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.
出处
《中国循证医学杂志》
CSCD
2005年第10期767-777,共11页
Chinese Journal of Evidence-based Medicine
