Wileman Samantha M, McCann Sharon, Grant Adrian M, Krukowski Zygmunt H, Bruce Julie
Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK, AB25 2ZD.
Cochrane Database Syst Rev. 2010 Mar 17(3):CD003243. doi: 10.1002/14651858.CD003243.pub2.
BACKGROUND: Gastro-oesophageal reflux disease (GORD) is a common condition with up to 20% of patients from Westernised countries experiencing heartburn, reflux or both intermittently. It is unclear whether medical or surgical (laparoscopic fundoplication) management is the most clinically and cost-effective treatment for controlling GORD. OBJECTIVES: To compare the effects of medical management versus laparoscopic fundoplication surgery on health-related and GORD-specific quality of life (QOL) in adults with GORD. SEARCH STRATEGY: We searched CENTRAL (Issue 2, 2009), MEDLINE (1966 to May 2009) and EMBASE (1980 to May 2009). We handsearched conference abstracts and reference lists from published trials to identify further trials. We contacted experts in the field for relevant unpublished material. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing medical management with laparoscopic fundoplication surgery. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data from articles identified for inclusion and assessed the methodological quality of eligible trials. Primary outcomes were: health-related and GORD-specific QOL, heartburn, regurgitation and dysphagia. MAIN RESULTS: Four trials were included with a total of 1232 randomised participants. Health-related QOL was reported by four studies although data were combined using fixed-effect models for two studies (Anvari 2006; REFLUX Trial 2008). There were statistically significant improvements in health-related QOL at three months and one year after surgery compared to medical therapy (mean difference (MD) SF36 general health score -5.23, 95% CI -6.83 to -3.62; I(2) = 0%). All four studies reported significant improvements in GORD-specific QOL after surgery compared to medical therapy although data were not combined. There is evidence to suggest that symptoms of heartburn, reflux and bloating are improved after surgery compared to medical therapy, but a small proportion of participants have persistent postoperative dysphagia. Overall rates of postoperative complications were low but surgery is not without risk and postoperative adverse events occurred although they were uncommon. The costs of surgery are considerably higher than the cost of medical management although data are based on the first year of treatment therefore the cost and side effects associated with long-term treatment of chronic GORD need to be considered. AUTHORS' CONCLUSIONS: There is evidence that laparoscopic fundoplication surgery is more effective than medical management for the treatment of GORD at least in the short to medium term. Surgery does carry some risk and whether the benefits of surgery are sustained in the long term remains uncertain. Treatment decisions for GORD should be based on patient and surgeon preference.
背景:胃食管反流病(GORD)是一种常见疾病,在西方国家,高达20%的患者会间歇性出现烧心、反流或两者皆有。目前尚不清楚药物治疗或手术治疗(腹腔镜胃底折叠术)哪种是控制GORD最具临床效果和成本效益的治疗方法。 目的:比较药物治疗与腹腔镜胃底折叠术对成年GORD患者健康相关及GORD特异性生活质量(QOL)的影响。 检索策略:我们检索了Cochrane系统评价数据库(CENTRAL,2009年第2期)、医学文献数据库(MEDLINE,1966年至2009年5月)和荷兰医学文摘数据库(EMBASE,1980年至2009年5月)。我们手工检索了会议摘要和已发表试验的参考文献列表以识别更多试验。我们联系了该领域的专家获取相关未发表资料。 选择标准:所有比较药物治疗与腹腔镜胃底折叠术的随机或半随机对照试验。 数据收集与分析:两位作者独立从纳入的文章中提取数据,并评估符合条件试验的方法学质量。主要结局指标为:健康相关及GORD特异性QOL、烧心、反流和吞咽困难。 主要结果:纳入了4项试验,共1232名随机参与者。4项研究报告了健康相关QOL情况,不过有2项研究(Anvari 2006;反流试验2008)的数据采用固定效应模型进行合并。与药物治疗相比,术后3个月和1年时健康相关QOL有统计学显著改善(平均差(MD)SF36总体健康评分 -5.23,95%置信区间 -6.83至 -3.62;I² = 0%)。所有4项研究均报告与药物治疗相比,术后GORD特异性QOL有显著改善,不过数据未合并。有证据表明,与药物治疗相比,术后烧心、反流和腹胀症状有所改善,但一小部分参与者术后存在持续性吞咽困难。术后并发症总体发生率较低,但手术并非没有风险,术后不良事件虽不常见但仍有发生。手术费用远高于药物治疗费用,不过数据基于第一年治疗,因此需要考虑慢性GORD长期治疗的成本和副作用。 作者结论:有证据表明,至少在短期至中期,腹腔镜胃底折叠术治疗GORD比药物治疗更有效。手术确实存在一定风险,手术的益处能否长期维持仍不确定。GORD的治疗决策应基于患者和外科医生的偏好。
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