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揭开瑞美替隆的面纱:关于其在非酒精性脂肪性肝炎治疗中对肝功能和安全性影响的系统评价与荟萃分析

Unveiling Resmetirom: A systematic review and meta-analysis on its impact on liver function and safety in non-alcoholic steatohepatitis treatment.

作者信息

Hashim Hashim Talib, Alhatemi Ahmed Qasim Mohammed, Riaz Sania, Al-Ghuraibawi Mohammedbaqer Ali, Alabide Arwa S, Saeed Humza, Sulaiman Fatimah Abdullah, Alhussain Mustafa Ali Abd, Shallan Maythum Ali, Al-Obaidi Ahmed Dheyaa, Saab Omar, Al-Obaidi Hasan, Hashim Ali Talib, Merza Nooraldin

机构信息

College of Medicine University of Warith Al-Anbiyaa Karbala Iraq.

Al-Nasiriyah Teaching Hospital Nasiriyah Iraq.

出版信息

JGH Open. 2024 Oct 1;8(10):e70025. doi: 10.1002/jgh3.70025. eCollection 2024 Oct.

Abstract

BACKGROUND AND AIM

The role of Resmetirom in non-alcoholic steatohepatitis (NASH) represents a promising therapeutic approach in addressing the growing global burden of liver disease. With NASH emerging as a leading cause of liver-related morbidity and mortality worldwide, there is an urgent need for effective treatments. Resmetirom, a selective thyroid hormone receptor-β agonist, offers potential benefits in improving liver histology and metabolic parameters in patients with NASH. This review examines the current evidence surrounding Resmetirom's role in NASH management.

METHODS

A systematic review and meta-analysis was done by searching in Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, MEDLINE (including MEDLINE InProcess) (OvidSP), Web of Science, Embase (OvidSP), and Scopus databases. ROB2 Cochrane tool was used for assessing risk of bias in randomized controlled trials (RCTs). In the analysis, we used RevMan Cochrane software.

RESULTS

The study showed that patients who were treated with Resmetirom had significantly lower low-density lipoprotein-cholesterol (LDL-C) levels (mean difference [MD] -10.45; 95% confidence interval [CI] -15.86 to -5.83;  < 0.001) and alanine aminotransferase (ALT) levels (MD -7.18; 95% CI -12.67 to -1.68;  = 0.01) as compared with those in the placebo group. The risk of adverse events including diarrhea [risk ratio (RR) 1.81; 95% CI 1.40 to 2.35;  < 0.001] and nausea (RR 1.72; 95% CI 1.31 to 2.27;  < 0.001) was significantly increased for the Resmetirom group as compared with the placebo group.

CONCLUSION

Resmetirom presents a promising therapeutic option for NASH, offering potential benefits in reducing liver fat content and improving histological outcomes. The encouraging results from clinical trials suggest that Resmetirom may address an unmet need in NASH management, providing hope for patients with this progressive liver disease. Further research and long-term studies are warranted to validate its efficacy and safety profile in larger patient populations.

摘要

背景与目的

Resmetirom在非酒精性脂肪性肝炎(NASH)中的作用代表了一种有前景的治疗方法,可应对全球日益增长的肝脏疾病负担。随着NASH成为全球肝脏相关发病率和死亡率的主要原因,迫切需要有效的治疗方法。Resmetirom是一种选择性甲状腺激素受体-β激动剂,在改善NASH患者的肝脏组织学和代谢参数方面具有潜在益处。本综述探讨了围绕Resmetirom在NASH治疗中作用的现有证据。

方法

通过检索Cochrane对照试验中心注册库(CENTRAL)、PubMed、MEDLINE(包括MEDLINE InProcess)(OvidSP)、Web of Science、Embase(OvidSP)和Scopus数据库进行系统综述和荟萃分析。使用ROB2 Cochrane工具评估随机对照试验(RCT)中的偏倚风险。在分析中,我们使用RevMan Cochrane软件。

结果

研究表明,与安慰剂组相比,接受Resmetirom治疗的患者的低密度脂蛋白胆固醇(LDL-C)水平显著降低(平均差值[MD] -10.45;95%置信区间[CI] -15.86至-5.83;P < 0.001),丙氨酸转氨酶(ALT)水平也显著降低(MD -7.18;95% CI -12.67至-1.68;P = 0.01)。与安慰剂组相比,Resmetirom组包括腹泻[风险比(RR)1.81;95% CI 1.40至2.35;P < 0.001]和恶心(RR 1.72;95% CI 1.31至2.27;P < 0.001)在内的不良事件风险显著增加。

结论

Resmetirom为NASH提供了一种有前景的治疗选择,在降低肝脏脂肪含量和改善组织学结果方面具有潜在益处。临床试验的令人鼓舞的结果表明,Resmetirom可能满足NASH治疗中未满足的需求,为患有这种进行性肝脏疾病的患者带来希望。需要进一步的研究和长期研究来验证其在更大患者群体中的疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d937/11444049/dfac40e60177/JGH3-8-e70025-g009.jpg

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