Clinical Study Of Lipo Prostaglandin E1 In The Treatment Of Severe Acute Pancreatitis Combined With Traditional Chinese Medicine And West

Objective: To investigate the efficacy of lipo prostaglandin El (Lipo PGE1) among pat i ents with severe acute pancreatitis combined with traditional Chinese medicine and west medicine in a randomized open-label and controlled trial.Method: 74 patients fulfilling the Bangkok meeting criteria for severe acute pancreatitis, within 72 hours of the onset of the symptoms were randomized equally to Lipo PGEl treated group and controlled group. Both groups accepted the integrated TCM-WM treatment of "Yi Huo Qing Xia" non-surgically, while the Lipo PGEl group received 20 u g of Lipo PGEl by intravenous injection once daily for 7 days additionally. Laboratory parameters, conditions of disease and therapeutic effect indexes, including occurrence of organic dysfunction, APACHâ…¡ scores, Ranson scores ,the morbidity of SIRS, CTSI(CT Severe Index) scores , SOFA(Sequential organ failure assessment) scores, local complications ,mortality, between the two groups were compared. The length of hospitalization and need for surgery were also compared.Results: 71 patients completed the study protocol (36 treated, 35 controlled). The distribution of variable at baseline describing gender, age, etiology, time from onset of the symptoms to hospital, APACH II scores, Ranson scores , SOFA scores, CTSI scores and the rate of SIRS was similar among patients in both groups. There were no significant difference in laboratory parameters on the third day; but on the eighth day, WBC(white blood cell) count, PLT(platelet) count, AST(aspartate aminotransferase), Uamy/Cr(urinary amylase/creatinine) were lowerin treatment group than the controlled group(P<0.05). The Lipo PGEl treatment decrease the level of total bilirubin, creatinine, lactate dehydrogenase, amylase and lipase of the blood at eighth day, but without statistically significance (p>0.05).Lipo PGEl had no influence on triglyceride of the blood. There was no significant difference in the rate of SIRS and SOFA scores between Lipo PGEl group and controlled group either on day 3 or on day 8. APACHII scores were reduced in Lipo PGEl group both on day 3Median (interquartile range) change-3 (7.0) versus 0(7.0) (P=0.047) and on day 8: -6(7.0) versus-3 (7.0)(P=0.009). The occurrence of organic dysfunction was similar in both groups. Pseudocysts occurred in 11/35(31.4%)patients in controlled group and in 7/36(19.4%) patients in PGEl group; pancreatic infection developed in 5 and 2 patients respectively; the overall local complications (pancreatic necrosis was not included) occurred in 16/35(45.7%) in controlled group and in 9/36(25%) in Lipo PGEl group (P=0.068). The length of hospitalization was 27 days (median) in controlled group and 24.5 days in Lipo PGEl group(P=0.272) 6 patients(17.1%) in controlled group and 3 patients(8.3%) in Lipo PGEl group got surgery(P=0.307) . 4 patients in controlled group and 2 patients in Lipo PGEl group died of severe acute pancreatitis(P=0.323). No obvious adverse events related to the drug were found in Lipo PGEl group.Conclusion: It's concluded that the application of Lipo PGEl to patients with severe acute pancreatitis may improve their conditions and decrease local complications based on integrated Traditional Chinese Medicine and West Medicine, but this was not statistically significant. So it should be verified by enlarging sample size.