Pavel Laura, Bălan Gheorghe Gh, Nicorescu Alexandra, Gîlcă-Blanariu Georgiana Emmanuela, Sfarti Cătălin, Chiriac Ștefan, Diaconescu Smaranda, Drug Vasile Liviu, Bălan Gheorghe, Ștefănescu Gabriela
Gastroenterology, "Grigore T. Popa" University of Medicine and Pharmacy, Iași 700115, România.
Endocrinology, "Grigore T. Popa" University of Medicine and Pharmacy, Iași 700115, România.
World J Clin Cases. 2019 Feb 6;7(3):300-310. doi: 10.12998/wjcc.v7.i3.300.
Despite significant technical and training improvements, the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has not significantly dropped. Although many studies have evaluated the efficacy of various agents, . nonsteroidal anti-inflammatory drugs, octreotide, antioxidants, administered various dosages, routes (oral, intrarectal or parenteral), and schedules (before or after the procedure), the results have been conflicting.
To evaluate efficacy of three pharmacologic prophylactic methods for prevention of PEP.
In this prospective, single-center randomized trial, patients who underwent first-time ERCP for choledocholithiasis were randomly assigned to three groups. The first group received 600 mg N-acetylcysteine 15 min prior to ERCP, and per-rectum administration of 50 mg indomethacin both prior to and after completion of the ERCP. The second group was administered only the 50 mg indomethacin per-rectum both prior to and after the ERCP. The third group was administered per-rectum 100 mg indomethacin only after the ERCP, representing the control group given the guideline-recommended regimen. The primary end-point was PEP prevention.
Among the total 211 patients evaluated during the study, 186 fulfilled the inclusion criteria and completed the protocol. The percentages of patients who developed PEP in each of the three groups were not significantly different ( = 2.793, = 0.247). Among the acute PEP cases, for all groups, 14 patients developed mild pancreatitis (77.77%) and 4 moderate. No severe cases of PEP occurred, and in all PEP cases the resolution was favorable. No adverse events related to the medications (digestive hemorrhage, rectal irritation, or allergies) occurred.
The efficacies of split-dose indomethacin and combined administration (N-acetylcysteine with indomethacin) for preventing PEP were similar to that of the standard regimen.
尽管在技术和培训方面有了显著改进，但内镜逆行胰胆管造影术（ERCP）后胰腺炎（PEP）的发生率并未显著下降。尽管许多研究评估了各种药物的疗效，包括非甾体类抗炎药、奥曲肽、抗氧化剂，采用了不同的剂量、给药途径（口服、直肠内或胃肠外）和给药方案（术前或术后），但结果一直存在矛盾。
评估三种药物预防方法对预防PEP的疗效。
在这项前瞻性、单中心随机试验中，因胆总管结石首次接受ERCP的患者被随机分为三组。第一组在ERCP前15分钟接受600毫克N-乙酰半胱氨酸，并在ERCP术前和术后经直肠给予50毫克吲哚美辛。第二组仅在ERCP术前和术后经直肠给予50毫克吲哚美辛。第三组仅在ERCP术后经直肠给予100毫克吲哚美辛，作为给予指南推荐方案的对照组。主要终点是预防PEP。
在研究期间评估的211例患者中，186例符合纳入标准并完成了方案。三组中发生PEP的患者百分比无显著差异（χ² = 2.793，P = 0.247）。在急性PEP病例中，所有组中，14例患者发生轻度胰腺炎（77.77%），4例为中度。未发生严重PEP病例，所有PEP病例均预后良好。未发生与药物相关的不良事件（消化性出血、直肠刺激或过敏）。
分剂量吲哚美辛和联合给药（N-乙酰半胱氨酸与吲哚美辛）预防PEP的疗效与标准方案相似。
