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首页> 外文期刊>European journal of gastroenterology and hepatology >Does melatonin addition to indomethacin decrease post endoscopic retrograde cholangiopancreatography pancreatitis? A randomized double-blind controlled trial
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Does melatonin addition to indomethacin decrease post endoscopic retrograde cholangiopancreatography pancreatitis? A randomized double-blind controlled trial

机译：褪黑激素是否添加到吲哚美辛术后内窥镜逆行胆管胰岛素胰腺炎胰腺炎？ 随机双盲对照试验

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Objective Post-ERCP pancreatitis (PEP) is the most prevalent complication of endoscopic retrograde cholangiopancreatography (ERCP). Melatonin has been mentioned as a protective factor against acute pancreatitis. The present study was conducted to determine whether melatonin addition to indomethacin reduces the rate of PEP occurrence. Methods A double-blind randomized clinical trial was conducted on 411 patients undergoing ERCP. Baseline blood samples were collected, and the patients were given melatonin 3 mg tablets plus indomethacin suppository 100 mg or placebo plus indomethacin suppository 100 mg, 1 h before ERCP. The occurrence of PEP was the primary outcome. The concentrations of amylase and lipase were also measured 24 h after ERCP. Results Demographic characteristics of patients, characteristics of ERCP procedures, and baseline levels of amylase and lipase were found to be similar in both groups. The overall rate of PEP was equal to 9.5% in intention-to-treat (ITT) and 11.4% in per-protocol (PP) analyses. There was a significant difference in the rate of PEP between the melatonin and placebo groups (8.7% vs. 11.4% in ITT and 9.3% vs. 13.6% in PP, respectively). In addition, after 24 h, amylase and lipase levels were lower in the melatonin group than in the placebo group (P = 0.041 and 0.032, respectively). Conclusion The results of the present study showed that, administration of melatonin 3 mg tablets plus indomethacin suppository 100 mg 1 h before ERCP could decrease the PEP rate and amylase and lipase levels compared to administration of indomethacin suppository 100 mg alone.
机译：目的ERCP后胰腺炎（PEP）是内窥镜逆行胆管癌（ERCP）最普遍的并发症。褪黑激素已被提及为急性胰腺炎的保护因素。进行了本研究以确定褪黑素是否吲哚美辛的添加量降低了PEP发生的速率。方法采用双盲随机临床试验，对接受ERCP的411名患者进行。收集基线血样，患者给予褪黑素3mg片剂加上吲哚美辛栓100mg或安慰剂加上吲哚美辛栓100mg，在ERCP之前1小时。 PEP的发生是主要结果。在ERCP后24小时也测量淀粉酶和脂肪酶的浓度。结果患者人口统计学特征，ERCP程序的特征，以及淀粉酶和脂肪酶的基线水平在两组中都相似。 PEP的整体率在每方案（PP）分析中的意图（ITT）和11.4％的意图（ITT）等于9.5％。褪黑激素和安慰剂组之间的PEP率有显着差异（ITT中的8.7％，分别为PP中的9.3％和13.6％）。另外，在24小时后，褪黑激素组中淀粉酶和脂肪酶水平低于安慰剂组（P = 0.041和0.032）。结论本研究结果表明，褪黑素3mg片剂的施用3mg片剂在ERCP之前可以降低ERCP率和脂肪酶和脂肪酶水平，与单独的Indomethacin栓剂100mg的施用可以降低PEP速率和淀粉酶和脂肪酶水平。

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