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2.
Am Heart J ; 273: 1-9, 2024 07.
Artículo en Inglés | MEDLINE | ID: mdl-38508571

RESUMEN

BACKGROUND: Kawasaki disease is a pediatric acute systemic vasculitis that specifically involves the coronary arteries. Timely initiation of immunoglobulin plus aspirin is necessary for diminishing the incidence of coronary artery abnormalities (CAAs). The optimal dose of aspirin, however, remains controversial. The trial aims to evaluate if low-dose aspirin is noninferior to moderate-dose in reducing the risk of CAAs during the initial treatment of Kawasaki disease. METHODS: This is a multi-center, prospective, randomized, open-label, blinded endpoint, noninferiority trial to be conducted in China. The planned study duration is from 2023 to 2026. Data will be analyzed according to intention-to-treat principles. Participants are children and adolescents under the age of 18 with Kawasaki disease, recruited from the inpatient units. A sample size of 1,346 participants will provide 80% power with a one-sided significance level of 0.025. Qualifying children will be randomized (1:1) to receive either intravenous immunoglobulin (2 g/kg) plus oral moderate-dose aspirin (30-50 mg·kg-1·d-1) until the patient is afebrile for at least 48 hours, or immunoglobulin plus low-dose aspirin (3-5 mg·kg-1·d-1) as initial treatment. The primary outcome will be the occurrence of CAAs at 8 weeks after immunoglobulin infusion. Independent blinded pediatric cardiologists will assess the primary endpoint using echocardiography. CONCLUSIONS: There is a shortage of consensus on the dose of aspirin therapy for Kawasaki disease due to the lack of evidence. The results of our randomized trial will provide more concrete evidence for the efficacy and adverse events of low- or moderate-dose aspirin in the acute phase of Kawasaki disease. TRIAL REGISTRATION: www.chictr.org.cn: ChiCTR2300072686.


Asunto(s)
Aspirina , Enfermedad de la Arteria Coronaria , Inmunoglobulinas Intravenosas , Síndrome Mucocutáneo Linfonodular , Adolescente , Niño , Preescolar , Femenino , Humanos , Masculino , Aspirina/administración & dosificación , Aspirina/uso terapéutico , China/epidemiología , Enfermedad de la Arteria Coronaria/prevención & control , Enfermedad de la Arteria Coronaria/etiología , Vasos Coronarios/diagnóstico por imagen , Relación Dosis-Respuesta a Droga , Quimioterapia Combinada , Estudios de Equivalencia como Asunto , Inmunoglobulinas Intravenosas/uso terapéutico , Inmunoglobulinas Intravenosas/administración & dosificación , Factores Inmunológicos/administración & dosificación , Factores Inmunológicos/uso terapéutico , Síndrome Mucocutáneo Linfonodular/complicaciones , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto
3.
Rev. Soc. Bras. Med. Trop ; 48(3): 243-248, May-Jun/2015. tab, graf
Artículo en Inglés | LILACS | ID: lil-749872

RESUMEN

INTRODUCTION: The objective of this study was to investigate the possible link between influenza (Flu) infection and Kawasaki disease (KD). METHODS: We examined the medical records of 1,053 KD cases and 4,669 influenza infection cases hospitalized at our institute from January 1, 2011 to December 31, 2013. Cases of KD with concomitant influenza infection formed the KD + Flu group. Each KD + Flu case was matched with 2 KD cases and 2 influenza infection cases, and these cases were assigned to the KD group and Flu group, respectively. The differences in the principal clinical manifestations, course of disease, incomplete KD rate, intravenous immunoglobulin (IVIG) resistance rate, and echocardiographic detection results between the KD + Flu group and KD group were compared. The fever durations and laboratory test results of these three groups were compared. RESULTS: 1) The seasonal variations of the KD + Flu group, KD group and Flu group were similar. 2) The morbidity rate of incomplete KD was higher in the KD + Flu group compared with the KD group. 3) Patients in the KD + Flu group exhibited a longer time to KD diagnosis compared with patients in the KD group. 4) The KD + Flu group exhibited the longest fever duration among the three groups. 5) The CRP and ESR values in the KD + Flu group were higher those in the Flu or KD groups. CONCLUSIONS: Concomitant influenza infection affects the clinical manifestations of KD and can impact the laboratory test results and the diagnosis and treatment of the disease. However, it remains unclear whether influenza contributes to KD etiology. .


Asunto(s)
Preescolar , Femenino , Humanos , Lactante , Masculino , Gripe Humana/complicaciones , Síndrome Mucocutáneo Linfonodular/complicaciones , Virus de la Influenza A/aislamiento & purificación , Virus de la Influenza B/aislamiento & purificación , Gripe Humana/diagnóstico , Gripe Humana/epidemiología , Gripe Humana/virología , Síndrome Mucocutáneo Linfonodular/epidemiología , Estudios Retrospectivos , Estaciones del Año
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