Wanying Liao, Siyang Fu, Aiming Yang, Yingyun Yang
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Randomized controlled trials published in English that involved the treatment of PPAR agonists and reported on the levels of alkaline phosphatase (ALP), biochemical response rates, pruritus score, or severe and serious adverse events (AEs) were selected. The primary outcomes assessed were the effects of PPAR agonists on ALP levels and biochemical response rates. Secondary outcomes included the rates of severe or serious AEs and relief of pruritus.</p><p><strong>Results: </strong>Fourteen studies with 1137 patients were included. Compared to the control group, PPAR agonists significantly reduced ALP levels by a mean difference of -155.87 U/L (95% confidence interval (CI): -208.30 to -103.44; random-effects). Patients who received PPAR agonists showed a significantly higher biochemical response rate (risk ratio (RR), 4.42; 95% CI: 2.37-8.26; random-effects). 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引用次数: 0
摘要
背景：管理对熊去氧胆酸反应不足或出现无法忍受的副作用的原发性胆道胆管炎（PBC）患者仍然是一个重大的临床挑战。目的：本研究旨在探讨过氧化物酶体增殖激活受体（PPAR）激动剂治疗PBC的有效性和安全性。设计：荟萃分析和系统评价。方法：系统检索PubMed、Embase、Web of Science和Cochrane Central Register of Controlled Trials中的出版物。选择英文发表的涉及PPAR激动剂治疗的随机对照试验，并报道碱性磷酸酶（ALP）水平、生化反应率、瘙痒评分或严重和严重不良事件（ae）。评估的主要结果是PPAR激动剂对ALP水平和生化反应率的影响。次要结局包括严重不良反应发生率和瘙痒缓解。结果：纳入14项研究，1137例患者。与对照组相比，PPAR激动剂显著降低ALP水平，平均差值为-155.87 U/L(95%置信区间（CI）： -208.30至-103.44；随机)。接受PPAR激动剂治疗的患者生化反应率显著高于对照组(风险比（RR）， 4.42；95% ci: 2.37-8.26；随机)。此外，PPAR激动剂组和安慰剂组的严重ae （RR, 1.05; 95% CI, 0.49-2.28）或严重ae （RR, 1.02; 95% CI, 0.65-1.60）发生率无显著差异。结论：PPAR激动剂治疗PBC有效、安全。普洛斯彼罗试验注册：CRD42024545743。
Efficacy and safety of PPAR agonists in primary biliary cholangitis: a systematic review and meta-analysis.
Background: Managing patients with primary biliary cholangitis (PBC) who demonstrate an inadequate response to ursodeoxycholic acid or experience intolerable side effects remains a significant clinical challenge.
Objectives: This study aims to investigate the efficacy and safety of peroxisome proliferator-activated receptor (PPAR) agonists in the treatment of PBC.
Design: Meta-analysis and systematic review.
Methods: A systematic search of publications in PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials was performed. Randomized controlled trials published in English that involved the treatment of PPAR agonists and reported on the levels of alkaline phosphatase (ALP), biochemical response rates, pruritus score, or severe and serious adverse events (AEs) were selected. The primary outcomes assessed were the effects of PPAR agonists on ALP levels and biochemical response rates. Secondary outcomes included the rates of severe or serious AEs and relief of pruritus.
Results: Fourteen studies with 1137 patients were included. Compared to the control group, PPAR agonists significantly reduced ALP levels by a mean difference of -155.87 U/L (95% confidence interval (CI): -208.30 to -103.44; random-effects). Patients who received PPAR agonists showed a significantly higher biochemical response rate (risk ratio (RR), 4.42; 95% CI: 2.37-8.26; random-effects). Furthermore, there was no significant difference in the rate of severe (RR, 1.05; 95% CI, 0.49-2.28) or serious AEs (RR, 1.02; 95% CI, 0.65-1.60) between the PPAR agonists and placebo groups.
Conclusion: PPAR agonists are effective and safe to treat patients with PBC.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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