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作者：Alice Goodman  
出處：WebMD醫學新聞

　　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。
　　
　　這個開放標籤、平行組別、多中心隨機研究，包括了626名慢性GERD且確定對esomeprazole有反應的病患，在每天服用esomeprazole 40 mg、為期3個月，以評估對esomeprazole的反應之後，確定有反應的554名病患被隨機分派接受每天esomeprazole 20 mg(若因控制症狀之需要，可增加到每天2次、每次20 mg)或者LARS。在5年時，還有372名病患參與研究。
　　
　　兩個治療組之間，在開始時的基礎特徵相彷，約70%是男性，平均年紀大約45歲，兩組都觀察到高緩解率(esomeprazole組有92%、LARS組有85%；P= .048)，若排除違反協定者，緩解率分別是94%與85% (P= .048)。
　　
　　治療失敗的定義是「你的胃灼熱和胃酸逆流有充分的控制嗎？」這個問題的答案為否定者，LARS組有33名病患、esomeprazole組有19名病患。(對於LARS組病患，治療失敗也定義為手術時期死亡或者術後30天內死亡，或者需要再度手術者)。
　　
　　在esomeprazole組中，80%的病患可以用每天20 mg的劑量維持緩解，在5年時，LARS 組在減少胃灼熱發生率方面略優於esomeprazole組，而esomeprazole組有較少的吞嚥困難和胃腸脹氣。
　　
　　Galmiche醫師向聽眾表示，就症狀而指出兩組治療策略之間有小差異的臨床發現是有疑慮的。
　　
　　就生活品質(以GI Rating Scale和逆流疾病以及消化不良之生活品質對睡眠的影響)而言，兩種治療方式之間的差異微乎其微。
　　
　　Galmiche醫師表示，兩種治療都相當安全，LARS組的30天發病率只有3%，嚴重不良反應事件比率在LARS組有28%，esomeprazole組有24%。
　　
　　【共病症關鍵在病患選擇】
　　Deborah Proctor醫師在專訪中對此研究發表評論時指出，此研究所用的藥物並不貴，每天或許只要1美元，但是，手術就是手術，有其風險存在；Proctor醫師是康乃狄克州紐哈芬耶魯大學發炎性腸道疾病計畫醫療主任，也是內科教授。
　　
　　Proctor醫師表示，在慢性GERD選擇治療策略時，年紀和共病症等因素應被考量，較年輕但是嚴重GERD的病患應考慮進行LARS，而80歲又有共病症的患者或許應優先考慮藥物而非手術。
　　
　　Galmiche醫師報告接受來自AstraZeneca藥廠的資金進行LOTUS研究，Proctor醫師宣告沒有相關財務關係。
　　
　　2010年消化道疾病週(DDW)：摘要284，發表於2010年5月3日。  


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.

Digestive Disease Week (DDW) 2010: Abstract?284. Presented May?3, 2010.