Eliabe S Abreu, Pedro Henrique Reginato, Jorge Ferreira Jasmineiro Pitanga, Pedro Neves Borges, Pierre-Antoine Soret, Christophe Corpechot, Guilherme Grossi Lopes Cançado
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引用次数: 0
Abstract
Background: Around 40% of patients diagnosed with Primary Biliary Cholangitis (PBC) experience a suboptimal biochemical response to ursodeoxycholic acid (UDCA).
Aims: We aimed to compare fibrates and obeticholic acid (OCA) as add-on second-line therapy and evaluate whether these drugs hold superiority over each other.
Methods: We systematically searched Embase, MEDLINE, and Cochrane CENTRAL for studies comparing fibrates and OCA published by May 6, 2024. A pooled analysis was conducted to evaluate changes in liver biochemistry and response rates based on validated criteria. Data were expressed as mean difference (MD) for continuous outcomes and as Odds Ratio (OR) when binary.
Results: We included 883 patients from 4 studies, 468 (53.0%) under UDCA + OCA. Follow-up time ranged from 6 to 12 months. Patients treated with fibrates have similar mean bilirubin post-intervention values (MD 0.11 × upper limit of normal [ULN]; 95% CI - 0.26 to 0.49) compared to OCA. However, fibrates demonstrated superiority over OCA for percentual reduction in ALP compared to baseline (MD 20.13%; 95% CI 11.84-28.41), ALP post-intervention values (MD - 0.59 xULN; 95% CI - 1.02 to - 0.15), and rate of ALP normalization (OR 32.34; 95% CI 14.54-71.92). Patients treated with fibrates also more frequently met Barcelona (OR 4.28; 95% CI 2.26-8.11), POISE (OR 5.48; 95% CI 2.70-11.13), and Paris II (OR 5.88; 95% CI 3.96-8.74) response criteria.
Conclusion: In patients with PBC and an incomplete response to UDCA, fibrates seem to be associated with greater ALP reduction and achievement of response criteria compared to OCA.
背景：大约40%被诊断为原发性胆道胆管炎（PBC）的患者对熊脱氧胆酸（UDCA）的生化反应不理想。目的：我们的目的是比较贝特酸和奥贝胆酸（OCA）作为附加二线治疗，并评估这些药物是否具有优势。方法：我们系统地检索Embase、MEDLINE和Cochrane CENTRAL，检索截至2024年5月6日发表的比较贝特酸盐和OCA的研究。我们进行了一项汇总分析，以评估肝脏生化变化和基于验证标准的反应率。连续结果用平均差（MD）表示，二值结果用比值比（OR）表示。结果：我们纳入了来自4项研究的883例患者，其中468例（53.0%）采用UDCA + OCA。随访时间6 ~ 12个月。接受贝特类药物治疗的患者干预后平均胆红素值相似(MD = 0.11 ×正常值上限[ULN]；95% CI - 0.26 ~ 0.49)。然而，与基线相比，贝特酸盐在ALP降低百分比方面优于OCA (MD为20.13%；95% CI 11.84-28.41)，干预后ALP值(MD - 0.59 xULN；95% CI - 1.02 ~ - 0.15)， ALP正常化率(OR 32.34；95% ci 14.54-71.92)。接受贝特类药物治疗的患者也更频繁地遇到巴塞罗那(OR 4.28；95% ci 2.26-8.11)，泊值(或5.48；95% CI 2.70-11.13)和Paris II (OR 5.88；95% CI 3.96-8.74)反应标准。结论：在对UDCA不完全反应的PBC患者中，与OCA相比，贝特类药物似乎与更大的ALP降低和反应标准的实现相关。
期刊介绍：
Digestive Diseases and Sciences publishes high-quality, peer-reviewed, original papers addressing aspects of basic/translational and clinical research in gastroenterology, hepatology, and related fields. This well-illustrated journal features comprehensive coverage of basic pathophysiology, new technological advances, and clinical breakthroughs; insights from prominent academicians and practitioners concerning new scientific developments and practical medical issues; and discussions focusing on the latest changes in local and worldwide social, economic, and governmental policies that affect the delivery of care within the disciplines of gastroenterology and hepatology.
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