Zakaria Amr Y, Badawi Rehab, Osama Hasnaa, Abdelrahman Mona A, El-Kalaawy Asmaa M
Pharmacy Practice (Clinical Pharmacy) Department, Faculty of Pharmacy, Horus University-Egypt, New Damietta 34517, Egypt.
Tropical Medicine and Infectious Diseases Department, Faculty of Medicine, Tanta University, Tanta 31527, Egypt.
Pharmaceuticals (Basel). 2025 Apr 29;18(5):650. doi: 10.3390/ph18050650.
: Non-alcoholic steatohepatitis (NASH) is characterized by increased production of proinflammatory cytokines, fibrosis, and hepatocyte apoptosis. This study aimed to assess the efficacy of N-acetyl cysteine (NAC), rosuvastatin (RSV), and vitamin E (VE) in patients with NASH. : A double-blinded, parallel, randomized, controlled study was conducted and registered on clinicaltrials.gov (Identifier: NCT06105060), involving 135 NASH participants, who were divided into three groups: the control group (group 1), consisting of patients receiving standard therapy VE at a dosage of 400 IU twice daily. In the treated group (group 2), patients were administered NAC at a dosage of 1200 mg twice daily, while treatment (group 3) received RSV at a dosage of 20 mg once daily. FibroScan examination of liver tissue and fibrosis scores, along with tests for liver aminotransferases, lipid profile, glycemic parameters, and renal and hepatic functions, were assessed before and after six months of treatment. : The analyzed groups demonstrated a significant reduction in steatosis and lipid peroxidation ( < 0.05). The NAC group demonstrated greater anti-inflammatory and anti-apoptotic effects compared to the RSV group, although this difference was not significant in the control group. NAC is conceded as the only significant antifibrotic agent in liver stiffness measurement (LSM), biological marker findings, and non-invasive liver fibrosis scores ( < 0.05), in addition to its improvement of several metabolic parameters and health-related quality of life. : Patients receiving NAC demonstrated safety and efficacy in enhancing steatosis, fibrosis, and metabolic parameters, representing a novel strategy in the management of NASH.
非酒精性脂肪性肝炎(NASH)的特征是促炎细胞因子产生增加、纤维化和肝细胞凋亡。本研究旨在评估N-乙酰半胱氨酸(NAC)、瑞舒伐他汀(RSV)和维生素E(VE)对NASH患者的疗效。:进行了一项双盲、平行、随机对照研究,并在clinicaltrials.gov上注册(标识符:NCT06105060),纳入135名NASH参与者,他们被分为三组:对照组(第1组),由每天两次接受400 IU标准治疗VE的患者组成。在治疗组(第2组)中,患者每天两次服用1200 mg NAC,而治疗组(第3组)每天一次服用20 mg RSV。在治疗六个月前后评估肝组织的FibroScan检查和纤维化评分,以及肝转氨酶、血脂谱、血糖参数以及肾和肝功能测试。:分析的各组均显示脂肪变性和脂质过氧化显著降低(<0.05)。与RSV组相比,NAC组表现出更大的抗炎和抗凋亡作用,尽管在对照组中这种差异不显著。除了改善几个代谢参数和健康相关生活质量外,NAC在肝脏硬度测量(LSM)、生物标志物结果和非侵入性肝纤维化评分方面被认为是唯一显著的抗纤维化药物(<0.05)。:接受NAC治疗的患者在改善脂肪变性、纤维化和代谢参数方面显示出安全性和有效性,代表了NASH管理的一种新策略。