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

Sohn, Sejung; Kim, Seong Ho; Bae, Eun Jung; Park, In Seung

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(p<0.05), respectively. Even though there was no significant difference in clinical response rate(78.9 vs 60.0%, p>0.1), 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.