Effect Of Leukotriene Receptor Antagonist Research Articles

Can Leukotriene Receptor Antagonist Therapy Improve the Control of Patients with Severe Asthma on Biological Therapy and Coexisting Bronchiectasis? A Pilot Study.

Introduction: Asthma and bronchiectasis appear to be two related diseases and in their complex inflammatory interaction, the cysteinyl leukotriene/cysteinyl leukotriene receptor 1 (cysLT/cysLTR1) axis appears to play an important role given its involvement also in the neutrophilic pathway. To our knowledge, few studies have been conducted so far to evaluate the role of the leukotriene cysLT/cysLTr1 axis in the management of clinical and inflammatory outcomes within a population of patients with severe asthma and bronchiectasis. The aim of our study was to verify in this population the effect of leukotriene receptor antagonist (LTRA) therapy in clinical and inflammatory control before and after 6 months of introduction of biologic therapy. Methods: We retrospectively enrolled, from eight different severe asthma centers’ outpatients, 36 atopic patients with the simultaneous presence of non-cystic fibrosis (non-CF) and non-allergic bronchopulmonary aspergillosis (non-ABPA) bronchiectasis and severe asthma. The first biological injection was performed at baseline (T0 time). Patients who were already taking LTRA therapy at time T0 were recorded, and no new prescriptions were made. We observed our population over a 6-month period (T1 time). At the baseline we collected the following data: baseline characteristics, clinical history, high resolution computed tomography and bronchiectasis-related parameters and skin prick test. At both times T0 and T1 we collected the following data: asthma control test (ACT), asthma control questionnaire (ACQ), immunoglobulin E (IgE) level, blood count, fractional exhaled nitric oxide 50 (FeNO 50) and flow-volume spirometry. The study was retrospectively registered. Results: Our population had a mean age of 59.08 ± 11.09 and 50% were female. At T1, patients on LTRA therapy had a significantly lower FeNO value (33.03 ± 23.61 vs. 88.92 ± 77.96; p = 0.012). We assessed that the value of ΔFeNO (FeNO 50 T1 − FeNO 50 T0) and the number of unplanned specialist visits allowed a discrimination of 66.7% in the presence of LTRA therapy. We also verified how low FeNO values at time T1 were statistically significant predictors of LTRA therapy (ODD = 9.96 (0.94–0.99); p = 0.032). Conclusion: The presence of LTRA in therapy in a population of severe asthmatics with coexisting non-ASBPA bronchiectasis and non-cystic fibrosis, acting simultaneously on the T helper type 2 (TH2) pathway and probably on the neutrophilic component of bronchiectasis, would allow a further amplification of the beneficial effects of biological therapy, leading to a reduction in the number of unplanned visits to specialists.

The Use of Leukotriene Inhibitors as Basic Therapy in Children with Bronchial Asthma

In the pharmacotherapy of bronchial asthma, a "step-by-step" approach is recommended, which includes an increase or decrease in the volume of therapy, depending on the severity of clinical symptoms. In complex therapy, it is possible to use non-drug methods of treatment, although the effectiveness of some of them is debatable and needs further study. To achieve this goal, children over the age of 3 years (the group of patients consisted of 26 children) with different forms and degrees of severity of bronchial asthma were included in the study. Patients of the main group took L-Montus (montelukast), children of the ketotifen comparison group. Leukotriene receptor antagonists (montelukast, zafirlukast) are the first mediator-specific therapy of AD and represent a new therapeutic class of drugs in the treatment of the disease. The effectiveness of leukotriene receptor antagonists has been proven in randomized clinical trials among adults and children with bronchial asthma. Leukotriene receptor blockers, in particular L-Montus relieves the symptoms of AD and is a drug for the basic therapy of this disease, leads to a significant improvement in control, reduces the frequency of exacerbations of AD caused by viral infection in children aged 3-5 years. It has an anti-inflammatory effect, complementary to the action of glucocorticosteroids.

Ameliorating effect of leukotriene receptor antagonist in multi-organ toxicity induced in rat offspring, a possible role for epidermal growth factor

Purpose: Nowadays, there is a dramatic increase in the interest of potential impact of consumer-relevant engineered nanoparticles on pregnancy. Materials and methods: This study investigated the possible protective effect of montelukast in neonatal organ toxicity induced by maternal exposure to silver nanoparticles (AgNPs) in rats. Results: It was noticed that montelukast reduced serum urea, creatinine, renal caspase-3 immunoreactivity and IL-1β and increased total antioxidant capacity, as compared to AgNPs. In kidney and bone tissue, montelukast reduced oxidative stress parameters and TNF-α level that was increased with AgNPs. Surprisingly, montelukast administration increased epidermal growth factor (EGF) in bone and reduced it in kidney. Furthermore, as compared to AgNPs, montelukast improved histopathological picture of kidney and bone. Conclusions: In conclusion, montelukast antagonized the biochemical and histopathological changes occurred in kidneys and bones of rat offspring by maternal exposure to AgNPs, mostly by anti-oxidant, anti-apoptotic and anti-inflammatory actions with a possible role for EGF.

Effectiveness of leukotriene receptor antagonists in the treatment for atopic pathology in children

Objective: to study the effectiveness of leukotriene receptor antagonists in the treatment foratopic pathology in children.Material and methods. 224 children with allergic diseases were prescribed to take montelucast for 3– 6 months.Results. Taking montelucast has lead to positive clinical dynamics in 75 % of the cases.A significant reduction of the eosinophil count was achieved on days 10–15 of the therapy. The Cys-LTC4/D4/E4 indices came to normal after a one-month course of montelucast therapy in 40.3 % of cases in children with bronchial asthma, in 63.3 % of cases in children with allergic rhinitis and in 60.5 % of cases in children with atopic dermatitis.Conclusions. The use of montelucast has significantly enhanced the control incidencerate ofallergic diseases in children.

Pharmacotherapy of allergic rhinitis

The clinical picture of allergic rhinitis includes sneezing, nasal discharge, impaired nasal breathing, and itching of the nose and roof of mouth. Depending on the duration of symptoms, allergic rhinitis is divided into intermittent and persistent forms, and depending on the severity of symptoms, it can be mild, moderate, and severe. Treatment for allergic rhinitis includes elimination of allergic contacts, allergen-specific immunotherapy, and pharmacotherapy. The choice of a treatment regimen is determined by the severity of symptoms, age of a patient and presence of concomitant diseases. The work is aimed to review the most common pharmaceuticals to treat allergic rhinitis. Saline solutions are used as monotherapy when symptoms are mild, or before use of other topical drugs to clean mucous membranes before their application. Intranasal glucocorticosteroids can be used as monotherapy, if symptoms have different levels of severity, and supplemented with other drugs, in case they are not efficient. Intranasal glucocorticosteroids do not have a systemic effect due to minimal bioavailability. The patients with moderate/severe allergic rhinitis are recommended to use them jointly with second generation antihstamines, intranasal cromones, intranasal antihistamines and leukotriene receptor antagonists. The significant side effect of antihistamines, especially of the first generation, are sedative effects on the central nervous system. The side effects of leukotriene receptor antagonists are neuropsychological disorders. Intranasal cromones have a high safety profile, which makes them popular in paediatric practice. However, the dosage regimen up to 3–4 times a day reduces patient adherence to treatment. Decongestants are not indicated as monotherapy for allergic rhinitis but can be used in combination with other drugs in short courses, taking into account the possible side effects.

Effect of LTRA in L-ASA Challenge for Aspirin-Exacerbated Respiratory Disease Diagnosis

Aspirin-exacerbated respiratory disease (AERD) consists of asthma, chronic rhinosinusitis with polyps, and hypersensitivity to aspirin and/or nonsteroidal anti-inflammatory drugs (NSAIDs). Nasal Lysine Aspirin Challenge is an effective tool for the diagnosis of hypersensitivity to aspirin and/or NSAIDs in patients with AERD. However, there is no unified international consensus version to perform nasal provocation tests (NPTs). To investigate the effect of a leukotriene receptor antagonist (LTRA), montelukast, on the lysine-acetylsalicylate (L-ASA) nasal challenge. We included 86 patients divided into 3 samples: group A (AERD without LTRA), group B (AERD with LTRA), and the control group (NSAID-tolerant asthmatics). NPT with L-ASA was performed with 25 mg of L-ASA every 30 minutes 4 times followed by rhinomanometry and spirometric measurements and evaluation of symptoms using a novel clinical scale. In group A, 94.5% of patients (35 of 37) developed a positive response to NPT (drop >40% in total nasal flow), whereas only 46% of group B subjects (13 of 28) showed a positive response to the nasal challenge (P < .001). Control subjects did not show any response to the L-ASA challenge. A novel clinical score demonstrated accuracy in classifying the hypersensitivity to aspirin and/or NSAIDs when patients avoid LTRA (33 of 37). Patients with AERD without LTRA showed a greater positive response to the L-ASA challenge than those taking this drug; therefore, LTRA treatment should be discontinued before the challenge for optimal diagnostic accuracy.

A Comparison of Leukotriene Receptor Antagonists to Low-Dose Inhaled Corticosteroids in the Elderly with Mild Asthma

Although elderly patients with asthma have clinical characteristics different from those of young adults, few studies or guidelines have focused on specific treatments for this population. This study compared the effectiveness of leukotriene receptor antagonists (LTRAs) versus inhaled corticosteroids (ICSs) in elderly patients with asthma in real-world settings. We extracted records for elderly patients with asthma who were newly prescribed LTRAs or low-dose ICSs from January 2003 to December 2010 from National Sample Cohort data of Korea. We defined the first prescription date for each medication as the index date. We compared the risks of asthma exacerbation between the 2 groups using Cox proportional-hazard regression after propensity score-based inverse probability of treatment weighting to balance covariates between treatment groups. We also compared asthma-related health care resource utilization and medication compliance in both groups using chi-square test and t test. The number of identified patients newly treated with LTRAs and low-dose ICSs was 1571 and 121, respectively. The risks of asthma exacerbation in the LTRA and low-dose ICS groups after weighting were not significantly different (hazard ratio, 0.98; 95% CI, 0.65-1.54). The proportion with high compliance (medication possession ratio ≥80%) in the LTRA group was higher than that in the low-dose ICS group. The effectiveness of LTRAs was not different from that of low-dose ICSs regarding the risk of asthma exacerbation in elderly patients with asthma in real-world settings. Given the practical benefits gained from convenient administration, LTRAs can be considered a reasonable alternative first-line therapy for elderly patients with mild asthma.

The Role of Leukotriene Receptor Antagonist as an add on therapy to β2-Agonists in Acute Asthma

Objective:This study was designed to determine the role of leukotriene receptor antagonist as an add on therapy to s2-agonists in acute asthma. Methods: A prospective study carried out in ESIC hospital in which the total number of 100 patients were enrolled. The study has two arms, the group A treated with salbutamol alone and the group B treated with salbutamol and montelukast. The symptomatic changes and variation in pulmonary function test (PFT), pulse rate (PR), respiratory rate (RR) were compared between both the group. The data were collected, compiled, analysed with statistical tools (SPSS – Microsoft Version 6). Results: In comparison of force expiratory volume % (FEV1 PRED) between the group A and group B, after 24 hours significant change was noticed in group B. The results of forced expiratory volume/forced vital capacity (FEV1/FVC%) shows a significant difference after 24 hours of the treatment with salbutamol in group A and salbutamol plus leukotriene receptor antagonist (Montelukast) from the baseline measurement. Base line asthma score shows p value (p = 0.58). But after 48 hours, significant change was noticed in both groups. p value was significant (p = 0.05). In group B, asthma score was significantly improved with passage of time. Conclusion: The study revealed the effectiveness of leukotriene receptor antagonist in preventing many types of aggravated asthmatic responses. Once-daily treatment with 10 mg of montelukast, as compared with s2-agonists, provided significant protection against severe broncho-constriction. Parameters strongly confirmed the role of leukotriene receptor antagonist when in addition added with s2-agonists.

Leukotriene receptor antagonists do not improve lung function decline in COPD: a meta-analysis.

Leukotriene receptor antagonists (LTRA), the anti-inflammatory agents, have been reported new therapeutic value in chronic obstructive pulmonary disease (COPD). However, the effects of LTRA on lung function decline in COPD were determined with inconsistent results and a meta-analysis is needed. Published cohort or randomized controlled studies were retrieved from PubMed and Embase databases. Pooled standardized mean difference (SMD) with 95% confidence interval (CI) was calculated in a random effects model. Six studies involving 221 COPD patients were included. Pooled effect size showed no significant improvements in FEV1 (SMD: 0.28, 95% CI: -0.17 to 0.72, p=0.227), FVC (SMD: 0.54, 95% CI: -0.10 to 1.18, p=0.597) and FEV1/FVC (SMD: 0.18, 95% CI: -0.09 to 0.46, p=0.189) in COPD patients after LTRA treatment. In subgroup analysis, neither short-term (<1 year) (SMD: 0.47, 95% CI: -0.06 to 0.99, p=0.082) nor long-term (≥1 year) (SMD: -0.13, 95% CI: -0.57 to 0.31, p=0.561) LTRA exposure could benefit lung function decline in COPD. This meta-analysis suggests neither short-term nor long-term exposure of LTRA can improve lung function decline in COPD. However, large scale randomized controlled trials are urgently warranted.

The comparison of the effectiveness of leukotriene receptor antagonists and inhaled corticosteroids in children with asthma

This study was conducted to compare the effectiveness of the leukotriene receptor antagonist and inhaled corticosteroid treatment in children diagnosed with asthma. Material and Methods: Sixty - two patients diagnosed with asthma in the age group of 6-14 years were included in the study. Patients were consecutively divided into 2 groups, and the first group was given 5 mg of montelukast before sleep and the second group received 400 mcg/day of inhaled corticosteroid budesonide in two doses. The patients were followed up for 6 months. Primary target were changes in the FEV1. Furthermore, daily short-acting β2 agonist use, night awakenings, admission to the emergency department, absenteeism at school were compared before and after the treatment. Results: Significant improvement was observed in both groups during postoperative period when compared to the pre-treatment period in terms of the mean FEV1, shortacting β2 agonist use, night awakenings, admission to the emergency department, and absenteeism at school p=0,001 . However, no statistical difference was determined between two groups.Conclusion: It was determined that montelukast therapy alone in children with asthma is an easy-to-administer and safe option, which is as effective as inhaled corticosteroids

Leukotriene receptor antagonist attenuated airway inflammation and hyperresponsiveness in a double-stranded RNA-induced asthma exacerbation model

BackgroundViral infections are the most common triggers of asthma exacerbation, but the key molecules involved in this process have not been fully identified. Although cysteinyl leukotrienes (cysLTs) have been postulated as the key mediators, their precise roles remain largely unclear. To investigate the roles of cysLTs in virus-induced asthma exacerbation, we developed a murine model using a viral double-stranded RNA analog, polyinosinic–polycytidylic acid (poly I:C), and analyzed the effect of leukotriene receptor antagonist (LTRA) administration. MethodsA/J mice were immunized with ovalbumin (OVA) + alum (days 0, 28, 42, and 49), followed by intranasal challenge with OVA (phase 1: days 50–52) and poly I:C (phase 2: days 53–55). Montelukast was administered during poly I:C challenge (phase 2) in the reliever model or throughout the OVA and poly I:C challenges (phases 1 and 2) in the controller model. Airway responsiveness to acetylcholine chloride was assessed, and bronchoalveolar lavage (BAL) was performed on day 56. ResultsAdministration of poly I:C to OVA-sensitized and -challenged mice increased the number of eosinophils and levels of IL-13, IL-9, CCL3, and CXCL1 in BAL fluid (BALF) and tended to increase airway responsiveness. Montelukast significantly attenuated the poly I:C-induced increase in the number of eosinophils and levels of IL-13, IL-9, and CCL3 in BALF and airway hyperresponsiveness in both the reliever and controller models. ConclusionsThis is the first report showing that LTRA functionally suppressed the pathophysiology of a virus-induced asthma exacerbation model, suggesting the importance of cysLTs as a potential treatment target.

Leukotriene Receptor Antagonists and Antiallergy Drugs.

As one of the candidates of the therapeutic strategy for asthma in addition to inhaled corticosteroids (ICS), leukotriene receptor antagonists (LTRAs) are known to be useful for long-term management of asthma patients complicated by allergic rhinitis (AR) or exercise-induced asthma (EIA). Currently available LTRAs are pranlukast hydrate, zafirlukast, and montelukast. These LTRAs have a bronchodilator action and inhibit airway inflammation, resulting in a significant improvement of asthma symptoms, respiratory function, inhalation frequency of as-needed inhaled β2-agonist, airway inflammation, airway hyperresponsiveness, dosage of ICSs, asthma exacerbations, and patients' QOL. Although cys-LTs are deeply associated with the pathogenesis of asthma, LTRAs alone are less effective compared with ICS. However, the effects of LTRAs in combination with ICS are the same as those of LABAs in combination with ICS in steroid-naïve asthmatic patients. Concerning antiallergy drugs other than LTRAs, some mediator-release suppressants, H1 histamine receptor antagonists (H1RAs), thromboxane A2 (TXA2) inhibitors/antagonists, and Th2 cytokine inhibitor had been used mainly in Japan until the late 1990s. However, the use of these agents rapidly decreased after ICS/long acting beta agonist (LABA) combination was introduced and recommended for the management of asthma in the early 2000s. The effectiveness of other antiallergic agents on asthma management seems to be quite limited, and the safety of oral antiallergic agents has not been demonstrated in fetuses during pregnancy. Further effectiveness studies are needed to determine the true value of these orally administered agents in combination with ICS as an anti-asthma treatment.

Leukotriene receptor antagonists as maintenance and intermittent therapy for episodic viral wheeze in children.

Episodic viral wheeze (EVW) associated with viral respiratory tract infections is a common reason for pre-school children to utilise health care resources and for carers to take time away from employment. About a third of children experience a wheezing episode before the age of five years. EVW therefore represents a significant public health problem. Many pre-school children only wheeze in association with viral infections and in such cases EVW appears to be a separate entity from atopic asthma. Some trials have explored the effectiveness of leukotriene receptor antagonists (LTRAs) as regular (maintenance) or episodic (intermittent) treatment in this context. To evaluate the evidence for the efficacy and safety of maintenance and intermittent LTRAs in the management of EVW in children aged one to six years. We searched the Cochrane Airways Group register of trials with pre-specified terms. We performed additional searches by consulting the authors of identified trials, online trial registries of manufacturers' web sites, and reference lists of identified primary papers and reviews. Search results are current to June 2015. We included randomised controlled trials with a parallel-group or cross-over (for intermittent LTRA only) design. Maintenance was considered as treatment for more than two months and intermittent as less than 14 days. EVW was defined as a history of at least one previous episode of wheezing in association with a viral respiratory tract infection in the absence of symptoms between episodes. As far as possible, relevant specific data were obtained from authors of studies that included children of a wider age group or phenotype. Two authors independently assessed studies for inclusion in the review and assessed risk of bias. The primary outcome was number of children with one or more viral-induced episodes requiring one or more treatments with rescue oral corticosteroids. We analysed combined continuous data outcomes with the mean difference and dichotomous data outcomes with an odds ratio (OR). We identified five studies eligible for inclusion in the review (one investigated maintenance treatment, three intermittent therapy and one had both maintenance and intermittent treatment arms) these included 3741 participants. Each study involved oral montelukast and was of good methodological quality, but differed in choice of outcome measures thus limiting our ability to aggregate data across studies. Only primary outcome and adverse event data are reported in this abstract.For maintenance treatment, specific data obtained from a single study, pertaining to children with only an EVW phenotype, showed no statistically significant group reduction in the number of episodes requiring rescue oral corticosteroids associated with daily montelukast versus placebo (OR 1.20, 95% CI 0.70 to 2.06, moderate quality evidence).For intermittent LTRA, pooled data showed no statistically significant reduction in the number of episodes requiring rescue oral steroids in children treated with LTRA versus placebo (OR 0.77, 95% CI 0.48 to 1.25, moderate quality evidence). Specific data for children with an EVW phenotype obtained from a single study of intermittent montelukast treatment showed a small, but statistically significant reduction in unscheduled medical attendances due to wheeze (RR 0.83, 95% CI 0.71 to 0.98).For maintenance compared to intermittent LTRA treatment no data relating to the primary outcome of the review were identified.There were no other significant group differences identified in other secondary efficacy outcomes for maintenance or intermittent LTRA treatment versus placebo, or maintenance versus intermittent LTRA treatment. We collected descriptive data on adverse events as reported by four of the five included studies, and rates were similar between treatment and placebo groups.Potential heterogeneity in the phenotype of participants within and across trials is a limitation of the evidence. In pre-school children with EVW, there is no evidence of benefit associated with maintenance or intermittent LTRA treatment, compared to placebo, for reducing the number of children with one or more viral-induced episodes requiring rescue oral corticosteroids, and little evidence of significant clinical benefit for other secondary outcomes. Therefore until further data are available, LTRA should be used with caution in individual children. When used, we suggest a therapeutic trial is undertaken, during which efficacy should be carefully monitored. It is likely that children with an apparent EVW phenotype are not a homogeneous group and that subgroups may respond to LTRA treatment depending on the exact patho-physiological mechanisms involved.

Expression of leukotriene and its receptors in eosinophilic chronic rhinosinusitis with nasal polyps.

Cysteinyl leukotriene (LT) has been proposed in the pathogenesis of chronic rhinosinusitis with nasal polyps (CRSwNP). This study sought to examine the expression of the LT receptor (LTR) in CRSwNP patients and evaluate the potential role of LTR antagonist (LTRA) in the management of eosinophilic CRSwNP (ECRS) patients. Nasal polyps and uncinate process tissues were collected from 18 ECRS patients, 13 non-eosinophilic CRSwNP (non-ECRS) patients, and 16 control subjects. The messenger RNA (mRNA) and protein expression of LTR (cysteinyl leukotriene receptor 1 [CysLT1R] and cysteinyl leukotriene receptor 2 [CysLT2R]) was examined using quantitative reverse-transcription polymerase chain reaction (qRT-PCR), immunohistochemistry, and Western blot analysis. Moreover, the effects of LTRA and steroids on total nasal symptom scores (TNSS) of uncontrolled ECRS patients were evaluated. The mRNA and protein expression of CysLT1R and CysLT2R was significantly increased in polyp tissues compared with healthy controls (p < 0.05). Compared with the non-ECRS subset, the ECRS subset showed significantly increased expression of CysLT1R and CysLT2R, as well as leukotriene C4 (LTC4) and leukotriene D4 (LTC4) levels (p < 0.05). Moreover, combined LTRA and steroids significantly decreased TNSS more than steroids alone in uncontrolled ECRS patients (p < 0.01). Our findings indicate that LTR was differentially expressed between ECRS and non-ECRS patients, and that LTRA may be used as an additional therapy for ECRS patients.

More Effective Strategies are Needed for Elderly Asthmatics in Real-World Practice.

More Effective Strategies are Needed for Elderly Asthmatics in Real-World Practice.

Meta-analysis of leukotriene receptor antagonist montelukast in the treatment of allergic rhinitis

To evaluate the treatment outcomes of leukotriene receptor antagonists (LTRA) as monotherapy or combined with the second-generation oral H1-histamines in the treatment of allergic rhinitis (AR), and to provide a basis for optimizing clinical therapeutic strategies. PubMed,EMBASE, CBMdisc and CJFD databases, retrieving randomized controlled trials (RCTs) of AR therapy literatures were searched. Based on the literature inclusion and exclusion criteria, the related literatures were selected and the quality was evaluated by using the Jadad scale. Meta-analysis was performed by Stata 12.1 software.For continuous outcomes, the weighted mean difference (WMD) and its 95% confidence intervals (CI) were calculated. The forest plots were drawn. The treatment outcomes included daytime nasal symptom scores (DNSS), nighttime symptom scores (NSS), composite symptom scores (CSS), daytime eye symptom scores (DESS), and the rhinoconjunctivitis quality of life questionnaire (RQLQ) were used to evaluate the therapeutic effects of LTRA on seasonal and perennial AR. Eleven of clinical RCTs including 14 809 cases of AR patients, aged 15 to 85 years old, were available for Meta-analysis. Montelukast, a drug of LTRA, was primarily evaluated in the study. The results of Meta-analysis showed: (1) Compared with the placebo, montelukast statistically significantly reduced the DNSS,NSS, CSS, and RQLQ scores in patients with seasonal and perennial AR, as well as the DESS in patients with seasonal AR.(2) There were no statistical differences in the improvement of the CSS,DESS, and RQLQ scores in patients with seasonal AR after the treatment by montelukast compared with loratadine, a second-generation oral H1-histamine.(3) Montelukast statistically significantly reduced the NSS, but not DNSS, in patients with seasonal AR compared with loratadine.(4) The combination therapy of montelukast and loratadine statistically significantly improved the CSS compared with either montelukast or loratadine monotherapy. Montelukast, a representative drug of LTRA, can be used as first-line therapy for AR, with comprehensive improvement of the nasal and ocular symptoms and the quality of life in AR patients. Montelukast combined with loratadine can significantly improve the diurnal and nocturnal symptoms for patients with seasonal AR, and the curative effect is better than the single use of montelukast or loratadine.

Efficacy versus effectiveness trials

Randomized controlled trials, known as efficacy trials and long considered the gold standard for evidence-based asthma guidelines, are designed to test whether interventions have a benefit for selective patient populations under ideal conditions. The goal of pragmatic trials and observational studies instead is to understand real-life efficacy, known as effectiveness. This review summarizes the strengths and limitations of efficacy and effectiveness trials, results of recent effectiveness trials in asthma and initiatives promoting effectiveness research. Recent pragmatic trials and observational studies have examined outcomes of interventions for diverse real-life patient populations, including smokers and patients with variable adherence, inhaler technique and baseline asthma control. Study results challenge practice guidelines regarding relative effectiveness of leukotriene receptor antagonists and inhaled corticosteroids (ICS); supplement guidelines with regard to effectiveness of interventions in smokers; and begin to address gaps in guidelines regarding choice of ICS and inhaler device. Initiatives are ongoing to refine methods of observational research and to harmonize asthma outcomes for better integration of results from all types of trials. Results of pragmatic trials and observational studies are an important component of the evidence needed to inform guideline recommendations and decision-making by healthcare providers, patients and policymakers.

Progress in Pediatrics in 2012: choices in allergy, endocrinology, gastroenterology, hematology, infectious diseases, neurology, nutrition and respiratory tract illnesses

In this review, we summarize the progresses in allergy, endocrinology, gastroenterology, hematology, infectious diseases, neurology, nutrition and respiratory tract illnesses that have been published in The Italian Journal of Pediatrics in 2012. The induction of Treg activity by probiotics might be effective for promoting tolerance towards food allergens. Nasal cytology is useful in patients with rhinitis for diagnosing chronic non-allergic non-infectious diseases. Atopic eczema is associated both with an aberrant skin matrix and impaired systemic immune response. Therefore, isolated topical treatment may have suboptimal effect. Diagnostic work-up of exercise-induced anaphylaxis, including exercise challenge test, is necessary to reach a diagnosis. Studies may support a role for nutrition on prevention of asthma and cardiovascular diseases. Clinicians need to early identify adolescent menstrual abnormalities to minimize sequelae, and to promote health information. In Multiple Endocrine Neoplasia type 2B investigations include acetylcholinesterase study of rectal mucosa followed by the molecular analysis of RET mutation. Low adherence to gluten-free diet and osteopenia are common problems in children with diabetes mellitus type 1 and celiac disease. In infantile colic, laboratory tests are usually unnecessary and the treatment is based on reassurance. Prevalence of obesity and stunting is elucidated by several studies. Evidences are growing that dietetic measures are needed to prevent obesity in children with acute leukemia. Treatment studies for infectious diseases show promise for probiotics along with standard triple therapy in children with Helicobacter pilori infection, while zinc has no effect on pneumonia. Educational programs about the proper management of the febrile child are warranted. A new hour-specific total serum bilirubin nomogram has been shown to be able to predict newborns without hyperbilirubinemia after 48 to 72 hours of life. Newborns with hypoxic-ischemic encephalopathy present ECG and cardiac enzymes alterations leading to reduced neonatal survival. Rehabilitation programs including sensory integration therapy and motor performance, may improve activities of daily life in children with developmental coordination disorder. Aerobic exercise training in addition to chest physiotherapy might be useful in children with cystic fibrosis. Studies on effectiveness of leukotriene receptor antagonists, alone or with other drugs in preschool wheezing are needed.

Leukotriene Receptor Antagonists in Allergic Eye Disease: A Systematic Review and Meta-analysis

Allergic eye diseases are common and cause significant morbidity. Leukotrienes are implicated in the pathogenesis of seasonal and perennial allergic conjunctivitis (AC), commonly seen in conjunction with allergic rhinitis, and in vernal keratoconjunctivitis and atopic keratoconjunctivitis. To assess the available evidence for an effect of leukotriene receptor antagonists (LTRAs) on the ocular symptoms of allergic eye diseases. Selected studies, identified with systematic review search methods, were single/double-blind, randomized, controlled trials that compared LTRAs with other common treatments. Eighteen trials, using the LTRA montelukast (in AC only), were identified. Six studies were suitable for meta-analysis, in patients with seasonal AC [treated over a 2-week period, symptoms scored 0 (mild) to 3 (severe)]. These trials were at low risk of bias without significant heterogeneity. Six trials were analyzed and showed that montelukast improved patients' ocular symptoms to a greater extent than placebo, with a difference in mean change-from-baseline score of -0.10 (95% CI, -0.14 to -0.07; P < .00001). Three trials compared montelukast with oral antihistamine. The difference in mean change-from-baseline score was 0.08 (95% CI, 0.02 to 0.14; P = .007), in favor of antihistamines. Two trials compared montelukast and oral antihistamine with placebo. The difference in mean change-from-baseline score was -0.30 (95% CI, -0.38 to -0.21; P < .00001), in favor of combination treatment. In seasonal AC LTRAs are more efficacious than placebo but less efficacious than oral antihistamines in adult patients. Clinical trials should be conducted to determine whether combination treatment with LTRA and oral antihistamine has a synergistic effect. Further research is required to clarify the role of LTRAs in other allergic eye diseases.

Type 1 Allergy-Induced Endolymphatic Hydrops and the Suppressive Effect of Leukotriene Receptor Antagonist

To investigate allergic endolymphatic hydrops (EH) and the effect of leukotriene receptor antagonist (LTRA). Experiment 1: Thirty-six guinea pigs were actively sensitized with DNP-ascaris twice and were provoked with DNP-bovine serum albumin 1 week after the second sensitization. Alterations in the inner ear were investigated histologically at 1, 12, 24, and 36 hours after the provocation, and changes of the endolymphatic space were quantitatively assessed. The animals in the control group received no sensitization but only distilled water. Experiment 2: Twenty-four guinea pigs were actively sensitized and provoked in the same manner. Animals received oral administration of LTRA 1 hour before the provocation. Alterations in the inner ear were investigated as same manner as in Experiment 1. Experiment 3: Eleven of 19 guinea pigs were actively sensitized and provoked in the same manner. Eight animals in the control group received distilled water. One hour after these procedures, the changes in p-AVP levels were investigated. Experiment 1: EH was observed 12, 24, and 36 hours after the last sensitization. In these groups, their cross-sectional areas of the scala media were significantly larger than that of the control group. Degranulation of mast cells was observed in the endolymphatic sac. Experiment 2: In animal groups with LTRA, EH was not observed at all. Experiment 3: P-AVP levels were significantly elevated in animals with the sensitization. The sensitization with DNP-Ascaris produced allergic EH and elevation of p-AVP, and allergic EH was inhibited by LTRA.