Abstract Background The aim was to evaluate the cost-effectiveness and cost–utility of ursodeoxycholic acid (UDCA) prophylaxis for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass (RYGB) in patients without gallstones before surgery. Methods Data from a multicentre, double-blind, randomized placebo-controlled superiority trial were used. Patients scheduled for laparoscopic RYGB or sleeve gastrectomy were randomized to receive 900 mg UDCA or placebo for 6 months. Indicated by the clinical report, prophylactic prescription of UDCA was evaluated economically against placebo from a healthcare and societal perspective for the subgroup of patients without gallstones before surgery who underwent RYGB. Volumes and costs of in-hospital care, out-of-hospital care, out-of-pocket expenses, and productivity loss were assessed. Main outcomes were the costs per patient free from symptomatic gallstone disease and the costs per quality-adjusted life-year (QALY). Results Patients receiving UDCA prophylaxis were more likely to remain free from symptomatic gallstone disease (relative risk 1.06, 95 per cent c.i. 1.02 to 1.11; P = 0.002) compared with patients in the placebo group. The gain in QALYs, corrected for a baseline difference in health utility, was 0.047 (95 per cent bias-corrected and accelerated (Bca) c.i. 0.007 to 0.088) higher (P = 0.022). Differences in costs were –€356 (95 per cent Bca c.i. €–1573 to 761) from a healthcare perspective and –€1392 (–3807 to 917) from a societal perspective including out-of-pocket expenses and productivity loss, both statistically non-significant, in favour of UDCA prophylaxis. The probability of UDCA prophylaxis being cost-effective was at least 0.872. Conclusion UDCA prophylaxis after RYGB in patients without gallstones before surgery was cost-effective.

中文翻译：

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熊去氧胆酸预防 Roux-en-Y 胃绕道手术后新发症状性胆石病的成本效益

摘要 背景目的是评估熊去氧胆酸（UDCA）预防对于术前无胆结石患者进行 Roux-en-Y 胃绕道手术（RYGB）后预防症状性胆结石疾病的成本效益和成本效用。 方法使用来自多中心、双盲、随机安慰剂对照优效性试验的数据。计划进行腹腔镜 RYGB 或袖状胃切除术的患者随机接受 900 mg UDCA 或安慰剂治疗 6 个月。临床报告表明，对于手术前没有胆结石但接受 RYGB 的患者亚组，从医疗保健和社会角度对 UDCA 预防性处方与安慰剂进行了经济评估。评估了院内护理、院外护理、自付费用和生产力损失的数量和费用。主要结果是每位无症状胆石病患者的费用以及每个质量调整生命年（QALY）的费用。 结果与安慰剂组患者相比，接受 UDCA 预防的患者更有可能摆脱有症状的胆石病（相对风险 1.06，95% CI 1.02 至 1.11；P = 0.002）。根据健康效用的基线差异进行校正后，QALY 的增益提高了 0.047（95% 偏差校正和加速 (Bca) CI 0.007 至 0.088）（P = 0.022）。从医疗保健角度来看，成本差异为 –356 欧元（95% Bca ci 1573 至 761 欧元），从社会角度来看，成本差异为 –1392 欧元（–3807 至 917 欧元），包括自付费用和生产力损失，两者均具有统计学意义不显着，有利于 UDCA 预防。UDCA 预防具有成本效益的概率至少为 0.872。 结论对于术前无胆结石的患者，RYGB 后使用 UDCA 预防具有成本效益。