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

Abstract

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.

Experience of Intravenous Injection of Normal Human Immunoglobulin in a Patient With Kawasaki Syndrome

“…Доказано, что введение ВВИГ в дозе 2 г/кг однократно непрерывно в течение 8-12 ч более эффективно предупреждает формирование коронарных аневризм, чем ежедневное использование иммуногло-булина по 0,4 г/кг в течение 5 дней [10]. Доказано также преимущество дозы ВВИГ 2 г/кг по сравнению с 1 г/кг [11]. ВВИГ назначают и после 10-го дня болезни детям, у которых ранее диагноз не был поставлен, если у них продолжается немотивированная лихорадка или обнару-жены коронарные аневризмы и сохраняются показатели системного воспаления (увеличение СОЭ или СРБ) [1].…”

Inhibition of Toxic Shock by Human Monoclonal Antibodies against Staphylococcal Enterotoxin B

“…Finally, polyclonal antibodies from pooled human sera are currently used to treat various diseases such as Kawasaki's syndrome, Clostridium difficile colitis, respiratory syncytial virus, cytomegalovirus, chronic dysimmune neuropathies, chronic inflammatory demyelinating polyradiculo-neuropathy, and polyarteritis nodosa [56]–[62]. These IVIg products naturally vary in batch-to-batch potency, represent a potential risk for transmitting infectious agents, and the mechanisms of action are generally not well characterized [31].…”

Indications and safety of intravenous and subcutaneous immunoglobulin therapy

“…Children fulfilling the diagnostic criteria for this acute febrile vasculitic disease receive a single dose of 2 g/kg of IVIg in combination with aspirin as standard therapy within 10 days of the onset of symptoms for prevention of coronary artery aneurysms, resulting in a significant decrease in morbidity and mortality [101][102][103][104][105][106]. It has been reported that in patients who respond to IVIg therapy, the secretion of IL-1 decreases, thus inhibiting T-cell responses to bacterial superantigens [107].…”