Gastrointestinal Unit, Massachusetts General Hospital, Boston, MA.
Institute for Technology Assessment, Massachusetts General Hospital, Boston, MA.
Hepatology. 2017 Apr;65(4):1156-1164. doi: 10.1002/hep.28958. Epub 2017 Feb 21.
Nonalcoholic steatohepatitis (NASH) affects 2%-3% of the US population and is expected to become the leading indication for liver transplantation in the next decade. Bariatric surgery may be an effective but expensive treatment for NASH. Using a state-transition model, our analysis assessed the effectiveness and cost-effectiveness of surgery to manage NASH. We simulated the benefits and harms of laparoscopic Roux-en-Y gastric bypass surgery in patients defined by weight class (overweight, mild obesity, moderate obesity, and severe obesity) and fibrosis stage (F0-F3). Comparators included intensive lifestyle intervention (ILI) and no treatment. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios were calculated. Our results showed that surgery and ILI in obese patients (with F0-F3) increased QALYs by 0.678-2.152 and 0.452-0.618, respectively, compared with no treatment. Incremental cost-effectiveness ratios for surgery in all F0-F3 patients with mild, moderate, or severe obesity were $48,836/QALY, $24,949/QALY, and $19,222/QALY, respectively. In overweight patients (with F0-F3), surgery increased QALYs by 0.050-0.824 and ILI increased QALYs by 0.031-0.164. In overweight patients, it was cost-effective to reserve treatment only for F3 patients; the incremental cost-effectiveness ratios for providing surgery or ILI only to F3 patients were $30,484/QALY and $25,367/QALY, respectively.
Surgery was both effective and cost-effective for obese patients with NASH, regardless of fibrosis stage; in overweight patients, surgery increased QALYs for all patients regardless of fibrosis stage, but was cost-effective only for patients with F3 fibrosis; our results highlight the promise of bariatric surgery for treating NASH and underscore the need for clinical trials in this area. (Hepatology 2017;65:1156-1164).
非酒精性脂肪性肝炎（NASH）影响美国人群的 2%-3%，预计在未来十年内将成为肝移植的主要指征。减重手术可能是治疗 NASH 的有效但昂贵的方法。使用状态转移模型，我们的分析评估了手术治疗 NASH 的效果和成本效益。我们模拟了腹腔镜 Roux-en-Y 胃旁路手术在体重类别（超重、轻度肥胖、中度肥胖和重度肥胖）和纤维化阶段（F0-F3）定义的患者中的益处和危害。对照包括强化生活方式干预（ILI）和不治疗。计算了质量调整生命年（QALY）、成本和增量成本效益比。
在肥胖患者（F0-F3）中，手术和 ILI 分别使 QALY 增加了 0.678-2.152 和 0.452-0.618，与不治疗相比。在所有 F0-F3 肥胖患者中，手术的增量成本效益比分别为$48836/QALY、$24949/QALY 和$19222/QALY，轻度、中度和重度肥胖患者。在超重患者（F0-F3）中，手术使 QALY 增加了 0.050-0.824，ILI 使 QALY 增加了 0.031-0.164。对于超重患者，仅为 F3 患者保留治疗是具有成本效益的；仅为 F3 患者提供手术或 ILI 的增量成本效益比分别为$30484/QALY 和$25367/QALY。
手术对 NASH 肥胖患者无论纤维化阶段如何均有效且具有成本效益；在超重患者中，手术使所有患者的 QALY 增加，无论纤维化阶段如何，但仅对 F3 纤维化患者具有成本效益；我们的结果突显了减重手术治疗 NASH 的前景，并强调了该领域临床试验的必要性。
