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Addition of Methylprednisolone to Initial Treatment for Kawasaki Disease Patients

2019-09-11 01:53:34 | BioPortfolio

Summary

This study evaluates the efficacy of the addition of methylprednisolone to conventional initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in children with Kawasaki disease (KD).

Description

This is a multicenter, open-label, blind-endpoints, randomized controlled trial at 10 hospitals in China. The investigators enrolled KD children diagnosed within 10 days of onset. Participants will be randomly assigned in a 1:1 ratio to the control group (receiving 2g/kg IVIG and 30 mg/kg aspirin) or the intervention group (receiving 2 g/kg IVIG, 30 mg/kg aspirin and additinal 2 mg/kg intravenous methylprednisolone). Baseline characteristics of each patient will be collected, including sex, age of onset, height, body weight, subtype of KD, fever days before initial IVIG, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at admission, at week 2, week 4, week 8, and week 12 after onset of KD to assess the coronary artery lesions.

Study Design

Conditions

Kawasaki Disease

Intervention

IVIG, Aspirin, Methylprednisolone

Location

Children's Hospital of Fudan University
Shanghai
China
201102

Status

Not yet recruiting

Source

Children's Hospital of Fudan University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-11T01:53:34-0400

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Medical and Biotech [MESH] Definitions

A water-soluble ester of METHYLPREDNISOLONE used for cardiac, allergic, and hypoxic emergencies.

A non-steroidal anti-inflammatory agent that is less effective than equal doses of ASPIRIN in relieving pain and reducing fever. However, individuals who are hypersensitive to ASPIRIN may tolerate sodium salicylate. In general, this salicylate produces the same adverse reactions as ASPIRIN, but there is less occult gastrointestinal bleeding. (From AMA Drug Evaluations Annual, 1992, p120)

Asthmatic adverse reaction (e.g., BRONCHOCONSTRICTION) to conventional NSAIDS including aspirin use.

A drug combination of aspirin and dipyridamole that functions as a PLATELET AGGREGATION INHIBITOR, used to prevent THROMBOSIS and STROKE in TRANSIENT ISCHEMIC ATTACK patients.

The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)

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