BackgroundThe common cold and other viral airway infections are highly prevalent in the population, and their treatment often requires the use of medications for symptomatic relief. Paracetamol is as an analgesic and antipyretic; chlorphenamine is an antihistamine; and phenylephrine, a vasoconstrictor and decongestant. This randomized, double-blind, placebo-controlled trial sought to evaluate the efficacy and safety of a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine in the symptomatic treatment of the common cold and flu-like syndrome in adults.MethodsThis study enrolled 146 individuals aged 18 to 60 years who had moderate to severe flu-like syndrome or common cold. After clinical examination and laboratory tests, individuals were randomly assigned to receive the fixed-dose combination (73) or placebo (73), five capsules per day for 48 to 72 hours. The primary efficacy endpoint was the sum of the scores of 10 symptoms on a four-point Likert-type scale. To evaluate treatment safety, the occurrence of adverse events was also measured.ResultsMean age was 33.5 (±9.5) years in the placebo group and 33.8 (±11.5) in the treatment group. There were 55 women and 18 men in the placebo group, and 46 women and 27 men in the treatment group. Comparison of overall symptom scores in the two groups revealed a significantly greater reduction in the treatment group than in the placebo group (p = 0.015). Analysis at the first 13 dose intervals (± 66 h of treatment) showed a greater reduction of symptom scores in the treatment group than in the placebo group (p < 0.05). The number and distribution of adverse events were similar in both groups.ConclusionA fixed-dose combination of paracetamol, chlorphenamine and phenylephrine was safe and more effective than placebo in the symptomatic treatment of the common cold or flu-like syndrome in adults.Trial registrationNCT01389518
BackgroundBotulinum toxin type A (btxA) is one of the main treatment choices for patients with spasticity. Prosigne® a new released botulinum toxin serotype A may have the same effectiveness as Botox® in focal dystonia. However, there are no randomized clinical trials comparing these formulations in spasticity treatment. The aim of our study was to compare the efficacy and safety of Prosigne® with Botox® in the treatment of spasticity.Methodology/Principal FindingsWe performed a double-blind, randomized, crossover study consisting of 57 patients with clinically meaningful spasticity. The patients were assessed at baseline, 4 and 12 weeks after Prosigne® or Botox® administration. The main outcomes were changes in the patients’ Modified Ashworth Scale (MAS), Functional Independence Measure (FIM) and Pediatric Evaluation of Disability Inventory (PEDI) scores and adverse effects related to the botulinum toxin. Both of the toxins were significantly effective in relieving the level of spasticity in adults and children. There were no significant differences found between the Prosigne® and Botox® treatments regarding their MAS, FIM and PEDI scores. Likewise, the incidence of adverse effects was similar between the two groups.ConclusionOur results suggest that Prosigne® and Botox® are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity.Trial RegistrationClinicalTrials.gov NCT00819065.
Aim:Peginterferon plus ribavirin (peg-IFN/RBV) is still the standard of care for treatment of hepatitis C virus (HCV) in many countries. Given the high toxicity of this regimen, our study aimed to develop a prediction tool that can identify which patients are unlikely to benefit from peg-IFN/RBV and could thus postpone treatment in favor of new-generation direct-acting antivirals.Materials and methods:Binary regression was performed using demographic, clinical, and laboratory covariates and sustained virological response (SVR) outcomes from a prospective cohort of individuals referred for therapy from 2003 to 2008 in a public HCV treatment center in Rio Grande do Sul, Brazil.Results:Of the 743 participants analyzed, 489 completed 48 weeks of treatment (65.8%). A total of 202 of those who completed peg-IFN/RBV therapy achieved SVR (27.2% responders), 196 did not (26.4%), and 91 had missing viral load (VL) at week 72 (12.2% loss to follow-up). The remainder discontinued therapy (n = 254 [34.2%]), 78 (30.7%) doing so due to adverse effects. Baseline covariates included in the regression model were sex, age, human immunodeficiency virus, infection status, aspartate transaminase, alanine transaminase, hemoglobin, platelets, serum creatinine, prothrombin time, pretreatment VL, cirrhosis on liver biopsy, and treatment naivety. A predicted SVR of 17.9% had 90.0% sensitivity for detecting true nonresponders. The negative likelihood ratio at a predicted SVR of 17.9% was 0.16, and the negative predictive value was 92.6%.Conclusion:Easily obtainable variables can identify patients that will likely not benefit from peg-IFN-based therapy. This prediction model might be useful to clinicians.Clinical significance:To our knowledge, this is the only prediction tool that can reliably help clinicians to postpone peg-IFN/RBV therapy for HCV genotype 1 patients.How to cite this article: Picon RV, Fendt L, Amaral K, Picon PD. Prediction of Sustained Virological Response to Peginterferon-based Therapy for Chronic Hepatitis C: Regression Analysis of a Cohort from Rio Grande do Sul, Brazil. Euroasian J Hepato-Gastroenterol 2017;7(1):27-33.
Cutaneous manifestations are considered an infrequent presentation of coronavirus disease 2019 (COVID-19) and are mostly described in outpatient settings. Its onset during the course of the severe COVID-19 disease has been poorly described in severe cases. Studies focused on dermatological manifestations mostly described maculopapular or pernio-like lesions and less frequently vesicular or varicella-like eruption. We described the occurrence of a vesiculopapular eruption in three laboratoryconfirmed COVID-19 patients associated with severe lung injury in whom the skin findings preceded viral reactivation and recrudescence of hypoxemia. The potential mechanisms for COVID-19-related cutaneous manifestations include immune hypersensitivity, cytokine-release syndrome, deposition of microthrombi, and vasculitis.
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