Laparoscopic Antireflux Surgery vs Esomeprazole Treatment for Chronic GERD

作者：Jean-Paul Galmiche, Jan Gunnar Hatlebakk, Stephen Attwood, Christian Ell, Roberto Fiocca, Stefan Eklund, Göran Långström, Tore Lind, Lars Lundell, for the LOTUS Trial Collaborators · 发表于：JAMA · 年份：2011 · DOI：10.1001/jama.2011.626 · 被引用次数：419 · 研究领域：Gastroesophageal reflux and treatments、Gastrointestinal motility and disorders、Bariatric Surgery and Outcomes

CONTEXT: Gastroesophageal reflux disease (GERD) is a chronic, relapsing disease with symptoms that have negative effects on daily life. Two treatment options are long-term medication or surgery. OBJECTIVE: To evaluate optimized esomeprazole therapy vs standardized laparoscopic antireflux surgery (LARS) in patients with GERD. DESIGN, SETTING, AND PARTICIPANTS: The LOTUS trial, a 5-year exploratory randomized, open, parallel-group trial conducted in academic hospitals in 11 European countries between October 2001 and April 2009 among 554 patients with well-established chronic GERD who initially responded to acid suppression. A total of 372 patients (esomeprazole, n = 192; LARS, n = 180) completed 5-year follow-up. Interventions Two hundred sixty-six patients were randomly assigned to receive esomeprazole, 20 to 40 mg/d, allowing for dose adjustments; 288 were randomly assigned to undergo LARS, of whom 248 actually underwent the operation. MAIN OUTCOME MEASURE: Time to treatment failure (for LARS, defined as need for acid suppressive therapy; for esomeprazole, inadequate symptom control after dose adjustment), expressed as estimated remission rates and analyzed using the Kaplan-Meier method. RESULTS: Estimated remission rates at 5 years were 92% (95% confidence interval [CI], 89%-96%) in the esomeprazole group and 85% (95% CI, 81%-90%) in the LARS group (log-rank P = .048). The difference between groups was no longer statistically significant following best-case scenario modelin...