Picibanil (OK-432) is a sclerosing agent derived from a low-virulence strai
n of Streptococcus pyogenes that induces regression of macrocystic lymphang
iomas. This report describes a prospective, nonrandomized trial to evaluate
the efficacy of Picibanil in the treatment of 13 affected children ranging
in age from 1 to 94 months. On average, 4.1 fluoroscopically guided intrac
ystic injections were performed per child. with an average total dose of 0.
56 mg of Picibanil. As judged by physical examination and radiographic stud
ies, 5 children (42%) showed a complete or substantial response, and 2 chil
dren (16%) showed an intermediate response. No response was seen in 5 child
ren (42%), 2 of whom had massive craniofacial lymphangioma. Factors that co
ntribute to failure with Picibanil sclerotherapy are the presence of a sign
ificant microcystic component to the lesion, massive craniofacial involveme
nt, and previous surgical resection. Macrocystic lymphangiomas of the infra
temporal fossa or cervical area have the best response to therapy.