Laneh

作者：Laurie Barclay, MD  
出處：WebMD醫學新聞

　　March 24, 2010 — 根據3月17日線上發表在考科藍系統性綜論資料庫的研究結果，至少在短期到中期內，腹腔鏡胃底摺疊術比起藥物治療更可有效地治療胃食道逆流（稱為GERD或GORD）。
　　
　　英國亞伯丁大學衛生服務研究小組的Samantha M. Wileman博士與來自考科藍上消化道與胰腺疾病團隊的同事們寫到，胃食道逆流是一種常見的情況，西化的國家有高達20％的病患經歷胃灼熱、逆流或兩者間歇出現。在控制胃食道逆流方面，目前還不清楚藥物或手術（腹腔鏡胃底折疊術）何者最符合臨床和經濟效益。
　　
　　這項系統性綜論的目標是比較藥物與腹腔鏡胃底手術，在成人胃食道逆流有關健康及其特定生活品質（QOL）的差異。搜尋包括CENTRAL（第2期，2009年）、MEDLINE（1966年至2009年5月）與EMBASE（1980年至2009年5月）資料庫，同時蒐集會議摘要和參考文獻目錄。該評論還接觸專家以確定未發表的相關研究。
　　
　　納入標準為比較藥物與腹腔鏡胃底手術的隨機或準隨機控制試驗。兩位作者獨立由研究提取數據，並評估研究的方法學。主要研究終點是與健康相關以及胃食道逆流特定的生活品質、胃灼熱、逆流和吞嚥困難。
　　
　　有四項研究符合收納標準，共收納1232位隨機分配的受試者。四項研究報告與健康相關的生活品質，雖然數據是結合兩個使用固定效應模式的研究。相對於藥物治療，手術組在健康相關生活品質術後三個月與一年達統計上顯著改善（醫療預後研究36項短版健康調查平均差為-5.23，95％信賴區間為 -6.83至 - 3.62，I 2 = 0％）。
　　
　　雖然未合併數據，四項研究結果皆為，相較於藥物治療，術後胃食道逆流特定相關的生活品質有顯著改善，而胃灼熱、逆流、腹脹症狀在術後似乎也有減少；但是一小部分受試者在術後持續吞嚥困難。
　　
　　術後不良反應並不常見，整體術後併發症發生率也很低，但是手術並非沒有風險，且醫療花費遠高於藥物治療。因為這是治療第一年的數據，因此長期治療胃食道逆流的花費與不良反應必須加以考量，且治療決策應根據病患本身與臨床醫師的偏好。
　　
　　Wileman博士在新聞中提到，證據建議至少在短期到中期內手術比藥物更能有效治療胃食道逆流，但是手術帶來的風險是否遠高於好處，在長期仍然未定。
　　
　　這篇系統性綜論的限制包括，四項研究都有中度與低度潛在誤差風險，且在不同時間點，缺乏特定次級預後詳細資訊。此外，兩項研究都未提供分派保密的資訊。
　　
　　Wileman博士的結論是，過去的研究，在發展鑰鎖孔手術治療胃食道逆流前，認為手術的好處並不持久，因此強調胃底摺疊手術研究的重要性與長期追蹤。我們也需要知道更多關於長期投予藥物與手術對於臨床及成本的影響。
　　
　　作者表示沒有相關資金的往來。


Laparoscopic Fundoplication Surgery May Be Effective for Treating GERD

By Laurie Barclay, MD
Medscape Medical News

March 24, 2010 — Laparoscopic fundoplication surgery is more effective than medical management for treating gastro-oesophageal reflux disease (GERD, also referred to as GORD), at least in the short to medium term, according to the results of a systematic review reported online in the March 17 issue of the Cochrane Database of Systematic Reviews.

"...GORD is a common condition with up to 20% of patients from Westernised countries experiencing heartburn, reflux or both intermittently," write Samantha M. Wileman, PhD, from the Health Services Research Unit at the University of Aberdeen, Aberdeen, United Kingdom, and colleagues from the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group. "It is unclear whether medical or surgical (laparoscopic fundoplication) management is the most clinically and cost-effective treatment for controlling GORD."

The goals of this review were to compare the effects of medical management vs laparoscopic fundoplication surgery on health-related and GERD-specific quality of life (QOL) in adults with GERD. The search included an electronic search of CENTRAL (Issue 2, 2009), MEDLINE (1966 to May 2009), and EMBASE (1980 to May 2009), as well as a manual search of conference abstracts and reference lists from published trials. The reviewers also contacted experts to identify relevant unpublished material.

Inclusion criteria were all randomized or quasirandomized controlled trials in which medical management was compared vs laparoscopic fundoplication surgery. Two authors independently extracted data from identified articles and evaluated the methodologic quality of eligible trials. The main study endpoints were health-related and GERD-specific QOL, heartburn, regurgitation, and dysphagia.

There were 4 trials meeting selection criteria, enrolling a total of 1232 randomly assigned participants. Four studies reported health-related QOL, although data were combined with use of fixed-effect models for 2 studies. Compared with medical therapy, surgery was associated with statistically significant improvements in health-related QOL at 3 months and at 1 year postoperatively (mean difference 36-item Short Form Survey general health score, –5.23; 95% confidence interval, –6.83 to –3.62; I 2 = 0%).

Although data were not combined, there were significant improvements in GERD-specific QOL after surgery vs medical therapy in all 4 studies. Symptoms of heartburn, reflux, and bloating appeared to be reduced after surgery vs medical therapy. However, a small proportion of participants had persistent postoperative dysphagia.

Postoperative adverse events were uncommon, and overall rates of postoperative complications were low, but surgery is not without risk, and surgical costs are considerably higher than those of medical management. Because these data are based on the first year of treatment, the cost and adverse effects associated with long-term treatment of chronic GERD need to be considered, and treatment decisions for GERD should be based on patient and surgeon preference.

"There is evidence to suggest that, at least in the short to medium term, surgery is more effective than tablets for treatment of GORD," said Dr. Wileman in a news release. "But surgery does carry a risk and whether this is outweighed by the benefits in the long term is still not certain."

Limitations of this review include medium risk or low risk for bias in the 4 included studies and some lack of detailed information for particular secondary outcomes at different follow-up time points. In addition, 2 studies failed to provide detailed information about whether allocation was concealed.

"Previous research, prior to the development of keyhole surgery for GORD, has suggested that the benefits of surgery for GORD are not sustained over time, highlighting the importance for future keyhole fundoplication studies to include longer term follow-up," Dr. Wileman concluded. "We also need to know more about the clinical and cost implications of long term medication versus surgery."

The review authors have disclosed no relevant financial relationships.

Cochrane Database Syst Rev. Published online March 17, 2010.