May 10, 2010 (紐澳良) — 根據LOTUS研究的5年追蹤結果，腹腔鏡抗逆流手術(Laparoscopic antireflux surgery，LARS)和質子幫浦抑制劑(PPI)esomeprazole對於控制慢性胃食道逆流疾病(gastroesophageal reflux disease，GERD)的效果相當。LOTUS研究比較了此疾病的藥物和手術治療，結果顯示，兩種治療都安全且耐受良好。
法國Dieu–CHU de Nantes醫院的Jean-Paul Galmiche醫師在2010年消化道疾病週表示，PPI和LARS兩者都被用來治療慢性GERD，我們的研究試圖比較這些方式。研究結果來自有豐富手術經驗與良好訓練之醫師的醫學中心，因此或許無法代表社區醫師的結果；這些資料代表有最佳醫師環境的結果。
Medical and Surgical Management Equally Effective in GERD
By Alice Goodman
Medscape Medical News
May 10, 2010 (New Orleans, Louisiana) — Laparoscopic antireflux surgery (LARS) and the proton pump inhibitor (PPI) esomeprazole were equally effective in maintaining control of chronic gastroesophageal reflux disease (GERD), according to the 5-year follow-up of the LOTUS study, which compared medical and surgical management of the disease. Both treatments were safe and well tolerated.
"Both a PPI and LARS are used to treat chronic GERD. Our study sought to compare these modalities. These results were obtained at centers with high volumes of surgery and with well-trained surgeons. They probably don't reflect results with community surgeons; these data represent results with the best surgeons around," said Jean-Paul Galmiche, MD, from Hotel Dieu–CHU de Nantes in France, here at Digestive Disease Week 2010.
The open-label, parallel-group, multicenter, randomized study involved 626 patients with chronic GERD and confirmed response to esomeprazole. After a 3-month run-in period to assess response to esomeprazole 40?mg daily, 554 patients with a confirmed response were randomized to receive either esomeprazole 20?mg daily (escalated to 20?mg twice a day if needed for symptom control) or LARS. At 5 years, 372 patients remained in the study.
Baseline characteristics were well matched in the 2 treatment groups. About 70% were male, and mean age was around 45 years. High remission rates were observed in both groups (92% for esomeprazole vs 85% for LARS; P?= .048). When protocol violations were excluded, remission rates were 94% vs 85%, respectively (P?= .048).
Treatment failures — defined as a negative answer to the question, "Do you have sufficient control of heartburn and acid regurgitation?" — were reported in 33 patients in the LARS group and in 19 patients in the esomeprazole group. (For patients in the LARS group, treatment failure was also defined as perioperative death or death within 30 days, and need for reoperation.)
In the esomeprazole group, 80% of patients were able to maintain remission at a dose of 20?mg daily. At 5 years, LARS was slightly better than esomeprazole at reducing the prevalence of heartburn, whereas less dysphagia and flatulence were observed in the esomeprazole group.
"The clinical relevance of the small differences noted between the 2 therapeutic strategies in terms of symptoms is questionable," Dr. Galmiche told listeners.
Quality of life, as assessed by the GI Rating Scale and the Quality of Life in Reflux and Dyspepsia for sleep disturbance, showed negligible differences between the 2 treatments.
Both treatments were extremely safe, Dr. Galmiche said. Thirty-day morbidity with LARS was only 3%. Serious adverse events were reported in 28% of the LARS group and 24% of the esomeprazole group.
Comorbidities Key in Patient Selection
Commenting on this study in a separate interview, Deborah Proctor, MD, said that the medication used in this study was not inexpensive, and probably cost about $1 per day. "But surgery is surgery, with all its risks," she noted. Dr. Proctor is professor of medicine and medical director of the Inflammatory Bowel Disease Program at Yale University in New Haven, Connecticut.
In selecting a treatment strategy for chronic GERD, factors such as age and comorbidities should be considered, Dr. Proctor said. "Younger patients with severe GERD might be candidates for LARS, whereas an 80-year-old with comorbid illness might prefer medications to surgery."
Dr. Galmiche reports receiving funding for the LOTUS study from AstraZeneca. Dr. Proctor has disclosed no relevant financial relationships.
