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经口内镜下肌切开术:一项来自美国大型单中心系列研究的 10 年结果,具有较高的随访完成率以及对长期疗效、安全性、客观胃食管反流病和内镜下功能性腔道评估的综合分析。

Peroral endoscopic myotomy: 10-year outcomes from a large, single-center U.S. series with high follow-up completion and comprehensive analysis of long-term efficacy, safety, objective GERD, and endoscopic functional luminal assessment.

机构信息

Division of Gastroenterology, Hepatology & Nutrition, NYU-Winthrop Hospital, Mineola, New York, USA.

Department of Medicine, Mt Sinai St Luke's-West Hospital Center, New York, New York, USA.

出版信息

Gastrointest Endosc. 2021 Nov;94(5):930-942. doi: 10.1016/j.gie.2021.05.014. Epub 2021 May 12.

Abstract

BACKGROUND AND AIMS

Peroral endoscopic myotomy (POEM) is becoming the treatment of choice for achalasia. Data beyond 3 years are emerging but are limited. We herein report our 10-year experience, focusing on long-term efficacy and safety including the prevalence, management, and sequelae of postoperative reflux.

METHODS

This was a single-center prospective cohort study.

RESULTS

Six hundred ten consecutive patients received POEM from October 2009 to October 2019, 160 for type 1 achalasia (26.2%), 307 for type II (50.3%), 93 for type III (15.6%), 25 for untyped achalasia (4.1%), and 23 for nonachalasia disorders (3.8%). Two hundred ninety-two patients (47.9%) had prior treatment(s). There was no aborted POEM. Median operation time was 54 minutes. Accidental mucosotomies occurred in 64 patients (10.5%) and clinically significant adverse events in 21 patients (3.4%). No adverse events led to death, surgery, interventional radiology interventions/drains, or altered functional status. At a median follow-up of 30 months, 29 failures occurred, defined as postoperative Eckardt score >3 or need for additional treatment. The Kaplan-Meier clinical success estimates at years 1, 2, 3, 4, 5, 6, and 7 were 98%, 96%, 96%, 94%, 92%, 91%, and 91%, respectively. These are highly accurate estimates because only 13 patients (2%) were missing follow-up assessments. One hundred twenty-five patients (20.5%) had reflux symptoms more than once per week. At a median of 4 months, the pH study was completed in 406 patients (66.6%) and was positive in 232 (57.1%), and endoscopy was completed in 438 patients (71.8%) and showed reflux esophagitis in 218 (49.8%), mostly mild.

CONCLUSIONS

POEM is exceptionally safe and highly effective on long-term follow-up, with >90% clinical success at ≥5 years.

摘要

背景与目的

经口内镜下肌切开术(POEM)已成为贲门失弛缓症的首选治疗方法。目前已有超过 3 年的数据,但数量有限。本研究报告了我们 10 年的经验,重点关注长期疗效和安全性,包括术后反流的发生率、处理方法和后遗症。

方法

这是一项单中心前瞻性队列研究。

结果

2009 年 10 月至 2019 年 10 月,610 例连续患者接受了 POEM 治疗,其中 160 例为 1 型贲门失弛缓症(26.2%),307 例为 2 型(50.3%),93 例为 3 型(15.6%),25 例为未分型贲门失弛缓症(4.1%),23 例为非贲门失弛缓症(3.8%)。292 例(47.9%)患者有既往治疗史。无 POEM 术中转开腹。中位手术时间为 54 分钟。64 例(10.5%)发生意外黏膜切开,21 例(3.4%)发生有临床意义的不良事件。无不良事件导致死亡、手术、介入放射学干预/引流或功能状态改变。中位随访 30 个月时,29 例(4.8%)发生术后失败,定义为术后 Eckardt 评分>3 分或需要额外治疗。术后 1、2、3、4、5、6 和 7 年的 Kaplan-Meier 临床成功率估计分别为 98%、96%、96%、94%、92%、91%和 91%。这些是非常准确的估计,因为只有 13 例(2%)患者失访。125 例(20.5%)患者每周有超过 1 次的反流症状。中位随访 4 个月时,406 例(66.6%)患者完成 pH 研究,其中 232 例(57.1%)为阳性,438 例(71.8%)患者完成内镜检查,218 例(49.8%)有反流性食管炎,大多为轻度。

结论

POEM 是一种非常安全且非常有效的治疗方法,长期随访效果良好,≥5 年的临床成功率超过 90%。

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