经口内镜肌切开术与气囊扩张治疗腹腔镜 Heller 肌切开术后持续性或复发性贲门失弛缓症患者的疗效：一项随机临床试验。
The Efficacy of Peroral Endoscopic Myotomy vs Pneumatic Dilation as Treatment for Patients With Achalasia Suffering From Persistent or Recurrent Symptoms After Laparoscopic Heller Myotomy: A Randomized Clinical Trial.
机构信息
Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Digestive Endoscopy Unit, Agostino Gemelli University Hospital, Università Cattolica del Sacro Cuore, Rome, Italy.
出版信息
Gastroenterology. 2023 Jun;164(7):1108-1118.e3. doi: 10.1053/j.gastro.2023.02.048. Epub 2023 Mar 11.
BACKGROUND & AIMS: For patients with achalasia experiencing persistent or recurrent symptoms after laparoscopic Heller myotomy (LHM), pneumatic dilation (PD) is the most frequently used treatment. Per-oral endoscopic myotomy (POEM) is increasingly being investigated as rescue therapy. This study aimed to determine the efficacy of POEM vs PD for patients with persistent or recurrent symptoms after LHM.
METHODS
This randomized multicenter controlled trial included patients after LHM with an Eckardt score >3 and substantial stasis (≥2 cm) on timed barium esophagogram and randomized to POEM or PD. The primary outcome was treatment success, defined as an Eckardt score of ≤3 and without unscheduled re-treatment. Secondary outcomes included the presence of reflux esophagitis, high-resolution manometry, and timed barium esophagogram findings. Follow-up duration was 1 year after initial treatment.
RESULTS
Ninety patients were included. POEM had a higher success rate (28 of 45 patients [62.2%]) than PD (12 of 45 patients [26.7%]; absolute difference, 35.6%; 95% CI, 16.4%-54.7%; P = .001; odds ratio, 0.22; 95% CI, 0.09-0.54; relative risk for success, 2.33; 95% CI, 1.37-3.99). Reflux esophagitis was not significantly different between POEM (12 of 35 [34.3%]) and PD (6 of 40 [15%]). Basal lower esophageal sphincter pressure and integrated relaxation pressure (IRP-4) were significantly lower in the POEM group (P = .034; P = .002). Barium column height after 2 and 5 minutes was significantly less in patients treated with POEM (P = .005; P = .015).
CONCLUSIONS
Among patients with achalasia experiencing persistent or recurrent symptoms after LHM, POEM resulted in a significantly higher success rate than PD, with a numerically higher incidence of grade A-B reflux esophagitis.
NETHERLANDS TRIAL REGISTRY
NL4361 (NTR4501), https://trialsearch.who.int/Trial2.aspx?TrialID = NTR4501.
背景与目的
对于腹腔镜 Heller 肌切开术（LHM）后持续或复发症状的贲门失弛缓症患者，气动扩张（PD）是最常用的治疗方法。经口内镜肌切开术（POEM）作为抢救治疗的应用越来越多。本研究旨在确定 POEM 与 PD 治疗 LHM 后持续或复发症状患者的疗效。
方法
这是一项多中心随机对照试验，纳入了 LHM 后 Eckardt 评分>3 分且食管钡餐造影显示有明显淤滞（≥2cm）的患者，并随机分为 POEM 组或 PD 组。主要结局是治疗成功，定义为 Eckardt 评分≤3 分且无需计划外再次治疗。次要结局包括反流性食管炎、高分辨率测压和食管钡餐造影结果。随访时间为初始治疗后 1 年。
结果
共纳入 90 例患者。POEM 组的成功率（45 例患者中的 28 例[62.2%]）高于 PD 组（45 例患者中的 12 例[26.7%]；绝对差异，35.6%；95%CI，16.4%-54.7%；P=.001；比值比，0.22；95%CI，0.09-0.54；成功的相对风险，2.33；95%CI，1.37-3.99）。POEM 组（35 例中的 12 例[34.3%]）与 PD 组（40 例中的 6 例[15%]）之间的反流性食管炎发生率无显著差异。POEM 组的基础食管下括约肌压力和整合松弛压力（IRP-4）显著低于 PD 组（P=.034；P=.002）。POEM 组治疗后 2 分钟和 5 分钟时的钡柱高度显著较低（P=.005；P=.015）。
结论
在 LHM 后持续或复发症状的贲门失弛缓症患者中，POEM 的成功率显著高于 PD，且 A-B 级反流性食管炎的发生率较高。
荷兰临床试验注册处
NL4361（NTR4501），https://trialsearch.who.int/Trial2.aspx？TrialID=NTR4501。
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