BMJ:胃食管反流病的微创手术治疗与药物治疗的比较

　　目的：研究慢性胃食管反流病（GOPD）的作为药物治疗替代疗法的腹腔镜下胃底折术的长期临床效果。

　　设计：多中心、随机对照试验的5年随访（包括平行的非随机对照群体）。

　　地点：21家英国医院。

　　受试者：纳入810名最初的受试者中回复年度调查问卷的患者，所有受试者GOPD病史都＞12个月。

　　干预：外科医生选择胃底折叠术的术式。由专家对治疗方案进行回顾和优化。后续治疗由负责治疗的临床医生决定，通常在初级医疗机构中进行。

　　主要结局测量：主要结局测量为自己报告的胃食管反流疾病特异生命质量评分的调查问卷。其他测量为健康状态问卷（SF-36和EuroQol EQ-5D问卷），治疗反流药物使用和并发症发生情况。

　　结果：至5年随访结束，随机至接受外科手术组的患者中有63%（112/178）的患者已经接受了胃底折叠术，药物治疗组有13%（24/179）的患者进行了胃底折叠术（而且有85% (222/261)和3%（6/192）的患者分别表示比较喜欢外科手术方式或药物治疗的方式。在第5年的应答者中，44%（56/127）随机外科手术者接受了抗反流药物治疗，在随机至药物治疗组的患者中用药比例则为82%（98/119）。在胃食管反流病评分中的差异显著性的偏好于随机外科手术组（第五年，平均差异8.5，95% CI 3.9～13.1，P＜0.001）。SF-36和EQ-5D评分同样显示偏好于外科手术治疗，但是在第5年时没有显著性差异。胃底折叠术后，3%（12/364）由于并发症接受了外科手术治疗，4%（16）接受了后续的反流相关手术——大多数为修补术。吞咽困难、胃肠胀气和不能呕吐的长期发生率在两个随机组中相似。

　　结论：5年后，与药物治疗相比，腹腔镜下胃底折术依然提供了更好的GOPD症状的改善。外科手术的副作用不普遍，并且通常在手术后短期内发生。小部分患者要接受二次手术。无证据表明外科手术会引起长期副反应症状。

Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX)
Abstract
Objectives To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD).
Design Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups).
Setting Initial recruitment in 21 UK hospitals.
Participants Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months.
Intervention The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care.
Main outcome measures Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications.
Results By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), P<0.001, at five years). SF-36 and EQ-5D scores also favoured surgery, but were not statistically significant at five years. After fundoplication, 3% (12/364) had surgical treatment for a complication and 4% (16) had subsequent reflux-related operations—most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups.
Conclusions After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse symptoms caused by surgery.