Effects of extrafine-particle versus fine-particle inhaled corticosteroids combined with formoterol on large and small airway function in patients with bronchial asthma / 中国医师进修杂志

Objective:To compare the effects of extrafine-particle versus fine-particle inhaled corticosteroids (ICS) combined with formoterol on clinical symptoms, airway inflammation and airway function in patients with bronchial asthma (referred to as asthma).Methods:This prospective, randomized controlled clinical trial enrolled a total of 111 patients diagnose of asthma and cough variant asthma with forced expired volume in one second (FEV 1) percentage of predicted (FEV 1%pred) >70% in Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine from November 2020 to October 2022. The patients were divided into observation group (57 cases) and control group (54 cases) by random digits table method. The patients in observation group were treated with extrafine-particle ICS combined with formoterol, while the patients in control group were treated with fine-particle ICS combined with formoterol. Both groups were treated for 4 weeks. During treatment 10 patients lost follow up and a total of 101 patients complete the final study: 52 cases in observation group and 49 cases in control group. At baseline, the asthma control test (ACT) score was calculated to evaluate the clinical symptoms, fractional exhaled nitric oxide (FeNO) was applied to evaluate the airway inflammatory level, and the pulmonary function test and bronchodilation test were perfromed. The symptom relief time was record. After treatment, all of the parameters were reevaluated. Results:The FEV 1, peak expiratory flow (PEF), forced expired flow at 50% of forced vital capacity (MEF 50), forced expired flow at 25% of forced vital capacity (MEF 25), maximal expiratory flow-volume curve (MMEF) and ACT score after treatment in both groups were significantly improved compared to baseline, and there were statistical differences ( P<0.01). The improvement of ACT score in observation group was significantly higher than that in control group: (5.90 ± 2.25) scores vs. (4.10 ± 2.18) scores, and there was statistical difference ( P<0.01); there were no statistical differences in the symptom relief time and the improvement rates of FEV 1, PEF, MEF 50, MEF 25, MMEF between the two groups ( P>0.05). Further subgroup analysis was performed on 78 patients with small airway dysfunction, 39 patients were treated with extrafine-particle ICS combined with formoterol (observation subgroup), and 39 patients were treated with fine-particle ICS combined with formoterol (control subgroup). The improvement of ACT score in observation subgroup was significantly higher than that in control subgroup: (6.05 ± 2.22) scores vs. (3.95 ± 2.19) scores, and there was statistical difference ( P<0.01); there were no statistical differences in the symptom relief time and the improvement rates of FEV 1, PEF, MEF 50, MEF 25, MMEF between the two subgroups ( P>0.05). Spearman correlation analysis result showed that the improvement rates of MEF 50, MEF 25 and MMEF after treatment were positive correlated with baseline bronchodilator responses of FEV 1, FEV 1/FVC, MEF 50, MEF 25, MMEF ( r = 0.22 to 0.58, P<0.05), but not with baseline bronchodilator responses of PEF ( P>0.05). In terms of safety, neither of the two treatments had major adverse reactions that affect treatment. Conclusions:For asthma patients with baseline FEV 1%pred>70%, the extrafine-particle ICS combined with formoterol has more significantly improved of clinical symptoms compared to fine-particle ICS combined with formoterol, and potentially with better safety profile. The improvement ratio of small airway function parameters in baseline bronchodilation test could potentially predict treatment response.

Pharmacoeconomic evaluation of 2 kinds of inhalation schemes of budesonide for mild asthma / 中国药房

OBJECTIVE To evaluate the cost-utility of as-needed inhaled budesonide/formoterol versus budesonide maintenance therapy combined with as-needed inhaled terbutaline （hereinafter referred to as budesonide maintenance therapy） in patients with mild asthma from the perspective of the Chinese health service system. METHODS A Markov model of mild asthma was established based on an international multicenter randomized controlled clinical study （SYGMA 2 study）； the model cycle was one week， and the model had a whole horizon of 60 years. The cost only included direct medical cost， and utility value was derived from the data of EuroQol 5-Dimension 5-Level in the SYGMA 2 study and published literature. The total cost and total output of the above two inhalation therapies for patients with mild asthma were calculated， with discount rate of 5%. The stability of the model was evaluated by sensitivity analysis. RESULTS The total cost of as-needed inhaled budesonide/formoterol and budesonide maintenance therapy were 25 884 yuan and 45 822 yuan， respectively， and the effectiveness were 30.51 quality- adjusted life years （QALYs） and 30.50 QALYs， respectively. The former scheme was an absolute advantage. One-way sensitivity analyses showed that the price of drug （terbutaline and budesonide/formoterol） and average number of inhalations per day were the main influencing parameters， but they had little influence on the results of basic analysis. Probabilistic sensitivity analysis showed that the probability of as-needed budesonide/formoterol being cost-effective was 100%. CONCLUSIONS Compared with budesonide maintenance therapy， as-needed inhalation of budesonide/formoterol in mild asthma patients is more cost-effective.

Consultas a urgencia y valores espirométricos tras el reemplazo de salmeterol/fluticasona por budesonida/formoterol en pacientes con asma moderada a grave / Emergency consultations and spirometric values after replacement of salmeterol/fluticasone with budesonide/formoterol in patients with moderate to severe asthma

El asma se caracteriza por su impacto deletéreo que incluye gran coste económico para el sistema de salud. En pacientes con asma mal controlada a pesar del tratamiento, se propone un régimen de mantenimiento con corticoides inhalados y formoterol. El objetivo del presente estudio observacional retrospectivo fue evaluar las modificaciones espirométricas tras el cambio del medicamento controlador en pacientes con asma moderada a severa asistidos en el Hospital Clínico de Magallanes de Punta Arenas, así como también cuantificar la modificación en el número de exacerbaciones graves (consulta a un servicio de urgencia y/u hospitalización por asma). Participaron 61 adultos con asma moderada a severa (mediana de edad: 60 años [rango: 21-87], mujeres: 69,4%; comorbilidad atópica/alérgica: 79%; otras comorbilidades: 46,8%) en los que se cambió el tratamiento con fluticasona/salmeterol 250/25 μg por budesónida/formoterol 160/4,5 μg. No se observaron cambios significativos en los índices espirométricos tras el cambio. Con el tratamiento inicial, el 46,9% presentó ≥ 1 visita a urgencias (total: 50 consultas). Tras el cambio por budesonida/formoterol, el 21% requirió al menos una visita a urgencias (total: 14 consultas; p < 0,01). La proporción de pacientes con ≥ 2 consultas a urgencias fue de 19,7% con el tratamiento basal y de 1,6% tras el cambio a budesonida/formoterol (p < 0,01). No se observaron diferencias significativas en la cantidad de hospitalizaciones. En este estudio del mundo real de pacientes con asma moderada a grave, el cambio del tratamiento a budesonida/formoterol se asoció con reducción significativa de las consultas a urgencias, a pesar de no detectarse cambios de significación estadística en los índices espirométricos habituales.

Asthma is characterized by its deleterious impact, including a high cost to the healthcare system. In patients with poorly controlled asthma despite treatment, a maintenance regimen of inhaled corticosteroids and formoterol is proposed. The aim of this retrospective, observational study was to evaluate the spirometric changes after switching the controller medication in patients with moderate to severe asthma attended in our institution ("Hospital Clínico de Magallanes"), as well as the variation in the number of severe exacerbations (consultation to an emergency department and/or hospitalization for asthma). Sixty-one adults with moderate to severe asthma (median age: 60 years-old [range: 21-87], women: 69.4%; atopic/allergic comorbidity: 79%; other comorbidities: 46.8%) in whom treatment with fluticasone/salmeterol 250/25 μg was switched to budesonide/formoterol 160/4.5 μg participated in our study. No significant changes in spirometric parameters were observed after the replacement treatment. With the initial treatment, 46.9% patients presented ≥ 1 visit to the emergency department (total: 50 visits). After the switch to budesonide/formoterol, 21% required at least one emergency department visit (total: 14 consultations; p < 0.01). The proportion of patients with ≥ 2 emergency department visits was 19.7% with baseline treatment and 1.6% after switching to budesonide/formoterol (p < 0.01). No significant differences were observed in the number of hospitalizations. In this real-world study of moderate to severe asthma patients, switching to budesonide/formoterol was associated with a significant reduction in emergency department visits, despite no statistically significant changes in the usual spirometric parameters.

Estudio aleatorizado, cruzado, de no inferioridad para evaluar la eficacia, la seguridad y la tolerabilidad de dos formulaciones de budesonida/fumarato de formoterol en adultos asmáticos / Randomized, Crossover, Non-Inferiority Study to Evaluate the Efficacy, Safety and Tolerability of Two Budenoside/Formoterol Fumarate Formulations in Asthmatic Adults

RESUMEN El asma es un grave problema de salud mundial. Según el último informe del Ministerio de Salud, 1 380 000 sujetos padecen asma en la Argentina.1 Las guías internacionales (Europa, Estados Unidos, OMS) varían en su enfoque para definir la equivalencia y la posibilidad de intercambio de los productos para inhalación respiratorios. Si bien es posible un enfoque in vitro, en general las guías recomiendan brindar más indi cios clínicos que avalen la posibilidad de intercambiar el producto innovador por otro posteriormente desarrollado con iguales principios activos en polvo seco para inhalar. Este estudio, aleatorizado de fase IV, se realizó para establecer la eficacia, seguridad y tolerabilidad de Neumoterol® 400 en comparación con el producto medicinal de refe rencia Symbicort forte budesonida/fumarato de formoterol 320/9 μg, indicados 2 veces al día en pacientes asmáticos. Además, se evaluó la preferencia de los pacientes por uno u otro dispositivo. Se demostró la no inferioridad de la formulación evaluada en comparación con el pro ducto medicinal de referencia. El límite inferior del IC del 95% para la diferencia entre los tratamientos fue mayor que el margen predefinido de no inferioridad de -125 mL (diferencia: 0,044 l [IC del 95%: -0,008 a 0,096]). Asimismo, se comprobaron valores más altos para el AUC0-10h del FEV1 y un mayor cambio respecto del puntaje basal en la prueba de control del asma el día 29 para las cápsulas de budesonida/fumarato de formoterol 400/12 μg. En un análisis exploratorio sobre la preferencia de los pacientes por los dispositivos, una mayor proporción de participantes expresaron su preferencia global por la cápsula de budesonida/fumarato de formoterol 400/12 μg. No se informa ron diferencias en la incidencia de AE o SAE (del inglés Adverse event: evento adver so y Severe Adverse Event: evento adverso severo) graves durante el tratamiento o después de este. El perfil de seguridad de ambos productos en general concordó con el perfil comprobado de budesonida/fumarato de formoterol.

ABSTRACT Asthma is a serious worldwide health problem. According to the last report of the Min istry of Health, 1,380,000 subjects suffer from asthma in Argentina.1 The International Guidelines (Europe, United States, WHO [World Health Organization]) have varying approaches to define the equivalence and possibility of switching respiratory inhalation products. Whereas an in vitro approach is possible, in general Guidelines recommend providing more clinical evidence that support the possibility of switching from the inno vative product to another one subsequently developed with the same active ingredient in the form of dry powder inhaler. This randomized, phase IV study has been conduct ed to establish the efficacy, safety and tolerability of Neumoterol® 400 compared to the reference medicinal product Symbicort forte, budenoside/formoterol fumarate 320/9 μg twice a day in asthmatic patients. Also, the patients' preference for one device or the other has been evaluated. The evaluated formulation has proven to be non-inferior compared to the reference medicinal product. The lower 95% CI (confidence interval) limit for the difference be tween treatments was higher than the predefined non-inferiority margin of -125 mL (difference: 0.044 l [95% CI: -0.008 to 0.096]). Also, higher values were evidenced for the AUC0-10h (are under the curve) of the FEV1 (forced expiratory volume in the first second) and a more important change of the baseline score in the asthma control test on day 29 for the budenoside/formoterol fumarate capsules of 400/12 μg. In one exploratory test about the patients' preference for one device or the other, a higher pro portion of participants expressed their global preference for the budenoside/formoterol fumarate capsule of 400/12 μg. No differences were reported in the incidence of AEs (adverse events) or SAEs (serious adverse events) during or after the treatment. The safety profile of both products in general agreed with the verified profile of budenoside/ formoterol fumarate.

Comparative, Prospective Study Regarding Efficacy, Safety & Adverse Effects of Anti-Asthmatic Drugs in Case of Mild to Moderate Chronic Stable Persistent Bronchial Asthma in Adults.

Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation, bronchoconstriction and airway hyper responsiveness. The addition of an inhaled corticosteroid (ICS) to an inhaled long-acting β2-agonist (LABA) gives optimal control of asthma in most patients. There are few international studies regarding efficacy and safety of LABA/ICS. But in India there is paucity of such studies. Hence the present study was undertaken.METHODSA comparative, prospective, observational study was conducted among 120 patients attending the Out Patient Department of Chest Medicine and Pharmacology of Burdwan Medical College and Hospital, diagnosed as having mild to moderate chronic stable persistent bronchial asthma, receiving combination of LABA and ICS therapy, out of which 16 patients were lost due to follow up, and 104 patients were studied. Patients were divided into 2 groups. Group A received respicaps of combined formoterol 6 μg and budesonide 400 μg DPI, Group B received combined formoterol 6 μg and mometasone 400 μg DPI, twice daily. During exacerbations inhaled salbutamol was utilized as rescue medication. Spirometric parameters, clinical parameters, and adverse effects were recorded on three visits (at 4th, 8th and 12th weeks) and analysed by using different statistical tests.RESULTSComparable clinical improvement of spirometric parameters, Asthma Control Test score of both groups were observed (p-value>0.05). Adverse effects like tremor, pharyngitis, headache, oral candidiasis and dysphonia were recorded among both the groups which was statistically insignificant.CONCLUSIONPatients who received ICS with LABA in both groups experienced a statistically significant improvement in symptoms. Improvement was seen in spirometric parameters as well with a comparable degree of safety

A pharmacoepidemiological study of prescription patterns of ?2 sympathomimetic bronchodilators in exacerbation of non-severe asthma in tertiary care hospitals, not needing hospitalization

Background: Arformoterol, the (R, R) enantiomer of the racemic (R, R / S, S) diastereomer, formoterol, is a short and long acting ?2 agonist bronchodilator. Levosalbutamol, the (R, R) enantiomer of racemic diastereomer (R, R / S, S) salbutamol, has a greater affinity for the ?2 receptor. Occupation of ?2 receptors by agonists result in the activation of the Gs-adenylyl cyclase-cAMP-PKA pathway, followed by phosphorylative events leading to bronchial smooth muscle relaxation. The aim of this pharmacoepidemiological study was to analyse the prescription patterns, and prescription content analysis, of arformoterol, levosalbutamol, formoterol or salbutamol, in non-severe asthma exacerbation in tertiary care hospitals, not needing hospitalization.Methods: It was a multi-centre, retrospective, observational and analytical study of 100 asthmatic patients’ hospital medical records, treated with 3 doses of arformoterol, levosalbutamol, formoterol or salbutamol nebulization, followed by peak expiratory flow rates (PEFR) measurement at the baseline and 6 minutes, after each dose; along with adverse effects recording. The number of prescriptions of 100 patients was recorded, the percentage of prescriptions was calculated, and the prescription content analysis was done.Results: PEFR of the patients showed significant increase after the first, second and third doses of bronchodilator nebulisation, with negligible adverse effects. Salbutamol was most commonly prescribed (45 prescriptions, 45%), followed by levosalbutamol (35 prescriptions, 35%), formoterol (15 prescriptions, 15%) and arformoterol (5 prescriptions, 5%). All aspects of prescription content analysis showed 100% completeness.Conclusions: Arformoterol was more effective, but equally safe, as compared to levosalbutamol, formoterol and salbutamol. Prescription frequency of salbutamol was followed by levosalbutamol, formoterol and arformoterol. Prescription content analyses showed 100% completeness.

Simultaneous Estimation Of Mometasone Furoate And Formoterol Fumarate By Hplc Method In Rotacaps

Objective: To develop and validate a simple and sensitive RP-HPLC method for the simultaneous determination of mometasone furoate (MOM) and formoterol fumarate (FOR) in pharmaceutical dosage forms. Methods: In RP-HPLC method, chromatographic separation was achieved using a mixture of a solvent system consisting of methanol–water (pH 3.5) in the ratio of 85:15 % v/v at a flow rate of 1 ml/min and detection was carried out at 225 nm. Results: The run time for the simultaneous estimation of drugs for the proposed method was 10 min as drugs eluted at 5.217 min (MOM) and 8.650 min (FOR). The linearity was found in the range of 33.33-299.97 μg/ml and 1-9 μg/ml for MOM and FOR, respectively. The values of limit of detection and limit of quantification were 3.634, 0.266 µg/ml and 11.014, 0.807 µg/ml, which indicates the sensitivity of the method for the estimation of MOM and FOR, respectively. The results of recovery studies for both the drugs were within the range i.e. 98.87-101.48 % which indicates the accuracy of the method. Relative standard deviation obtained from repeatability and reproducibility studies were less than 2% indicates the precision of the method. The proposed method was validated according to ICH guidelines. Conclusion: The proposed RP-HPLC method was found to be sensitive and precise because of the low LOD, LOQ and % RSD values (<2). The proposed work does not require acetonitrile and ion pairing reagent as compared to the reported methods. Therefore, method can be used preferably for routine analysis due to its simplicity and economic advantages.

Eficacia de la budesonida/formoterol comparado con la fluticasona/salmeterol en la mejoría de la capacidad pulmonar de personas mayores con Enfermedad Pulmonar Obstructiva Crónica: revisión sistemática de literatura / Effectiveness of budesonide/formoterol compared to fluticasone / salmeterol in improving the lung capacity of older people with Chronic Obstructive Pulmonary Disease: systematic literature review / Eficiência da budesonida/formoterol comparado com fluticasona/salmeterol na melhora da capacidade pulmonar de idosos com Doença Pulmonar Obstrutiva Crônica: revisão sistemática da literatura

Introducción. La Enfermedad Pulmonar Obstructiva Crónica (EPOC) es una patología no transmisible, caracterizada por una limitación de flujo de aire en las vías respiratorias debido a una respuesta inmunológica anormal frente a partículas. Objetivo. Conocer la eficacia que tiene la budesonida/formoterol comparado con la fluticasona/salmeterol en la mejoría de la capacidad pulmonar en personas mayores de 40 años con Enfermedad Pulmonar Obstructiva Crónica. Materiales y métodos. Se realizó una revisión sistemática de documentos producidos entre el año 2000 y 2018 en distintas bases de datos, donde se incluyeron ensayos clínicos. Se identificaron cuatro artículos para el análisis final. Resultados. Durante la evaluación comparativa de budesonida con formoterol, los artículos muestran un total de 709 personas evaluadas, con un promedio de edad de 53,5 años. El 65,4 % eran varones, el 21 % manifestaba no haber consumido tabaco, todos con diagnóstico de Enfermedad Pulmonar Obstructiva Crónica moderada-severa, según la escala GOLD (Global Initiative For Chronic Obstrutive Lung Disease). Los estudios determinaron que al administrar budesonida/formoterol de 400/12 mcg y 320/9 mcg, los pacientes tuvieron una leve mejoría en el Volumen Espiratorio Forzado del primer segundo (VEF1). Solo dos pacientes presentaron efectos adversos. No obstante, para los resultados mencionados anteriormente no se encontró diferencias significativas. Conclusiones. El uso de budesonida/formoterol es eficaz al mejorar la capacidad ventilatoria pulmonar, disminuye el número de exacerbaciones anuales y genera un adecuado control de los síntomas, sin embargo, es igual de efectivo a la fluticasona/salmeterol.

Introduction. Chronic Obstructive Pulmonary Disease (COPD) is a not transmissible disease, characterized by a limitation of airflow in the respiratory tract, due to an abnormal immune response to particles. Objective. This article aims to show that the application of budesonide / formoterol improves lung capacity in people over 40 years with Chronic Obstructive Pulmonary Disease. Materials and methods. A systematic review was conducted in the period between 2000 and 2018 in different databases where clinical trials were included. Four articles were identified for the final analysis. Results. During the comparative evaluation of budesonide with formoterol, a total of 709 people were evaluated, with an average age of 53.5 years, 65.4% were male, 21% reported not having used tobacco, all with a diagnosis of moderate-severe Chronic Obstructive Pulmonary Disease according to the GOLD scale (Global Initiative For Chronic Obstrutive Lung Disease). The studies determined that when budesonide / formoterol of 400/12 mcg and 320/9 mcg was administered, the patients had a slight improvement in the Forced Expiratory Volume of the first second (FEV1). Only two patients presented adverse effects. However, for the results mentioned above no significant differences were found. Conclusions. The use of budesonide / formoterol is effective in improving pulmonary ventilatory capacity, decreases the number of annual exacerbations and generates adequate control of symptoms, however, it is equally effective in fluticasone / salmeterol.

Introdução. A Doença Pulmonar Obstrutiva Crônica (DPOC) é uma patologia não transmissível, caraterizada por uma limitação do fluxo de ar nas vias aéreas devido a uma resposta imune anormal contra partículas. Objetivo. Conhecer a eficiência que apresenta a budesonida/formoterol comparado com fluticasona/salmeterol na melhora da capacidade pulmonar em pessoas com mais de 40 anos com Doença Pulmonar Obstrutiva Crônica. Materiais e métodos. Foi realizada uma revisão sistemática dos documentos produzidos entre 2000 e 2018 em diferentes bancos de dados, onde foram incluídos ensaios clínicos. Quatro artigos foram identificados para a análise final. Resultados. Durante a avaliação comparativa de budesonida com formoterol, os artículos mostram um total de 709 pessoas avaliadas, com uma idade média de 53,5 anos. O 65,4 % eram do sexo masculino, o 21 % disseram que não usavam tabaco, todos diagnosticados com Doença Pulmonar Obstrutiva Crônica moderada a grave, de acordo com a escala GOLD (Global Initiative For Chronic Obstrutive Lung Disease). Os estudos determinaram que administrar budesonida/formoterol de 400/12 mcg e 320/9 mcg, os pacientes apresentaram uma leve melhora no Volume Expiratório Forçado no primeiro segundo (VEF1). Apenas dois pacientes tiveram efeitos adversos. No entanto, não foram encontradas diferenças significativas para os resultados mencionados acima. Conclusões. O uso de budesonida/formoterol é eficaz na melhora da capacidade ventilatória pulmonar, diminui o numero de exacerbações anuais e gera controle adequado dos sintomas, no entanto, é igualmente eficaz para a fluticasona/salmeterol.

Effects of Fufang-Haqing capsule with formoterol in the treatment of pulmonary emphysema combined with chronic wheezing bronchitis / 国际中医中药杂志

Objective To explore the effects of Fufang-Haqing capsule with formoterol in the treatment of elderly pulmonary emphysema combined with chronic wheezing bronchitis. Methods A total of 156 patients with elderly pulmonary emphysema combined with chronic wheezing bronchitis in our hospital were divided into control group (88 cases) and observation group (88 cases). The control group was treated with formoterol, the observation group was treated with Fufang-Haqing capsule combined with formoterol. Both group treatment last three months. In the 2 groups, the levels of lung function indicators (FEV1, FEV1/FVC, PEF and PEFR), inflammatory markers [Matrix metalloproteinase inhibitors-1 (TIMP-1), interleukin-17 (IL-17), matrix metalloproteinase-9 (MMP-9) and interleukin-8 (IL-8)], immune function indicators [T lymphocyte subgroup (CD3+ and CD4+), immunoglobulin (IgA, IgG and IgM)] were detected before and after the treatment. During the treatment, the adverse actions were observed. Results The effect rate in treatment group was 93.2% (82/88), significantly higher than 80.7% (71/88) in control group (Z=3.781, P<0.05). After the treatment, the levels of FEV1 (2.89 ± 0.37 L vs. 2.22 ± 0.33 L, t=3.781), FEV1/FVC (65.10% ± 6.67% vs. 57.56% ± 5.98%, t=3.894), PEF (6.76 ± 0.69 L/S vs. 5.57 ± 0.59 L/S, t=3.351) and PEFR (3.67 ± 0.39 L/S vs. 2.87 ± 0.32 L/S, t=3.561) in the treatment group were significantly higher than those in the control group (P<0.05). The TIMP-1, IL-17, IL-8 and MMP-9 in the treatment group were significantly lower than those in the control group (t were 3.567, 3.692, 3.491, 3.394, all Ps<0.05), while the levels of CD3+, CD4+, IgA, IgG and IgM were in the treatment group were significantly higher than those in the control group (t were 3.791, 3.593, 3.258, 3.682, 3.526, all Ps<0.05). There was no significantly difference between the 2 groups in the adverse actions. Conclusions The Fufang-Haqing capsule with formoterol in the treatment of elderly pulmonary emphysema combined with chronic wheezing bronchitis showd good effect, could promote the levels of lung function, inflammatory and immune function.

Formoterol versus montelukast as add on therapy to low dose budesonide in persistent asthma: effect on lung function

Background: Choice between LABAs and LTRAs as add on drugs to low dose ICS in persistent asthma remains unclear due to limited data on the comparative efficacy of these two groups of drugs. The aim of this study was to compare the effects of formoterol and montelukast on lung function, when added to low dose Budesonide in persistent asthma.Methods: This was an institution based randomized open label study. 72 asthmatics satisfying selection criteria of the study were randomized to receive either inhaled budesonide and formoterol (FB group) or inhaled budesonide and oral montelukast (MB group) for 12 weeks. PEF value at end point was primary efficacy measure. Secondary efficacy measures were PEF values measured at the end of 1, 4 and 8 weeks and the end point value of FEV1.Results: Both the groups showed significant improvement in the lung function tests. However inter-group comparison showed that PEF value at end point of FB group was significantly greater than that of MB group (81.94%vs 63.82%, p<0.05). Notable observation was that the superiority of the FB group with respect to PEF values was maintained from the first week itself. FB group also had significantly better results than MB group for FEV1 (67.88% vs 64.88%, p<0.05).Conclusions: In the present study, formoterol was found to be superior to montelukast in improving lung function when added to low dose budesonide in persistent asthma.

Simultaneous use of budesonide and formoterol in asthma control and relieving therapy:a Meta analysis / 重庆医学

Objective To systematically assess the effectiveness and safety of simultaneously using budesonide(BUD) and formoterol(FORM) in asthma control and relieving therapy.Methods The databases including PubMed,Cochrane Library,EM-base,VIP,CNKI,CBM,Wanfang Data Knowledge Service Platform Database were retrieved by computer.The randomized controlled trials(RCTs) about BUD and FORM simultaneous use in asthma control and relieving therapy(observation group),BUD and FORM use in asthma control and terbutaline(TER) use in relieving therapy were collected in the various databases from their establishment to May 2017.The meta analysis was conducted by adopting the RevMan 5.3 software.Results A total of 5 RCTs(6 control groups) involving 10158 patients were included.The observation group was lower than the control group in the aspects of asthma aggravation admission or emergency person-times(OR=0.70,95％CI:0.59-0.85,P＜0.01),occurrence rate of serious adverse events(OR=0.66,95％CI:0.52-0.82,P＜0.01),occurrence rate of experiment termination by various causes[OR=0.84,95％CI:0.73-0.96,P=0.01);compared with the observation group,the improvement of night PEF value and FEV1 value after treatment in the control group was more significant (MD=4.05,95 ％ CI:0.18-7.93,P =0.04;MD =0.04,95 ％ CI:0.03-0.05,P＜0.01);the number of nocturnal awakening decrease times and occurrence rate of fatal adverse events had no statistically significant difference between the two groups[OR=1.25,95％CI:1.00-1.56,P=0.05;OR=1.01,95％CI:0.23-4.45,P=0.99).Conclusion BUD and FORM simultaneous use in asthma control and relieving therapy has an advantage in the aspects of reducing asthma acute attack and safety;BUD and FORM is used in asthma control,while TER is used in relieving therapy and has better effect for improving the lung function.

Real-Life Clinical Use of Symbicort® Maintenance and Reliever Therapy for Asthmatic Patients in Korea

The aim of this study was to examine the daily practice patterns of Symbicort® Maintenance and Reliever Therapy (SMART) in Korean asthmatic patients and to analyze clinical signs related to overuse. This study used an observational, multicenter, noninterventional, prospective, uncontrolled design for examining asthmatic patients prescribed SMART to assess the frequency and pattern of Symbicort® usage as a maintenance and reliever medication. The characteristics of patients showing signs of overuse (frequency of inhalation: 8 or more times per day) were also analyzed. Among the 1,518 patients analyzed, 1,292 (85.1%) completed the trial. The number of mean inhalations per day was 2.14±1.15; the number of patients who had at least 1 as needed usage (PRN) inhalation per day was 843 (55.5%); the mean frequency of PRN use was 0.25±0.67 inhalations per day. The number of patients who overused for at least 1 day was 260 (17.1%). In particular, young patients, patients with limited physical activity, and patients with nocturnal symptoms demonstrated high frequency of overuse. The frequency of overuse during SMART was not high in Korean asthmatic patients and the asthma status of follow-up outpatients improved overall. However, there is a need for careful education targeted toward younger patients, patients with limited physical activity, and patients with nocturnal symptoms owing to their tendency to frequently overuse.

Effects of Budesonide and Formoterol on Pulmonary Ventilation Function and Prognosis in Patients with Acute Exacerbation of Mild to Moderate Bronchial Asthma / 中国药房

OBJECTIVE:To observe therapeutic efficacy and safety of budesonide and formoterol in the treatment of acute exacerbation of mild to moderate asthma.METHODS:A total of 89 patients with acute exacerbation of mild to moderate asthma were randomized divded into study group (45 cases) and control group (44 cases).Study group was given Budesonide and formoterol dry powder inhalation,one inhalation,q6 h,gargling 5 times after inhalation,6 inhalation per day at most+Montelukast tablet 10 mg orally,once a day.Control group received Prednisone tablet 25 mg orally after breakfast,once a day,d1-5+Theophylline sustained-release capsule 0.2 g,twice a day+Montelukast tablet 10 mg,once a day in the evening.Both groups were treated for 5 d.Acute AQLQ score,FEV1,PEF％pred and SpO2 were observed in 2 groups before and after treatment,and the occurrence of ADR was recorded.RESULTS:Before treatment,there was no statistical significance in acute AQLQ score,FEV1,PEF％pred or SpO2 between 2 groups(P＞0.05).After treatment,acute AQLQ score,FEV1,PEF％pred and SpO2 of 2 groups were significantly higher than before treatment,with statistical significance (P＜0.05),but there was no statistical significance between 2 groups (P＞ 0.05).There was statistical significance in the incidence of ADR between 2 group(P＜0.05).CONCLUSIONS:Budesonide and formoterol can improve pulmonary ventilation function and prognosis in patients with acute exacerbation of mild to moderate asthma with good safety.

Clinical Observation of Tiotropium Bromide Combined with Budesonide Formoterol in the Treatment of Severe Bronchial Asthma in Adults / 中国药房

OBJECTIVE:To observe clinical efficacy and safety of tiotropium bromide combined with budesonide formoterol in the treatment of severe bronchial asthma in adults. METHODS:A total of 110 adult patients with severe bronchial asthma were selected from our hospital during Mar. 2013-Mar. 2016 were divided into control group and observation group according to random number table,with 55 cases in each group. Control group was given Budesonide formoterol powder for inhalation,2 inhalations each time,bid;observation group was additionally given Tiotropium bromide powder for inhalation 18 μg,qd,on the basis of con-trol group. Both groups were treated for 6 months. Clinical efficacies as well as ACT scores,respiration function indexes and the times of acute attack of asthma before and after treatment,the occurrence of ADR were compared between 2 groups. RESULTS:The efficiency rate and total response rate of observation group were 54.55% and 96.36%,which were significantly higher than 32.73%,78.18% in control group,with statistical significance(P0.05). After treatment,ACT scores of 2 groups were significantly higher than before treatment;FEV1,FEV1/FVC and PEF were significantly greater than be-fore treatment,PEFR was significantly lower than before treatment;and the indexes in observation group was significantly better than control group,with statistical significance(P0.05). CONCLUSIONS:Tiotropium bromide combined with budesonide formoter-ol in the treatment of severe bronchial asthma in adults can effectively relieve the severity of disease,improve respiration function, reduce the times of acute attack of asthma,and have good therapeutic efficacy and safety.

Clinical study of Xiao'er Qingfeihuatan oral solution in the treatment of children with chronic cough / 中国基层医药

Objective To investigate the clinical efficacy of Qingfeihuatan oral solution in the treatment ofchildren with chronic cough.Methods According to the digital table,a total of 116 patients with cough variantasthma induced by chronic cough were randomly divided into control group and observation group,each group had58 cases.The two groups were given budesonide and formoterol fumarate powder for treatment,on this basis,theobservation group added Xiao'er Qingfeihuatan oral solution,the two groups were continuously treated for 4 weeks.Thechanges of lung function indicators,clinical efficacy and adverse reaction etc were observed.Results Aftertreatment,the clinical total effective rate of the observation group was 94.8％,which of the control group was 77.6％,the difference was statistically significant (x2 =3.625,P ＜ 0.05).The lung function indicators of FEV,FEV1 andFEV1/FEV in the two groups had statistically significant differences between before and after treatment (all P ＜0.05),but the pulmonary function indicators of FEV,FEV1 and FEV1/FEV in the observation group compared withthe control group had statistically significant differences (all P ＜ 0.05).The incidence rate of adverse reactions in theobservation group was 13.8％,which in the control group was 15.5％,the difference was not statistically significant(x2 =0.034,P ＞ 0.05).Conclusion On the basis of routine treatment,Qingfeihuatan oral solution in the treatmentof children with chronic cough can significantly improve the pulmonary function of patients,improve the clinicaltreatment effect,and has good safety and great clinical significance.

Clinical effect of budesonide/formoterol single inhaler combined with tiotropium bromide in stable chronic obstructive pulmonary disease / 药物评价研究

Objective To investigate the clinical effect of budesonide/formoterol single inhaler combined with tiotropium bromide in stable chronic obstructive pulmonary disease (COPD).Methods 80 cases of patients with stable COPD in China Aviation Industrial Xi'an Hospital from May 2014 to May 2016 were divided into observation group and control group,40 cases in each group.Patients in the control group were treated with budesonide/formoterol single inhaler,and in the observation group were treated with budesonide/formoterol single inhaler combined with tiotropium bromide.Compared the pulmonary function,life quality,serum levels of matrix metalloproteinases 9 (MMP-9) and interleukin 6 (IL-6),drug adverse reaction during the treatment and exacerbations episodes within the next six months.Results After treatment,the FEV1,FEV1/FVC,FEV1％ of two groups were significantly higher than before treatment (P ＜ 0.05),and in the observation group were significantly higher than that in control group (P ＜ 0.05).SGRQ scores,serum levels of MMP-9 and IL-6 of two groups were significantly lower than before treatment (P ＜ 0.05),and these indexes in the observation group were significantly lower than that in control group (P ＜ 0.05).The differences in the adverse reaction rate of two groups has no significant,the number of acute exacerbation in observation group were significantly lower than that of control group (P ＜ 0.05).Conclusion Budesonide/formoterol single inhaler combined with tiotropium bromide has remarkable clinical effect in stable COPD,and can effectively improve the pulmonary function,life quality,reduce the number of acute exacerbation,and reduce the serum levels of MMP-9,IL-6.

Effect of montelukast combined with budesonide formoterol treatment for acute bronchial asthma / 中国基层医药

Objective To explore the effect of montelukast combined with budesonide for treating acute bronchial asthma, pulmonary function improvement and to provide the basis for clinical treatment.Methods 192 patients with acute asthma were selected.They were divided into the control group and the observation group according to the admission order and odd and even numbers randomly, 96 patients in each group.The control group was treated with budesonide based on routine treatment, and the observation group was given budesonide formoterol based on the control group.The clinical effect, pulmonary function (forced expiratory volume in one second (FEV1),FEV1/forced vital capacity (FVC) and peak expiratory flow (PEF) the percentage of predicted value index percentage were observed.The daytime and night asthma symptoms and airway reactivity score: early respiratory resistance (Rrsc) and response threshold (Dmin) were assessed.Results The cough disappeared, shortness of breath, wheezing relieving, moist rales disappeared and wheeze disappeared time of the observation group after treatment were (5.92±1.03)d,(3.48±0.71)d,(3.74±0.69)d,(5.32±0.96)d and (5.12±0.77)d, which were lower than those of the control group (t=9.31,7.26,8.11,9.02,8.31,all P<0.05).The daytime and nighttime asthma symptom scores of the observation group after treatment were (0.54±0.31)points and (0.62±0.29)points, which were lower than those of the control group (t=7.90,7.33,all P<0.05).Rrsc score of the observation group after treatment was (2.20±0.56)points, which was lower than that of the control group (t=7.86,P<0.05).The Dmin score of the observation group after treatment was (8.33±0.81)points, which was higher than that of the control group (t=9.15,P<0.05).FEV1,FEV1/FVC and PEF of the two groups after treatment were significantly higher than those before treatment(all P<0.05).FEV1,FEV1/FVC and PEF of the observation group after treatment were (2.95±0.58)L,(71.91±0.69) and (96.45±6.11), which were higher than those of the control group after treatment (t=7.60,9.45,10.21,all P<0.05).Conclusion Montelukast combined with budesonide formoterol in the treatment of acute attack of bronchial asthma has better effect, could significantly reduce the symptoms of asthma patients and shorten the treatment time with synergistic effect, and improve the pulmonary ventilation function of the patients.

Comparison of the efficacy of high dose and conventional dose of budesonide/formoterol inhalation in stable COPD / 中国生化药物杂志

Objective To compare large dose or conventional dose of budesonide/formoterol fumarate powder in treatment of stable chronic obstructive pulmonary disease(COPD).Methods 120 patients with stable COPD from March 2015 to March 2016 in Jiaxing Second hospital were selected,were treated with budesonide/formoterol,and were divided into the conventional dose group and high dose groupaccording to different doses,60 cases in each group.Pulmonary function tests,CAT Chinese version scale assessment and 6 min walking distance(6MWD)test were performed before and after treatment,and adverse reactions and acute attack were observed.Results FEV1/FVC and FEV1％were significantly improved after treatment in the two groups,and those in the high dose group were significantly better than those in the conventional dose group,the difference was statistically significant(P<0.05),CAT score and 6MWD were significantly improved after treatment in the two groups,and those in the high dose group were significantly higher than those in the conventional dose group,the difference was statistically significant(P<0.05),adverse reactions such as palpitations,tachycardiain the high dose group were significantly higher than those in the conventional dose group,while the acute attack rate was significantly lower than that of the conventional dose group,the difference was statistically significant(P<0.05).Conclusion High dose of budesonide/formoterol inhalation in the treatment of patients with stable COPD powder can improve the pulmonary function and health status,but adverse reactions increase.

Budesonide and Formoterol Fumarate Powder for Inhalation combined effect of psychological intervention on the treatment of chronic obstructive pulmonary disease / 中国生化药物杂志

Objective To study the effect of psychological intervention combined with the analysis of Budesonide and Formoterol Fumarate Powder for Inhalation in treatment of chronic obstructive pulmonary disease. Methods 100 patients with chronic obstructive pulmonary disease treated in our hospital from February 2015 to March 2016 were selected and randomly divided into the control group and the experimental group, with 50 patients in each group. The control group was treated with the Budesonide and Formoterol Fumarate Powder for Inhalation treatment,the experimental group on the basis of psychological intervention on the mental status of patients and patients,strengthen communication and exchanges, increase confidence in the treatment and the treatment compliance of patients. Results After treatment, the SGRQ score of the experimental group was (57.33±16.81), and the score of the control group was (43.86±12.68) points, with statistical difference (P<0.05). The scores of depression and anxiety in the experimental group were significantly better than those in the control group,with statistical difference(P<0.05). Conclusion Budesonide and Formoterol Fumarate Powder for Inhalation combined with mental intervention in the treatment of chronic obstructive pulmonary disease can significantly improve the patients, improve the quality of life, help patients recover as soon as possible, has clinical significance.

Clinical Efficacy of Budesonide and Formoterol Fumarate Powder in the Treatment of Patients with Bronchial Asthma and Its Effect on the Serum Levels of Inflammatory Factors / 现代生物医学进展

Objective:To explore the clinical efficacy of Budesonide and Formoterol Fumarate Powder in the treatment of patients with bronchial asthma and its effect on the serum levels of inflammatory factors.Methods:123 cases treated and diagnosed as bronchial asthma in our hospital from February,2014 to February,2016 were randomly divided into the observation group (65 cases) and control group (58 cases).The serum levels of IL-17,IL-33,MMP-9,pulmonaryfunction,quality of life,total effective rate and incidence of adverse reactions were compared between the two groups.Results:The total effective rate of observation group was 92.3％,which was significantly higher than that of the control group (81.03％,P＜0.05).After therapy,the serum level ofIL-17,IL-33 in both groups were largely decreased compared with those before therapy (p＜0.05),and those of observation group were significantly lower than the control group (p ＜0.05);the serum level of MMP-9 in both groups showed no statistical difference compared with that of before therapy.Similarly,the level of FEV1,PEF and FEV1/FVC of observation group were obviously increased compared with those before therapy (p＜0.05) and were significantly higher than those of the control group (p＜0.05);the quality of life in the observation group was better than that of the control group based on the SGRQ score (p ＜0.05).Conclusion:Budesonide and Formoterol Fumarate Powder was effective on the patients with chronic bronchial asthma,which could control the inflammatory reactions,improve the pulmonary function as well as the quality of life.