蛋白酶抑制剂预防内镜逆行胰胆管造影术后胰腺炎的Meta分析

Meta analysis of protease inhibitors in preventing post-ERCP pancreatitis

目的探讨蛋白酶抑制剂能否降低内镜逆行胰胆管造影术(ERCP)后胰腺炎(PEP)等并发症的发生率及临床安全性。方法计算机检索Cochrane图书馆(2011年第2期)、PubMed、EMBASE、CBM、CNKI、VIP、万方(截至2011年9月),并辅以手工检索。全面收集蛋白酶抑制剂预防ERCP后胰腺炎的随机对照试验,采用Cochrane系统评价的方法,提取数据并由2名评价者独立评价并交叉核对纳入研究的质量,对同质研究采用RevMan5.0软件进行Meta分析。结果共纳入12个蛋白酶抑制剂干预性RCT包括4217例患者。Meta分析结果显示:①加贝酯组:可降低PEP的发生率[OR=0.62,95%C(I0.44,0.86);P<0.05;NNT=37];可降低轻-中度PEP的发生率[OR=0.61,95%C(I0.43,0.87);P<0.05;NNT=40];未能降低重度PEP、高危患者PEP、ER-CP后高淀粉酶血症及ERCP术后腹痛的发生率。②乌司他丁组:未能降低PEP和轻-中度PEP、高危患者PEP、ERCP后高淀粉酶血症和腹痛的发生率,其研究未见重度胰腺炎发生。③甲磺酸萘莫司他组:可降低PEP的发生率[P<0.05;OR=0.39,95%C(I0.21,0.70);NNT=22]和轻-中度PEP的发生率,未能降低高危患者PEP及ERCP后高淀粉酶血症的发生率,未见重度胰腺炎的发生及ERCP术后腹痛的发生。④抑肽酶未能降低PEP及ERCP术后高淀粉酶血症的发生率。结论加贝酯及甲磺酸萘莫司他可降低轻-中度PEP的发生率,加贝酯、乌司他丁、甲磺酸萘莫司他均未能降低ERCP术后高淀粉酶血症、高危患者PEP的发生率或ERCP术后腹痛的发生率,抑肽酶对PEP及ERCP术后高淀粉酶血症的发生均无积极预防作用。

【Objectives】To evaluate the clinical efficacy and safety of protease inhibitors in preventing post-ERCP pancreatitis.【Methods】We searched for the electronic bibliographic databases, including Cochrane Library, PubMed, EMbase, CBM, CNKI, VIP database and Wanfang database to assemble the randomized controlled trials (RCTs) of protease inhibitors in preventing post-ERCP pancreatitis. The deadline of the retrieval time was September 2011. Data were extracted and evaluated by two reviewers independently with a designed extraction form. The RevMan 5.0 software was used for meta-analysis on homogeneous studies. 【Results】Twelve RCTs involving 4217patients were included. The results of meta-analyses showed: ①In Gabexate group: Gabexate could decrease the in-cidence of PEP[OR=0.62, 95%CI (0.44,0.86); P <0.05; NN T=37], while it also reduced the incidence of mild-mod-erate PEP [OR=0.61, 95%CI (0.43,0.87); P <0.05; NNT=40], gabexate could not decrease the incidence of severe PEP, PEP for high risk patient, post-ERCP hyperamylasemia and post-ERCP abdominal pain. ②In ulinastain group: Ulinastain could not reduce the incidence of PEP, mild-moderate PEP, PEP for high risk patient, post-ERCP hyper-amylasemia and post-ERCP abdominal pain, no severe PEP has been reported. ③In nafamostat group: Nafamostat could reduce the incidence of PEP [P <0.05; OR=0.39, 95%CI (0.21,0.70); NNT=22] and the incidence of mild-moderate PEP, post-ERCP hyperamylasemia and PEP for high risk patient could not be decreased by nafamostat, no severe PEP and post-ERCP abdominal pain have been reported. ④In aprotinin group: aprotinin could not reduce the incidence of PEP and post-ERCP hyperamylasemia.【Conclusion】Gabexate and nafamostat could decrease the inci-dence of mild-moderate PEP, while gabexate and nafamostat could not reduce the incidence of post-ERCP hyper-amylasemia, PEP for high risk patient, severe PEP or post-ERCP abdominal pain. Existing evidence does not support that ulinastain and aprotinin can reduce the incidence of PEP, so they are not recommended for this indication.