Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial)
Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial)
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DOI：
10.3310/hta17220
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发表时间：
2013-06-01
影响因子：
3.6
通讯作者：
Campbell, M. K.
中科院分区：
文献类型：
--
作者：
Grant, A. M.;Boachie, C.;Campbell, M. K.
背景：尽管有很有希望的证据表明，腹腔镜下胃食管反流病（GORD）的短期缓解效果优于持续的药物治疗，但仍不确定益处是否持续且大于风险。目的：评价需要长期用药且适合外科和内科治疗的GORD患者腹腔镜手术的长期临床疗效、成本效益和安全性。设计：一项随机试验的5年随访（平行非随机偏好组），比较基于腹腔镜手术的政策与持续医疗管理政策。成本效益与试验同时进行评估，采用NHS的成本观点，并以质量调整生命年（QALYs）表示健康结果。设置：通过年度邮寄问卷和选择性医院病例记录进行随访；在21家英国医院进行初步招聘。参与者：810名原始参与者中的问卷应答者。入院时，所有患者均有GORD的书面证据，症状持续10 ~ 12个月。问卷回复率（1-5年）为89.5% ~ 68.9%。干预措施：357名参与者被招募到随机比较组（178名随机分配到手术组，179名随机分配到持续医疗管理组），453名参与者被招募到偏好组（261名手术组和192名医疗管理组）。外科医生选择了眼底复制的类型。主要结局指标：主要：疾病特异性结局指标（反流问卷）；次要调查：简短问卷36项（SF-36），欧洲生活质量5维度（EQ-5D）， NHS资源使用，反流药物，并发症。结果：随机分组平衡良好。5年后，63%的随机手术组和13%的随机医疗管理组接受了全部或部分包底术（85%和3%的优先组），围手术期并发症很少，无相关死亡。在手术后1年（和5年），36%（41%）的随机手术组15%（26%）的手术患者服用质子泵抑制剂药物，而随机手术组为87%（82%）。每年，反流评分的差异明显有利于随机手术组（三分之一SD； 5年时p < 0.01）。SF-36和EQ-5D评分也倾向于手术，但随着时间的推移差异逐渐减弱，通常在5年内无统计学意义。试验开始时症状越严重，手术后观察到的益处越大。那些随机分配到医疗管理组并随后进行手术的患者基线评分较低，手术后明显改善。在复底后，3%的人因并发症接受手术治疗，4%的人随后进行了与反流相关的手术——最常见的是翻修包膜。在两个随机分组中，吞咽困难、肠胃胀气和无法呕吐的情况相似。经济分析表明，手术是该患者组更具成本效益的选择。在基本情况下，每增加一个QALY，手术的增量成本-效果比为7028英镑；这些发现对于方法和假设的改变是强有力的。在每个额外QALY阈值为20,000英镑的情况下，手术具有成本效益的概率在所有分析中为bb0.80。结论：5年后，腹腔镜下扩底术继续提供更好的缓解GORD症状，并改善与健康相关的生活质量。手术并发症不常见。尽管最初费用较高，但手术策略极有可能具有成本效益。试验注册：当前对照试验ISRCTN15517081。
Background: Despite promising evidence that laparoscopic fundoplication provides better short-term relief of gastro-oesophageal reflux disease (GORD) than continued medical management, uncertainty remains about whether benefits are sustained and outweigh risks.Objective: To evaluate the long-term clinical effectiveness, cost-effectiveness and safety of laparoscopic surgery among people with GORD requiring long-term medication and suitable for both surgical and medical management.Design: Five-year follow-up of a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. Cost-effectiveness was assessed alongside the trial using a NHS perspective for costs and expressing health outcomes in terms of quality-adjusted life-years (QALYs).Setting: Follow-up was by annual postal questionnaire and selective hospital case notes review; initial recruitment in 21 UK hospitals. Participants: Questionnaire responders among the 810 original participants. At entry, all had documented evidence of GORD and symptoms for > 12 months. Questionnaire response rates (years 1-5) were from 89.5% to 68.9%.Interventions: Three hundred and fifty-seven participants were recruited to the randomised comparison (178 randomised to surgical management and 179 randomised to continued medical management) and 453 to the preference groups (261 surgical management and 192 medical management). The surgeon chose the type of fundoplication.Main outcome measures: Primary: disease-specific outcome measure (the REFLUX questionnaire); secondary: Short Form questionnaire-36 items (SF-36), European Quality of Life-5 Dimensions (EQ-5D), NHS resource use, reflux medication, complications.Results: The randomised groups were well balanced. By 5 years, 63% in the randomised surgical group and 13% in the randomised medical management group had received a total or partial wrap fundoplication (85% and 3% in the preference groups), with few perioperative complications and no associated deaths. At 1 year (and 5 years) after surgery, 36% (41%) in the randomised surgical group 15% (26%) of those who had surgery - were taking proton pump inhibitor medication compared with 87% (82%) in the randomised medical group. At each year, differences in the REFLUX score significantly favoured the randomised surgical group (a third of a SD; p < 0.01 at 5 years). SF-36 and EQ-5D scores also favoured surgery, but differences attenuated over time and were generally not statistically significant at 5 years. The worse the symptoms at trial entry, the larger the benefit observed after surgery. Those randomised to medical management who subsequently had surgery had low baseline scores that markedly improved after surgery. Following fundoplication, 3% had surgical treatment for a complication and 4% had subsequent reflux-related operations - most often revision of the wrap. Dysphagia, flatulence and inability to vomit were similar in the two randomised groups. The economic analysis indicated that surgery was the more cost-effective option for this patient group. The incremental cost-effectiveness ratio for surgery in the base case was pound 7028 per additional QALY; these findings were robust to changes in approaches and assumptions. The probability of surgery being cost-effective at a threshold of pound 20,000 per additional QALY was > 0.80 for all analyses.Conclusions: After 5 years, laparoscopic fundoplication continues to provide better relief of GORD symptoms with associated improved health-related quality of life. Complications of surgery were uncommon. Despite being initially more costly, a surgical policy is highly likely to be cost-effective.Trial registration: Current Controlled Trials ISRCTN15517081.