The Effects of Lipo Prostaglandin E1(Eglandin ) in Patients with Ductus Dependent Congenital Heart Disease

ABSTRACT

PURPOSE: The adverse reactions of prostaglandin E1(PGE1) are troublesome in the preoperative management of critical patients with ductus dependent congenital heart disease, and a preparation with less adverse reactions is preferable. The effects of Lipo PGE1, a new preparation of PGE1 contained in lipid microspheres, were compared with those of conventional PGE1(PGE1-CD). METHODS: Lipo PGE1 was infused at a rate of 5 ng/kg/min in 19 patients, PGE1-CD at a rate between 10 and 50 ng/kg/min in 15 patients. The effects of drugs were assessed in terms of clinical response rate and overall safety. RESULTS: Clinically, both treatment were effective in relieving cyanosis and hypoxemia except in patients already having either a closed ductus or severe hypoxemia and acidosis. The increments of PaO2 1 hour after infusion were 10.9 and 6.2 mmHg (p>0.1), respectively and those 4 hours postinfusion were 16.0 and 7.8 mmHg(p0.1), the mean dose of Lipo PGE1 at appearance of response was about 1/5 of that of PGE1-CD in overall patients and also in patients with ductus dependent pulmonary circulation(6.7 vs 31.7 ng/kg/min, p<0.005). The adverse reactions occurred in 52.6% of the patients given Lipo PGE1, while it was 86.7% in those administered PGE1-CD(p<0.05). The adverse reactions in Lipo PGE1 group was much less severe than that in PGE1-CD group. There was a significant difference in overall safety between the two drugs(84.2 vs 40%, p<0.01). As the incidence of the adverse reactions increased at dose over 5 ng/kg/min, the initial dose of 5 ng/kg/min seemed to be appropriate for Lipo PGE1. CONCLUSIONS: Lipo PGE1 was effective at a lower dose than was PGE1-CD, and was associated with fewer or less severe adverse reactions, and is therefore judged to be more suitable for clinical use than conventional PGE1-CD.