口服类固醇凝胶预防广泛内镜黏膜下剥离术后食管狭窄的疗效：一项随机对照试验。
Efficacy of oral steroid gel in preventing esophageal stricture after extensive endoscopic submucosal dissection: a randomized controlled trial.
机构信息
The Department of Gastroenterology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.
出版信息
Surg Endosc. 2022 Jan;36(1):402-412. doi: 10.1007/s00464-021-08296-2. Epub 2021 Jan 25.
BACKGROUND AND AIMS
Esophageal stricture is a distressing issue for patients with early esophageal cancer following extensive endoscopic submucosal dissection (ESD), and the current steroid-based approaches are unsatisfactory for stricture prophylaxis. We evaluated the efficacy of oral hydrocortisone sodium succinate and aluminum phosphate gel (OHA) for stricture prophylaxis after extensive ESD.
METHODS
Patients undergoing > 3/4 circumferential ESD were randomized to either the endoscopic loco-regional triamcinolone acetonide injection (ETI) plus oral prednisone group or the OHA group. The primary endpoint was incidence of esophageal stricture, and the secondary endpoints included adverse events (AEs) and endoscopic balloon dilations (EBDs).
RESULTS
The incidence of esophageal stricture in OHA group (per-protocol analysis, 9.4%, 3/32; intention-to-treat analysis, 12.1%, 4/33) was significantly less than that of control group (per-protocol analysis, 35.5%, 11/31, P = 0.013; intention-to-treat analysis, 39.4%, 13/33, P = 0.011). Two sessions of EBD were necessary to release all strictures in the OHA group, while the similar EBDs (median 2, range 1-4) for 11 of the control. Operation-related AEs included infection (control vs. OHA group = 9.7% vs. 31.3%, P = 0.034), operation-related hypokalemia (19.4% vs. 31.3%, P = 0.278), perforation (3.2% vs. 3.1%), post-ESD hemorrhage (6.5% vs. 0%), and cardiac arrhythmia (0% vs. 6.3%). Steroid-related AEs included steroid-related hypokalemia (16.1% vs. 25%) and bone fracture (3.2% vs. 0%). Multivariate logistic regression analysis demonstrated that OHA was an independent protective factor for stricture (OR 0.079; 95%CI 0.011, 0.544; P = 0.01) and mucosal defect > 11/12 circumference was an independent risk factor (OR 49.91; 95%CI 6.7, 371.83; P < 0.001).
CONCLUSIONS
OHA showed significantly better efficacy in preventing esophageal stricture after > 3/4 circumferential ESD compared to ETI plus oral prednisone.
背景与目的
广泛内镜黏膜下剥离术（ESD）后早期食管癌患者发生食管狭窄是一个令人痛苦的问题，目前基于类固醇的方法在预防狭窄方面并不令人满意。我们评估了口服氢可琥钠和磷酸铝凝胶（OHA）在广泛 ESD 后预防狭窄的疗效。
方法
接受>3/4 周缘 ESD 的患者被随机分为内镜局部曲安奈德注射（ETI）加口服泼尼松组或 OHA 组。主要终点是食管狭窄的发生率，次要终点包括不良事件（AE）和内镜球囊扩张（EBD）。
结果
OHA 组（按方案分析，9.4%，3/32；意向治疗分析，12.1%，4/33）的食管狭窄发生率明显低于对照组（按方案分析，35.5%，11/31，P=0.013；意向治疗分析，39.4%，13/33，P=0.011）。OHA 组需要进行两次 EBD 才能解除所有狭窄，而对照组需要进行 11 次类似的 EBD（中位数 2 次，范围 1-4 次）。与对照组相比，OHA 组的操作相关 AE 包括感染（9.7% vs. 31.3%，P=0.034）、操作相关低钾血症（19.4% vs. 31.3%，P=0.278）、穿孔（3.2% vs. 3.1%）、ESD 后出血（6.5% vs. 0%）和心律失常（0% vs. 6.3%）。与激素相关的 AE 包括激素相关低钾血症（16.1% vs. 25%）和骨折（3.2% vs. 0%）。多变量逻辑回归分析表明，OHA 是狭窄的独立保护因素（OR 0.079；95%CI 0.011，0.544；P=0.01），黏膜缺损>11/12 周长是狭窄的独立危险因素（OR 49.91；95%CI 6.7，371.83；P<0.001）。
结论
与 ETI 加口服泼尼松相比，OHA 在预防>3/4 周缘 ESD 后食管狭窄方面显示出更好的疗效。
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