乌司他丁预防ERCP术后胰腺炎的Meta分析

Effect of ulinastatin in prevention of post-ERCP pancreatitis:a Meta-analysis

目的:评价乌司他丁预防内镜逆行胰胆管造影术后胰腺炎(post-ERCP pancreatitis,PEP)的安全性和有效性。方法:计算机检索Cochrane图书馆(1970—2010年)、PubMed(1966—2010年)、EM-BASE(1966—2010年)及中国生物医学文献数据库(1978—2010年),查找乌司他丁预防PEP的随机对照试验及其参考文献。由两名研究者独立选择试验、提取资料和评估方法学质量,采用Cochrane协作网RevM4.2软件进行统计。结果:共有6篇随机对照试验,包括1096例患者被纳入分析。乌司他丁组与安慰剂组比较,两组PEP发生率有统计学意义(P=0.04,OR=0.55,95%CI[0.30,0.98]),两组ERCP术后高淀粉血症发生率有统计学意义(P<0.0001,OR=0.48,95%CI[0.34,0.66]);乌司他丁组与加贝酯组比较,两组PEP发生率无统计学意义(P=0.52,OR=1.57,95%CI[0.39,6.24]),两组ERCP术后高淀粉血症发生率无统计学意义(P=0.13,OR=1.85,95%CI[0.83,4.13])。结论:乌司他丁可以有效预防PEP的发生,对ERCP术后高淀粉酶血症的预防也有一定的效果,但需剂量充足(≥15万U);乌司他丁与加贝酯比较,两者预防效果相同。

Objective： To evaluate the effectiveness and safety of ulinastatin in preventing post-ERCP pancreatitis.Methods： Searching Cochrane library（1970—2010）、PubMed（1966—2010）、EMBASE（1966-2010） and CBM（1978—2010） to identify Randomized Controlled Trials（RCT） and references of gabexate in post-endoscopic retrograde cholangiopancreatography pancreatitis（PEP） prevention.Two researchers choose experiments,collect datas,assess methodological quality,use the software RevM4.2.of Cochrane Collaboration.Results： 6 trails involving 1096 patients undergoing ERCP were included.The results of Meta analysis showed that,between ulinastatin group and placebo group,the incidence of the post-ERCP pancreatitis（P=0.04,OR=0.55,95%CI[0.30,0.98]）and the incidence of the post-ERCP hyperlipidemia（P0.00001,OR=0.48,95%CI[0.34,0.66]）had significant difference.However,between ulinastatin group and gabexate group,both of them（P=0.52,OR=1.57,95%CI[0.39,6.24];P=0.13,OR=1.85,95%CI[0.83,4.13]）had no significant difference.Conclusion： The high dose（≥15 000U） is effective for prevention of post-ERCP pancreatitis and post-ERCP hyperlipidemia.The effect which gabexate prevents post-ERCP pancreatitis and post-ERCP hyperlipidemia is the same to ulinastatin.