德国汉堡大学医院Thomas Rösch研究组近日取得一项新成果。他们比较了内窥镜或手术肌切开术治疗特发性贲门失弛缓症的效果。该研究2019年12月5日发表于国际一流学术期刊《新英格兰医学杂志》。

气囊扩张和腹腔镜海勒肌切开术（LHM）是治疗特发性贲门失弛缓症的有效方法。经口内镜下肌切开术（POEM）是一种微创治疗方法，具有良好的早期研究效果。

在这项多中心随机试验中，研究组招募了221例症状性贲门失弛缓症患者，将其随机分组，其中112例接受POEM术，109例接受LHM联合Dor胃底折叠术。临床成功定义为术后2年在不进行额外治疗的情况下，Eckardt症状评分为3分及以下。

随访2年后，POEM组中有83.0%的患者获得临床成功，LHM组为81.7%。POEM组的严重不良事件发生率为2.7%，LHM组为7.3%。两组间术后2年的食管功能改善和胃肠道生活质量指数得分均没有显著差异。

经内镜检查，术后3个月，POEM组有57%的患者发生反流性食管炎，LHM组为20%；术后24个月，则分别为44%和29%。

研究结果表明，术后2年，POEM在控制贲门失弛缓症症状方面并不优于LHM联合Dor胃底折叠术，且更容易发生胃食管反流。

附：英文原文

Title: Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia

Author: Yuki B. Werner, M.D.,, Bengt Hakanson, M.D.,, Jan Martinek, M.D.,, Alessandro Repici, M.D.,, Burkhard H.A. von Rahden, M.D.,, Albert J. Bredenoord, M.D.,, Raf Bisschops, M.D.,, Helmut Messmann, M.D.,, Marius C. Vollberg, M.Sc.,, Tania Noder, R.N.,, Jan F. Kersten, M.Sc.,, Oliver Mann, M.D.,, Jakob Izbicki, M.D.,, Alexander Pazdro, M.D.,, Uberto Fumagalli, M.D.,, Riccardo Rosati, M.D.,, Christoph-Thomas Germer, M.D.,, Marlies P. Schijven, M.D.,, Alice Emmermann, M.D.,, Daniel von Renteln, M.D.,, Paul Fockens, M.D.,, Guy Boeckxstaens, M.D.,, and Thomas Rsch, M.D.

Issue&Volume: 2019-12-04

Abstract:

Background

Pneumatic dilation and laparoscopic Heller’s myotomy (LHM) are established treatments for idiopathic achalasia. Peroral endoscopic myotomy (POEM) is a less invasive therapy with promising early study results.

Methods

In a multicenter, randomized trial, we compared POEM with LHM plus Dor’s fundoplication in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less (range, 0 to 12, with higher scores indicating more severe symptoms of achalasia) without the use of additional treatments, at the 2-year follow-up; a noninferiority margin of ?12.5 percentage points was used in the primary analysis. Secondary end points included adverse events, esophageal function, Gastrointestinal Quality of Life Index score (range, 0 to 144, with higher scores indicating better function), and gastroesophageal reflux.

Results

A total of 221 patients were randomly assigned to undergo either POEM (112 patients) or LHM plus Dor’s fundoplication (109 patients). Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group and 81.7% of patients in the LHM group (difference, 1.4 percentage points; 95% confidence interval [CI], ?8.7 to 11.4; P=0.007 for noninferiority). Serious adverse events occurred in 2.7% of patients in the POEM group and 7.3% of patients in the LHM group. Improvement in esophageal function from baseline to 24 months, as assessed by measurement of the integrated relaxation pressure of the lower esophageal sphincter, did not differ significantly between the treatment groups (difference, ?0.75 mm Hg; 95% CI, ?2.26 to 0.76), nor did improvement in the score on the Gastrointestinal Quality of Life Index (difference, 0.14 points; 95% CI, ?4.01 to 4.28). At 3 months, 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis, as assessed by endoscopy; at 24 months, the corresponding percentages were 44% and 29%.

Conclusions

In this randomized trial, POEM was noninferior to LHM plus Dor’s fundoplication in controlling symptoms of achalasia at 2 years. Gastroesophageal reflux was more common among patients who underwent POEM than among those who underwent LHM.

DOI: 10.1056/NEJMoa1905380

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1905380