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氩等离子凝固治疗低级别异型增生的 Barrett 食管:一项基于功率设定和质子泵抑制剂剂量影响的长期随访的随机试验。

Argon plasma coagulation for Barrett's esophagus with low-grade dysplasia: a randomized trial with long-term follow-up on the impact of power setting and proton pump inhibitor dose.

机构信息

Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.

Department of Gastroenterological Oncology, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.

出版信息

Endoscopy. 2021 Feb;53(2):123-132. doi: 10.1055/a-1203-5930. Epub 2020 Jul 10.

Abstract

BACKGROUND

This study evaluated the impact of power setting and proton pump inhibitor (PPI) dose on efficacy and safety of argon plasma coagulation (APC) of Barrett's esophagus (BE) with low-grade dysplasia (LGD). METHODS : 71 patients were randomized to APC with power set at 90 W or 60 W followed by 120 mg or 40 mg omeprazole. The primary outcome was the rate of complete (endoscopic and histologic) ablation of BE at 6 weeks. Secondary outcomes included safety and long-term efficacy. RESULTS : Complete ablation rate in the 90 W/120 mg, 90 W/40 mg, and 60 W/120 mg groups was 78 % (18/23; 95 % confidence interval [CI] 61-95), 60 % (15/25; 95 %CI 41-79), 74 % (17/23; 95 %CI 56-92), respectively, at 6 weeks and 70 % (16/23; 95 %CI 51-88), 52 % (13/25; 95 %CI 32-72), and 65 % (15/23; 95 %CI 46-85) at 2 years post-treatment (differences not significant). Additional APC was required in 28 patients (23 residual and 5 recurrent BE). At median follow-up of 108 months, 66/71 patients (93 %; 95 %CI 87-99) maintained complete ablation. No high-grade dysplasia or adenocarcinoma developed. Overall, adverse events (97 % mild) did not differ significantly between groups. Chest pain/discomfort was more frequent in patients receiving 90 W vs. 60 W power ( < 0.001). One patient had esophageal perforation and two developed stenosis.

CONCLUSIONS

APC power setting and PPI dose did not impact efficacy and safety of BE ablation. Complete ablation of BE with LGD was durable in > 90 % of patients, without any evidence of neoplasia progression in the long term.

摘要

背景

本研究评估了功率设置和质子泵抑制剂(PPI)剂量对低级别异型增生(LGD) Barrett 食管(BE)氩等离子凝固(APC)疗效和安全性的影响。

方法

71 例患者随机分为功率设置为 90W 或 60W 的 APC 组,以及接受 120mg 或 40mg 奥美拉唑的治疗组。主要结局为 6 周时 BE 完全(内镜和组织学)消融的比例。次要结局包括安全性和长期疗效。

结果

90W/120mg、90W/40mg 和 60W/120mg 组的完全消融率分别为 78%(18/23;95%置信区间[CI] 61-95)、60%(15/25;95%CI 41-79)和 74%(17/23;95%CI 56-92),6 周时分别为 70%(16/23;95%CI 51-88)、52%(13/25;95%CI 32-72)和 65%(15/23;95%CI 46-85),治疗后 2 年时分别为 66%(16/23;95%CI 51-88)、52%(13/25;95%CI 32-72)和 65%(15/23;95%CI 46-85)(差异无统计学意义)。28 例患者(23 例残余 BE 和 5 例复发 BE)需要额外的 APC。中位随访 108 个月时,71 例患者中有 66 例(93%;95%CI 87-99)维持完全消融。无高级别异型增生或腺癌进展。总体而言,各组间不良事件(97%为轻度)无显著差异。与 60W 相比,90W 组的胸痛/不适更为常见( < 0.001)。1 例患者发生食管穿孔,2 例发生狭窄。

结论

APC 功率设置和 PPI 剂量不影响 BE 消融的疗效和安全性。LGD 的 BE 完全消融在>90%的患者中具有持久性,长期无肿瘤进展证据。

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