Academic Medical Center, Amsterdam, The Netherlands.
N Engl J Med. 2011 May 12;364(19):1807-16. doi: 10.1056/NEJMoa1010502.
Many experts consider laparoscopic Heller's myotomy (LHM) to be superior to pneumatic dilation for the treatment of achalasia, and LHM is increasingly considered to be the treatment of choice for this disorder.
We randomly assigned patients with newly diagnosed achalasia to pneumatic dilation or LHM with Dor's fundoplication. Symptoms, including weight loss, dysphagia, retrosternal pain, and regurgitation, were assessed with the use of the Eckardt score (which ranges from 0 to 12, with higher scores indicating more pronounced symptoms). The primary outcome was therapeutic success (a drop in the Eckardt score to ≤3) at the yearly follow-up assessment. The secondary outcomes included the need for retreatment, pressure at the lower esophageal sphincter, esophageal emptying on a timed barium esophagogram, quality of life, and the rate of complications.
A total of 201 patients were randomly assigned to pneumatic dilation (95 patients) or LHM (106). The mean follow-up time was 43 months (95% confidence interval [CI], 40 to 47). In an intention-to-treat analysis, there was no significant difference between the two groups in the primary outcome; the rate of therapeutic success with pneumatic dilation was 90% after 1 year of follow-up and 86% after 2 years, as compared with a rate with LHM of 93% after 1 year and 90% after 2 years (P=0.46). After 2 years of follow-up, there was no significant between-group difference in the pressure at the lower esophageal sphincter (LHM, 10 mm Hg [95% CI, 8.7 to 12]; pneumatic dilation, 12 mm Hg [95% CI, 9.7 to 14]; P=0.27); esophageal emptying, as assessed by the height of barium-contrast column (LHM, 1.9 cm [95% CI, 0 to 6.8]; pneumatic dilation, 3.7 cm [95% CI, 0 to 8.8]; P=0.21); or quality of life. Similar results were obtained in the per-protocol analysis. Perforation of the esophagus occurred in 4% of the patients during pneumatic dilation, whereas mucosal tears occurred in 12% during LHM. Abnormal exposure to esophageal acid was observed in 15% and 23% of the patients in the pneumatic-dilation and LHM groups, respectively (P=0.28).
After 2 years of follow-up, LHM, as compared with pneumatic dilation, was not associated with superior rates of therapeutic success. (European Achalasia Trial Netherlands Trial Register number, NTR37, and Current Controlled Trials number, ISRCTN56304564.).
许多专家认为腹腔镜 Heller 肌切开术（LHM）优于气囊扩张术，用于治疗贲门失弛缓症，并且 LHM 越来越被认为是这种疾病的首选治疗方法。
我们将新诊断为贲门失弛缓症的患者随机分配接受气囊扩张或 Dor 胃底折叠的 LHM。使用 Eckardt 评分（范围为 0 至 12，分数越高表示症状越明显）评估包括体重减轻、吞咽困难、胸骨后疼痛和反流在内的症状。主要结局是在每年的随访评估中治疗成功（Eckardt 评分降至≤3）。次要结局包括需要再次治疗、食管下括约肌压力、钡餐食管造影排空时间、生活质量和并发症发生率。
共有 201 名患者被随机分配至气囊扩张组（95 名患者）或 LHM 组（106 名患者）。中位随访时间为 43 个月（95%置信区间[CI]，40 至 47）。在意向治疗分析中，两组在主要结局方面没有显著差异；气囊扩张组在 1 年随访后的治疗成功率为 90%，2 年随访后的治疗成功率为 86%，而 LHM 组在 1 年随访后的治疗成功率为 93%，2 年随访后的治疗成功率为 90%（P=0.46）。在 2 年随访后，两组之间的食管下括约肌压力（LHM，10mmHg[95%CI，8.7 至 12]；气囊扩张，12mmHg[95%CI，9.7 至 14]；P=0.27）、钡剂对比柱高度评估的食管排空（LHM，1.9cm[95%CI，0 至 6.8]；气囊扩张，3.7cm[95%CI，0 至 8.8]；P=0.21）或生活质量均无显著差异。在方案设定的分析中也得到了类似的结果。在气囊扩张过程中有 4%的患者发生食管穿孔，而在 LHM 过程中有 12%的患者发生黏膜撕裂。在气囊扩张组和 LHM 组中，分别有 15%和 23%的患者出现食管酸异常暴露（P=0.28）。
在 2 年的随访后，与气囊扩张相比，LHM 并未显示出更高的治疗成功率。（欧洲贲门失弛缓症试验荷兰试验注册编号 NTR37 和当前对照试验编号 ISRCTN56304564。）
