Dumot J A, Conwell D L, O'Connor J B, Ferguson D R, Vargo J J, Barnes D S, Shay S S, Sterling M J, Horth K S, Issa K, Ponsky J L, Zuccaro G
Department of Gastroenterology, Cleveland Clinic Foundation, Ohio 44195, USA.
Am J Gastroenterol. 1998 Jan;93(1):61-5. doi: 10.1111/j.1572-0241.1998.061_c.x.
Pancreatitis remains the major complication of endoscopic retrograde cholangiopancreatography (ERCP). Uncontrolled data suggest a lower incidence of pancreatitis in patients with a history of iodine sensitivity when given pretreatment with corticosteroids. We conducted a clinical trial to assess the efficacy of a commonly prescribed corticosteroid, methylprednisolone, to prevent ERCP-induced pancreatitis.
Patients were entered into a randomized, multicenter, double-blind, placebo-controlled study of intravenous methylprednisolone (125 mg) versus a saline placebo immediately before the ERCP. All patients were evaluated for early and late complications.
Two hundred eighty-six patients were randomized. Thirty-one randomized patients were excluded for technical reasons at the time of ERCP. Overall, the incidence of pancreatitis was 16 of 129 (12.4%, 95% CI: 6.7-18.1%) in the methylprednisolone group and 11 of 126 (8.7%, 95% CI: 4.4-15.1%) in the placebo group, which was not significantly different (p = 0.34). Although there was a higher rate of sphincterotomy performed in the methylprednisolone group compared to the control group (31.8% vs 16.8%, p = 0.005), the incidence of pancreatitis was not different when patients undergoing sphincterotomy were analyzed separately (13.6% in the methylprednisolone group and 9.6% in the placebo group,p = 0.50). There was no significant difference between the two groups for those with ERCP-induced pancreatitis in hospital length of stay (p = 0.22), days of parenteral analgesia (p = 0.09), or days of parenteral nutrition (p = 0.15).
Intravenous methylprednisolone is not beneficial in preventing ERCP-induced pancreatitis.
胰腺炎仍然是内镜逆行胰胆管造影术（ERCP）的主要并发症。无对照数据表明，有碘过敏史的患者在接受皮质类固醇预处理后胰腺炎发生率较低。我们进行了一项临床试验，以评估常用皮质类固醇甲泼尼龙预防ERCP诱导性胰腺炎的疗效。
患者进入一项随机、多中心、双盲、安慰剂对照研究，在ERCP前立即静脉注射甲泼尼龙（125mg）或生理盐水安慰剂。所有患者均评估早期和晚期并发症。
286例患者被随机分组。31例随机分组患者在ERCP时因技术原因被排除。总体而言，甲泼尼龙组129例中有16例发生胰腺炎（12.4%，95%CI：6.7-18.1%），安慰剂组126例中有11例发生胰腺炎（8.7%，95%CI：4.4-15.1%），差异无统计学意义（p=0.34）。尽管甲泼尼龙组与对照组相比括约肌切开术的实施率更高（31.8%对16.8%，p=0.005），但单独分析接受括约肌切开术的患者时，胰腺炎发生率并无差异（甲泼尼龙组为13.6%，安慰剂组为9.6%，p=0.50）。两组ERCP诱导性胰腺炎患者的住院时间（p=0.22）、胃肠外镇痛天数（p=0.09）或胃肠外营养天数（p=0.15）无显著差异。
静脉注射甲泼尼龙对预防ERCP诱导性胰腺炎无益。
