Comparative safety and efficacy of two immune globulin products in Kawasaki disease.

OBJECTIVE: To compare the safety and efficacy of various intravenously administered immune globulin (IVGG) products in patients with Kawasaki disease. METHODS: We performed a retrospective matched-pair study of 45 pairs of patients, matched by age, gender, hospital, and illness day when IVGG therapy was initiated. All patients received aspirin, 80 to 100 mg/kg per day; one of each pair received Venoglobulin, 2 gm/kg (product A), and the other received Iveegam, 2 gm/kg (product B). Safety was assessed during and after IVGG infusion by recording rigors, pruritus, hypotension, urticaria, and nausea. Treatment efficacy was evaluated by posttreatment height and duration of fever, and subsequent echocardiographic changes. RESULTS: Untoward reactions during infusions occurred more often with product A (25%) than with product B (2%) (p < 0.025); most reactions were rigors (18% vs 2%) (p < 0.05). Therapy was completed in all patients. Height of fever and proportion of patients febrile each day after product A or B did not differ significantly. No differences were found in the frequency of coronary artery abnormalities 1 year after illness. CONCLUSIONS: No significant differences in efficacy appeared between the two IVGG products, but they differed significantly in non-life-threatening adverse reactions, especially infusion-related rigors. Other IVGG products should be evaluated in a similar fashion.

Kawasaki disease in infants less than one year of age.

OBJECTIVE: To identify risk factors for severe sequelae, analyze disease characteristics, and assess efficacy of intravenously administered immune globulin (IVGG) therapy in infants less than 12 months of age with Kawasaki disease. DESIGN: Retrospective chart review of children less than 12 months of age with Kawasaki disease between 1980 and 1993. RESULTS: Of 443 patients with Kawasaki disease, 57 (13%) were less than 1 year of age, including 14 (3%) less than 6 months. Age at onset was a predictor of the development of coronary artery aneurysms (CAA) and of giant (> 8 mm) aneurysms: 11 (79%) of 14 children < 6 months and 17 (44%) of 39 children 6 to 12 months of age acquired CAA (p = 0.06), and 5 (37%) of 14 children < 6 months and 2 (5%) of 39 children 6 to 12 months of age acquired giant CAA (p < 0.01). No specific clinical or laboratory features predicted the development of CAA, which was found in 7 (29%) of 24 patients treated with IVGG by illness day 10 and in 21 (73%) of 29 patients treated after day 10 or never treated with IVGG (p < 0.01). Only 1 (4%) of 24 patients treated by day 10 but 6 (21%) of 29 children treated after day 10 or never treated with IVGG acquired giant CAA (p = 0.01). Persistent (> 1 year) CAA were present in 4 (17%) of 24 IVGG-treated children by day 10 and in 14 (48%) of 29 children not treated by day 10 or never treated with IVGG (p < 0.025). There was no difference in outcome if IVGG was given by illness day 7 or on illness days 8 to 10. CONCLUSIONS: Patients with Kawasaki disease less than 6 months of age are at particularly increased risk of having CAA and giant CAA. Therapy with IVGG, given by illness day 10, is associated with substantial reduction in the frequency of CAA and giant CAA in this high-risk population.

Clindamycin treatment of chronic pharyngeal carriage of group A streptococci.

We previously demonstrated that chronic pharyngeal carriage of group A beta-hemolytic streptococci (GABHS) can be terminated by intramuscular administration of benzathine penicillin plus 4 days of orally administered rifampin. Because an effective oral regimen would be desirable, we compared clindamycin with P + R for treating GABHS carriage. Healthy, symptom-free GABHS carriers were randomly assigned to receive orally administered clindamycin (20 mg/kg per day) three times a day for 10 days or intramuscularly administered benzathine penicillin with oral doses of rifampin (20 mg/kg per day) twice a day for 4 days. Compliance was documented by antibiotic activity in urine. Throat cultures for GABHS were obtained every 3 weeks for up to 9 weeks after treatment. Patients who had positive throat cultures for their original GABHS T type 3 weeks after randomization were crossed over to the other treatment. Treatment success was defined as eradication of the original GABHS T type, with all follow-up cultures negative. Clindamycin eradicated carriage in 24 (92%) of 26 patients; penicillin plus rifampin was effective in 12 (55%) of 22 patients (p less than 0.025). Including patients crossed over 3 weeks after enrollment, clindamycin was effective in 28 (85%) of 33 treatment courses compared with 12 of 22 courses of penicillin plus rifampin (p less than 0.05). We conclude that 10 days of oral clindamycin therapy was significantly more effective than benzathine penicillin plus 4 days of orally administered rifampin for treatment of symptom-free GABHS carriers.