Lundell L, Miettinen P, Myrvold H E, Pedersen S A, Liedman B, Hatlebakk J G, Julkonen R, Levander K, Carlsson J, Lamm M, Wiklund I
Department of Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.
J Am Coll Surg. 2001 Feb;192(2):172-9; discussion 179-81. doi: 10.1016/s1072-7515(00)00797-3.
The efficacy of antireflux surgery (ARS) and proton pump inhibitor therapy in the control of gastroesophageal reflux disease is well established. A direct comparison between these therapies is warranted to assess the benefits of respective therapies.
There were 310 patients with erosive esophagitis enrolled in the trial. There were 155 patients randomized to continuous omeprazole therapy and 155 to open antireflux surgery, of whom 144 later had an operation. Because of various withdrawals during the study course, 122 patients originally having an antireflux operation completed the 5-year followup; the corresponding figure in the omeprazole group was 133. Symptoms, endoscopy, and quality-of-life questionnaires were used to document clinical outcomes. Treatment failure was defined to occur if at least one of the following criteria were fulfilled: Moderate or severe heartburn or acid regurgitation during the last 7 days before the respective visit; Esophagitis of at least grade 2; Moderate or severe dysphagia or odynophagia symptoms reported in combination with mild heartburn or regurgitation; If randomized to surgery and subsequently required omeprazole for more than 8 weeks to control symptoms, or having a reoperation; If randomized to omeprazole and considered by the responsible physician to require antireflux surgery to control symptoms; If randomized to omeprazole and the patient, for any reason, preferred antireflux surgery during the course of the study. Treatment failure was the primary outcomes variable.
When the time to treatment failure was analyzed by use of the intention to treat approach, applying the life table analysis technique, a highly significant difference between the two strategies was revealed (p < 0.001), with more treatment failures in patients who originally were randomized to omeprazole treatment. The protocol also allowed dose adjustment in patients allocated to omeprazole therapy to either 40 or 60 mg daily in case of symptom recurrence. The curves subsequently describing the failure rates still remained separated in favor of surgery, although the difference did not reach statistical significance (p = 0.088). Quality of life assessment revealed values within normal ranges in both therapy arms during the 5 years.
In this randomized multicenter trial with a 5-year followup, we found antireflux surgery to be more effective than omeprazole in controlling gastroesophageal reflux disease as measured by the treatment failure rates. But if the dose of omeprazole was adjusted in case of relapse, the two therapeutic strategies reached levels of efficacy that were not statistically different.
抗反流手术（ARS）和质子泵抑制剂治疗在控制胃食管反流病方面的疗效已得到充分证实。有必要对这些疗法进行直接比较，以评估各自疗法的益处。
310例糜烂性食管炎患者纳入该试验。155例患者随机接受持续奥美拉唑治疗，155例接受开放式抗反流手术，其中144例后来接受了手术。由于研究过程中的各种退出情况，122例最初接受抗反流手术的患者完成了5年随访；奥美拉唑组相应数字为133例。使用症状、内镜检查和生活质量问卷来记录临床结果。如果满足以下至少一项标准，则定义为治疗失败：在各自就诊前最后7天内出现中度或重度烧心或反酸；至少2级食管炎；伴有轻度烧心或反流报告的中度或重度吞咽困难或吞咽痛症状；如果随机分配接受手术，随后需要奥美拉唑治疗超过8周以控制症状，或进行再次手术；如果随机分配接受奥美拉唑治疗，且负责医生认为需要抗反流手术以控制症状；如果随机分配接受奥美拉唑治疗，且患者在研究过程中出于任何原因倾向于接受抗反流手术。治疗失败是主要结局变量。
当采用意向性分析方法，运用生命表分析技术分析治疗失败时间时，两种策略之间显示出高度显著差异（p<0.001），最初随机接受奥美拉唑治疗的患者治疗失败更多。该方案还允许在症状复发时将分配接受奥美拉唑治疗的患者剂量调整为每日40或60毫克。随后描述失败率的曲线仍然分开，有利于手术，尽管差异未达到统计学意义（p = 0.088）。生活质量评估显示，在5年期间，两个治疗组的值均在正常范围内。
在这项进行了5年随访的随机多中心试验中，我们发现，以治疗失败率衡量，抗反流手术在控制胃食管反流病方面比奥美拉唑更有效。但如果在复发时调整奥美拉唑剂量，两种治疗策略的疗效水平无统计学差异。
