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作 者:潘涛[1] 王一平[1] 杨锦林[1] 吴宗英[1] 曾超[1]
出 处:《中国循证医学杂志》2005年第10期767-777,共11页Chinese Journal of Evidence-based Medicine
摘 要:目的评价生长抑素及其类似物能否降低内镜逆行胰胆管造影术(ERCP)后胰腺炎(PEP)的发生率及严重程度,以及临床应用的安全性。方法计算机检索、Cochrane临床对照试验试验资料库(2004年第1期)、MEDLINE(1966~2004.4)、EMBASE(1985~2004.4)、中国生物医学文献数据库(1970~2004.4)和中国循证医学中心随机对照试验资料库,并辅以手工检索,全面收集全世界关于生长抑素及其类似物预防PEP的RCT,按Cochrane协作网推荐的方法进行系统评价。结果共31篇RCT包括4728例患者被纳入评价。Meta分析结果显示,生长抑素可降低PEP的发生率[OR0.33,95%CI(0.20,0.54);P=0.00001;NNT=13];与安慰剂或空白对照试验相比,生长抑素类似物奥曲肽可降低ERCP术后高淀粉酶血症的发生率[OR=0.54,95%CI(0.38,0.77);P=0.0007],但对PEP、重度PEP和ERCP术后腹痛的发生率无影响。结论生长抑素可降低PEP的发生率,可能是预防PEP的有效方法。由于纳入的研究数量较多,有4篇为高质量的研究,且敏感性分析的结果与Meta分析的结果一致,上述结论具有一定的可信度。但目前的证据不支持奥曲肽降低PEP的发生率,故不推荐临床用于PEP的预防。鉴于敏感性分析的结果提示奥曲肽甚至有增高PEP发生率的趋势,是否有必要进行进一步的临床试验需审慎看待。Objective To evaluate the effectiveness and safety of somatostatin and the analogue-octreotide in preventing post-ERCP pancreatitis. Methods We searched Cochrane Clinical Trial Register (Issue 1, April, 2004 ), MEDLINE (1966- April, 2004), EMBASE (1985- April, 2004), CBM disc (1970- April, 2004) and The Clinical Trial Register of Chinese Evidence-Based Medicine Center and handsearched the related journals to identify Randomized Controlled Trials (RCT) of somatostatin and octreotide in post-endoscopic retrograde chnlangiopancreatography pancreatitis(PEP) prevention. Systematic review was conducted using the method recommended by The Cochrane Collaboration. Results Thirty-one trials involving 4 728 patients undergoing ERCP were included. Meta-analysis showed that the incidence of post-ERCP pancreatitis [ OR 0.33, 95% CI 0. 20 to 0. 54; P =0. 000 01 ; NNT =13] was significantly reduced by somatostatin. Octreotide could only reduce the incidence of hyperamylasemia [ OR 0. 54, 95% CI 0. 38 to 0. 77 ; P =0. 000 7 ]. The inci- dence of PEP, severe PEP and post-ERCP abdominal pain could not be reduced by octreotide. Conclusions Somatostatin can prevent post-ERCP pancreatitis. Four trials are of high quality in the 12 included studies and the results are consistent with the sensitive-analysis, so it is credible to some extent. However, existing evidence does not support that octreotide can reduce the incidence of PEP, so it is not recommended for this indication. Sensitive-analysis even showed that octreotide could increase the incidence of PEP. Therefore, whether it is necessary to carry out further clinical trials should be considered with caution.
关 键 词:内镜逆行胰胆管造影术后胰腺炎 生长抑素 奥曲肽 META分析 系统评价
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