerbations who were not critically ill. Additional well-designed prospective studies are needed in both the acute care and ambulatory settings. We provide perspective on how this evidence might be applied in clinical practice.


Assuntos
Corticosteroides/administração & dosagem , Broncodilatadores/administração & dosagem , Budesonida/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Corticosteroides/efeitos adversos , Broncodilatadores/efeitos adversos , Budesonida/efeitos adversos , Dióxido de Carbono , Progressão da Doença , Volume Expiratório Forçado , Humanos , Hiperglicemia/induzido quimicamente , Nebulizadores e Vaporizadores , Oxigênio , Pressão Parcial , Doença Pulmonar Obstrutiva Crônica/fisiopatologia
15.
Eur Respir J ; 52(3)2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30220648

RESUMO

TELOS compared budesonide (BD)/formoterol fumarate dihydrate (FF) metered dose inhaler (BFF MDI), formulated using innovative co-suspension delivery technology that enables consistent aerosol performance, with its monocomponents and budesonide/formoterol fumarate dihydrate dry powder inhaler (DPI) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), without a requirement for an exacerbation history.In this phase III, double-blind, parallel-group, 24-week study (NCT02766608), patients were randomised to BFF MDI 320/10 µg (n=664), BFF MDI 160/10 µg (n=649), FF MDI 10 µg (n=648), BD MDI 320 µg (n=209) or open-label budesonide/formoterol DPI 400/12 µg (n=219). Primary end-points were change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV1) and FEV1 area under the curve from 0-4 h (AUC0-4). Time to first and rate of moderate/severe exacerbations were assessed.BFF MDI 320/10 µg improved pre-dose trough FEV1versus FF MDI (least squares mean (LSM) 39 mL; p=0.0018), and BFF MDI 320/10 µg and 160/10 µg improved FEV1 AUC0-4versus BD MDI (LSM 173 mL and 157 mL, respectively; both p<0.0001) at week 24. BFF MDI 320/10 µg and 160/10 µg improved time to first and rate of moderate/severe exacerbations versus FF MDI. Treatments were well tolerated, with pneumonia incidence ranging from 0.5-1.4%.BFF MDI improved lung function versus monocomponents and exacerbations versus FF MDI in patients with moderate to very severe COPD.


Assuntos
Broncodilatadores/administração & dosagem , Budesonida/administração & dosagem , Volume Expiratório Forçado/efeitos dos fármacos , Fumarato de Formoterol/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Idoso , Broncodilatadores/efeitos adversos , Budesonida/efeitos adversos , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Fumarato de Formoterol/efeitos adversos , Humanos , Internacionalidade , Masculino , Inaladores Dosimetrados , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Resultado do Tratamento
16.
Gastroenterol. hepatol. (Ed. impr.) ; 41(7): 458-471, ago.-sept. 2018. tab
Artigo em Espanhol | IBECS | ID: ibc-180633

RESUMO

La budesonida oral es un glucocorticoide de acción fundamentalmente local. En la especialidad de Aparato Digestivo, se emplea sobre todo en la enfermedad inflamatoria intestinal, aunque también en otras indicaciones. Esta revisión aborda aspectos acerca de la farmacología, la farmacodinámica y el empleo terapéutico de la budesonida. Se contemplan sus indicaciones reconocidas y se especula acerca de otras situaciones en las que podría desempeñar un papel de interés, con el objeto de facilitar su uso y mejorar la exactitud de su prescripción


Oral budesonide is a glucocorticoid of primarily local action. In the field of digestive diseases, it is used mainly in inflammatory bowel disease, but also in other indications. This review addresses the pharmacology, pharmacodynamics and therapeutic use of budesonide. Its approved indications are reviewed, as well as other clinical scenarios in which it could play a role, in order to facilitate its use and improve the accuracy of its prescription


Assuntos
Humanos , Anti-Inflamatórios/uso terapêutico , Budesonida/uso terapêutico , Doença de Crohn/tratamento farmacológico , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/efeitos adversos , Anti-Inflamatórios/farmacologia , Budesonida/administração & dosagem , Budesonida/efeitos adversos , Budesonida/farmacologia , Colite Ulcerativa/tratamento farmacológico , Ensaios Clínicos Controlados como Assunto , Doença de Crohn/cirurgia , Ileostomia , Complicações Pós-Operatórias/prevenção & controle , Guias de Prática Clínica como Assunto
17.
Lancet Gastroenterol Hepatol ; 3(11): 742-753, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30122356

RESUMO

BACKGROUND: The majority of patients with ulcerative colitis have mildly to moderately active disease. To inform the management of patients with left-sided or extensive mildly to moderately active ulcerative colitis, we assessed the comparative efficacy and tolerability of different therapies. METHODS: In this systematic review and network meta-analysis, we searched Epub, MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Scopus, and Web of Science from inception to Dec 14, 2015, and updated on MEDLINE on March 1, 2018, for randomised controlled trials in adults (age ≥17 years) with left-sided or extensive mild to moderate ulcerative colitis. Studies were included if patients were treated with oral sulfasalazine, diazo-bonded 5-aminosalicylates (5-ASAs), mesalazine (low dose <2 g/day, standard dose 2-3 g/day, or high dose >3 g/day), controlled ileal-release budesonide, or budesonide multimatrix, alone or in combination with rectal 5-ASA therapy, and were compared with each other or placebo for induction or maintenance of clinical remission. The minimum duration of therapy was 4 weeks for trials of induction and 24 weeks for trials of maintenance therapy. We did pairwise and random-effects network meta-analysis using a frequentist approach, and calculated odds ratios (ORs) and 95% CIs; agents were ranked using surface under the cumulative ranking (SUCRA) probabilities. We used Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria to appraise quality of evidence. We examined heterogeneity with the I2 statistic. FINDINGS: Our search identified 1316 unique studies, from which 75 randomised trials with 12 215 patients were eligible for analysis. Based on 48 induction randomised trials (8020 participants) that met inclusion criteria, combined oral and rectal 5-ASAs (SUCRA 0·99) and high-dose mesalazine (>3 g/day; SUCRA 0·82) were ranked highest for induction of remission. Both interventions were superior to standard-dose mesalazine (2-3 g/day; failure to induce remission with combined oral and rectal 5-ASAs OR 0·41, 95% CI 0·22-0·77; high-dose mesalazine 0·78, 0·66-0·93) with moderate confidence in estimates. On the basis of 28 randomised trials (4218 participants) that met inclusion criteria, all interventions were superior to placebo for maintenance of remission; however, neither combined oral and rectal 5-ASAs nor high-dose mesalazine were superior to standard-dose mesalazine. INTERPRETATION: In patients with mildly to moderately active left-sided or extensive ulcerative colitis, combined oral and topical mesalazine therapy and high-dose mesalazine are superior to standard-dose mesalazine for induction of remission, but not maintenance of remission. Standard-dose mesalazine might be preferred for maintenance in most patients. FUNDING: None.


Assuntos
Anti-Inflamatórios não Esteroides/efeitos adversos , Anti-Inflamatórios não Esteroides/uso terapêutico , Colite Ulcerativa/tratamento farmacológico , Administração Oral , Administração Retal , Budesonida/efeitos adversos , Budesonida/uso terapêutico , Humanos , Mesalamina/efeitos adversos , Mesalamina/uso terapêutico , Meta-Análise em Rede , Indução de Remissão , Sulfassalazina/efeitos adversos , Sulfassalazina/uso terapêutico
18.
Medicine (Baltimore) ; 97(30): e11557, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30045280

RESUMO

This study investigated the effectiveness and safety of montelukast combined budesonide (MCB) treatment for children with chronic cough-variant asthma (CCVA).In total, 82 cases of children with CCVA, aged 4 to 11 years were included in this study. All cases received either MCB or budesonide alone between May 2015 and April 2017. The primary outcome was lung function, measured by the peak expiratory flow rates (PEFRs) and forced expiratory volume in 1 second (FEV1). The secondary outcome was measured by the clinical assessment score. Furthermore, adverse events (AEs) were also recorded in this study. All outcomes were measured after 8-week treatment.After 8-week treatment, MCB showed greater effectiveness than did budesonide alone in improving the lung function, measured by PEFR V1 (P = .02), and FEV1 (P < .01). Similarly, the clinical assessment score also demonstrated significant difference between the 2 groups (P < .05). In addition, no serious AEs occurred in both groups.The results of this study demonstrate that the effectiveness of MCB is superior to budesonide alone in the treatment of children with CCVA.


Assuntos
Acetatos , Asma , Budesonida , Tosse , Quinolinas , Acetatos/administração & dosagem , Acetatos/efeitos adversos , Antiasmáticos/administração & dosagem , Antiasmáticos/efeitos adversos , Asma/diagnóstico , Asma/tratamento farmacológico , Asma/fisiopatologia , Broncodilatadores/administração & dosagem , Broncodilatadores/efeitos adversos , Budesonida/administração & dosagem , Budesonida/efeitos adversos , Criança , Pré-Escolar , Tosse/tratamento farmacológico , Tosse/etiologia , Tosse/fisiopatologia , Monitoramento de Medicamentos/métodos , Quimioterapia Combinada/métodos , Feminino , Humanos , Masculino , Quinolinas/administração & dosagem , Quinolinas/efeitos adversos , Testes de Função Respiratória/métodos , Estudos Retrospectivos , Avaliação de Sintomas/métodos , Resultado do Tratamento
19.
Allergy Asthma Proc ; 39(5): 350-358, 2018 Sep 23.
Artigo em Inglês | MEDLINE | ID: mdl-30037361

RESUMO

BACKGROUND: This is the first study of the inhaled corticosteroid, budesonide, delivered by metered-dose inhaler (BD MDI) using innovative co-suspension delivery technology in adults with asthma. OBJECTIVE: To characterize the effects of BD delivered by MDI on lung function and safety. METHODS: Randomized, double-blind, 4-week cross-over, placebo-controlled, phase IIb study of adults (18-65 years of age) with mild-to-moderate persistent asthma. The subjects received twice-daily BD MDI 320 µg, 160 µg, and placebo MDI, and either BD MDI 80 µg or 40 µg. The primary endpoint was change from baseline in morning trough forced expiratory volume in 1 second (FEV1) at the end of the treatment period (EOT). Secondary endpoints included change from baseline in morning and evening predose peak expiratory flow rate (PEFR), rescue medication use, and Asthma Control Questionnaire 5-question version (ACQ-5) score. Safety was also assessed. RESULTS: A total of 147 subjects were randomized. All doses of BD MDI improved morning trough FEV1 at EOT, and morning and evening predose PEFR in the last treatment week versus placebo (all p < 0.01), with improvements in trough FEV1 exceeding 100 mL for BD MDI 320 µg, and 160 µg only. Compared with placebo, all BD MDI doses reduced rescue medication use in the last week of treatment (p < 0.01) and improved ACQ-5 scores at EOT (all p < 0.01). All treatments were well tolerated. CONCLUSION: Analysis of the data demonstrated greater efficacy improvements for the higher doses of BD MDI (320 µg and 160 µg), with similar adverse event profiles compared with the lower doses. Hence, BD MDI 320 µg and 160 µg warrant further evaluation in subjects with persistent asthma.Clinical trial NCT02105012, www.clinicaltrials.gov.


Assuntos
Antiasmáticos/administração & dosagem , Asma/tratamento farmacológico , Budesonida/administração & dosagem , Inaladores Dosimetrados , Administração por Inalação , Adolescente , Adulto , Idoso , Antiasmáticos/efeitos adversos , Asma/diagnóstico , Budesonida/efeitos adversos , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Testes de Função Respiratória , Resultado do Tratamento , Adulto Jovem
20.
Gastroenterol Hepatol ; 41(7): 458-471, 2018.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-30007787

RESUMO

Oral budesonide is a glucocorticoid of primarily local action. In the field of digestive diseases, it is used mainly in inflammatory bowel disease, but also in other indications. This review addresses the pharmacology, pharmacodynamics and therapeutic use of budesonide. Its approved indications are reviewed, as well as other clinical scenarios in which it could play a role, in order to facilitate its use and improve the accuracy of its prescription.


Assuntos
Anti-Inflamatórios/uso terapêutico , Budesonida/uso terapêutico , Doença de Crohn/tratamento farmacológico , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/efeitos adversos , Anti-Inflamatórios/farmacologia , Budesonida/administração & dosagem , Budesonida/efeitos adversos , Budesonida/farmacologia , Colite Ulcerativa/tratamento farmacológico , Ensaios Clínicos Controlados como Assunto , Doença de Crohn/cirurgia , Humanos , Ileostomia , Complicações Pós-Operatórias/prevenção & controle , Guias de Prática Clínica como Assunto
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