Gastroenterology Unit, Department of Medical Sciences, University of Foggia, 71100 Viale Pinto 1, Foggia, Italy.
Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Surg Endosc. 2021 Aug;35(8):4305-4314. doi: 10.1007/s00464-020-07920-x. Epub 2020 Aug 27.
Several interventions with variable efficacy are available as first-line therapy for patients with achalasia. We assessed the comparative efficacy of different strategies for management of achalasia, through a network meta-analysis combining direct and indirect treatment comparisons.
We identified six randomized controlled trials in adults with achalasia that compared the efficacy of pneumatic dilation (PD; n = 260), laparoscopic Heller myotomy (LHM; n = 309), and peroral endoscopic myotomy (POEM; n = 176). Primary efficacy outcome was 1-year treatment success (patient-reported improvement in symptoms based on validated scores); secondary efficacy outcomes were 2-year treatment success and physiologic improvement; safety outcomes were risk of gastroesophageal reflux disease (GERD), severe erosive esophagitis, and procedure-related serious adverse events. We performed pairwise and network meta-analysis for all treatments, and used GRADE criteria to appraise quality of evidence.
Low-quality evidence, based primarily on direct evidence, supports the use of POEM (RR [risk ratio], 1.29; 95% confidence intervals [CI], 0.99-1.69), and LHM (RR, 1.18 [0.96-1.44]) over PD for treatment success at 1 year; no significant difference was observed between LHM and POEM (RR 1.09 [0.86-1.39]). The incidence of severe esophagitis after POEM, LHM, and PD was 5.3%, 3.7%, and 1.5%, respectively. Procedure-related serious adverse event rate after POEM, LHM, and PD was 1.4%, 6.7%, and 4.2%, respectively.
POEM and LHM have comparable efficacy, and may increase treatment success as compared to PD with low confidence in estimates. POEM may have lower rate of serious adverse events compared to LHM and PD, but higher rate of GERD.
几种疗效不同的干预措施可作为贲门失弛缓症患者的一线治疗方法。我们通过直接和间接治疗比较相结合的网络荟萃分析，评估了不同策略治疗贲门失弛缓症的比较疗效。
我们在患有贲门失弛缓症的成年人中确定了六项比较气囊扩张（PD；n=260）、腹腔镜 Heller 肌切开术（LHM；n=309）和经口内镜肌切开术（POEM；n=176）疗效的随机对照试验。主要疗效结局为 1 年治疗成功率（根据经过验证的评分，患者报告的症状改善）；次要疗效结局为 2 年治疗成功率和生理改善；安全性结局为胃食管反流病（GERD）、严重腐蚀性食管炎和与手术相关的严重不良事件的风险。我们对所有治疗方法进行了两两和网络荟萃分析，并使用 GRADE 标准评估证据质量。
基于主要直接证据的低质量证据支持 POEM（RR[风险比]，1.29；95%置信区间[CI]，0.99-1.69）和 LHM（RR，1.18[0.96-1.44]）在 1 年时的治疗成功率高于 PD；LHM 和 POEM 之间无显著差异（RR 1.09[0.86-1.39]）。POEM、LHM 和 PD 后严重食管炎的发生率分别为 5.3%、3.7%和 1.5%。POEM、LHM 和 PD 后与手术相关的严重不良事件发生率分别为 1.4%、6.7%和 4.2%。
POEM 和 LHM 的疗效相当，与 PD 相比，估计疗效增加的置信度较低。与 LHM 和 PD 相比，POEM 可能具有较低的严重不良事件发生率，但 GERD 发生率较高。
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