双氯芬酸预防经内镜逆行胰胆管造影术后胰腺炎疗效与安全性的系统评价

Diclofenac for Preventing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Systematic Review

目的系统评价常规非甾体类抗炎药双氯芬酸预防经内镜逆行胰胆管造影术后胰腺炎(PEP)的有效性及安全性。方法计算机检索Cochrane图书馆、PubMed、EMbase、OVID、CBM、CNKI、VIP、WanFang Data,并辅以手工检索2011年6月以前出版的《胃肠病学杂志》等12种中文专业期刊及相关学术会议纪要,追溯所获文献的参考文献,全面收集双氯芬酸预防PEP的随机对照试验(RCT),并按Cochrane协作网推荐的方法进行系统评价。结果共纳入5个RCT,共计675例PEP患者。Meta分析结果显示:应用双氯芬酸可降低PEP发病率[OR=0.41,95%CI(0.18,0.95),P=0.04],但敏感性分析提示结果稳定性较差;双氯芬酸不能显著降低重度PEP发病率[OR=0.40,95%CI(0.08,2.06),P=0.27]。5个纳入研究均未报告药物相关不良反应。结论双氯芬酸预防PEP相对安全,有可能会降低PEP的发病率,但对于重度PEP,双氯芬酸预防效果不明显。鉴于本系统评价纳入研究的方法学局限性,且例数有限,上述结论尚待开展更多大样本、高质量的RCT加以验证。

Objective To assess the effectiveness and safety of diclofenac,one of the routine-used NSAIDs,in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis（PEP）.Methods Firstly,the electronic searches were conducted to retrieve Randomized controlled trials（RCTs） from The Cochrane Library,PubMed,Embase,OVID,CBM,CNKI,VIP and WanFang Data.Secondly,12 kinds of specific Chinese journals like Chinese Journal of Gastroenterology and conference proceedings were hand-searched till June 2011,and all references in all included trials were searched,too.The RCTs on diclofenac for preventing PEP were identified and retrieved.The systematic review was conducted by using methods and principles recommended by the Cochrane Collaboration.Results A total of 5 RCTs involving 675 PEP patients were included.The Meta-analysis showed that diclofenac might reduce the incidence of PEP（OR=0.41,95%CI 0.18 to 0.95,P=0.04）,but the sensitivity analysis indicated this result was not stable.No evidence showed diclofenac could reduce the incidence of severe PEP（OR=0.40,95%CI 0.08 to 2.06,P=0.27）.And no adverse reactions related to the drug were reported.Conclusion Diclofenac may be safe and effective in reducing the incidence of PEP,but it has no significant effect on preventing severe PEP.Considering the methodological and scale limitation of included studies,this conclusion still needs to be proved by more large-scale and high-quality RCTs.