Abuelazm Mohamed, Alsakarneh Saqr, Tanashat Mohammad, Manasrah AlMothana, Ibrahim Ahmed A, Parajuli Sandesh, Eltaly Hatem, Amin Ahmed Mazen
Faculty of Medicine Tanta University Tanta Egypt.
Gastroenterology and Hepatology Division Mayo Clinic Rochester Minnesota USA.
JGH Open. 2025 Aug 28;9(9):e70265. doi: 10.1002/jgh3.70265. eCollection 2025 Sep.
Seladelpar is an oral, once-daily medication that improves cholestasis through its selective peroxisome proliferator-activated receptor (PPAR-δ) agonism. It shows promising efficacy in treating primary biliary cholangitis (PBC) patients.
A systematic review and meta-analysis synthesizing evidence from randomized controlled trials (RCTs) obtained from PubMed, Cochrane, Scopus, and WOS until July 19th, 2025. Dichotomous outcomes were reported using risk ratio (RR) and continuous outcomes using mean difference (MD), with a 95% confidence interval (CI).
Three RCTs with 499 patients were included. Seladelpar was significantly associated with an increased ALP normalization (RR: 21.12 with 95% CI [4.14, 107.58], < 0.01), biochemical response (RR: 3.06 with 95% CI [2.00, 4.70], < 0.01), and decreased pruritus NRS score change (MD: -1.47 with 95% CI [-2.73, -0.21], = 0.02). Seladelpar was also significantly associated with a decreased incidence of pruritus (RR: 0.54 with 95% CI [0.31, 0.94], = 0.03) but with an increased incidence of headache (RR: 3.37 with 95% CI [1.11, 10.23], = 0.03). However, there was no significant difference between seladelpar and placebo regarding the incidence of any adverse events (RR: 0.96 with 95% CI [0.87, 1.06], = 0.43).
Seladelpar improved liver biomarkers of cholestasis and reduced pruritus in patients with PBC without significantly increasing the adverse effects. This makes seladelpar a promising addition to the treatments available for PBC. PROSPERO: CRD42024521208.
塞拉德尔帕是一种口服的每日一次药物，通过其选择性过氧化物酶体增殖物激活受体（PPAR-δ）激动作用改善胆汁淤积。它在治疗原发性胆汁性胆管炎（PBC）患者方面显示出有前景的疗效。
进行一项系统评价和荟萃分析，综合从PubMed、Cochrane、Scopus和WOS获取的截至2025年7月19日的随机对照试验（RCT）证据。二分结局采用风险比（RR）报告，连续结局采用均值差（MD）报告，并给出95%置信区间（CI）。
纳入了3项包含499例患者的RCT。塞拉德尔帕与碱性磷酸酶（ALP）正常化增加显著相关（RR：21.12，95%CI[4.14, 107.58]，P<0.01）、生化反应（RR：3.06，95%CI[2.00, 4.70]，P<0.01）以及瘙痒数字评分量表（NRS）评分变化降低（MD：-1.47，95%CI[-2.73, -0.21]，P = 0.02）。塞拉德尔帕还与瘙痒发生率降低显著相关（RR：0.54，95%CI[0.31, 0.94]，P = 0.03），但与头痛发生率增加相关（RR：3.37，95%CI[1.11, 10.23]，P = 0.03）。然而，在任何不良事件发生率方面，塞拉德尔帕与安慰剂之间无显著差异（RR：0.96，95%CI[0.87, 1.06]，P = 0.43）。
塞拉德尔帕改善了PBC患者胆汁淤积的肝脏生物标志物并减轻了瘙痒，且未显著增加不良反应。这使得塞拉德尔帕成为PBC现有治疗方法中有前景的补充药物。 国际前瞻性系统评价注册库（PROSPERO）：CRD42024521208。
