摘要
对20例伴有血氧不足呼吸衰竭及氧合指数大于20的足月/接近足月的新生儿进行Ⅰ或Ⅱ期的PGE1(IPGE1)吸入的可行性、安全性及剂量增加研究。对13例新生儿使用喷雾器持续2h增加剂量吸入IPGE1,间隔1h吸入一氧化氮(第1组)。
Twenty term/near term neonates with hypoxemic respiratory failure and oxygenation index ≥20 were enrolled in a Phase Ⅰ/Ⅱ feasibility, safety and dose escalation study of inhaled PGE1 (IPGE1) . Incremental doses of IPGE1, delivered by a jet nebulizer over a 2 - h period, followed by weaning over 1 h, were given to 13 patients before receiving inhaled nitric oxide (INO) (Group Ⅰ), and to seven patients, who failed to respond to INO (Group Ⅱ) . Response was defined as an increase in PaO 2 of either ≥25 (full) or 10-25 (partial) torr. Exit criteria included an acute deterioration in oxygenation status, a persistent oxygenation index above 35 in Group Ⅰ, or the availability of extracorporeal membrane oxygenation (ECMO) in Group Ⅱ. The mean (SD) increase in PaO 2 at the end of IPGE1 administration was 63 (62. 3) in Group Ⅰ (p - 0. 024), and 40 (62. 1) in Group Ⅱ (p > 0.05). In Group Ⅰ, 8 of 13 neonates had a full response, but 4 deteriorated following discontinuation of IPGE1. Of these four, two responded to INO and two were placed on ECMO. Five patients deteriorated before or during IPGE1 and none of them responded to INO. In Group Ⅱ, three of seven patients had a full response to IPGE1. One patient with a partial response and all patients exiting before or during IPGE1 administration were placed on ECMO. The results of our study indicate that IPGE1 may be a safe, selective pulmonary vasodilator in neonatal hypoxemic respiratory failure.
