Sotoudehmanesh Rasoul, Khatibian Morteza, Kolahdoozan Shadi, Ainechi Sanaz, Malboosbaf Ramin, Nouraie Mehdi
Digestive Diseases Research Center, Medical Sciences/University of Tehran, Tehran, Iran.
Am J Gastroenterol. 2007 May;102(5):978-83. doi: 10.1111/j.1572-0241.2007.01165.x. Epub 2007 Mar 13.
Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Many medications have been used to prevent this complication. We aimed to evaluate the efficacy of rectally administered indomethacin for the prevention of post-ERCP pancreatitis.
During 18 months, all eligible patients who underwent ERCP were enrolled in this study. In a double-blind randomized trial, patients received a suppository containing indomethacin, 100 mg, or an inert placebo immediately before ERCP. Serum amylase levels and clinically pertinent evaluations were measured in all patients after ERCP.
A total of 490 patients entered the trial, of which half received indomethacin. Twenty-two patients developed pancreatitis; seven cases in the indomethacin group and 15 in the placebo group (P=0.06). Pancreatic duct injection (OR=3.0, 95% CI: 1.3-7.4), pancreatic duct cannulation more than once (OR=4.2, 95% CI: 1.7-10.0), and age less than 60 yr (OR=2.7, 95% CI: 1.0-7.1) were shown to be significant risk factors for developing post-ERCP pancreatitis. In patients who underwent pancreatography with or without cholangiography, the risk of pancreatitis was significantly lower in the indomethacin group compared with the control group (P=0.01, RRR=88%, ARR=0.16, NNT=6). Moderate to severe pancreatitis was significantly higher in the placebo group (P= 0.03).
This trial shows that rectal indomethacin given immediately before ERCP can reduce the incidence and severity of post-ERCP pancreatitis.
急性胰腺炎是内镜逆行胰胆管造影术（ERCP）最常见的并发症。许多药物已被用于预防这一并发症。我们旨在评估直肠给予吲哚美辛预防ERCP术后胰腺炎的疗效。
在18个月期间，所有接受ERCP的符合条件的患者均纳入本研究。在一项双盲随机试验中，患者在ERCP前立即接受含100 mg吲哚美辛的栓剂或惰性安慰剂。所有患者在ERCP后均检测血清淀粉酶水平并进行临床相关评估。
共有490例患者进入试验，其中一半接受吲哚美辛治疗。22例患者发生胰腺炎；吲哚美辛组7例，安慰剂组15例（P=0.06）。胰管注射（比值比[OR]=3.0，95%可信区间[CI]：1.3 - 7.4）、多次胰管插管（OR=4.2，95%CI：1.7 - 10.0）以及年龄小于60岁（OR=2.7，95%CI：1.0 - 7.1）被证明是发生ERCP术后胰腺炎的显著危险因素。在接受胰管造影术（无论是否进行胆管造影术）的患者中，吲哚美辛组胰腺炎的风险显著低于对照组（P=0.01，相对危险度降低率[RRR]=88%，绝对危险度降低率[ARR]=0.16，需治疗人数[NNT]=6）。安慰剂组中重度胰腺炎的发生率显著更高（P=0.03）。
本试验表明，在ERCP前立即直肠给予吲哚美辛可降低ERCP术后胰腺炎的发生率和严重程度。
