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Overuse of steroids in Kawasaki challenged

By ZHOU WENTING in Shanghai | China Daily | Updated: 2026-04-22 09:03
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A landmark clinical study led by the Children's Hospital of Fudan University has found that hormone therapy does not reduce the risk of life-threatening cardiovascular complications in children with Kawasaki disease, resolving a decades-long debate in the global medical community.

The study, the largest of its kind, involved 29 medical institutions across China. Researchers say the findings will provide a road map for preventing the overuse of steroids in treating the condition, which causes systemic vasculitis, a dangerous inflammation of the blood vessels throughout the body. The research was published in The New England Journal of Medicine on Thursday.

Kawasaki disease predominantly affects children under 5 years. While it occurs worldwide, it is most prevalent in East Asia. In China, approximately one in every 1,000 children under age 4 is diagnosed with the disease annually.

The primary danger of the condition is the development of coronary artery lesions, which are damaged areas or scars in the blood vessels that supply oxygen to the heart. Even with standard treatments, 10 to 20 percent of children develop these lesions. In more severe cases, 0.5 percent to 1 percent of patients develop giant coronary artery aneurysms, which are large, weakened bulges in the artery wall that can lead to heart attacks or death.

For 20 years, doctors have been divided over whether hormones, specifically corticosteroids, can help reduce this inflammation. Previous studies were often too small or inconsistent to provide a clear answer. The new trial, which began in 2021, tracked more than 3,050 participants and found no statistical difference in heart complications between children who received hormone therapy and those who did not at the two-week, one-month, and three-month marks. Furthermore, for patients who did not respond to initial standard treatments, the use of hormones actually increased the risk of developing cardiovascular complications.

Medical experts say the results will shift the focus away from broad hormone treatments toward targeted therapies. Rather than dampening the entire immune system, researchers hope to develop drugs that stop the specific biological triggers causing the artery walls to swell. Jane W. Newburger, a cardiologist from the United States, said,"Future research must move beyond conventional markers to identify the specific biologic factors driving tissue-level inflammation and to enable the development of targeted therapies for the children at highest risk for life-threatening cardiovascular complications."

Wang Yi, president of the Children's Hospital of Fudan University, noted that the hospital treated over 7,000 international patients in 2025, many with critical genetic conditions. She said this study is a step toward establishing Shanghai as a global medical hub and will help clarify the logic of such diseases to guide the development of new medical disciplines.

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