Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia
Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia
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DOI：
10.1056/nejmoa1905380
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发表时间：
2019-12-05
影响因子：
158.5
通讯作者：
Roesch, Thomas
中科院分区：
文献类型：
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作者：
Werner, Yuki B.;Hakanson, Bengt;Roesch, Thomas
气囊扩张和腹腔镜Heller肌切开术（LHM）是特发性贲门失弛缓症的既定治疗方法。经口内镜下肌切开术（POEM）是一种微创治疗与有前途的早期研究result. METHODS在一个多中心，随机试验，我们比较POEM与LHM加多尔胃底折叠术在有症状的贲门失弛缓症患者。主要终点是临床成功，定义为2年随访时Eckardt症状评分≤ 3（范围：0 - 12，评分越高表明贲门失弛缓症症状越严重），未使用其他治疗;主要分析中使用的非劣效性界值为-12.5个百分点。次要终点包括不良事件、食管功能、胃肠道生活质量指数评分（范围0 - 144，评分越高表示功能越好）和胃食管反流。POEM组和LHM组分别有83.0%和81.7%的患者在2年随访时观察到临床成功（差异，1.4个百分点; 95%置信区间[CI]，-8.7至11.4;非劣效性P = 0.007）。POEM组和LHM组分别有2.7%和7.3%的患者发生严重不良事件。通过测量下食管括约肌的综合松弛压评估，从基线到24个月，食管功能的改善在治疗组之间没有显著差异（差异，-0.75 mmHg; 95% CI，-2.26至0.76），胃肠道生活质量指数评分也没有改善（差异，0.14分; 95% CI，-4.01至4.28）。在3个月时，POEM组57%的患者和LHM组20%的患者有反流性食管炎，通过内窥镜检查评估;在24个月时，相应的百分比分别为44%和29%.CONCLUSION在这项随机试验中，POEM在2年时控制贲门失弛缓症症状方面不劣于LHM + Dor胃底折叠术。胃食管反流在接受POEM的患者中比接受LHM的患者更常见。
BACKGROUNDPneumatic 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.METHODSIn 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.RESULTSA 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%.CONCLUSIONSIn 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.