Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph's Healthcare, Hamilton, ON, Canada.
Value Health. 2011 Mar-Apr;14(2):263-73. doi: 10.1016/j.jval.2010.09.004.
Very few randomized controlled trials (RCTs) have compared laparoscopic Nissen fundoplication (LNF) to proton pump inhibitors (PPI) medical management for patients with chronic gastroesophageal reflux disease (GERD). Larger RCTs have been relatively short in duration, and have reported mixed results regarding symptom control and effect on quality of life (QOL). Economic evaluations have reported conflicting results.
To determine the incremental cost-utility of LNF versus PPI for treating patients with chronic and controlled GERD over 3 years from the societal perspective.
Economic evaluation was conducted alongside a RCT that enrolled 104 patients from October 2000 to September 2004. Primary study outcome was GERD symptoms (secondary outcomes included QOL and cost-utility). Resource utilization and QOL data collected at regular follow-up intervals determined incremental cost/QALY gained. Stochastic uncertainty was assessed using bootstrapping and methodologic assumptions were assessed using sensitivity analysis.
No statistically significant differences in GERD symptom scores, but LNF did result in fewer heartburn days and improved QOL. Costs were higher for LNF patients by $3205/patient over 3 years but QOL was also higher as measured by either QOL instrument. Based on total costs, incremental cost-utility of LNF was $29,404/QALY gained using the Health Utility Index 3. Cost-utility results were sensitive to the utility instrument used ($29,404/QALY for Health Utility Index 3, $31,117/QALY for the Short Form 6D, and $76,310/QALY for EuroQol 5D) and if current lower prices for PPIs were used in the analysis.
Results varied depending on resource use/costs included in the analysis, the QOL instrument used, and the cost of PPIs; however, LNF was generally found to be a cost-effective treatment for patients with symptomatic controlled GERD requiring long-term management.
仅有少数随机对照试验（RCT）比较了腹腔镜 Nissen 胃底折叠术（LNF）与质子泵抑制剂（PPI）药物治疗对慢性胃食管反流病（GERD）患者的疗效。更大规模的 RCT 研究时间相对较短，其报告的症状控制和生活质量（QOL）改善效果存在差异。经济评估报告的结果也不一致。
从社会角度出发，确定在 3 年内，LNF 相较于 PPI 治疗慢性和控制良好的 GERD 患者的增量成本-效用。
经济评估与一项 RCT 同时进行，该 RCT 于 2000 年 10 月至 2004 年 9 月期间纳入了 104 名患者。主要研究结果为 GERD 症状（次要结果包括 QOL 和成本-效用）。定期随访收集的资源利用和 QOL 数据确定了增量成本/QALY 的增加。使用 bootstrap 进行随机不确定性评估，并使用敏感性分析评估方法学假设。
LNF 组和 PPI 组的 GERD 症状评分无统计学差异，但 LNF 组的烧心天数更少，QOL 更高。LNF 组患者在 3 年内的成本比 PPI 组高 3205 美元/人，但 QOL 也更高，这两个结果都分别通过两种 QOL 工具测量得到。基于总成本，使用健康效用指数 3 时，LNF 的增量成本-效用为 29404 美元/QALY；使用健康量表 6D 时为 31117 美元/QALY；使用 EuroQol 5D 时为 76310 美元/QALY。成本-效用结果对使用的效用工具敏感（使用健康效用指数 3 时为 29404 美元/QALY，使用健康量表 6D 时为 31117 美元/QALY，使用 EuroQol 5D 时为 76310 美元/QALY），以及分析中是否使用了当前较低的 PPI 价格。
结果因纳入分析的资源使用/成本、使用的 QOL 工具和 PPI 的成本而异；然而，对于需要长期管理的有症状的控制良好的 GERD 患者，LNF 通常被认为是一种具有成本效益的治疗方法。
