Department of Internal Medicine, Spaarne Gasthuis, Hoofddorp, the Netherlands.
Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, the Netherlands.
Br J Surg. 2022 Oct 14;109(11):1116-1123. doi: 10.1093/bjs/znac273.
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.
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).
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.
UDCA prophylaxis after RYGB in patients without gallstones before surgery was cost-effective.
本研究旨在评估熊去氧胆酸（UDCA）预防术前行胆囊结石且行 Roux-en-Y 胃旁路术（RYGB）患者术后症状性胆石病的成本效益和成本效用。
本研究使用了一项多中心、双盲、随机安慰剂对照优效性试验的数据。拟行腹腔镜 RYGB 或袖状胃切除术的患者被随机分为 UDCA 组（900mg，6 个月）或安慰剂组。根据临床报告，从卫生保健和社会角度评估了在手术前行胆囊结石且行 RYGB 的患者中，与安慰剂相比，预防性应用 UDCA 的经济性。评估了住院护理、院外护理、自付费用和生产力损失的数量和成本。主要结局为无症状胆石病患者的成本和每质量调整生命年（QALY）的成本。
与安慰剂组相比，UDCA 预防组更有可能无症状胆石病（相对风险 1.06，95%可信区间 1.02 至 1.11；P=0.002）。校正基线健康效用差异后，QALY 的增益为 0.047（95%偏倚校正和加速（Bca）可信区间 0.007 至 0.088；P=0.022）。从卫生保健角度看，UDCA 预防组的成本差异为-€356（95% Bca 可信区间 €-1573 至 761），从社会角度看，UDCA 预防组的成本差异为-€1392（-3807 至 917），均不具有统计学意义，UDCA 预防组更有利。UDCA 预防的成本效益概率至少为 0.872。
在手术前行胆囊结石且行 RYGB 的患者中，术后应用 UDCA 预防是具有成本效益的。
