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1.
JAMA Intern Med ; 182(4): 426-435, 2022 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-35179551

RESUMO

Importance: Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19. Evidence-based data to recommend either for or against the use of ivermectin are needed. Objective: To determine the efficacy of ivermectin in preventing progression to severe disease among high-risk patients with COVID-19. Design, Setting, and Participants: The Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was an open-label randomized clinical trial conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and October 25, 2021. Within the first week of patients' symptom onset, the study enrolled patients 50 years and older with laboratory-confirmed COVID-19, comorbidities, and mild to moderate disease. Interventions: Patients were randomized in a 1:1 ratio to receive either oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care (n = 241) or standard of care alone (n = 249). The standard of care consisted of symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging. Main Outcomes and Measures: The primary outcome was the proportion of patients who progressed to severe disease, defined as the hypoxic stage requiring supplemental oxygen to maintain pulse oximetry oxygen saturation of 95% or higher. Secondary outcomes of the trial included the rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events. Results: Among 490 patients included in the primary analysis (mean [SD] age, 62.5 [8.7] years; 267 women [54.5%]), 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk [RR], 1.25; 95% CI, 0.87-1.80; P = .25). For all prespecified secondary outcomes, there were no significant differences between groups. Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09). The most common adverse event reported was diarrhea (14 [5.8%] in the ivermectin group and 4 [1.6%] in the control group). Conclusions and Relevance: In this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19. Trial Registration: ClinicalTrials.gov Identifier: NCT04920942.


Assuntos
COVID-19 , Ivermectina , Adulto , Progressão da Doença , Feminino , Mortalidade Hospitalar , Humanos , Ivermectina/efeitos adversos , Ivermectina/uso terapêutico , Pessoa de Meia-Idade , SARS-CoV-2 , Resultado do Tratamento
2.
Malays J Med Sci ; 26(4): 101-109, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31496899

RESUMO

BACKGROUND: Antimicrobial resistance is a global problem that is perpetuated by the inappropriate use of antibiotics among doctors. This study aims to assess the antibiotic prescription rate for patients with acute upper respiratory infection (URI) and acute diarrhoea. METHODS: A completed clinical audit cycle was conducted in 2018 in the busy emergency department of a public hospital in Malaysia. Pre- and post-intervention antibiotic prescription data were collected, and changes were implemented through a multifaceted intervention similar to Thailand's Antibiotics Smart Use programme. RESULTS: Data from a total of 1,334 pre-intervention and 1,196 post-intervention patients were collected from the hospital's electronic medical records. The mean (SD) age of participants was 19.88 (17.994) years. The pre-intervention antibiotic prescription rate was 11.2% for acute diarrhoea and 29.1% for acute URI, both of which are above the average national rates. These antibiotic prescription rates significantly reduced post-intervention to 6.2% and 13.7%, respectively, falling below national averages. Antibiotic prescription rate was highest for young children. There were no significant changes in rates of re-attendance or hospital admission following the intervention. CONCLUSION: The multifaceted intervention, which included continuing medical education, physician reminders and patient awareness, was effective in improving the antibiotic prescription rates for these two conditions.

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