Shaheen Nicholas J, Stuart Eugene, Schmitz Sarah M, Mitchell Kate L, Fried Michael W, Zacks Steven, Russo Mark W, Galanko Joseph, Shrestha Roshan
Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
Hepatology. 2005 Mar;41(3):588-94. doi: 10.1002/hep.20593.
Elective esophageal variceal ligation (EVL) is performed to decrease the risk of variceal hemorrhage. Side effects of EVL include hemorrhage, chest pain, dysphagia, and odynophagia. Because gastric acid may exacerbate postbanding ulcers and delay healing, proton pump inhibition may decrease side effects associated with EVL. The aim of this study was to assess the efficacy of pantoprazole, a proton pump inhibitor, as an adjunct to elective EVL. We performed a double-blinded, randomized, placebo-controlled trial of pantoprazole after elective EVL. Subjects in the pantoprazole arm received 40 mg pantoprazole intravenously after EVL followed by 40 mg oral pantoprazole for 9 days. Control subjects received intravenous and oral placebo. Subjects underwent upper endoscopy 10 to 14 days after banding. Primary outcomes included the size and number of ulcers and the subjects' reports of dysphagia, chest pain, and heartburn. Forty-four subjects were randomized: 42 completed the protocol. At follow-up endoscopy, the mean number of ulcers was similar in the two groups. However, the ulcers in the pantoprazole group were on average half as large as in the placebo group (37 mm(2) vs. 82 mm(2), P < .01). Chest pain, dysphagia, and heartburn scores were not significantly different. Four subjects, all in the placebo group, had adverse outcomes, including 3 who bled from postbanding ulcers and 1 with sepsis. In conclusion, subjects receiving pantoprazole after elective EVL had significantly smaller postbanding ulcers on follow-up endoscopy than subjects receiving placebo. However, the total ulcer number and patient symptoms were not different between the groups.
进行选择性食管静脉曲张结扎术（EVL）是为了降低静脉曲张出血的风险。EVL的副作用包括出血、胸痛、吞咽困难和吞咽痛。由于胃酸可能会加重套扎术后溃疡并延迟愈合，质子泵抑制可能会减少与EVL相关的副作用。本研究的目的是评估质子泵抑制剂泮托拉唑作为选择性EVL辅助治疗的疗效。我们在选择性EVL后进行了一项关于泮托拉唑的双盲、随机、安慰剂对照试验。泮托拉唑组的受试者在EVL后静脉注射40 mg泮托拉唑，随后口服40 mg泮托拉唑，持续9天。对照组受试者接受静脉和口服安慰剂。受试者在套扎后10至14天接受上消化道内镜检查。主要结局包括溃疡的大小和数量以及受试者关于吞咽困难、胸痛和烧心的报告。44名受试者被随机分组：42名完成了方案。在随访内镜检查中，两组的平均溃疡数量相似。然而，泮托拉唑组的溃疡平均大小是安慰剂组的一半（37平方毫米对82平方毫米，P <.01）。胸痛、吞咽困难和烧心评分无显著差异。4名受试者，均在安慰剂组，出现了不良结局，包括3名因套扎术后溃疡出血和1名发生败血症。总之，选择性EVL后接受泮托拉唑的受试者在随访内镜检查中套扎术后溃疡明显小于接受安慰剂的受试者。然而，两组之间的溃疡总数和患者症状并无差异。
