熱射頻賁門緊縮術 （熱射頻手術，stretta procedure）真的能治癒胃食道逆流嗎？

近日有一個熱門話題是北部某家醫院從國外引進熱射頻手術來治療胃食道逆流，很多病人問我這種手術的優缺點，效果如何？在此引用國外的醫學文章（英譯中)，供大家參考。
翻閱了國外的相關資訊，有幾點結論：1)若此種手術方法療效真的很好，為什麼在國外已行之多年，卻從未被國內腸胃科權威所運用，直到現在？2)它是使用熱能去針對賁門造成發炎反應，使組織膨脹僵硬，期望賁門鬆弛的程度能降低，但賁門是具有彈性的括約肌，膨脹僵硬的組織會減低括約肌的彈性，此種手術有可能也會傷害負責賁門開關的神經，造成永久性的傷害3)國外的文獻有敘述此種手術或許能縮小賁門鬆弛的開口，減輕胃酸逆流的症狀，但仍然離不開制酸劑的使用4)甚至文獻的結論是此種熱射頻手術與傳統的外科手術尼氏胃底摺疊術相比較，療效並沒多大的差別。
大家在勇於嘗試之前或許應該謹慎思考 …

Stretta is a minimally invasive endoscopic procedure for the treatment of gastroesophageal reflux disease (GERD) that delivers radiofrequency energy in the form of electromagnetic waves through electrodes at the end of a catheter to the lower esophageal sphincter (LES) and the gastric cardia - the region of the stomach just below the LES. The energy heats the tissue, ultimately causing it to swell and stiffen; the way this works was not understood as of 2015, but it was thought that perhaps the heat causes local inflammation, collagen deposition and muscular thickening of the LES and that it may disrupt the nerves there.[1]

Stretta 是一種微創內鏡手術治療胃食管反流病 (胃食管回流), 提供射頻能量形式的電磁波通過電極在導管末端的下食管括約肌 (les) 和胃賁門-胃的區域就在 LES 的下方。能量加熱組織, 最終導致它膨脹和僵硬;這項工作的方式沒有被理解為 2015年, 但它被認為可能是熱引起局部炎症, 膠原沉積和肌肉增厚的 LES, 它可能會擾亂那裡的神經。[1]

Its relative safety and efficacy are controversial, with the American College of Gastroenterology recommending against its use in 2013, and in the same year the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) giving it a strong recommendation for people who refuse laparascopic Nissen fundoplication, which involves making incisions in the torso and wrapping part of the stomach around the base of the esophagus, and which is considered the gold standard for efficacy.[2][3][4] In 2015 an American Society for Gastrointestinal Endoscopy guideline noted that the quality of evidence was low for Stretta and the other available endoscopic treatment for GERD (transoral incisionless fundoplication) and called for better research to be conducted; it suggested that endoscopic treatments for GERD be considered.[5]

它的相對安全性和有效性是有爭議的, 與美國胃腸病學學院建議反對它的使用在 2013年, 並在同年美國胃腸道和內窺鏡外科醫生協會 (聖賢) 給它一個強大的建議的人誰拒絕腹腔尼森胃, 這涉及在軀幹和腹部的一部分, 在食道的底部包的部分, 這被認為是金標準的功效。[2][3][4] 在2015年美國社會為胃腸內窺鏡指南注意到證據的品質是低的為 Stretta 和其他可利用的內窺鏡治療為胃食管反流 (口 incisionless 胃) 並且要求更好的研究是進行;建議考慮內鏡治療食管反流療法。[5]

The device for carrying out the procedure was originally developed by a company called Curon which obtained FDA approval for the device in 2000 but then went bankrupt in 2006; the device was brought back to market by Mederi Therapeutics in 2010.[2][6] The procedure costs between $2,500 and $3,000.

該裝置的實施過程最初是由一家名為 Curon 的公司開發了 FDA 批准的設備在 2000年, 但後來在2006年破產;該裝置於2010年被 Mederi 療法帶回市場。[2][6] 做法費用在 $ 2500 和 $ 3000 之間。

Evidence[edit] 證據 [編輯]
An American Society of Gastrointestinal Endoscopy (ASGE) statement in June 2015 state that endoscopic antireflux therapy is a potential treatment based on the 2012 review.[7]

美國胃腸內窺鏡協會 (ASGE) 在2015年6月聲明, 內窺鏡 antireflux 治療是一種潛在的治療基礎上的2012審查。[7]

In 2015 three reviews were published discussing the relative safety and effectiveness of the procedure compared with other endoscopic procedures delivered through the mouth, drug treatment (generally proton-pump inhibitors), and fundoplication.[1][2][6]

在2015年三評論發表了討論相對安全和有效性的程式相比, 其他內窺鏡手術通過口, 藥物治療 (一般質子泵抑制劑), 和胃。[1][2][6]

One was a systematic review and meta-analysis of clinical trials conducted with Stretta, done in response to the 2013 SAGES review (which did not include meta-analysis).[2] This review found that quality of studies that had been conducted was generally poor, and that compared with sham therapy (used a placebo for medical device clinical trials), the procedure did not change time spent at a pH less than 4, did not increase lower esophageal sphincter pressure (LESP), did not allow people to stop treatment with proton-pump inhibitors, and did not improve health-related quality of life.[2

其中一個是對 Stretta 的臨床試驗進行系統的回顧和薈萃分析, 這是針對2013聖賢的回顧而進行的 (不包括 meta 研究)。[2] 這個回顧發現, 被進行的研究的品質一般是貧寒的, 並且那與假療法比較 (使用安慰劑為醫療設備臨床試驗), 做法沒有改變花費的時間在 pH 值少於 4, 沒有增加更低食道括約肌壓力 (LESP), 不允許人們停止使用質子泵抑制劑治療, 並沒有改善健康相關的生活品質。[2]

Another of the 2015 reviews was a narrative literature review, noted its long history of use, and found the procedure safe and effective, and noted that the procedure complemented drug treatment and fundoplication, providing a useful option.[6]

2015審查的另一項是敘述性文獻回顧, 注意到它的使用歷史悠久, 併發現該程式的安全和有效, 並指出該程式補充了藥物治療和胃, 提供了一個有用的選擇。[6]

The other 2015 review was a narrative literature review was more tentative, noting the long safety record but only willing to state that the procedure "may be effective in reducing symptom burden and quality of life scores up to 8 years post-intervention. However, there does not appear to be any sustained improvement in objective outcomes and there is no evidence that Stretta results in improved outcomes as compared to surgical intervention.[1]
另外2015回顧是一篇記敘文回顧更加試探性, 注意長的安全紀錄, 但只願意陳述程式 "可能有效地減少症狀負擔和生活品質比分8年干預。然而, 在客觀結果方面似乎沒有任何持續的改善, 也沒有證據表明 Stretta 的結果與外科手術相比有改善的效果。[1]

A 2012 systematic review and meta-analysis upon which the 2013 SAGES review had relied, had found that it improves GERD symptoms.[4][8]

2013聖賢評論所依賴的2012系統回顧和薈萃分析發現, 它改善了胃食管反流症狀。