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Cell Biochemistry and Function Oct 2023This study aimed to determine the effects of Xiebai Zengye decoction (XBZY) on airway inflammation and respiratory function in rats with postinfectious cough...
This study aimed to determine the effects of Xiebai Zengye decoction (XBZY) on airway inflammation and respiratory function in rats with postinfectious cough (PIC), and its regulatory effects on the extracellular signal-regulated kinase (ERK) signaling pathway. Compared with the normal group, the rats from the PIC group had significantly shortened expiratory time (TE) and enhanced pause (EEP), increased resistance (RT), and enhanced pause (Penh), along with increased levels of serum interleukin-4 (IL-4) and IL-6, and decreased levels of IL-10. The lung and colon tissues of rats from the PIC group showed histopathological changes, including inflammatory cell infiltration, damaged mucosal epithelium, and crypt structure, with significantly increased ERK mRNA and protein expression levels. Treatment with XBZY and montelukast sodium (MAS) improved the respiratory function and serum cytokine levels, reduced tissue inflammation, and decreased ERK mRNA and protein expression levels in the lung and colon tissues. In the lung tissues, XBZY treatment significantly decreased the expression of phosphorylated-ERK (p-ERK) protein, as well as p-MEK1/2, p-ERK1/2, and p-c-Fos proteins, while in the colon tissues, XBZY significantly decreased the expression of p-ERK1/2 and p-c-Fos proteins. However, MAS treatment only showed significant improvement in the lung tissue inflammation score, and the expression level of p-ERK protein in the lung tissue was decreased. In conclusion, the present study suggests that XBZY has a potential therapeutic effect on PIC by improving respiratory function and attenuating inflammation, and this effect may be associated with the inhibition of the ERK signaling pathway. These findings could provide a new direction for the development of treatments for PIC. However, further research is needed to elucidate the underlying molecular mechanisms of XBZY and to confirm its safety and efficacy in clinical trials.
Topics: Rats; Animals; Extracellular Signal-Regulated MAP Kinases; Cough; Proto-Oncogene Proteins c-fos; MAP Kinase Signaling System; Signal Transduction; Inflammation; RNA, Messenger
PubMed: 37606071
DOI: 10.1002/cbf.3835 -
Pediatric Pulmonology Dec 2023Growth impairment is a known adverse event (AE) of corticosteroids in children. This study aimed to assess the effect of once-daily (QD) inhaled fluticasone furoate (FF)... (Randomized Controlled Trial)
Randomized Controlled Trial
A multicenter randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effects of a 1-year regimen of orally inhaled fluticasone furoate 50 µg once daily on growth velocity in prepubertal, pediatric participants with well-controlled asthma.
INTRODUCTION
Growth impairment is a known adverse event (AE) of corticosteroids in children. This study aimed to assess the effect of once-daily (QD) inhaled fluticasone furoate (FF) versus placebo on growth velocity over 1 year in prepubertal children with well-controlled asthma.
MATERIALS AND METHODS
This randomized, double-blind, parallel-group, placebo-controlled, multicenter study (NCT02889809) included prepubertal children, aged 5 to <9 years (boys), and 5 to <8 years (girls), with ≥6 months' asthma history. Children received inhaled placebo QD plus background open-label montelukast QD for a 16-week run-in period and were then randomized 1:1 to receive inhaled FF 50 μg QD or placebo QD (whilst continuing background open-label montelukast) for a 52-week treatment period. The primary endpoint was the difference in growth velocity (cm/year) over the treatment period. Other growth endpoints were measured, as were incidence of AEs and asthma exacerbation. Growth analyses included all intent-to-treat (ITT) participants with ≥3 post-randomization, on-treatment clinic visit height assessments (GROWTH population).
RESULTS
Of 644 children in the run-in period, 477 (mean age 6.2 years, 63% male) entered the 52-week treatment period (ITT population: FF N = 238, placebo N = 239; GROWTH population: N = 457 [FF N = 231; placebo N = 226]). The least-squares mean difference in growth velocity for FF versus placebo was -0.160 cm/year (95% confidence interval: -0.462, 0.142). There were no new safety signals.
CONCLUSIONS
Over 1 year, FF 50 μg QD had a minimal effect on growth velocity versus placebo, with no new safety signals.
Topics: Female; Humans; Child; Male; Bronchodilator Agents; Administration, Inhalation; Asthma; Double-Blind Method; Treatment Outcome; Fluticasone
PubMed: 37728224
DOI: 10.1002/ppul.26679 -
Frontiers in Medicine 2024This network meta-analysis was to analyze and rank the efficacy and safety of different systemic drugs in the treatment of uremic pruritus (UP) among hemodialysis...
Efficacy and safety of different systemic drugs in the treatment of uremic pruritus among hemodialysis patients: a network meta-analysis based on randomized clinical trials.
AIM
This network meta-analysis was to analyze and rank the efficacy and safety of different systemic drugs in the treatment of uremic pruritus (UP) among hemodialysis patients.
METHOD
PubMed, Embase, Cochrane Library, and Web of Science databases were searched from inception to 10 July 2023 for randomized controlled trials (RCTs) investigating different drugs in the treatment of UP among hemodialysis patients. Drugs including cromolyn sodium, dexchlorpheniramine, difelikefalin, gabapentin, hydroxyzine, ketotifen, melatonin, montelukast, nalbuphine, nalfurafine, nemolizumab, nicotinamide, pregabalin, sertraline, thalidomide, and placebo were assessed. Outcome measures, including pruritus relief, response, and adverse events, were analyzed. Network plots, forest plots, league tables, and the surface under the cumulative ranking (SUCRA) probabilities were depicted for each outcome.
RESULTS
The network meta-analysis retrieved 22 RCTs. Gabapentin (69.74%) had the highest likelihood to be the most effective drug for pruritus relief in UP patients receiving hemodialysis, followed by cromolyn sodium and hydroxyzine. Thalidomide (60.69%) and gabapentin (58.99%) were associated with significantly more drug responses for treating UP among patients receiving hemodialysis. Patients who were treated with gabapentin (40.01%) were likely to have risks of adverse events and dizziness. Lower risks of adverse events, nausea, and diarrhea were found in patients who received cromolyn sodium and lower risks of somnolence.
CONCLUSION
This study suggests considering gabapentin treatment when facing a patient suffering from UP. This study provides a reference for the selection of drug therapy for UP patients receiving hemodialysis.
PubMed: 38646551
DOI: 10.3389/fmed.2024.1334944 -
Postepy Dermatologii I Alergologii Feb 2024Atopic dermatitis (AD) is one of the most common chronic skin conditions affecting about 20% of children and 5% of adults. However, the studies assessing novel therapies...
INTRODUCTION
Atopic dermatitis (AD) is one of the most common chronic skin conditions affecting about 20% of children and 5% of adults. However, the studies assessing novel therapies for AD have been focused mainly on paediatric patients and only few studies have involved adult participants.
AIM
To compare the treatment outcomes between the antihistamine monotherapy and combined intervention with an antihistamine agent and a cysteinyl leukotriene receptor antagonist in adult patients with atopic dermatitis.
MATERIAL AND METHODS
Patients were randomized into two groups to receive 5 mg oral desloratadine or the combined therapy with 5 mg oral desloratadine and 10 mg montelukast. Both groups were also administered topical treatment using the same protocol (topical Elocon and moisturizer). To estimate the efficacy of the implemented therapy methods, different skin health scores (SCORAD, GISS, EASI, PPNRS and DLQI) and skin functional assessment outcomes (corneometry, pH and transepidermal water loss) were evaluated before and after the treatment.
RESULTS
Significant differences were revealed in compared measurement results for scales of the Extent and Severity of Eczema assessment, Global Individual Signs Score, Eczema Area and Severity Index, Pruritus Numerical Rating Scale, Dermatology Life Quality Index and Skin Functional Properties (p > 0.05).
CONCLUSIONS
Comparison of data presenting the therapy outcomes in two groups showed that administration of the combined therapy was significantly more effective compared to the antihistamine monotherapy. The results revealed considerable efficacy of the combined therapy reinforced by the use of cysteinyl leukotriene receptor antagonist, montelukast.
PubMed: 38533375
DOI: 10.5114/ada.2023.135759 -
Clinical Rheumatology Jun 2024The association between the use of certain medications (including sulfonamides, hydralazine, and procainamide) and the occurrence of drug-induced lupus or hepatitis is... (Review)
Review
The association between the use of certain medications (including sulfonamides, hydralazine, and procainamide) and the occurrence of drug-induced lupus or hepatitis is well established. More recently, cases of immune-related adverse events ranging from inflammatory polyarthritis to necrotizing myositis in patients taking checkpoint inhibitors have been reported. However, data linking drugs to systemic vasculitis are scarce and at times debatable. Propylthiouracil, hydralazine, and minocycline have been associated with rare cases of ANCA-associated syndromes, including life-threatening pulmonary-renal syndromes and systemic polyarteritis nodosa-like diseases. Eosinophilic granulomatosis with polyangiitis (EGPA) has been reported in patients taking leukotriene inhibitors. Since the link between the use of leukotriene inhibitors and occurrence of EGPA remains highly controversial, we performed a literature review for cases of EGPA in patients taking montelukast without prior history of oral corticosteroid use. We found 24 cases, along with our own two cases described, making 26 cases in total. The mean age was 43 and a majority (18/26) were female. In majority of cases EGPA-like disease never relapsed after they were taken off leukotriene inhibitors suggesting a clear causal relationship between the use of these drugs and occurrence of eosinophil-rich systemic EGPA.
Topics: Humans; Sulfides; Quinolines; Cyclopropanes; Acetates; Leukotriene Antagonists; Female; Churg-Strauss Syndrome; Male; Granulomatosis with Polyangiitis; Middle Aged; Adult
PubMed: 38720163
DOI: 10.1007/s10067-024-07000-8 -
Cureus Jul 2023Eosinophilic gastrointestinal disorders (EGIDs) are a spectrum of disorders including eosinophilic esophagitis, eosinophilic gastroenteritis, and eosinophilic colitis....
Eosinophilic gastrointestinal disorders (EGIDs) are a spectrum of disorders including eosinophilic esophagitis, eosinophilic gastroenteritis, and eosinophilic colitis. We report a case of EGID involving the esophagus, small intestine, and large intestine simultaneously. A 38-year-old male patient presented with chronic diarrhea, abdominal pain, and unquantified weight loss for the last two months, which not improving with routine empirical treatment. Endoscopy revealed erosions in the stomach, duodenum, terminal ileum, and proximal colon. Biopsy revealed eosinophilic infiltration in the esophagus, terminal ileum, and proximal colon. Contrast-enhanced CT showed multiple skip areas of short- and long-segment circumferential mural thickening with enhancement in the jejunum and ileal loops, causing mild luminal narrowing with pelvic ascites, indicating involvement of muscular and probably serosal layer to a lesser degree (absence of obstructive symptoms with minimal ascites) along with predominant mucosal involvement (responsible for clinical symptoms). The patient was treated with elimination diet, systemic corticosteroids, and montelukast. Diarrheal episodes decreased, and the treatment was shifted to oral budesonide. We believe it to be one of the first reports to show a simultaneous involvement of the esophagus, small intestine, and large intestine, along with mucosal and mural involvement. It strengthens the fact that a common underlying pathogenesis causes EGIDs and an underlying muscular layer involvement in patients with predominant mucosal disease.
PubMed: 37621796
DOI: 10.7759/cureus.42349 -
Health Science Reports Nov 2023To reduce death rates for critical patients hospitalized in intensive care units (ICUs), coronavirus (COVID-19) lacks proven and efficient treatment methods. This...
BACKGROUND AND AIMS
To reduce death rates for critical patients hospitalized in intensive care units (ICUs), coronavirus (COVID-19) lacks proven and efficient treatment methods. This cross-sectional study aims to evaluate how physicians treat severe and suspected COVID-19 patients in the ICU department in the absence of an established approach, as well as assess the rational use of the medication in the ICU department.
METHODS
Between June 16, 2021, and December 10, 2022, a total of 428 prescriptions were randomly gathered, including both suspected (yellow zone) and confirmed (red zone) COVID-19 patients. For data management, Microsoft Excel 2021 was utilized, while STATA 17 provided statistical analysis. To find associations between patients' admission status and demographic details, exploratory and bivariate analyses were conducted.
RESULTS
Of the 428 patients admitted to the ICU, 228 (53.27%) were in the yellow zone and 200 (46.73%) were in the verified COVID-19 red zone. The majority of patients were male (54.44%), and the age range from 41 to 60 was the most common (41.82%). No significant deviation was detected to the yellow and red groups' prescription patterns. A total of 4001 medicines (mean 9.35/patient) were prescribed. Antiulcerants, antibiotics, respiratory, analgesics, anticoagulants, vitamins and minerals, steroids, cardiovascular, antidiabetic drugs, antivirals, antihistamines, muscle relaxants, and antifungal treatments were widely prescribed drugs. Enoxaparin (67.06%) appeared as the most prescribed medicine, followed by montelukast (60.51%), paracetamol (58.41%), and dexamethasone (51.64%).
CONCLUSION
The prescription patterns for the yellow and red groups were comparable and mostly included symptomatic treatment. Respiratory drugs constituted the most frequent therapeutic class. Polypharmacy should be taken under considerations. In ICU settings, the outcomes emphasize the need of correct diagnosis, cautious antibiotic usage, suitable therapy, and attentive monitoring.
PubMed: 38028685
DOI: 10.1002/hsr2.1711 -
Multiple Sclerosis (Houndmills,... May 2024Effective and safe treatment options for multiple sclerosis (MS) are still needed. Montelukast, a leukotriene receptor antagonist (LTRA) currently indicated for asthma...
Montelukast as a repurposable additive drug for standard-efficacy multiple sclerosis treatment: Emulating clinical trials with retrospective administrative health claims data.
BACKGROUND
Effective and safe treatment options for multiple sclerosis (MS) are still needed. Montelukast, a leukotriene receptor antagonist (LTRA) currently indicated for asthma or allergic rhinitis, may provide an additional therapeutic approach.
OBJECTIVE
The study aimed to evaluate the effects of montelukast on the relapses of people with MS (pwMS).
METHODS
In this retrospective case-control study, two independent longitudinal claims datasets were used to emulate randomized clinical trials (RCTs). We identified pwMS aged 18-65 years, on MS disease-modifying therapies concomitantly, in de-identified claims from Optum's Clinformatics Data Mart (CDM) and IQVIA PharMetrics Plus for Academics. Cases included 483 pwMS on montelukast and with medication adherence in CDM and 208 in PharMetrics Plus for Academics. We randomly sampled controls from 35,330 pwMS without montelukast prescriptions in CDM and 10,128 in PharMetrics Plus for Academics. Relapses were measured over a 2-year period through inpatient hospitalization and corticosteroid claims. A doubly robust causal inference model estimated the effects of montelukast, adjusting for confounders and censored patients.
RESULTS
pwMS treated with montelukast demonstrated a statistically significant 23.6% reduction in relapses compared to non-users in 67.3% of emulated RCTs.
CONCLUSION
Real-world evidence suggested that montelukast reduces MS relapses, warranting future clinical trials and further research on LTRAs' potential mechanism in MS.
Topics: Humans; Sulfides; Cyclopropanes; Quinolines; Acetates; Adult; Middle Aged; Female; Male; Retrospective Studies; Leukotriene Antagonists; Multiple Sclerosis; Young Adult; Case-Control Studies; Adolescent; Aged; Administrative Claims, Healthcare; Recurrence
PubMed: 38660773
DOI: 10.1177/13524585241240398 -
Luminescence : the Journal of... Dec 2023An innovative, simple, accurate, sensitive, and eco-friendly synchronous fluorescence spectrofluorimetric method has been developed for the simultaneous analysis of...
Eco-friendly synchronous fluorescence spectrofluorimetric method for simultaneous determination of montelukast sodium and fexofenadine hydrochloride in their antiallergic rhinitis fixed-dose combination tablets.
An innovative, simple, accurate, sensitive, and eco-friendly synchronous fluorescence spectrofluorimetric method has been developed for the simultaneous analysis of montelukast sodium (MON) and fexofenadine hydrochloride (FEX). The method relies on measuring the relative synchronous fluorescence intensity of both drugs using Δλ of 60 nm in methanol at 405 nm for MON and 288 nm for FEX. The experimental parameters influencing the developed method were investigated and optimized. The method was linear over the ranges 0.1-2.0 and 2.0-20.0 μg/ml for MON and FEX, respectively. The limits of detection were 0.018 and 0.441 μg/ml, and the limits of quantitation were 0.055 and 1.336 μg/ml for MON and FEX, respectively. The developed method was applied successfully for the determination of the two drugs in their newly released fixed-dose combination prescribed for the treatment of allergic rhinitis. The mean per cent recoveries were found to be 100.680 ± 0.890 and 100.110 ± 0.940 for MON and FEX, respectively. Furthermore, the method was found to be eco-friendly green as was evaluated according to the Green Analytical Procedure Index tool guidelines and analytical eco-scale.
PubMed: 38098178
DOI: 10.1002/bio.4648 -
Cureus Apr 2024A black box warning, signaling potential life-threatening adverse effects of medications or medical devices, is crucial for public and healthcare professional awareness.... (Review)
Review
A black box warning, signaling potential life-threatening adverse effects of medications or medical devices, is crucial for public and healthcare professional awareness. Comprehending and adhering to these warnings can prevent serious harm. This review aims to elucidate their significance. Data on drugs with black box warnings were collected from the Food and Drug Administration's (FDA's) official website using the search term 'Boxed warnings' from January 1, 2015, to January 31, 2024. A Microsoft Excel spreadsheet (Microsoft Corporation, Redmond, WA, USA) containing black box warnings for this period was downloaded from the FDA's website. Additional parameters, such as drug class and whether the warnings were new or existing, were added to the downloaded spreadsheet. The collected data were organized by year, categorizing new and existing warnings, along with details on the evidence source, system-wise classification, and black box warnings for commonly used drugs, including their clinical significance. Results show that in the past decade, 40% of black box warnings were issued in 2023, followed by 12% in 2022. Most warnings (67%) comprised existing ones with minor revisions while 29% were new. Nine existing warnings were removed during the period. Post-marketing studies predominantly provided evidence for these warnings. Neuropsychiatric concerns like addiction potential (31%), suicidal tendency (7%), and hypersensitivity reactions (12%) were the frequently encountered black box warnings. Black box warnings play a crucial role in highlighting the serious adverse effects of medications. Neuropsychiatric warnings have been frequent over the past decade. Awareness of these warnings is essential to prevent adverse effects and enhance patient care, especially concerning drugs like guaifenesin/hydrocodone bitartrate, zolpidem, and montelukast commonly encountered in clinical practice.
PubMed: 38706997
DOI: 10.7759/cureus.57597