瑞舒伐他汀对无明显糖尿病的中重度代谢相关脂肪性肝病代谢综合征患者的影响：一项随机临床试验。

Impact of rosuvastatin on metabolic syndrome patients with moderate to severe metabolic associated fatty liver disease without overt diabetes: A randomized clinical trial.

作者信息

Wang Xuan, Lyu Lu, Li Wei, Xu Lingling, Zhang Huabing, Wang Shitian, Liu Yiwen, Ping Fan, Li Yuxiu

机构信息

Department of Radiology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.

Department of Allergy, Beijing Key Laboratory of Precision Medicine for Diagnosis and Treatment of Allergic Diseases, National Clinical Research Center for Dermatologic and Immunologic Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, 100730, China.

出版信息

Diabetes Metab Syndr. 2024 Sep;18(9):103126. doi: 10.1016/j.dsx.2024.103126. Epub 2024 Sep 21.

DOI:10.1016/j.dsx.2024.103126

PMID:39326342

Abstract

OBJECTIVE

This investigation aimed to evaluate the efficacy and safety of rosuvastatin in treating moderate to severe metabolic associated fatty liver disease (MAFLD).

METHODS

This prospective, open-label, randomized study included non-diabetic participants with metabolic syndrome and intrahepatocellular lipid (IHCL) levels >10 %, as determined by proton magnetic resonance spectroscopy (H-MRS). The primary objective was the effect of a 52-week rosuvastatin treatment (10 mg/day) on IHCL content. Secondary objectives included the association between IHCL reduction and lipid metabolism parameters, along with safety indices such as glycemic control and hepatic and renal function.

RESULTS

Thirty-two participants completed the study. Rosuvastatin resulted in a significant absolute (△IHCL: 7.61 ± 4.51 vs. 1.54 ± 5.33, p = 0.002) and relative reduction in IHCL (△IHCL%: -42.28 ± 24.90 % vs. -8.91 ± 31.93 %, p = 0.003) compared to the control. Reduction in IHCL correlated significantly with decreases in low-density lipoprotein cholesterol (LDL-C) (r = 0.574, p < 0.01), apolipoprotein B (ApoB) (r = 0.660, p < 0.001), and free fatty acids (FFA) (r = 0.563, p = 0.005). No significant safety differences were observed between groups.

CONCLUSIONS

Rosuvastatin significantly reduced hepatic steatosis in individuals with moderate to severe MAFLD and metabolic syndrome over 52 weeks, while maintaining a favorable safety profile.

摘要

目的

本研究旨在评估瑞舒伐他汀治疗中度至重度代谢相关脂肪性肝病（MAFLD）的疗效和安全性。

方法

这项前瞻性、开放标签、随机研究纳入了非糖尿病的代谢综合征参与者，其肝细胞内脂质（IHCL）水平通过质子磁共振波谱（H-MRS）测定>10%。主要目的是评估瑞舒伐他汀52周治疗（10毫克/天）对IHCL含量的影响。次要目的包括IHCL降低与脂质代谢参数之间的关联，以及血糖控制、肝肾功能等安全性指标。

结果

32名参与者完成了研究。与对照组相比，瑞舒伐他汀导致IHCL显著的绝对降低（△IHCL：7.61±4.51对1.54±5.33，p = 0.002）和相对降低（△IHCL%：-42.28±24.90%对-8.91±31.93%，p = 0.003）。IHCL的降低与低密度脂蛋白胆固醇（LDL-C）降低（r = 0.574，p < 0.01）、载脂蛋白B（ApoB）降低（r = 0.660，p < 0.001）和游离脂肪酸（FFA）降低（r = 0.563，p = 0.005）显著相关。两组之间未观察到显著的安全性差异。