吲哚美辛栓纳肛降低高风险患者ERCP术后胰腺炎发生率的效果

Efficacy and safety of rectal indomethacin suppositories in reducing incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis(PEP) among high-risk patients

目的评估吲哚美辛栓术前纳肛,对ERCP术后胰腺炎(post-ERCP pancreatitis,PEP)高风险因素患者PEP发生率的影响。方法对需要行ERCP手术的患者,进行与其相关联的PEP风险因素评估,筛选出高风险患者共计293例,随机分为观察组(146例)和对照组(147例),分别术前30 min给予吲哚美辛栓和安慰剂栓剂纳肛。比较各组术后高淀粉酶血症及PEP发生情况。结果观察组PEP发生率为4.11%(6/146),对照组PEP发生率为18.37%(27/147)(P<0.01)。观察组6例PEP中1例为重度胰腺炎,对照组27例PEP中6例为重度胰腺炎。根据以上数据计算结果,绝对危险度减少率(ARR)为14%,相对危险度减少率(RRR)为78%,两组术后24 h血淀粉酶水平和高淀粉酶发生率均有统计学差异(P<0.01)。结论对于PEP高风险患者,术前吲哚美辛栓纳肛能够显著减少PEP的发生。

Objective To evaluate the efficacy of rectal administration of indomethacin in reducing the incidence of post-ERCP pancreatitis among high-risk patients.Methods From March 2015 to November 2017,a total of 293 patients at high risk of PEP were randomly divided into the observation group(146) and the control group(147).Both groups received rectal indomethacin and placebo respectively 30 minutes before ERCP.The incidences of PEP and hyperamylasemia were compared between the two groups.Results The incidence of PEP was 4.11%(6/146) in the indomethacin group and 18.37%(27/147) in the placebo group(P<0.01).There was one case of severe pancreatitis among the six cases of PEP in the observation group and six cases of severe pancreatitis among the twenty-seven cases of PEP in the control group,respectively.On the basis of these results,it was calculated that the absolute risk was reduced by 14%,while the relative risk was reduced by 78%.There was significant difference in serum amylase levels and the incidence of hyperamylasemia between the two groups 24 h after ERCP(P<0.01).Conclusions Rectal administration of indomethacin can significantly reduce the risk of PEP among high-risk patients.