Multicenter, Single-Arm, Phase IV Study of Combined Aspirin and High-Dose “IVIG-SN” Therapy for Pediatric Patients with Kawasaki Disease
Korean Circulation Journal
;
: 209-214, 2017.
Article
in English
| WPRIM
| ID: wpr-59343
ABSTRACT
BACKGROUND AND OBJECTIVES:
Intravenous immunoglobulin-SN (IVIG-SN) is a new human immunoglobulin product. Its safety is ensured by pathogen-elimination steps comprising solvent/detergent treatment and a nanofiltration process. This multicenter clinical study was designed to evaluate the efficacy and safety of combined aspirin and high-dose IVIG-SN therapy in pediatric patients with Kawasaki disease (KD). SUBJECTS ANDMETHODS:
We evaluated coronary artery lesions (CALs) at 2 and 7 weeks after administering IVIG-SN; total fever duration; and variations in erythrocyte sedimentation rate, N-terminal pro B-type natriuretic peptide or B-type natriuretic peptide, and creatine kinase-myocardial band level before and after treatment with IVIG-SN (2 g/kg). Adverse events were monitored.RESULTS:
Forty-five patients were enrolled, three of whom were excluded according to the exclusion criteria; the other 42 completed the study. The malefemale ratio was 0.911, and the mean age was 29.11±17.23 months. The mean fever duration before IVIG-SN treatment was 6.45±1.30 days. Although most patients had complete KD (40 patients, 90.91%), four had atypical KD (9.09%). After IVIG-SN treatment, one patient (2.38%) had CALs, which was significantly lower than the incidence reported previously (15%) (p=0.022), but not significantly different from recent data (5%). There were no serious adverse events, though 28 patients (63.64%) had mild adverse events. Three adverse drug reactions occurred in 2 patients (eczema, anemia, and increased eosinophil count), all of which were transient.CONCLUSION:
IVIG-SN treatment in patients with KD was safe and effective.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Blood Sedimentation
/
Coronary Artery Disease
/
Immunoglobulins
/
Aspirin
/
Incidence
/
Immunoglobulins, Intravenous
/
Coronary Vessels
/
Natriuretic Peptide, Brain
/
Creatine
/
Drug-Related Side Effects and Adverse Reactions
Type of study:
Controlled clinical trial
/
Incidence study
/
Prognostic study
Limits:
Humans
Language:
English
Journal:
Korean Circulation Journal
Year:
2017
Type:
Article
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