Abstract
We conducted a cooperative study to assess the usefulness of intralestional injection of OK-432 in childhood lymphangioma. The concentration of OK-432 (Picibanil) was set at 0.5 KE/10 ml of physiological saline in group A and at 1.0 KE/10 ml in group B on the basis of a phase II clinical study. The tumor redcuction rate was more than 80% in both groups A and B when evaluated at 6 months after the start of treatment. Side effects occurring during treatment were similar in both groups. Fever, swelling and reddening of the tumor, an increased white blood cell conut, and an inreased CRP level were common, but none of these reactions were serious. In the case of cervical lymphangioma, however, care must be taken to avoid tracheal compression when the mass becomes swollen following the intralesional injection of OK-432. When the usefulness of OK-432 was evaluated on the basis of the degree of tumor reduciton and the safety, more than 70% of the patients in both groups A and B received an evalutation of "useful" at 6 months of treatment. This therapy acheived a good cosmetic result, and was suggested to be a promising alternative to conventional therapy.