PH II STUDY RECOMBINANT PLATELET ACTIVATING FACTOR ACETYLHYDROLASE

本研究的目的是：1)确定预防性应用rPAF-AH是否以剂量依赖的方式降低内窥镜下逆行胆胰管造影术(ERCP)后胰腺炎的发生率和严重程度。2)评价预防性应用RPAH-AH预防ERCP术后胰腺炎的成本-效果。3)研究RPAH-AH静脉给药的安全性和药代动力学行为。

The objectives of this study are: 1)to determine if the prophylactic administration of rPAF-AH decreases in incidence and severity of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in a dose-dependent manner. 2)to evaluate the cost-efficacy of rPAH-AH when administered prophylactically to prevent post-ERCP pancreatitis. 3)to characterize the safety and pharmacokinetic behavior of rPAH-AH after intravenous administration in patients scheduled to undergo ERCP.