A randomized prospective study on the use of 2 g-IVIG or 1 g-IVIG as therapy for Kawasaki disease

• Published in: European journal of pediatrics Vol. 166; no. 6; pp. 565 - 571
• Main Authors: SAKATA, Koichi, HAMAOKA, Kenji, YAMAMOTO, Toru, HORII, Yoshihiro, KIDO, Sachiko, OZAWA, Sei-Ichiro, NIBOSHI, Ayumi, YOSHIHARA, Takao, NISHIKI, Tesuo, NAKAGAWA, Yumi, KAZUTA, Kikuko, MORIMOTO, Yoshiko, KAMIYA, Yasutaka
• Format: Journal Article
• Language: English
• Published: Heidelberg Springer 01.06.2007; Berlin Springer Nature B.V; National Library of Medicine - MEDLINE Abstracts
• Subjects: Aspirin; Biological and medical sciences; Body temperature; Child; Child, Preschool; Coronary Disease - etiology; Coronary Disease - prevention & control; Coronary vessels; Dose-Response Relationship, Drug; Fees, Pharmaceutical; Female; General aspects; Humans; Illnesses; Immunoglobulins, Intravenous - administration & dosage; Immunoglobulins, Intravenous - economics; Immunoglobulins, Intravenous - therapeutic use; Infant; Kawasaki disease; Male; Medical sciences; Mucocutaneous Lymph Node Syndrome - complications; Mucocutaneous Lymph Node Syndrome - drug therapy; Mucocutaneous Lymph Node Syndrome - physiopathology; Prospective Studies; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Working groups; Japan; Kawasaki syndrome; Immunopathology; Pediatrics; Therapy; Immunoglobulins; Immune globulin Resistance; Intravenous administration; Use; Cardiovascular disease; Autoimmune disease; Vascular disease; Randomization; Vasculitis; Immune resistance; Treatment; Follow up study; Health economy; Systemic disease; Clinical trial; Cost Discriminate analysis Kawasaki disease; Cost analysis
• ISSN: 0340-6199; 1432-1076
• DOI: 10.1007/s00431-006-0280-3

A single, 2 g/kg dose of immune globulin (IG), denoted 2 g-intravenous (IV)IG, has become a standard regimen for treating Kawasaki disease (KD) because of its highly preventive effect on coronary arterial lesions (CAL). However, IG is obtained from blood specimens, a drawback to many patients, and is also very expensive. This randomized prospective study reported here was carried out with the aim of developing a treatment regimen that would reduce the total dose of IG. The study tested two protocols (A: 2 g-IVIG; B: 1 g-IVIG) that included the strategy of administering additional IVIG to IVIG-resistant patients based on the criteria we described previously. In protocol A, an additional 2 g-IVIG was administered only once; in protocol B, the first additional IVIG was 1 g-IVIG and the second was 2 g-IVIG. One hundred and nine patients who were admitted before the seventh day of illness and had no CAL at the time of admission were enrolled in the study (protocol A: 54 patients; B: 55 patients). In the protocol A group, 7.4% (4/54) of the patients received 4 g/kg IG. In protocol B, 41.8% (23/55) were treated only with 1 g/kg IG, and 10.9% (6/55) received 4 g/kg IG. No significant differences were observed between the patients of the two subgroups receiving 4 g/kg IG in each protocol group. Discriminate analysis also suggested that 52.4% of the patients in the protocol A group could be treated only with 1 g/kg IG. On the other hand, no significant difference was observed in the incidence of aneurysms between patients in the protocol A group (1/54) and those in the protocol B group (4/55). Our protocol based on 1 g-IVIG, including additional IVIG, was assessed to be an effective treatment and to provide a considerably useful means to reduce the total dose of IG.