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Abstract

Objective: Non-responsive Kawasaki disease to intravenous immunoglobulin (IVIG) increases the risk of coronary artery damage in pediatric patients. There is an urgent clinical need for adjunctive therapies that can improve outcomes in these high-risk children. Dipyridamole, with its antiplatelet and vasodilatory effects, may improve outcomes in such patients, but prospective research evidence is currently lacking. Methods: This multicenter, randomized, open-label trial enrolled 144 pediatric patients with IVIG-resistant Kawasaki disease. Participants were randomly allocated to receive either standard therapy supplemented with oral dipyridamole (2 mg/kg, three times daily), or standard therapy alone. The primary endpoint was the change in mean coronary artery Z-score at 12 weeks. Secondary outcomes included time to fever resolution, changes in inflammatory biomarkers (C-reactive protein, erythrocyte sedimentation rate), platelet count, length of hospitalization, and drug safety. Results: At 12 weeks follow-up, the mean improvement in coronary artery Z-score was significantly greater in the dipyridamole group than in the control group (-0.81 ± 0.83 vs. -0.41 ± 0.80, P=0.004). Additionally, children in this group experienced shorter fever resolution times (19 vs. 25 hours, P=0.007), lower C-reactive protein levels at 72 hours post-treatment (19.3 ± 13.1 vs. 29.1 ± 15.8 mg/L, P<0.001) and erythrocyte sedimentation rate at one week (36.8 ± 17.2 vs. 46.2 ± 19.0 mm/h, P<0.001) were significantly lower, and the median length of hospital stay was shorter (6 vs. 7 days, P=0.043). When evaluating safety outcomes, there was no significant difference in the rate of serious adverse events between the two groups. However, the dipyridamole group had a higher incidence of headache (13.9% vs. 2.8%, P=0.017). Conclusion: The adjunctive use of dipyridamole improves coronary artery status and accelerates clinical recovery in children with IVIG-resistant Kawasaki disease. Given its acceptable safety profile, this medication represents an effective and readily accessible adjunctive treatment option for this patient population.

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