Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand.
Surg Endosc. 2021 Jun;35(6):2759-2764. doi: 10.1007/s00464-020-07707-0. Epub 2020 Jun 15.
Esophageal stricture is a significant complication of grade 2b and 3a esophageal injuries and causes much patient suffering. Preventing strictures would be beneficial to patients but there are currently no proven effective drugs. This study aimed to evaluate the effect of omeprazole for preventing esophageal stricture in adults with grade 2b and 3a corrosive esophageal injuries.
This study was an open single-center prospective randomized controlled trial that took place from April 2018 to January 2020. Patients were randomized to standard treatment or 80 mg/day intravenously × 3 days followed by 40 mg/day orally for 4 weeks. They were endoscoped at baseline and 4 weeks post discharge. Strictures were confirmed radiologically.
20 patients were enrolled: 15 with grade 2b and five with grade 3a injuries. Standard care and omeprazole groups numbered 10 each. At 1 month, seven and two patients developed strictures in the standard and omeprazole groups, respectively, p = 0.024, for a risk reduction of 71.4%.
Omeprazole reduced the risk of short-term developing esophageal strictures following grade 2b and 3a corrosive esophageal injuries. Larger studies are needed to reconfirm this finding. Thai Clinical Trials Registry (TCTR) number TCTR20190504001.
食管狭窄是 2b 级和 3a 级食管损伤的严重并发症，给患者带来极大痛苦。预防狭窄对患者有益，但目前尚无有效的药物。本研究旨在评估奥美拉唑预防 2b 级和 3a 级腐蚀性食管损伤成人食管狭窄的效果。
本研究为 2018 年 4 月至 2020 年 1 月期间开展的单中心、开放性、前瞻性随机对照试验。患者被随机分为标准治疗组或 80mg/天静脉滴注×3 天序贯 40mg/天口服 4 周。他们在基线和出院后 4 周时进行内镜检查。狭窄通过放射学确认。
共纳入 20 例患者：15 例 2b 级损伤，5 例 3a 级损伤。标准治疗组和奥美拉唑组各 10 例。1 个月时，标准治疗组和奥美拉唑组分别有 7 例和 2 例患者发生狭窄，p=0.024，奥美拉唑降低狭窄风险 71.4%。
奥美拉唑可降低 2b 级和 3a 级腐蚀性食管损伤后短期发生食管狭窄的风险。需要更大规模的研究来进一步证实这一发现。泰国临床试验注册中心（TCTR）编号 TCTR20190504001。
