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A randomized prospective study on the use of 2 g-IVIG or 1 g-IVIG as therapy for Kawasaki disease.
Eur J Pediatr. 2006 Nov 14
Sakata K, Hamaoka K, Ozawa SI, Niboshi A, Yoshihara T, Nishiki T, Nakagawa Y, Kazuta K, Morimoto Y, Kamiya Y, Yamamoto T, Horii Y, Kido S.
Pediatric
Cardiology and Nephrology, Kyoto Prefectural University of Medicine,
465 Kajiicho, Kyoto, 602-8586, Japan,
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.
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.
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