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Objetivo: El objetivo del presente estudio fue evaluar la eficacia y seguridad de la combinación de dosis fija montelukast/desloratadina 10mg/5mg cápsula versus la combinación de montelukast/loratadina 10 mg/10 mg tableta en adultos con diagnóstico de rinitis alérgica persistente. Material y métodos: El presente fue un estudio clínico aleatorizado, controlado, doble ciego, prospectivo, longitudinal, multicéntrico, con brazos paralelos. Sujetos con diag nóstico de rinitis alérgica persistente que cumplieran criterios de elegibilidad y firmaran consentimiento informado fueron enrolados para recibir uno de los dos tratamientos cada 24 horas vía oral durante 6 semanas. La eficacia se estableció mediante la evaluación clínica a través de escalas clínicas validadas en idioma español, siendo la variable primaria de eficacia la diferencia de puntuación del cuestionario SNOT-20 al final del tratamiento, mientras que la frecuencia y características de los eventos adversos fue considerada la variable de seguridad. Resultados: Se aleatorizaron 86 pacientes, 74 de ellos fueron analizados por protocolo. Los cuestionarios sobre síntomas de la enfermedad e indicadores de calidad de vida con ambos tratamientos mostraron que más del 90% de los pacientes no presentaron síntomas o solo fueron leves al final del estudio, por lo que ambos tratamientos me joraron significativamente (p < 0.05) la sintomatología de la enfermedad. Los eventos adversos presentados fueron leves a moderados. Conclusiones: El presente estudio demostró que la eficacia de montelukast/deslora tadina 10mg/5mg no es inferior al medicamento comparador. Por tanto, el tratamiento de prueba representa una alternativa eficaz y segura para el tratamiento de segunda línea de la rinitis alérgica persistente en pacientes que las monoterapias o primeras líneas de tratamiento no ofrecen mejoría clínicamente relevante.
Objective: The objective of the present study was to evaluate the efficacy and safety of the fixed dose combination of montelukast/desloratadine 10 mg/5 mg capsule versus the combination of montelukast/loratadine 10 mg/10 mg tablet in adults diagnosed with persistent allergic rhinitis. Materials and methods: The present study was a multicenter, controlled, prospective, longitudinal, randomized, double-blind clinical trial with parallel arms. Patients diagnosed with persistent allergic rhinitis who met eligibility criteria and signed informed consent were enrolled in the study to receive one of the two treatments every 24 hours orally for 6 weeks. Efficacy was established by clinical evaluation through clinical scales vali dated in Spanish, being the primary efficacy variable the difference in the score of the SNOT-20 (Sino-Nasal Outcome Test) questionnaire at the end of treatment; and the frequency and characteristics of adverse events were considered the safety variable. Results: 86 patients were randomized, 74 of which were analyzed per protocol. Ques tionnaires about the symptoms of the disease and quality of life indicators with both treatments showed that more than 90% of patients had mild symptoms or no symptoms at all at the end of the study. So, both treatments significantly improved (p < 0.05) the symptoms of the disease. Adverse events were mild to moderate. Conclusions: The present study showed that the efficacy of montelukast/desloratadine 10 mg/5 mg is not inferior to the comparator. Therefore, the study treatment represents an effective and safe alternative for the second-line treatment of persistent allergic rhinitis in patients in whom monotherapies or first-line treatments don't offer clinically relevant improvement.
Subject(s)
Rhinitis, AllergicABSTRACT
Introduction: Montelukast, a selective and active leukotriene receptor antagonist, is one of the most common agents in asthma treatment for both adults and children. Objective: To assess whether the pharmacokinetic profiles of two formulations of montelukast were similar after a single 5 mg dose (chewable tablets), administered orally under fasting conditions, sampling blood before and 36 hours after administration. Methods: This was a randomized, 2-sequence, 2-period, crossover study of 2 chewable tablet formulations of the drug: Singulair®, provided by Merck Sharp and Dohme Farmacêutica Ltda. (reference), and generic montelukast, manufactured by Eurofarma Laboratórios S.A. (test). Plasma samples obtained from 35 participants were analyzed for montelukast through high-performance liquid chromatography coupled to tandem mass spectrometry, with montelukast-d6 as the internal standard. Peak montelukast concentrations were 299.313 (SD, 11.039) ng/mL for the reference formulation and 279.803 (SD, 10.085) ng/mL for test formulation. Results: Statistical analysis showed no significant differences between AUC0-36h, AUC0-inf, or Cmax between formulations, with the following test/reference ratios: 102.458 for AUC0-36h, 102.522 for AUC0-inf, and 93.490 for Cmax. No serious adverse events were reported during the trial. Our results demonstrated the bioequivalence of Singulair® and Eurofarma's generic montelukast. Conclusions: Our results revealed that the new generic tablets are clinically safe and can be used interchangeably with the brand name product. Eurofarma's montelukast offers a safe, effective, and cheaper treatment option for people with asthma or allergic rhinitis.
Introdução: O montelucaste, um antagonista seletivo e ativo dos receptores de leucotrienos, é um dos agentes mais comumente usados na prática clínica no tratamento da asma, tanto em adultos quanto em crianças. Objetivo: Avaliar se os perfis farmacocinéticos de duas formulações de montelucaste eram semelhantes após uma dose única de comprimidos mastigáveis de 5 mg, administrados por via oral em jejum, coletando amostras de sangue desde antes da administração até 36 horas depois disso. Métodos: Estudo comparativo randomizado, 2 sequências e 2 períodos, cruzado, de dois medicamentos em comprimidos mastigáveis: Singulair®, fornecido pela Merck Sharp e Dohme Farmacêutica Ltda. (referência) e Montelucaste 5 mg, fabricado pela Eurofarma Laboratórios S.A. (teste). Amostras de plasma obtidas de 35 indivíduos elegíveis foram analisadas para montelucaste por cromatografia líquida de alta eficiência acoplada a espectrometria de massa em tandem, tendo Montelucaste-d6 como padrão interno. As concentrações máximas de montelucaste foram 299,313±11,039 ng/mL para referência e 279,803±10,085 ng/mL para formulação de teste. Resultados: A análise estatística não mostrou diferenças significativas para AUC0-36h, AUC0-inf e nem para Cmax entre as formulações, apresentando as razões Teste/Referência: 102,458 para AUC0-36h, 102,522 para AUC0-inf e 93,490 para Cmax. Nenhum evento adverso grave foi relatado durante o estudo. De acordo com a regulamentação brasileira, o atual estudo farmacocinético demonstrou bioequivalência entre os agentes individuais e forneceu evidências de bioequivalência entre Singulair® e Montelukast fabricado pela Eurofarma. Resultado: Os resultados mostraram que os novos comprimidos genéricos são clinicamente seguros e podem ser trocados pela marca original. O montelucaste da Eurofarma oferece uma opção de tratamento mais barata, segura e eficaz para indivíduos com asma ou rinite alérgica.
Subject(s)
Humans , Adolescent , Adult , Middle AgedABSTRACT
PURPOSE@#Patients with multiple traumas are at high risk of developing respiratory complications, including pneumonia and acute respiratory distress syndrome. Many pulmonary complications are associated with systemic inflammation and pulmonary neutrophilic infiltration. Leukotriene-receptor antagonists are anti-inflammatory and anti-oxidant drugs subsiding airway inflammation. The present study investigates the effectiveness of montelukast in reducing pulmonary complications among trauma patients.@*METHODS@#This randomized, double-blind, placebo-control trial was conducted in patients with multiple blunt traumas and evidence of lung contusion detected via CT scan. We excluded patients if they met at least one of the following conditions: < 16 years old, history of cardiopulmonary diseases or positive history of montelukast-induced hypersensitivity reactions. Patients were allocated to the treatment (10 mg of montelukast) or placebo group using permuted block randomization method. The primary measured outcome was the volume of pulmonary contusion at the end of the trial. The secondary outcomes were intensive care unit and hospital length of stay, ventilation days, multi-organ failure, and the in-hospital mortality rate.@*RESULTS@#In total, 65 eligible patients (treatment = 31, placebo = 34) were included for the final analysis. The treatment group had more pulmonary contusion volume (mean (SD), mm3) at the right (68726.97 (93656.54) vs. 59730.27 (76551.74)) and the left side (67501.71 (91514.04) vs. 46502.21 (80604.21)), higher initial C-reactive peptide level (12.16 (10.58) vs. 10.85 (17.87)) compared to the placebo group, but the differences were not statistically significant (p > 0.05). At the end of the study, the mean (SD) of pulmonary contusion volume (mm3) (right side = 116748.74 (361705.12), left side = 64522.03 (117266.17)) of the treatment group were comparable to that of the placebo group (right side = 40051.26 (64081.56), left side = 25929.12 (47417.13), p = 0.228 and 0.082, respectively). Moreover, both groups have statistically similar hospital (mean (SD), days) (10.87 (9.83) vs. 13.05 (10.12)) and intensive care unit length of stays (mean (SD), days) (7.16 (8.15) vs. 7.82 (7.48)). Of note, the frequency of the in-hospital complications (treatment vs. control group) including acute respiratory distress syndrome (12.9% vs. 8.8%, p = 0.71), pneumonia (19.4% vs. 17.6%, p = 0.85), multi-organ failure (12.9% vs. 17.6%, p = 0.58) and the mortality rate (22.6% vs. 14.7%, p = 0.41) were comparable between the groups.@*CONCLUSION@#Administrating montelukast has no preventive or therapeutic effects on lung contusion or its complications.
Subject(s)
Humans , Adolescent , Thoracic Wall , Pneumonia , Wounds, Nonpenetrating , Thoracic Injuries/drug therapy , Lung Injury , Contusions , Respiratory Distress Syndrome, Newborn/etiology , Inflammation , Tablets , Treatment OutcomeABSTRACT
Objective:To observe any effect of combining the anti-asthmatic drug montelukast with exercise therapy on the pulmonary function, clinical symptoms, functional exercise capacity and quality of life of children with asthma.Methods:Seventy children (between 7 and 14 years old) with mild asthma were randomly divided into an observation group ( n=35) and a control group ( n=35). Both groups were given the anti-asthmatic drug montelukast, while the observation group was additionally provided with breathing training and aerobic pedaling training. Before and after the intervention, both groups′ forced expiratory volume in 1 second, forced vital capacity and 6min walking test (6MWT) distance were tested. Their asthma symptoms were scored using the pediatric asthma quality of life questionnaire (PAQLQ). Any adverse events during the study were recorded. Results:After 8 weeks the observation group′s average 6MWT distance, total PAQLQ score, as well as the scores on each domain of the PAQLQ (symptoms, activity restriction, emotions) had improved significantly. The observation group′s average heart rate and perceived exertion rating after the 6MWT had also improved significantly, as had their average daytime and nighttime asthma symptom scores. The control group also demonstrated significant improvement in their PAQLQ symptom scores and their daytime and nighttime asthma symptom scores after the intervention. There was no significant difference in the incidence of adverse reactions between the two groups.Conclusions:Supplementing montelukast with exercise is effective and feasible in the treatment of children with mild asthma, with good safety and tolerance. Such combined therapy is worthy of further research and promotion.
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El montelukast se utiliza ampliamente en el tratamiento de sibilancias recurrentes y/o asma. Están descritas numerosas reacciones adversas medicamentosas (RAM) en niños relacionadas con montelukast; se destacan las neuropsiquiátricas. Realizamos un estudio observacional, retrospectivo, descriptivo, sobre RAM relacionadas con montelukast. Entre enero de 2012 y diciembre de 2017, en la Unidad de Neumonología Pediátrica se trataron con Montelukast 348 pacientes; de ellos, 20 presentaron RAM. Los síntomas más frecuentes fueron insomnio (n = 7), hiperactividad (n = 4), pesadillas (n = 3), dolor abdominal (n = 2) y parestesias en extremidades (n = 2). Se presentaron desde días hasta meses tras iniciar el tratamiento, y desaparecieron tras su suspensión. Se destacan dos pacientes con parestesias en extremidades, síntoma no descrito antes en niños. El 5,7 % de los pacientes tratados con montelukast presentaron RAM que requirieron suspender el tratamiento. Los trastornos del sueño fueron los más frecuentes.
Montelukast is widely used in recurrent wheezing and/or asthma treatment. Several adverse drug reactions (ADRs) have been described in children related to montelukast. Neuropsychiatric reactions are one of the most important. We designed an observational, retrospective, descriptive study on ADRs related to montelukast in the Pediatric Pulmonology Unit, Hospital Universitario Miguel Servet, Zaragoza, Spain. Between January 2012 and December 2017, in the Pediatric Pulmonology Unit, 348 patients were treated with Montelukast; of them, 20 presented RAM. The main symptoms described were insomnia (n = 7), hyperactivity (n = 4), nightmares (n = 3), abdominal pain (n = 2) and paraesthesia in extremities (n = 2). They appeared from the first days to months after the start of treatment and disappeared after stopping it. Two patients presented limb paresthesia, not described previously in children. The 5.7 % of our patients treated with montelukast had ADRs that required treatment discontinuation. Sleep disorders were the most frequent.
Subject(s)
Humans , Male , Female , Infant, Newborn , Infant , Child, Preschool , Child , Adolescent , Quinolines/adverse effects , Sulfides/adverse effects , Anti-Asthmatic Agents/adverse effects , Leukotriene Antagonists/adverse effects , Cyclopropanes/adverse effects , Acetates/adverse effects , Asthma/drug therapy , Sleep Wake Disorders/chemically induced , Retrospective StudiesABSTRACT
Objective:To evaluate the efficacy of Jiedu-Huaban Decoction combined with montelukast sodium chewable tablets in the treatment of children with henoch schonlein purpura (HSP). Methods:A total of 80 children with HSP and blood heat syndrome who met the inclusion criteria, from January 2017 to December 2019, were randomly divided into two groups by random number table method, 40 in each group. The control group took montelukast sodium chewable tablets at night, and the study group took Jiedu-Huaban Decoction on the basis of the control group. Both groups were treated for 2 weeks. The disappearance time of gastrointestinal disease, skin purpura, kidney disease, joint swelling and pain were observed. The improvement score of skin purpura was evaluated before and after treatment. The serum levels of IL-6, IL-4, interferon-γ (IFN-γ) and TNF-α were detected by ELISA, and the levels of IgG, IgA and IgM. The T lymphocyte subsets (CD4 + and CD8 +) were measured by nephelometry, and the CD4 +/CD8 +values were calculated. The clinical efficacy was evaluated. Results:The total effective rate was 87.5% (35/40) in the study group and 67.5% (27/40) in the control group, with significant difference between the two groups ( χ2 =4.588, P=0.032). The disappearance time of gastrointestinal disease, skin purpura, kidney disease and joint swelling and pain in the study group were significantly earlier than those in the control group ( t=7.802, 12.167, 7.309, 9.365, all Ps<0.001). After treatment, the serum levels of IL-6, IL-4, IFN-γ and TNF-α in the study group were significantly lower than those in the control group ( t=9.319, 6.738, 8.221, 6.553, all Ps<0.001). The improvement score of skin purpura at 1 week after treatment (2.75 ± 0.69 vs. 3.92 ± 0.83, t=6.856) and 2 weeks after treatment (0.41 ± 0.15 vs. 1.55 ± 0.37, t=18.095) in the study group were significantly lower than those in the control group ( P<0.01). After treatment, the level of IgG, CD4 +, CD4 +/CD8 + in the study group were significantly higher than those in the control group ( t=5.160, 4.558, 3.442, all Ps<0.01), the level of IgA, IgM, CD8 + in the study group were significantly lower than those in the control group ( t=2.614, 6.712, 5.468, all Ps< 0.05). During the treatment, the incidence of adverse reactions in the control group was 17.5% (7/40), and that of the study group was 15.0% (6/40), wherer there was no statistical difference between the two groups ( χ2=0.092, P=0.762). Conclusion:Jiedu-Huaban Decoction combined with montelukast sodium chewable tablets can improve the clinical symptoms of children with HSP and blood heat syndrome, reduce the body inflammatory reaction, improve immunity, with good safety.
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Bronchopulmonary dysplasia is one of the most common chronic respiratory diseases in premature infants, especially in very low birth weight infants.Lung immaturity, inflammatory injury, oxidative stress and abnormal repair after injury are the important factors.Leukotriene is an inflammatory mediator of 5-lipoxygenase pathway and participates in the occurrence of bronchopulmonary dysplasia.Montelukast, as a leukotriene receptor antagonist, may play a role in the treatment of bronchopulmonary dysplasia through anti-inflammation, anti-oxidation and anti-fibrosis.This article will review the potential mechanism and related clinical researches of montelukast which is used in treating bronchopulmonary dysplasia.
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Chronic lung allograft dysfunction (CLAD) is the largest obstacle to the long-term survival of lung transplant recipients, which represents a series of complicated clinical manifestations of significant and persistent deterioration of lung allograft function after surgery. Due to lack of effective strategies for early diagnosis and prevention, over half of lung transplant recipients will develop CLAD within postoperative 5 years, which is likely to increase to 75% within postoperative 10 years. At present, no drug can be administered to completely prevent or reverse the progression of CLAD. In recent years, since the definition, diagnosis and treatment of CLAD have been updated by International Society of Heart and Lung Transplantation (ISHLT) in 2019, the understanding of CLAD has been significantly deepened within the international community. In this article, comprehensive diagnostic methods and potential treatment strategies of CLAD were explicitly illustrated, aiming to provide theoretical reference and insights for early monitoring and management of the incidence and progression of CLAD.
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ABSTRACT Objective: Ethyl alcohol (EA) is a substance that is used commonly worldwide and known to have toxic effects on the liver. The aim of this study was to investigate the effect of montelukast sodium (MK) on acute hepatopathy induced by a single dose of EA in rats. Methods: The study consisted of four groups each containing eight Wistar albino male rats. The groups were classified as follows: the control group received distilled water; the EA group received 6 g/kg EA diluted with distilled water orally by gavage; the MK group received 30 mg/kg MK orally by gavage; the EA + MK group received, 2 hours after the EA administration, ie 30 mg/kg MK orally by gavage. After 24 hours, all the rats were sacrificed, and their blood and liver tissue samples were taken for biochemical and histopathological examinations. Results: The administration of EA caused a statistically significant increase in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels compared with the control group (220.50 ± 66.90 and 92.38 ± 5.90 versus 84.88 ± 15.66 and 43.75 ± 10.22). The administration of EA + MK caused a statistically significant decrease in the AST and ALT levels compared with the EA alone group. Ethyl alcohol administered to the rats caused lesion in the liver including congestions, hydropic degeneration and irregular shaped area caused coagulation necrosis. The histopathological changes seen in the EA group were not detected in the EA + MK group. Conclusion: Consequently, these data suggested that MK had beneficial effects in alleviating EA-induced hepatotoxicity in rats.
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Objective: To evaluate the effect of salbutamol, montelukast, and prednisone on orthodontic tooth movement in rats. Material and Methods: In vivo experimental preclinical study. The sample consisted of 48 rats randomly distributed in four study groups. Group A was given saline solution; to group B, salbutamol 4 mg/Kg; to group C, montelukast 2.5 mg/Kg and to group D, prednisone 2.5 mg/Kg. All were fitted with orthodontic devices and the medications were administered intraperitoneally every 12 hours for 5 days. The clinical evaluation (variation in the interincisal distance) was performed at one, three, five, and seven days and the histopathological analysis (cell count) at five and seven days. Results: In the clinical evaluation of the variation in the interincisal distance, a significant difference was found in all the evaluations (p <0.05). It was found that the salbutamol group presented higher variation values in the interincisal distance on all the days evaluated. In the histopathological analysis at five and seven days, it was found that the osteoblast and osteocyte count was significantly higher in the salbutamol group compared to the other groups (p <0.05). However, in the subgroup analysis, it was found that there was no significant difference in the osteoblast and osteocyte count between the prednisone, montelukast, and control group (p> 0.05). Conclusion: The administration of salbutamol increased the magnitude of orthodontic tooth movement; nonetheless, the administration of montelukast and prednisone did not modify the magnitude of orthodontic tooth movement in rats. (AU)
Objetivo: Avaliar o efeito do salbutamol, montelucaste e prednisona no movimento dentário ortodôntico em ratos. Material e métodos: Estudo pré-clínico experimental in vivo. A amostra foi composta por 48 ratos distribuídos aleatoriamente em quatro grupos de estudo. O grupo A recebeu solução salina; para o grupo B, salbutamol 4 mg/kg; ao grupo C, montelucaste 2,5 mg/kg e ao grupo D, prednisona 2,5 mg/kg. Todos foram equipados com dispositivos ortodônticos e os medicamentos foram administrados por via intraperitoneal a cada 12 horas por 5 dias. A avaliação clínica (variação da distância interincisal) foi realizada em um, três, cinco e sete dias e a análise histopatológica (contagem de células) em cinco e sete dias. Resultados: Na avaliação clínica da variação da distância interincisal, houve diferença significativa em todas as avaliações (p <0,05). Verificou-se que o grupo salbutamol apresentou maiores valores de variação na distância interincisal em todos os dias avaliados. Na análise histopatológica aos cinco e sete dias, verificou-se que a contagem de osteoblastos e osteócitos foi significativamente maior no grupo salbutamol em comparação aos demais grupos (p<0,05). No entanto, na análise de subgrupos, verificou-se que não houve diferença significativa na contagem de osteoblastos e osteócitos entre os grupos prednisona, montelucaste e controle (p>0,05). Conclusão: A administração de salbutamol aumentou a magnitude do movimento dentário ortodôntico; no entanto, a administração de montelucaste e prednisona não modificou a magnitude do movimento dos dentes ortodônticos em ratos. (AU)
Subject(s)
Animals , Rats , Osteoblasts , Osteocytes , Tooth Movement Techniques , Prednisone , AlbuterolABSTRACT
RESUMEN La hemorragia alveolar difusa es un hallazgo clínico patológico, consecuencia de una lesión en la microcirculación pulmonar que se presenta con sintomatología inespecífica e incluso en pacientes asintomáticos. Se diferencian tres diagnósticos histopatológicos, siendo la capilaritis el más común y secundario a patologías autoinmunes. Se presenta el caso de un paciente, con hallazgo imagenológico y en lavado broncoalveolar, compatible con hemorragia alveolar difusa en quien se descartó como causa, enfermedades autoinmunes e infecciosas; durante la anamnesis, se identificó inicio reciente de montelukast, con relación temporal, respuesta a suspensión, cambio imagenológico y escalas de probabilidad de reacción adversa de Naranjo que apoya el diagnóstico.
ABSTRACT Diffuse alveolar hemorrhage is a pathological finding, defined as a consequence of a lesion in pulmonary microcirculation which occurs with non-specific symptoms, and sometimes it may show no symptoms. Three histopathological diagnoses are to be differentiated. The most common is capillary inflammation, which is secondary to autoimmune conditions. We present the case of a patient with image studies and bronchoalveolar lavage compatible with diffuse alveolar hemorrhage, in whom autoimmune and infectious causes were ruled out. The history of the patient indicated recent use of montelukast, being this time-related with the patient's clinical condition. The patient responded when the drug was withheld, image studies showed particular findings, and results in the Naranjo ADR scale supported the diagnosis.
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OBJECTIVE：To study the effects of montelu kast sodium in the treatme nt of pertussis in children. METHODS ：A total of 160 children aged 6 months-6 years with pertussis admitted to our hospital from Jan. 2017 to Jul. 2018 were randomly divided into control group and observation group ，with 80 cases in each group. Control group received routine treatment such as antibiotics. Observation group was additionally given Montelukast sodium granule or chewable tablets orally （granule for age below 2 years old ，taking with warm water ；chewable tablets for age more than 2 years old ），4 mg/d，once a night. Treatment course of 2 groups lasted for 2 weeks. The changes of clinical indexes as clinical symptoms ，clinical efficacy ，the occurrence of ADR ，and lab indexes as lung function [VPEF/VE，TPTEF/TE，FEV1，FVC，FEV1/FVC]，T lymphocyte subsets （CD4+，CD8+ and CD 4+/CD8+） level，immunoglobulin（IgE，IgG，IgA）level，serum leukotriene （LTB4，LTC4，LTD4）level were compared between 2 groups. RESULTS：Compared with control group （80.00％），total effective rate rate of observation group （95.00％）was significantly increased（P＜0.05）；the cough time of spasm ，the echo time of cockcrow ，the blue and purple time of face caused by cough ，the time of vomit caused by cough ，the time of lung rale and the time of hospitalization were significantly shorter （P＜0.05）；new respiratory tract infection incidence of observation group was lower than that of control group （P＜0.05）；but there was no significant difference in the incidence of ADR between 2 groups after treatment （P＞0.05）. The levels of VPEF/VE ，TPTEF/TE or FEV1，FVC，FEV1/FVC，the levels of peripheral CD 4+ and CD 4+/CD8+，serum levels of IgG and IgA in observation group were significantly increased ，compared with control group ；the level of peripheral CD 8+ and the serum levels of IgE ，LTB4，LTC4 and LTD4 were significantly decreased ，compared with control group （P＜0.05）. CONCLUSIONS ：The addition of montelukast sodium to the routine treatment of pertussis can improve clinical symptoms and lung function of children ，regulate immune function of children and inhibit the release of airway leukotrienes ，which has certain clinical application value.
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OBJECTIVE@#To evaluate the efficacy of Chinese medicine acupoint application (CMAA) combined with Western medicine for perennial allergic rhinitis (PAR) in children.@*METHODS@#In this prospective, parallel, randomized, placebo-controlled and single-blind trial from August to September, 2017, 180 children with PAR were randomly assigned to an integrative group (CMAA and Montelukast), CMAA group (CMAA and placebo tablet), or Montelukast group (placebo CMAA and Montelukast). Participants were applied with CMAA for 6 sessions over 2 weeks, and/or Montelukast Chewable Tablet orally once daily for 12 weeks. The changes in severity of symptoms were measured by Visual Analog Scale (VAS) and rhinitis control assessment test (RCAT) at 0, 2, 4 and 12 weeks of treatment. Blood samples were collected for serum interleukin-4, interferon gamma γ and T helper type 1 (Th1)/Th2 flow cytometric analysis at the time points of 0, 4 and 12 weeks.@*RESULTS@#Eight cases dropped out from the trial, 3 in the integrative group, 2 in the CMAA group and 3 in the Montelukast group. The VAS scores decreased significantly while the RCAT scores increased significantly in all three groups at 4 and 12 weeks compared with baseline (P<0.01 or P<0.05). The VAS scores were significantly lower while the RCAT scores were significantly higher in the integrative and CMAA groups than the Montelukast group at 2 and 4 weeks (P<0.01 or P<0.05). At 2, 4 and 12 weeks, the scores of nasal congestion, sneezing, sleep problem, and rhinitis symptom control in the integrative and CMAA groups increased significantly compared with baseline (P<0.01 or P<0.05). The least percentages of Th2 and the most alleviated Th2 shift (highest Th1/Th2) were observed in the integrative group at 12 weeks compared with the other two groups (P<0.05).@*CONCLUSION@#The combination of CMAA with Montelukast might be more effective and appropriate than either option alone for children with PAR. (Registered at Chinese Clinical Trial Register, registration No. ChiCTR-IOR-17012434).
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Montelukast sodium is an effective and well-tolerated anti-asthmatic drug. Long non-coding RNAs (lncRNAs) are involved in the treatment of asthma. Therefore, this study aimed to investigate the effect of montelukast sodium on children with cough-variant asthma (CVA) and the role of lncRNA prostate cancer gene expression marker 1 (PCGEM1) in drug efficacy. The efficacy of montelukast sodium was evaluated by assessing the release of inflammatory factors and pulmonary function in CVA children after a 3-month treatment. An ovalbumin (OVA)-sensitized mouse model was developed to simulate asthmatic conditions. PCGEM1 expression in clinical peripheral blood samples and lung tissues of asthmatic mice was determined. Asthmatic mice experienced nasal inhalation of PCGEM1 overexpression with simultaneous montelukast sodium to investigate the roles of PCGEM1 in asthma treatment. The NF-κB axis after PCGEM1 overexpression was detected to explore the underling mechanisms. Consequently, montelukast sodium contributed to reduced levels of pro-inflammatory factors and improved pulmonary function in CVA children. PCGEM1 was poorly expressed in OVA-sensitized asthmatic mice and highly expressed in CVA children with response to the treatment. PCGEM1 overexpression enhanced the anti-inflammatory effects and promoted effects on pulmonary function of montelukast sodium in CVA children and OVA-sensitized asthmatic mice. Furthermore, PCGEM1 inhibited the activation of the NF-κB axis. This study demonstrated the anti-inflammatory and lung-protective effects of montelukast sodium on CVA, which was strengthened by overexpression of PCGEM1. Findings in this study highlighted a potential anti-asthmatic target of montelukast sodium.
Subject(s)
Quinolines/therapeutic use , Asthma/drug therapy , Anti-Asthmatic Agents/therapeutic use , Protective Agents/therapeutic use , Cough/drug therapy , RNA, Long Noncoding/metabolism , Acetates/therapeutic use , Asthma/blood , Cough/blood , Disease Models, Animal , Mice, Inbred BALB CABSTRACT
OBJECTIVE: To investigate the taste-masking effect of montelukast sodium orally disintegrating tablets using electronic tongue technology and human sensory evaluation and determine the optimum formulation. METHODS: Orally disintegrating tablets were prepared with five different concentrations of flavoring agents or without flavoring agent.The tastes of those tablets were determined by electronic tongue, and principal component analysis and linear discriminant analysis were used to evaluate differences of different formulations. The taste-masking effect of the tablets was investigated combined with electronic tongue analysis and sensory evaluation of subjects. RESULTS: The taste of orally disintegrating tablet was the best when the total amount of flavoring agent was 1.6 mg, and the ratio of sweetening agent to aromatic agent was 5∶3. CONCLUSION: The combination of electronic tongue and human sensory assess can evaluate the taste-masking effect of orally disintegrating tablets and provide the basis for determining the optimum formulation.
ABSTRACT
Resumen: En la última década se ha registrado un aumento en la prescripción de antileucotrienos, en particular montelukast. A partir del año 2007 comenzaron los primeros reportes efectos adversos de esfera neuropsiquiátrica en la edad pediátrica. Los efectos reportados incluían trastornos del sueño y del humor hasta una posible asociación con ideación suicida y suicidio consumado. En el presente trabajo se realiza una revisión de la seguridad de montelukast tema con objetivo de establecer o descartar una eventual asociación entes los fenómenos mencionados y la administración de antileucotrienos.
Summary: In the last decade there has been an increase in the prescription of antileukotrienes, specifically montelukast. The first pediatric reports discussing adverse neuropsychiatric effects go back to 2007. The reported effects included a range from sleep and mood disorders, to even a possible association with suicidal ideation and consummated suicide. In the present paper we carry out a review of the safety of using montelukast in order to confirm or rule out an eventual association between such adverse effects and the administration of antileukotrienes.
Resumo: Na última década, houve um aumento na prescrição de antileucotrienos, em particular do montelucaste. A partir de 2007, começaram a surgir os primeiros reportes relativos aos efeitos neuropsiquiátricos adversos na idade pediátrica. Os efeitos relatados incluíram desde distúrbios do sono e do humor até uma possível associação com ideação suicida e suicídio consumado. No presente paper realizamos uma revisão da segurança no uso do montelucaste com o objetivo de confirmar ou descartar uma eventual associação entre os seus efeitos adversos e a administração de antileucotrienos.
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Objective To explore the curative effect of montelukast combined with budesonide in the treatment of cough variant asthma in children,to provide guidance for clinical practice.Methods From March 2015 to March 2017,90 children with cough variant asthma in the People's Hospital of Yanggu County were randomly divided into observation group(n =45) and control group(n =45) according to the digital table.The observation group was given budesonide combined with montelukast,while the control group was given budesonide combined with salbutamol sulfate.All patients were followed up for 3 months.The curative effect,cough relief time,cough disappearance time,incidence rate of adverse reaction and recurrence rate were compared between the two groups.Results The total effective rate of the observation group(95.56％) was significantly higher than 77.78％ of the control group(P ＜ 0.05).The cough relief time[(7.79 ± 3.23)d] and the cough disappearance time [(10.78 ± 2.36)d] in the observation group were significantly shorter than those in the control group [(9.16 ± 2.23) d,(12.24 ± 2.78) d] (all P ＜ 0.05).The incidence rate of adverse reactions of the observation group was 2.22％,which of the control group was 6.67％,there was no statistically significant difference between the two groups (P ＞ 0.05).The recurrence rate of the observation group (4.44％) was significantly lower than 17.78％ of the control group(P ＜ 0.05).Conclusion It is feasible to treat cough variant asthma in children with montelukast combined with budesonide,and it is helpful to reduce recurrence.
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Objective To investigate the clinical value of atomization inhalation combined with montelukast in the treatment of infantile cough after infection.Methods From September 2015 to August 2017,300 children with post-infection cough in Taizhou Tumor Hospital were randomly divided into two groups,with 150 cases in each group.The control group was treated with montelukast,and the observation group was given atomization inhalation combined with montelukast.The clinical effect,symptom improvement time,adverse events and parents' satisfaction were observed.Results The total effective rate of the observation group was 97.33％,which was higher than 86.67％ in the control group(P ＜0.05).The improvement time of cough and expectoration of the observation group [(3.02 ± 0.45)d,(2.11 ± 0.71)d] was better than those of the control group(all P ＜ 0.05).The incidence rate of adverse events in the observation group(3.33％) was lower than that in the control group(P ＜0.05).The total satisfactory rate of parents in the observation group was 96.00％,which was obviously higher than that in the control group(P ＜ 0.05).Conclusion The effect of atomization inhalation combined with montelukast on children's cough after infection is good,it can effectively control the condition and relieve the symptoms such as cough,and the safety is higher.The risk of adverse reactions is low.
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Objective@#To compare the efficacy of montelukast or ketotifen combined with salmeterol/fluticasone powder inhalation in the treatment of cough variant asthma.@*Methods@#From July 2016 to July 2017, 74 patients with cough-variant asthma admitted to the 903rd Hospital of People's Liberation Army Joint Service Support Unit were selected.According to the random number table method, the patients were randomly divided into the control group and observation group, with 37 patients in each group.All patients were treated with inhalation of salmeterol/fluticasone, with montelukast chewable tablets in the observation group, and ketotifen tablets in the control group.The adverse reactions in the two groups after treatment were recorded, and the treatment effect and typical asthma conversion rate in the two groups were compared.@*Results@#The total effective rate of the observation group was 94.59%, which was significantly higher than 78.38% of the control group (χ2=8.283, P<0.05). The incidence rate of adverse reactions was 10.81% in the observation group and 16.22% in the control group, there was no statistically significant difference between the two groups (χ2=2.082, P>0.05). In the observation group, 2 patients had nausea, and 2 patients had laryngopharyngeal discomfort.In the control group, 1 patient had laryngopharyngeal discomfort, 2 patients had dizziness, and 3 patients had somnolence.All the above symptoms were mild and could be relieved after symptomatic treatment.After 1 year of follow-up, the recurrence rate of the observation group was 27.03%, which was significantly lower than 43.24% of the control group (χ2=8.072, P<0.05). After 1 year of follow-up, the typical asthma conversion rate of the observation group was 21.62%, which was significantly lower than 37.84% of the control group (χ2=7.322, P<0.05).@*Conclusion@#Montelukast in the treatment of cough variant asthma can greatly reduce the recurrence rate and the conversion rate of typical asthma.It is not only safe but also effective.It is worthy of popularizing in clinic.
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@#The aim of this paper was to study the species and sources of related substances in montelukast sodium granules based on HPLC-MS/MS. The related substances of the already marketed montelukast sodium granules(Singulair, 4 mg)were firstly separated and identified by HPLC-MS/MS method, and their chemical structures and sources were confirmed according to the pulished synthesis process and degradation studies. The results revealed that there were 7 related substances, whose chemical structures and sources were confirmed based on the MS/MS technique and the related literature. Impurity 7, montelukast quinoline ring oxynitride, had not been reported. This study systematically analyzed the related substances in the commercical product, which provides useful information for the development and quality control of the product.