Furusho 1991.
Methods | Study design: multicentre randomised controlled trial. Method of randomisation: unclear. Number of centres: 16. Power calculations: no. Number of patients randomised: 163 (includes 3 arms ‐ only 102 children in 2 arms relevant). Number of patients analysed: 151. Number of patients excluded from analysis: 12. Reason for exclusions from analysis: not managed according to protocol. Intention‐to‐treat analysis: no. Source of funding: not stated. |
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Participants | Location: Japan, 16 institutes. Inclusion criteria: children with KD enrolled within 7 days of onset October 1985 to June 1986. Exclusion criteria: recurrent KD; coronary artery lesions on admission. |
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Interventions | Group 1: IVIG 200 mg/kg daily for 5 days + ASA 30 to 50 mg/kg/day in 3 divided doses until fever subsided, then 10 to 30 mg/kg daily once a day until "acute reaction had disappeared". Group 2: IVIG 200 mg/kg daily for 5 days without ASA. Group 3: ASA 30 to 50 mg/kg/day in 3 divided doses until fever subsided, then 10 to 30 mg/kg daily once a day until "acute reaction had disappeared". Only children in Groups 1 and 2 considered relevant for this review. |
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Outcomes | Coronary artery abnormalities before day 30 of illness; and at day 30 of illness. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |
ASA: aspirin IVIG: intravenous imunoglobulin KD: Kawasaki disease