前列腺素E1治疗重症急性胰腺炎的随机对照研究

目的探讨前列腺素E1的脂微球载体制剂（Lipo PGE1）治疗重症急性胰腺炎（SAP）的临床疗效。方法 74例SAP病例,随机分为对照组与治疗组各37例。对照组给予中西医结合的基础治疗,治疗组则在对照组的基础上加用前列腺素E1的脂微球载体制剂,比较两组多项指标。结果治疗组与对照组SOFA评分无明显差异。APACHⅡ评分治疗组在第3天、第8天均较对照组低,但无统计学意义（P〉0.05）,APACHⅡ评分下降的幅度在第3天、第8天治疗组较对照组高,并有统计学意义（P〈0.05）;器官衰竭发生情况两组无明显差异;局部并发症发生率（25%比45.7%,P=0.068）、中转手术率（8.3%比17.1%,P=0.307）、病死率（11.4%比5.6%,P=0.323）较对照组低,但无统计学意义。住院时间治疗组少于对照组,但无统计学意义。结论前列腺素E1的脂微球制剂有助于病情的改善,可有降低局部并发症、减少中转手术率并对器官衰竭的发生无明显影响。

Clinical study of lipo prostaglandin E1 in treatment of severe acute pancreatitis

Objective To investigate the efficacy of lipo prostaglandin E1（Lipo PGE1） on patients with severe acute pancreatitis with 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 PGE1 treated group and controlled group.Both groups accepted the integrated TCM-WM treatment non-surgically,while the Lipo PGE1 group received 20μg of Lipo PGE1 by intravenous injection once daily for 7 days additionally.Laboratory parameters,conditions of disease and therapeutic effect indexes,including occurrence of organic dysfunction,APACHⅡscores,Ranson scores,CTSI（CT Severe Index） scores,SOFA（Sequential organ failure assessment） scores,local complications and 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,APACHⅡscores,Ranson scores,SOFA scores,CTSI scores were similar among patients in both groups.There was no significant difference in SOFA scores between Lipo PGE1 group and controlled group neither on day 3 or on day 8.APACHⅡscores were reduced in Lipo PGE1 group both on day 3 and on day 8.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 PGE1 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 PGE1 group（P=0.068）.The length of hospitalization was 27 days（median） in controlled group and 24.5 days in Lipo PGE1 group.6 patients（17.1%） in controlled group and 3 patients（8.3%） in Lipo PGE1 group got surgery.4 patients in controlled group and 2 patients in Lipo PGE1 group died of severe acute pancreatitis（P=0.323）. Conclusion It＇s concluded that the application of Lipo PGE1 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.