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Journal of Clinical Medicine Sep 2023Acute pharyngitis can cause sore throat. This multicentre, active-controlled, randomised, open-label, and parallel-group study, conducted according to the German Medical...
Effectiveness and Tolerability of Ectoin Mouth and Throat Spray Althaea Honey (ERS09) for Sore Throat due to Acute Pharyngitis and Dry Cough: A Multicentre, Actively Controlled, Open Label Study in Germany.
Acute pharyngitis can cause sore throat. This multicentre, active-controlled, randomised, open-label, and parallel-group study, conducted according to the German Medical Devices Act, compared the effectiveness and tolerability of ERS09 mouth and throat spray with a well-established device for the treatment of sore throat caused by acute pharyngitis and dry cough. Patients were randomised 1:1 into ERS09/comparator groups (EMSER Sore Throat Spray) for 7 ± 2 days. Patients and investigators reported effectiveness (change in total symptom score [TSS]) and safety endpoints (incidence of adverse events [AEs]; adverse device effects [ADEs]). A total of 186 patients were included (ERS09: = 92; comparator: = 94). The baseline-adjusted mean TSS over 7 days was -90.14 and -74.91 in the ERS09 and comparator groups, respectively ( < 0.05). The majority of patients reached a 50% reduction in symptoms by day 6 (ERS09 = 78.85; comparator = 75.8%). Most patients reported a soothing effect within five minutes (ERS09 = 82%; comparator = 71%). Improvements in individual symptoms were similar with no significant differences between groups; more patients in the ERS09 group reported an improvement in pharyngeal redness/swelling. Three AEs unrelated to medication, one ADE following ERS09, and no serious AE/ADE were reported. ERS09 was as well tolerated and effective as the established device, showing greater improvement in the management of some symptoms and greater patient preference.
PubMed: 37762768
DOI: 10.3390/jcm12185813 -
Maedica Sep 2023Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is known as a positivesense single-strand RNA virus and leads to Coronavirus disease 2019 (COVID-19)....
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is known as a positivesense single-strand RNA virus and leads to Coronavirus disease 2019 (COVID-19). Coronaviruses significantly impact the human respiratory tract. Coronavirus disease is potentially fatal and transmissible in the world. In this study we evaluated the presence or absence of SARS-CoV-2 in 220 patients with un-explained pneumonia by TaqMan real-time PCR assay regarding open reading frame (ORF1ab) and nucleocapsid (N) protein genes. Totally, 224 patients entered the study. Upper and lower respiratory tract secretion samples were obtained during 2020 from patients. Samples contained nose and throat swabs with viral transport medium. RNA was isolated from clinical samples with the GenePure Plus fully automatic Nucleic Acid Purification System, NPA-32+ (Hangzhou Bioer Technology Co. Ltd, Hangzhou, China). 72.32% of cases were positive for COVID-19. All positive cases had the most common symptoms of illness regarding fatigue, dry cough, dyspnea, headache, abdominal pain, nausa, vomiting and myalgia. Fever was observed in 50% of positive cases. Chest computed tomography (CT) scan of all tested patients indicated two-sided chest involvement. Detection of COVID-19 by TaqMan real-time PCR seems to be a powerful method for the screening and detection of novel corona virus infection.
PubMed: 38023762
DOI: 10.26574/maedica.2023.18.3.442 -
The Lancet. Respiratory Medicine Jul 2024Morbidity and mortality in pulmonary arterial hypertension (PAH) remain high. Activation of platelet-derived growth factor receptor, colony stimulating factor 1... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Morbidity and mortality in pulmonary arterial hypertension (PAH) remain high. Activation of platelet-derived growth factor receptor, colony stimulating factor 1 receptor, and mast or stem cell growth factor receptor kinases stimulates inflammatory, proliferative, and fibrotic pathways driving pulmonary vascular remodelling in PAH. Seralutinib, an inhaled kinase inhibitor, targets these pathways. We aimed to evaluate the efficacy and safety of seralutinib in patients with PAH receiving standard background therapy.
METHODS
The TORREY trial was a phase 2, randomised, multicentre, multinational, double-blind, placebo-controlled study. Patients with PAH from 40 hospital and community sites were randomly assigned 1:1 via interactive response technologies to receive seralutinib (60 mg twice daily for 2 weeks, then increased to 90 mg twice daily as tolerated) or placebo by dry powder inhaler twice daily for 24 weeks. Randomisation was stratified by baseline pulmonary vascular resistance (PVR; <800 dyne·s/cm and ≥800 dyne·s/cm). Patients were eligible if classified as WHO Group 1 PH (PAH), WHO Functional Class II or III, with a PVR of 400 dyne·s/cm or more, and a 6 min walk distance of between 150 m and 550 m. The primary endpoint was change in PVR from baseline to 24 weeks. Analyses for efficacy endpoints were conducted in randomly assigned patients (intention-to-treat population). Safety analyses included all patients who received the study drug. TORREY was registered with ClinicalTrials.gov (NCT04456998) and EudraCT (2019-002669-37) and is completed.
FINDINGS
From Nov 12, 2020, to April 20, 2022, 151 patients were screened for eligibility, and following exclusions, 86 adults receiving PAH background therapy were randomly assigned to seralutinib (n=44; four male, 40 female) or placebo (n=42; four male, 38 female), and comprised the intention-to-treat population. At baseline, treatment groups were balanced except for a higher representation of WHO Functional Class II patients in the seralutinib group. The least squares mean change from baseline to week 24 in PVR was 21·2 dyne·s/cm (95% CI -37·4 to 79·8) for the placebo group and -74·9 dyne·s/cm (-139·7 to -10·2) for the seralutinib group. The least squares mean difference between the seralutinib and placebo groups for change in PVR was -96·1 dyne·s/cm (95% CI -183·5 to -8·8; p=0·03). The most common treatment-emergent adverse event in both treatment groups was cough: 16 (38%) of 42 patients in the placebo group; 19 (43%) of 44 patients in the seralutinib group.
INTERPRETATION
Treatment with inhaled seralutinib significantly decreased PVR, meeting the primary endpoint of the study among patients receiving background therapy for PAH.
FUNDING
Gossamer Bio.
Topics: Humans; Male; Double-Blind Method; Female; Middle Aged; Adult; Treatment Outcome; Aged; Pulmonary Arterial Hypertension; Protein Kinase Inhibitors; Vascular Resistance; Administration, Inhalation; Hypertension, Pulmonary
PubMed: 38705167
DOI: 10.1016/S2213-2600(24)00072-9 -
Thoracic Research and Practice Jul 2023A rare case of a patient with chronic obstructive pulmonary disease who developed secondary anthracofibrosis to biomass exposure, fibrosing mediastinitis due to...
A rare case of a patient with chronic obstructive pulmonary disease who developed secondary anthracofibrosis to biomass exposure, fibrosing mediastinitis due to anthracotic enlarged lymph nodes in the mediastinum, and pulmonary hypertension because of compres- sion of the lymph nodes on the pulmonary arteries is presented. This is a case report of a 71-year-old female patient who has been followed up with chronic obstructive pulmonary disease for 10 years, has no history of smoking, and has been exposed to biomass for many years. The patient, who had been hospitalized in various centers for the last 3 years due to progressive shortness of breath and dry cough, applied to us with dry cough and dyspnea complaints. On echocardiography, systolic pulmonary arterial pressure was found to be 59 mmHg. For the etiology of pulmonary hypertension, dual-energy thoracic computed tomography was performed with the suspicion of chronic thromboembolic pulmonary hypertension. No filling defect compatible with thromboembolism was detected. In right heart catheterization, mean pulmonary artery pressure was 27 mmHg, pulmonary capillary tip pressure was 7 mmHg, and pulmonary vascular resistance was 3.71 woods units. Endobronchial ultrasound was applied to the patient with the preliminary diagnoses of lymphoma, anthracosis, fibrosing mediastinitis, and infection. Widespread anthracosis was observed in all lobes and segments macroscopically. The lymph node in the subcarinal area was interpreted as anthracotic lymph node. Anthracosis is defined as black pigmentation involving the mucosal, and submucosal layers of the tracheobronchial tree and the lung parenchyma. If anthracosis is associated with luminal obliteration and/or mucosal proliferation causing obstruction, it is considered anthracofibrosis. In this case, we saw that secondary anthracofibrosis, fibrosing mediastinitis due to anthracotic enlarged lymph nodes in the mediastinum, and pulmonary hypertension may develop because of compression of the lymph nodes on the pulmonary arteries, and we wanted to draw attention to it was a rare case.
PubMed: 37485714
DOI: 10.5152/ThoracResPract.2023.22110 -
Harmful Algae Nov 2023This investigation was undertaken to characterize health effects associated with a major bloom of blue-green algae due to the proliferation Microcystis aeruginosa that...
This investigation was undertaken to characterize health effects associated with a major bloom of blue-green algae due to the proliferation Microcystis aeruginosa that occurred in Florida in 2018. Cyanobacteria produce multiple toxins, including the potent hepatotoxic microcystins (MCs), that have been reported to cause illness in exposed persons worldwide. Widespread exposure to toxins released by blue-green algae during the 2018 bloom was shown by the presence of MCs in the nasal passages of 95 percent of the individuals studied previously in south Florida (Schaefer et al., 2020). The current analyses were conducted to determine whether self-reported symptoms were associated with activity patterns, direct contact with water, residential, recreational, and occupational exposure. The 125 persons who participated in the initial study reported an average of 4.94 (± 4.87) symptoms. Those reported most commonly included rhinorrhea, sneezing, headache, sore throat and dry cough. Respiratory symptoms were reported by 74%, ocular symptoms by 62%, and gastrointestinal symptoms by 35% of respondents. Residential and recreational exposures were associated with increased risks of respiratory, gastrointestinal, or ocular symptoms in univariate and adjusted multivariable analyses. Residential exposure was significantly associated with increased reporting of dry cough (p = 0.03), dyspnea (p < 0.01) and wheezy respirations (p = 0.04). Among persons reporting gastrointestinal symptoms, nausea (p = 0.02) and abdominal pain (p < 0.01) were significantly associated with residential exposure. Recreational exposure was significantly associated with sore throat and eye irritation. The findings add to the evidence that exposure to cyanobacteria at concentrations encountered during an algal bloom is associated with a diverse array of symptoms and that inhalation of aerosols constitutes an important exposure pathway.
Topics: Humans; Florida; Cough; Harmful Algal Bloom; Cyanobacteria; Pharyngitis
PubMed: 37951612
DOI: 10.1016/j.hal.2023.102526 -
Clinical Pediatrics Feb 2024The aim of this trial was to assess the effectiveness of Sediflù, a medical device containing active herbal ingredients, on nocturnal and diurnal persistent coughs in...
Efficacy and tolerability of SEDIFLÙ in treating dry or productive cough in the pediatric population (SEPEDIA): A pilot, randomized, double-blind, placebo-controlled, multicenter clinical trial.
The aim of this trial was to assess the effectiveness of Sediflù, a medical device containing active herbal ingredients, on nocturnal and diurnal persistent coughs in children, with a duration of 3 to 7 days. Children with a dry and/or productive cough were enrolled in this prospective, interventional, multicenter, placebo-controlled, double-blind, randomized clinical study. Clinical efficacy was assessed through the evaluation of the soothing action of Sediflù against dry and/or productive coughing, both at night and during the day, and other effects of coughing associated with quality of sleep: frequency, child's quality of sleep, parental quality of sleep and severity. Treatment with Sediflù improved both night-time and day-time cough scores from day 2. The diurnal score also improved significantly in the Sediflù group at days 3 and 7. Sediflù syrup can be considered a valid treatment for cough management in younger children with upper respiratory tract infections, shortening the cough duration.
PubMed: 38323572
DOI: 10.1177/00099228241228074 -
Human Vaccines & Immunotherapeutics Aug 2023To evaluated the risk ratio of Allergic rhinitis (AR) people on the symptoms after COVID-19 infection, and explored the relationship between AR and the symptoms after... (Observational Study)
Observational Study
To evaluated the risk ratio of Allergic rhinitis (AR) people on the symptoms after COVID-19 infection, and explored the relationship between AR and the symptoms after COVID-19 infection. An observational study was performed of people from outpatient department of the Hospital of Chengdu University of Chinese Medicine. Participants completed an electronic survey and between January 10 to January 20, 2023. We divided the participants into three groups according to the disease information of the population: non-AR people group (AR-N), AR patients with sublingual immunotherapy group (AR-S), and AR patients with conventional therapy group (AR-C). A total of 1116 participants were included in the study, with an average age of 21.76 ± 8.713, women accounted for 62.5%, men accounted for 37.5%. The final results showed that the risk of most symptoms after AR-C infection was not different from that of AR-N, except for sore throat, dry and itchy, chest distress, shortness of breath, and dyspnea. AR-S could effectively reduce the risk of post-infection symptoms including: dry and itchy (OR = 0.484, 95%CI: 0.335-0.698), pain (OR = 0.513, 95%CI:0.362-0.728), cough (OR = 0.506, 95% CI:0.341-0.749), expectoration (OR = 0.349, 95% CI:0.244-0.498), fever (OR = 0.569, 95% CI:0.379-0.853), head and body pain (OR = 0.456, 95% CI:0.323-0.644), fatigue (OR = 0.256, 95% CI:0.177-0.371), cold limbs (OR = 0.325, 95%CI:0.227-0.465), diarrhea (OR = 0.246, 95% CI:0.132-0.457), constipation (OR = 0.227, 95%CI:0.100-0.513), hyposmia (OR = 0.456, 95% CI:0.296-0.701), hypogeusia (OR = 0.397, 95% CI:0.259-0.607), chest distress (OR = 0.534, 95% CI:0.343-0.829), shortness of breath (OR = 0.622, 95% CI:0.398-0.974), palpitations (OR = 0.355, 95% CI:0.206-0.613). The risk of symptoms after COVID-19 infection in allergic rhinitis population receiving sublingual immunotherapy is lower.
Topics: Male; Humans; Female; Adolescent; Young Adult; Adult; Sublingual Immunotherapy; COVID-19; Rhinitis, Allergic; Dyspnea; Pain
PubMed: 37530139
DOI: 10.1080/21645515.2023.2236538 -
BMC Ophthalmology Jul 2023Dry eye disease (DED) is caused by a persistently unstable tear film leading to ocular discomfort and is treated mainly with tear supplementation. There is emerging... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Dry eye disease (DED) is caused by a persistently unstable tear film leading to ocular discomfort and is treated mainly with tear supplementation. There is emerging evidence that nicotinic acetylcholine receptor (nAChR) agonists (e.g., varenicline and simpinicline) nasal sprays are effective for DED. Our systematic review and meta-analysis assessed the efficacy and safety of varenicline nasal spray (VNS) for DED treatment.
METHODS
The Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched. Only randomized controlled trials (RCTs) that evaluated the efficacy of VNS versus placebo were included. The efficacy endpoint was the mean change in the anesthetized Schirmer test score (STS), a measure of basal tear production, from baseline. The safety endpoints were serious adverse events (SAEs) and adverse events (AEs). The standardized mean difference (SMD) was used for continuous outcomes, while the risk ratio (RR) was used to demonstrate dichotomous variables. The certainty of the evidence was rated utilizing the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The risk of bias assessment was conducted using the Revised Cochrane risk of bias tool for randomized trials.
RESULTS
Three RCTs (n = 1063) met the eligibility criteria. All RCTs had a low risk of bias. The meta-analysis found a statistically significant increase in the mean STS change from baseline on day 28. The pooled analysis found no significant difference between VNS and placebo in the frequency of SAEs and ocular AEs. However, VNS had a significant effect on developing nasal cavity-related AEs.
CONCLUSION
VNS caused a highly significant improvement regarding the efficacy endpoint but caused an increased frequency of some nasal cavity-related AEs (i.e., cough and throat irritation). However, it caused neither SAEs nor ocular AEs. Included studies had a low risk of bias.
Topics: Humans; Nasal Sprays; Varenicline; Dry Eye Syndromes
PubMed: 37452334
DOI: 10.1186/s12886-023-03069-y -
Respiratory Research Nov 2023Multiple prolonged symptoms are observed in patients who recover from acute coronavirus disease 2019 (COVID-19), defined as long COVID. Cough and sputum are presented by...
BACKGROUND
Multiple prolonged symptoms are observed in patients who recover from acute coronavirus disease 2019 (COVID-19), defined as long COVID. Cough and sputum are presented by patients with long COVID during the acute and post-acute phases. This study aimed to identify specific risk factors for cough and sputum in patients with long COVID.
METHODS
Hospitalized patients with COVID-19 aged 18 years were enrolled in a multicenter cohort study at 26 medical institutions. Clinical data during hospitalization and patient-reported outcomes after discharge were collected from medical records, paper-based questionnaires, and smartphone apps.
RESULTS
At the 3-, 6-, and 12-month follow-ups, there were no differences in the incidence rates of wet and dry coughs. In contrast, the proportion of patients presenting sputum without coughing increased over time compared to those with sputum and coughing. Univariate analyses of cough and sputum at all follow-up visits identified intermittent mandatory ventilation (IMV), smoking, and older age as risk factors for prolonged symptoms. At the 12-month follow-up, persistent cough and sputum were associated with the characteristics of severe COVID-19 based on imaging findings, renal and liver dysfunction, pulmonary thromboembolism, and higher serum levels of LDH, KL-6, and HbA1C. The Kaplan-Meier curves showed that the severity of acute COVID-19 infection was correlated with prolonged cough and sputum production. Multivariable logistic regression analysis showed that IMV ventilator management were independent risk factors for prolonged cough and sputum at 12 months.
CONCLUSIONS
In a Japanese population with long COVID, prolonged cough and sputum production were closely associated with severe COVID-19. These findings emphasize that a preventive approach including appropriate vaccination and contact precaution and further development of therapeutic drugs for COVID-19 are highly recommended for patients with risk factors for severe infection to avoid persistent respiratory symptoms.
Topics: Humans; COVID-19; Post-Acute COVID-19 Syndrome; Sputum; SARS-CoV-2; Cohort Studies; Japan; Cough
PubMed: 37964338
DOI: 10.1186/s12931-023-02591-3 -
Drug Metabolism and Personalized Therapy Sep 2023Development of the secondary to ACEI cough leads to discontinuation of the drugs of this group. Assessing the safety of the ACEIs with further development of customized...
OBJECTIVES
Development of the secondary to ACEI cough leads to discontinuation of the drugs of this group. Assessing the safety of the ACEIs with further development of customized approaches for their administration is a major scientific and practical problem. The objective of this study was to assess the association of the genetic markers with the development of the adverse drug reaction in the form of secondary to enalapril dry cough in the patients with essential arterial hypertension.
METHODS
Study involved 113 patients with the secondary to enalapril cough and 104 patients without development of the secondary to enalapril adverse drug reaction.
RESULTS
The patients carriers of the genotype AA rs2306283 of gene SLCO1B1 had 2-fold higher odds of developing the dry cough than those with the genotypes AG and GG (ОR=2.01, 95%CI=1.10-3.66, р=0.023). Similarly, the patients heterozygous for rs8176746 of gene АВО had 2.3-fold higher odds of developing the ADR in the form of dry cough than the carriers of the genotypes GG and TT (ОR=2.30, 95%CI=1.24-4.29, р=0.008).
CONCLUSIONS
Statistically significant association between the development of the ADR in the form of secondary to enalapril dry cough and polymorphisms rs2306283 of gene SLCO1B1 and rs8176746 of gene ABO was revealed.
Topics: Humans; Enalapril; Cough; Pharmacogenetics; Hypertension; Genotype; Liver-Specific Organic Anion Transporter 1
PubMed: 37201212
DOI: 10.1515/dmpt-2023-0008