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The Journal of Allergy and Clinical... Jun 2020Although nebulized corticosteroids (NebCSs) are a key treatment option for young children with asthma or viral-induced wheezing (VIW), there are no uniform... (Review)
Review
Although nebulized corticosteroids (NebCSs) are a key treatment option for young children with asthma or viral-induced wheezing (VIW), there are no uniform recommendations on their best use. This systematic review aimed to clarify the role of NebCSs in children 5 years or younger for the management of acute asthma exacerbations, asthma maintenance therapy, and the treatment of VIW. Electronic databases were used to identify relevant English language articles with no date restrictions. Studies reporting efficacy data in children 5 years or younger, with a double-blind, placebo- or open-controlled, randomized design, and inclusion of 40 or more participants (no lower patient limit for VIW) were included. Ten articles on asthma exacerbation, 9 on asthma maintenance, and 7 on VIW were identified. Results showed NebCSs to be at least as efficacious as oral corticosteroids in the emergency room for the management of mild to moderate asthma exacerbations. In asthma maintenance, nebulized budesonide, the agent of focus in all trials analyzed, significantly reduced the risk of further asthma exacerbations compared with placebo, cromolyn sodium, and montelukast. Intermittent NebCS treatment of VIW was as effective as continuous daily treatment. In summary, NebCSs are effective and well tolerated in patients 5 years or younger for the management of acute and chronic asthma.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Budesonide; Child; Child, Preschool; Humans; Randomized Controlled Trials as Topic; Respiratory Sounds
PubMed: 32006721
DOI: 10.1016/j.jaip.2020.01.042 -
The Cochrane Database of Systematic... Jan 2020Obstructive sleep apnoea (OSA) is characterised by partial or complete upper airway obstruction during sleep. Approximately 1% to 4% of children are affected by OSA,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Obstructive sleep apnoea (OSA) is characterised by partial or complete upper airway obstruction during sleep. Approximately 1% to 4% of children are affected by OSA, with adenotonsillar hypertrophy being the most common underlying risk factor. Surgical removal of enlarged adenoids or tonsils is the currently recommended first-line treatment for OSA due to adenotonsillar hypertrophy. Given the perioperative risk and an estimated recurrence rate of up to 20% following surgery, there has recently been an increased interest in less invasive alternatives to adenotonsillectomy. As the enlarged adenoids and tonsils consist of hypertrophied lymphoid tissue, anti-inflammatory drugs have been proposed as a potential non-surgical treatment option in children with OSA.
OBJECTIVES
To assess the efficacy and safety of anti-inflammatory drugs for the treatment of OSA in children.
SEARCH METHODS
We identified trials from searches of the Cochrane Airways Group Specialised Register, CENTRAL and MEDLINE (1950 to 2019). For identification of ongoing clinical trials, we searched ClinicalTrials.gov and the World Health Organization (WHO) trials portal.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing anti-inflammatory drugs against placebo in children between one and 16 years with objectively diagnosed OSA (apnoea/hypopnoea index (AHI) ≥ 1 per hour).
DATA COLLECTION AND ANALYSIS
Two authors independently performed screening, data extraction, and quality assessment. We separately pooled results for the comparisons 'intranasal steroids' and 'montelukast' against placebo using random-effects models. The primary outcomes for this review were AHI and serious adverse events. Secondary outcomes included the respiratory disturbance index, desaturation index, respiratory arousal index, nadir arterial oxygen saturation, mean arterial oxygen saturation, avoidance of surgical treatment for OSA, clinical symptom score, tonsillar size, and adverse events.
MAIN RESULTS
We included five trials with a total of 240 children aged one to 18 years with mild to moderate OSA (AHI 1 to 30 per hour). All trials were performed in specialised sleep medicine clinics at tertiary care centres. Follow-up time ranged from six weeks to four months. Three RCTs (n = 137) compared intranasal steroids against placebo; two RCTs compared oral montelukast against placebo (n = 103). We excluded one trial from the meta-analysis since the patients were not analysed as randomised. We also had concerns about selective reporting in another trial. We are uncertain about the difference in AHI (MD -3.18, 95% CI -8.70 to 2.35) between children receiving intranasal corticosteroids compared to placebo (2 studies, 75 participants; low-certainty evidence). In contrast, children receiving oral montelukast had a lower AHI (MD -3.41, 95% CI -5.36 to -1.45) compared to those in the placebo group (2 studies, 103 participants; moderate-certainty evidence). We are uncertain whether the secondary outcomes are different between children receiving intranasal corticosteroids compared to placebo: desaturation index (MD -2.12, 95% CI -4.27 to 0.04; 2 studies, 75 participants; moderate-certainty evidence), respiratory arousal index (MD -0.71, 95% CI -6.25 to 4.83; 2 studies, 75 participants; low-certainty evidence), and nadir oxygen saturation (MD 0.59%, 95% CI -1.09 to 2.27; 2 studies, 75 participants; moderate-certainty evidence). Children receiving oral montelukast had a lower respiratory arousal index (MD -2.89, 95% CI -4.68 to -1.10; 2 studies, 103 participants; moderate-certainty evidence) and nadir of oxygen saturation (MD 4.07, 95% CI 2.27 to 5.88; 2 studies, 103 participants; high-certainty evidence) compared to those in the placebo group. We are uncertain, however, about the difference in desaturation index (MD -2.50, 95% CI -5.53 to 0.54; 2 studies, 103 participants; low-certainty evidence) between the montelukast and placebo group. Adverse events were assessed and reported in all trials and were rare, of minor nature (e.g. nasal bleeding), and evenly distributed between study groups. No study examined the avoidance of surgical treatment for OSA as an outcome.
AUTHORS' CONCLUSIONS
There is insufficient evidence for the efficacy of intranasal corticosteroids for the treatment of OSA in children; they may have short-term beneficial effects on the desaturation index and oxygen saturation in children with mild to moderate OSA but the certainty of the benefit on the primary outcome AHI, as well as the respiratory arousal index, was low due to imprecision of the estimates and heterogeneity between studies. Montelukast has short-term beneficial treatment effects for OSA in otherwise healthy, non-obese, surgically untreated children (moderate certainty for primary outcome and moderate and high certainty, respectively, for two secondary outcomes) by significantly reducing the number of apnoeas, hypopnoeas, and respiratory arousals during sleep. In addition, montelukast was well tolerated in the children studied. The clinical relevance of the observed treatment effects remains unclear, however, because minimal clinically important differences are not yet established for polysomnography-based outcomes in children. Long-term efficacy and safety data on the use of anti-inflammatory medications for the treatment of OSA in childhood are still not available. In addition, patient-centred outcomes like concentration ability, vigilance, or school performance have not been investigated yet. There are currently no RCTs on the use of other kinds of anti-inflammatory medications for the treatment of OSA in children. Future RCTs should investigate sustainability of treatment effects, avoidance of surgical treatment for OSA, and long-term safety of anti-inflammatory medications for the treatment of OSA in children and include patient-centred outcomes.
Topics: Acetates; Adenoidectomy; Adolescent; Anti-Inflammatory Agents; Child; Child, Preschool; Cyclopropanes; Female; Humans; Infant; Male; Quinolines; Randomized Controlled Trials as Topic; Sleep Apnea, Obstructive; Sulfides; Tonsillectomy
PubMed: 31978261
DOI: 10.1002/14651858.CD007074.pub3 -
Pulmonary Pharmacology & Therapeutics Feb 2020Montelukast the leukotriene receptor antagonist is an anti-inflammatory drug that causes bronchodilation and for this reason it is used to improve inflammatory states in... (Review)
Review
Montelukast the leukotriene receptor antagonist is an anti-inflammatory drug that causes bronchodilation and for this reason it is used to improve inflammatory states in asthma and allergic rhinitis. Montelukast is generally considered a safe drug with the occurrence of a few adverse drug reactions (ADRs) and anti-leucotrienes are usually well-tolerated by adults and young patients. Starting from these premises the purpose of this review is so give un up-to-date scenario about skin adverse reactions due to Montelukast administration. Only few cases were reported during last years, however interestingly some recent reports let us enlarging our ADR data about Montelukast. We decided to divide the paragraph into sections evaluating the following skin lesions: vasculitic lesions, rash, urticaria and angioedema. As described in the results, CSS were the most frequent cases reported, belonging to the Vasculitis category. We speculated several mechanisms leading to the spread of the skin reactions. Montelukast still remains a safe drug used for the treatment of severe and moderate asthma. However, for some reasons still in course of analysis, in rare cases patients could develop ADR. Among these, about half of the patients show skin signs as rash, vescicles, bullous skin, purpura, maculopapular cutis, erythematous exanthema, urticaria and angioedema. Most of these symptoms are a consequence of the onset of a vasculitis as CSS and allergic granulomatous angiitis. In many cases the onset of the reactions happen within the first months of intake. For this reason, the prescribing physicians should be alert for signs, symptoms and genetic predisposition of these skin diseases.
Topics: Acetates; Adult; Aged; Anti-Asthmatic Agents; Cyclopropanes; Female; Humans; Leukotriene Antagonists; Male; Middle Aged; Quinolines; Skin; Sulfides
PubMed: 31837440
DOI: 10.1016/j.pupt.2019.101875